Discontinuation of disease-modifying anti-rheumatic drugs (DMARDs) in rheumatoid arthritis patients also using TNF inhibitors

Status Authorised, recruitment pending · 1 EU/EEA countries · 4 sites · Protocol 2025.36

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)

Status Authorised, recruitment pending

Participants planned 202

Countries 1

Sites 4

Rheumatoid arthritis

The primary objective is to investigate whether a strategy to attempt discontinuation of MTX or LEF (and restart when necessary) in RA patients treated with an optimal dose TNFi is non-inferior to a continuation of combination therapy strategy.

Key facts

Sponsor: Sint Maartenskliniek Stichting
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Decision date (initial): 2026-06-09
Transition trial: No
Low-intervention: Yes
Rare-disease indication: No
Vulnerable population: No
Funding sources: ZonMw

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Secondary objectives 12

Between-group difference in disease activity
Between-group difference at specific timepoint disease activity
Between-group difference in PROM
Between-group difference in radiographic progression
Between-group difference in physical functioning
Between-group difference in quality of life
Between-group difference in pharmacokinetic and immunogenicity parameters
Between-group difference in flares
Between-group difference in safety
Between-group difference in medication use
Between-group difference in cost-effectiveness
Predictors of successful csDMARD discontinuation

Conditions and MedDRA coding

Rheumatoid arthritis

Version	Level	Code	Term	System organ class
23.1	PT	10039073	Rheumatoid arthritis	100000004859

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

Age ≥ 18 years
Diagnosis of RA, according to the 2010 ACR/EULAR and/or 1987 RA classification criteria or clinical diagnosis by a rheumatologist
Stable disease activity for ≥ 6 months, defined as DAS28-CRP ≤ 2.9 or DAS28-CRP ≤ 3.5 combined with clinical judgment of LDA
Current combination therapy with MTX or LEF at a stable dose for at least 3 months and a TNFi at an optimal dose (optimal dose is defined as the authorized dose or lower and being maximally tapered, because of prior disease flare or patient preference)
Ability to comply with all study procedures, visits and follow-up assessments
Written informed consent provided prior to any study-related procedure

Exclusion criteria 7

A previous attempt within the last 12 months prior to screening to taper or discontinue MTX or LEF that required reintroduction or dose increase of the csDMARD due to a disease flare
Current MTX or LEF treatment for other indications than RA
Current treatment with prednisolone (equivalent) of > 5 mg per day
Current severe comorbidity or serious life-shortening condition that could interfere with adherence to the study protocol or completion of the 24-month follow-up period
Women that are pregnant, breast feeding or considering pregnancy during the study period (MTX and LEF are contraindicated in pregnancy and breastfeeding)
Inability to comply with the study procedures, visits, or follow-up assessments
Inability or unwillingness to provide informed consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

The primary endpoint is the between-group difference in mean time-weighted DAS28-CRP during 24 months of follow-up. A mean time-weighted DAS28-CRP is chosen to balance the limitations of assessing disease activity at a single timepoint with solely considering the occurrence of flare. The time-weighted DAS28-CRP consists of a weighted average of a patient’s DAS28-CRP scores, calculated using the trapezoid method and weighed by the time interval between measurements.

Secondary endpoints 22

Disease activity measured by DAS28-CRP at 3, 6, 12, 18 and 24 months
Proportion of patients in remission (DAS28-CRP ≤ 2.4) or LDA (DAS28-CRP ≤ 2.9) at 3, 6, 12, 18, and 24 months
Fatigue and pain, measured by the Numeric Pain Rating Scale 0-10 (NRS 0–10), at baseline, 3, 6, 12, 18 and 24 months and at flare visits
Disease impact, measured by Rheumatoid Arthritis Impact of Disease (RAID) questionnaire, at baseline, 3, 6, 12, 18 and 24 months and at flare visits
Disease impact, measured by Patient Acceptable Symptom State (PASS) at baseline, 3, 6, 12, 18 and 24 months and at flare visits
Disease impact, measured by Transition scale at baseline, 3, 6, 12, 18 and 24 months and at flare visits
Medication adherence, measured by Medical Adherence Rating Scale (MARS), at baseline, 3, 6, 12, 18 and 24 months and at flare visits
Change between baseline and 24 months in Simple Erosion Narrowing Score (SENS) for radiographic joint damage
Health Assessment Questionnaire-Disability Index (HAQ-DI) at baseline, 3, 6, 12, 18 and 24 months and at flare visits
Euro Quality of Life 5-Dimensions 5-Levels (EQ-5D-5L) questionnaire at baseline, 3, 6, 12, 18 and 24 months and at flare visits
TNFi and ADA serum levels at baseline, 3 (csDMARD discontinuation group only), and 24 months
Proportion of patients relapsing/restarting combination therapy over 24 months
Flare (DAS28-CRP increase from baseline of >1.2, or >0.6 if current DAS28-CRP >2.9) incidence calculated by cumulative incidence and incidence density (events per person-years) over 24 months
Time-to-event analysis of first flare over 24 months
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) using the Common Terminology Criteria for Adverse Events version 5 (CTCAEv5) over 24 months
Proportion of patients in the csDMARD discontinuation group using a csDMARD and/or TNFi at 24 months
Proportion of patients who have discontinued the baseline TNFi at month 24, including those who discontinue or switch to another b/tsDMARD at the 24-month visit
Dosing and route of administration of csDMARD and/or TNFi at 24 months
MTX and LEF usage characteristics, including route of administration, use and dosage of folic acid, and other RA-related comedication over 24 months
Medical costs measured using the institute for Medical Technology Assessment Medical Consumption Questionnaire (iMTA MCQ) at baseline, 3, 6, 12, 18 and 24 months
Productivity losses and participation measured using the institute for Medical Technology Assessment Productivity Cost Questionnaire (iMTA PCQ) and Work Productivity and Activity Impairment questionnaire (WPAI) at baseline, 3, 6, 12, 18 and 24 months
Prediction modelling using baseline pharmacological factors (TNFi levels and ADA levels) and drug and ADA levels after discontinuation of csDMARDs (3 months)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 107

Cimzia 200 mg solution for injection in pre-filled syringe

PRD2148621 · Product

Active substance: Certolizumab Pegol
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 200 mg milligram(s)
Max total dose: 10400 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB05 — -
Marketing authorisation: EU/1/09/544/004
MA holder: UCB PHARMA S.A.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cimzia 200 mg solution for injection in pre-filled pen

PRD4398501 · Product

Active substance: Certolizumab Pegol
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 200 mg milligram(s)
Max total dose: 10400 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB05 — -
Marketing authorisation: EU/1/09/544/005
MA holder: UCB PHARMA S.A.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Methotrexate

SUB08856MIG · Substance

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Methotrexate

SUB08856MIG · Substance

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Injexate 12,5 mg = 0,25 ml oplossing voor injectie in voorgevulde spuit

PRD11988791 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 117709
MA holder: ACCORD HEALTHCARE B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Injexate 22,5 mg = 0,45 ml oplossing voor injectie in voorgevulde spuit

PRD11988812 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 117714
MA holder: ACCORD HEALTHCARE B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Basitrin 22,5 mg=0,600 ml, oplossing voor injectie in een voorgevulde spuit 37,5 mg/ml

PRD6740618 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 121258
MA holder: BASIC PHARMA MANUFACTURING BV
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Methotrexate

SUB08856MIG · Substance

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Injexate 15 mg = 0,30 ml oplossing voor injectie in voorgevulde spuit

PRD11988796 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 117713
MA holder: ACCORD HEALTHCARE B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Injexate 20 mg = 0,40 ml oplossing voor injectie in voorgevulde spuit

PRD11988806 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 117710
MA holder: ACCORD HEALTHCARE B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Methotrexate

SUB08856MIG · Substance

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Methotrexate

SUB08856MIG · Substance

Active substance: Methotrexate
Pharmaceutical form: TABLETS
Route of administration: ORAL
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ebetrex 12,5 mg = 0,625 ml, oplossing voor injectie in voorgevulde injectiespuit 20 mg/ml

PRD2170107 · Product

Active substance: Methotrexate Disodium
Substance synonyms: METHOTREXATE DISODIUM SALT
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 116647
MA holder: SANDOZ B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Basitrin 7,5 mg=0,200 ml, oplossing voor injectie in een voorgevulde spuit 37,5 mg/ml

PRD6740612 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 121252
MA holder: BASIC PHARMA MANUFACTURING BV
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Injexate 7,5 mg = 0,15 ml oplossing voor injectie in voorgevulde injector

PRD10920248 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 128918
MA holder: ACCORD HEALTHCARE B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Injexate 10 mg = 0,20 ml oplossing voor injectie in voorgevulde spuit

PRD11988786 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 117708
MA holder: ACCORD HEALTHCARE B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ebetrex 20 mg = 1 ml, oplossing voor injectie in voorgevulde injectiespuit 20 mg/ml

PRD2170109 · Product

Active substance: Methotrexate Disodium
Substance synonyms: METHOTREXATE DISODIUM SALT
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 116650
MA holder: SANDOZ B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Injexate 17,5 mg = 0,35 ml oplossing voor injectie in voorgevulde injector

PRD10920254 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 128922
MA holder: ACCORD HEALTHCARE B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ebetrex 7,5 mg = 0,375 ml, oplossing voor injectie in voorgevulde injectiespuit 20 mg/ml

PRD12022331 · Product

Active substance: Methotrexate Disodium
Substance synonyms: METHOTREXATE DISODIUM SALT
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 116645
MA holder: SANDOZ B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Injexate 22,5 mg = 0,45 ml oplossing voor injectie in voorgevulde injector

PRD10920252 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 128924
MA holder: ACCORD HEALTHCARE B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Injexate 25 mg = 0,50 ml oplossing voor injectie in voorgevulde spuit

PRD11988816 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 117711
MA holder: ACCORD HEALTHCARE B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Methotrexate

SUB08856MIG · Substance

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Basitrin 25 mg=0,667 ml, oplossing voor injectie in een voorgevulde spuit 37,5 mg/ml

PRD6740619 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 121259
MA holder: BASIC PHARMA MANUFACTURING BV
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metoject 15 mg=0,3 ml oplossing voor injectie, voorgevulde injectiespuit 50 mg/ml

PRD11912336 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 117111
MA holder: MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Injexate 15 mg = 0,30 ml oplossing voor injectie in voorgevulde injector

PRD10920255 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 128921
MA holder: ACCORD HEALTHCARE B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Injexate 25 mg = 0,50 ml oplossing voor injectie in voorgevulde injector

PRD10920251 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 128925
MA holder: ACCORD HEALTHCARE B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metoject PEN 15 mg=0,3 ml oplossing voor injectie in een voorgevulde pen

PRD11826395 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 111965
MA holder: MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Injexate 10 mg = 0,20 ml oplossing voor injectie in voorgevulde injector

PRD10920257 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 128919
MA holder: ACCORD HEALTHCARE B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Basitrin 15 mg=0,400 ml, oplossing voor injectie in een voorgevulde spuit 37,5 mg/ml

PRD6740615 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 121255
MA holder: BASIC PHARMA MANUFACTURING BV
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ebetrex 25 mg = 1,25 ml, oplossing voor injectie in voorgevulde injectiespuit 20 mg/ml

PRD2170111 · Product

Active substance: Methotrexate Disodium
Substance synonyms: METHOTREXATE DISODIUM SALT
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 116652
MA holder: SANDOZ B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Injexate 20 mg = 0,40 ml oplossing voor injectie in voorgevulde injector

PRD10920253 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 128923
MA holder: ACCORD HEALTHCARE B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metoject 17,5 mg=0,35 ml oplossing voor injectie, voorgevulde injectiespuit 50 mg/ml

PRD11912779 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 117112
MA holder: MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metoject PEN 17,5 mg=0,35 ml oplossing voor injectie in een voorgevulde pen

PRD11817674 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 111966
MA holder: MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metoject PEN 20 mg=0,4 ml oplossing voor injectie in een voorgevulde pen

PRD11800491 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 111967
MA holder: MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metoject 10 mg=0,2 ml oplossing voor injectie, voorgevulde injectiespuit 50 mg/ml

PRD11912098 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 117109
MA holder: MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metoject 20 mg=0,4 ml oplossing voor injectie, voorgevulde injectiespuit 50 mg/ml

PRD11912845 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 117113
MA holder: MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metoject PEN 7,5 mg=0,15 ml oplossing voor injectie in een voorgevulde pen

PRD11839370 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 111962
MA holder: MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metoject PEN 22,5 mg=0,45 ml oplossing voor injectie in een voorgevulde pen

PRD11781843 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 111968
MA holder: MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metoject PEN 12,5 mg=0,25 ml oplossing voor injectie in een voorgevulde pen

PRD11838324 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 111964
MA holder: MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metoject 25 mg=0,5 ml oplossing voor injectie, voorgevulde injectiespuit 50 mg/ml

PRD11913181 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 117115
MA holder: MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metoject 7,5 mg=0,15 ml oplossing voor injectie, voorgevulde injectiespuit 50 mg/ml

PRD11910648 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 117108
MA holder: MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metoject PEN 10 mg=0,2 ml oplossing voor injectie in een voorgevulde pen

PRD11895060 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 111963
MA holder: MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metoject 22,5 mg=0,45 ml oplossing voor injectie, voorgevulde injectiespuit 50 mg/ml

PRD11912965 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 117114
MA holder: MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metoject PEN 25 mg=0,5 ml oplossing voor injectie in een voorgevulde pen

PRD11772501 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 111969
MA holder: MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metoject 12,5 mg=0,25 ml oplossing voor injectie, voorgevulde injectiespuit 50 mg/ml

PRD11912144 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 117110
MA holder: MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Methotrexate

SUB08856MIG · Substance

Active substance: Methotrexate
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Methotrexate

SUB08856MIG · Substance

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Basitrin 17,5 mg=0,467 ml, oplossing voor injectie in een voorgevulde spuit 37,5 mg/ml

PRD6740616 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 121256
MA holder: BASIC PHARMA MANUFACTURING BV
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Basitrin 12,5 mg=0,333 ml, oplossing voor injectie in een voorgevulde spuit 37,5 mg/ml

PRD6740614 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 121254
MA holder: BASIC PHARMA MANUFACTURING BV
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Injexate 17,5 mg = 0,35 ml oplossing voor injectie in voorgevulde spuit

PRD11988801 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 118144
MA holder: ACCORD HEALTHCARE B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Methotrexate

SUB08856MIG · Substance

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Methotrexate

SUB08856MIG · Substance

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Basitrin 10 mg=0,267 ml, oplossing voor injectie in een voorgevulde spuit 37,5 mg/ml

PRD6740613 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 121253
MA holder: BASIC PHARMA MANUFACTURING BV
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Basitrin 20 mg=0,533 ml, oplossing voor injectie in een voorgevulde spuit 37,5 mg/ml

PRD6740617 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 121257
MA holder: BASIC PHARMA MANUFACTURING BV
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Injexate 12,5 mg = 0,25 ml oplossing voor injectie in voorgevulde injector

PRD10920256 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 128920
MA holder: ACCORD HEALTHCARE B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Emthexate PF, oplossing voor injectie 25 mg/ml.

PRD11942790 · Product

Active substance: Methotrexate
Pharmaceutical form: INJECTION
Route of administration: INTRAVENOUS ADMINISTRATION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L01BA01 — METHOTREXATE
Marketing authorisation: RVG 08435
MA holder: TEVA B.V
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ebetrex 10 mg = 0,5 ml, oplossing voor injectie in voorgevulde injectiespuit 20 mg/ml

PRD2170106 · Product

Active substance: Methotrexate Disodium
Substance synonyms: METHOTREXATE DISODIUM SALT
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 116646
MA holder: SANDOZ B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Injexate 7,5 mg = 0,15 ml oplossing voor injectie in voorgevulde spuit

PRD11988781 · Product

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 2600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AX03 — -
Marketing authorisation: RVG 115411
MA holder: ACCORD HEALTHCARE B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Humira 80 mg solution for injection in pre-filled pen

PRD11996257 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 80 mg milligram(s)
Max total dose: 4160 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: PLGB 41042/0026
MA holder: ABBVIE LTD (UK)
MA country: XI
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Humira 80 mg solution for injection in pre-filled syringe

PRD11968220 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 80 mg milligram(s)
Max total dose: 4160 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: PLGB 41042/0096
MA holder: ABBVIE LTD (UK)
MA country: XI
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Idacio 40 mg solution for injection in pre-filled pen

PRD7188942 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 40 mg milligram(s)
Max total dose: 4160 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/19/1356/003
MA holder: FRESENIUS KABI DEUTSCHLAND GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hukyndra 40 mg solution for injection in pre-filled pen

PRD9342478 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 40 mg milligram(s)
Max total dose: 4160 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/21/1589/005
MA holder: STADA ARZNEIMITTEL AG
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hukyndra 80 mg solution for injection in pre-filled syringe

PRD9341002 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE.
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 80 mg milligram(s)
Max total dose: 4160 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/21/1589/007
MA holder: STADA ARZNEIMITTEL AG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Yuflyma 40 mg solution for injection in pre-filled syringe

PRD8752248 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 40 mg milligram(s)
Max total dose: 4160 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/20/1513/001
MA holder: CELLTRION HEALTHCARE HUNGARY KFT
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Yuflyma 40 mg solution for injection in pre-filled pen

PRD8752250 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 40 mg milligram(s)
Max total dose: 4160 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/20/1513/009
MA holder: CELLTRION HEALTHCARE HUNGARY KFT
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Yuflyma 80 mg solution for injection in pre-filled pen

PRD9509893 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 80 mg milligram(s)
Max total dose: 4160 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/20/1513/016
MA holder: CELLTRION HEALTHCARE HUNGARY KFT
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hyrimoz 40 mg solution for injection in pre-filled syringe

PRD10358548 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 40 mg milligram(s)
Max total dose: 4160 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/18/1286/012
MA holder: SANDOZ GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Idacio 40 mg solution for injection in pre-filled syringe

PRD7188938 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 40 mg milligram(s)
Max total dose: 4160 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/19/1356/002
MA holder: FRESENIUS KABI DEUTSCHLAND GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

AMGEVITA 40 mg solution for injection in pre-filled pen

PRD11345146 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 40 mg milligram(s)
Max total dose: 4160 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/16/1164/014
MA holder: AMGEN EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

AMGEVITA 80 mg solution for injection in pre-filled pen

PRD11562750 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 80 mg milligram(s)
Max total dose: 4160 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/16/1164/020
MA holder: AMGEN EUROPE B.V.
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

AMGEVITA 40 mg solution for injection in pre-filled syringe

PRD11345143 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 40 mg milligram(s)
Max total dose: 4160 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/16/1164/011
MA holder: AMGEN EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hukyndra 40 mg solution for injection in pre-filled syringe

PRD9340978 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE.
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 40 mg milligram(s)
Max total dose: 4160 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/21/1589/001
MA holder: STADA ARZNEIMITTEL AG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Humira 40 mg solution for injection in pre-filled syringe

PRD11968219 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 40 mg milligram(s)
Max total dose: 4160 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: PLGB 41042/0095
MA holder: ABBVIE LTD (UK)
MA country: XI
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Imraldi 40 mg solution for injection in pre-filled pen

PRD5895486 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 40 mg milligram(s)
Max total dose: 4160 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/17/1216/006
MA holder: SAMSUNG BIOEPIS NL B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Imraldi 40 mg solution for injection in pre-filled syringe

PRD5895408 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 40 mg milligram(s)
Max total dose: 4160 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/17/1216/002
MA holder: SAMSUNG BIOEPIS NL B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hyrimoz 40 mg solution for injection in pre-filled pen

PRD10358551 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 40 mg milligram(s)
Max total dose: 4160 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/18/1286/015
MA holder: SANDOZ GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hyrimoz 80 mg solution for injection in pre-filled pen

PRD10358655 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 80 mg milligram(s)
Max total dose: 4160 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: EU/1/18/1286/010
MA holder: SANDOZ GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Humira 40 mg solution for injection in pre-filled pen

PRD11968218 · Product

Active substance: Adalimumab
Substance synonyms: ABP 501, BI 695501, MSB11022
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 40 mg milligram(s)
Max total dose: 4160 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB04 — -
Marketing authorisation: PLGB 41042/0025
MA holder: ABBVIE LTD (UK)
MA country: XI
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Simponi 50 mg solution for injection in pre-filled syringe.

PRD3349057 · Product

Active substance: Golimumab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 100 mg milligram(s)
Max total dose: 2400 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB06 — -
Marketing authorisation: EU/1/09/546/004
MA holder: JANSSEN-CILAG INTERNATIONAL NV
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

GOBIVAZ 100 mg solution for injection in pre-filled pen.

PRD13172282 · Product

Active substance: Golimumab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 100 mg milligram(s)
Max total dose: 2400 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB06 — -
Marketing authorisation: EU/1/25/1988/005
MA holder: ADVANZ PHARMA LIMITED
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Simponi 50 mg solution for injection in pre-filled pen.

PRD3349060 · Product

Active substance: Golimumab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 100 mg milligram(s)
Max total dose: 2400 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB06 — -
Marketing authorisation: EU/1/09/546/002
MA holder: JANSSEN-CILAG INTERNATIONAL NV
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Simponi 100 mg solution for injection in pre-filled pen.

PRD3349054 · Product

Active substance: Golimumab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 100 mg milligram(s)
Max total dose: 2400 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB06 — -
Marketing authorisation: EU/1/09/546/006
MA holder: JANSSEN-CILAG INTERNATIONAL NV
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

GOBIVAZ 50 mg solution for injection in pre-filled pen.

PRD13173865 · Product

Active substance: Golimumab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 100 mg milligram(s)
Max total dose: 2400 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB06 — -
Marketing authorisation: EU/1/25/1988/001
MA holder: ADVANZ PHARMA LIMITED
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

GOBIVAZ 50 mg solution for injection in pre-filled syringe.

PRD13173890 · Product

Active substance: Golimumab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 100 mg milligram(s)
Max total dose: 2400 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB06 — -
Marketing authorisation: EU/1/25/1988/003
MA holder: ADVANZ PHARMA LIMITED
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Zessly 100 mg powder for concentrate for solution for infusion

PRD6241585 · Product

Active substance: Infliximab
Substance synonyms: ABP 710, CT-P13, NI-071, PF-06438179, R-TPR-015
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS ADMINISTRATION
Max daily dose: 7.5 mg/kg milligram(s)/kilogram
Max total dose: 97.5 mg/kg milligram(s)/kilogram
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB02 — -
Marketing authorisation: EU/1/18/1280/001
MA holder: SANDOZ GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Remsima 100 mg powder for concentrate for solution for infusion

PRD2620214 · Product

Active substance: Infliximab
Substance synonyms: ABP 710, CT-P13, NI-071, PF-06438179, R-TPR-015
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS ADMINISTRATION
Max daily dose: 7.5 mg/kg milligram(s)/kilogram
Max total dose: 97.5 mg/kg milligram(s)/kilogram
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB02 — -
Marketing authorisation: EU/1/13/853/002
MA holder: CELLTRION HEALTHCARE HUNGARY KFT
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Remsima 40 mg/mL concentrate for solution for infusion

PRD13158102 · Product

Active substance: Infliximab
Substance synonyms: ABP 710, CT-P13, NI-071, PF-06438179, R-TPR-015
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS ADMINISTRATION
Max daily dose: 7.5 mg/kg milligram(s)/kilogram
Max total dose: 97.5 mg/kg milligram(s)/kilogram
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB02 — -
Marketing authorisation: EU/1/13/853/018
MA holder: CELLTRION HEALTHCARE HUNGARY KFT
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Remsima 120 mg solution for injection in pre-filled pen

PRD7752781 · Product

Active substance: Infliximab
Substance synonyms: ABP 710, CT-P13, NI-071, PF-06438179, R-TPR-015
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 120 mg milligram(s)
Max total dose: 6240 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB02 — -
Marketing authorisation: EU/1/13/853/012
MA holder: CELLTRION HEALTHCARE HUNGARY KFT
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Remsima 120 mg solution for injection in pre-filled syringe

PRD7753572 · Product

Active substance: Infliximab
Substance synonyms: ABP 710, CT-P13, NI-071, PF-06438179, R-TPR-015
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 120 mg milligram(s)
Max total dose: 6240 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB02 — -
Marketing authorisation: EU/1/13/853/006
MA holder: CELLTRION HEALTHCARE HUNGARY KFT
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Remicade 100 mg powder for concentrate for solution for infusion.

PRD3349048 · Product

Active substance: Infliximab
Substance synonyms: ABP 710, CT-P13, NI-071, PF-06438179, R-TPR-015
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS ADMINISTRATION
Max daily dose: 7.5 mg/kg milligram(s)/kilogram
Max total dose: 97.5 mg/kg milligram(s)/kilogram
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB02 — -
Marketing authorisation: EU/1/99/116/003
MA holder: JANSSEN-CILAG INTERNATIONAL NV
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Inflectra 100 mg powder for concentrate for solution for infusion

PRD6483369 · Product

Active substance: Infliximab
Substance synonyms: ABP 710, CT-P13, NI-071, PF-06438179, R-TPR-015
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS ADMINISTRATION
Max daily dose: 7.5 mg/kg milligram(s)/kilogram
Max total dose: 97.5 mg/kg milligram(s)/kilogram
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB02 — -
Marketing authorisation: EU/1/13/854/001
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Flixabi 100 mg powder for concentrate for solution for infusion

PRD4101383 · Product

Active substance: Infliximab
Substance synonyms: ABP 710, CT-P13, NI-071, PF-06438179, R-TPR-015
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS ADMINISTRATION
Max daily dose: 7.5 mg/kg milligram(s)/kilogram
Max total dose: 97.5 mg/kg milligram(s)/kilogram
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB02 — -
Marketing authorisation: EU/1/16/1106/001
MA holder: SAMSUNG BIOEPIS NL B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Arava 20 mg film-coated tablets

PRD612888 · Product

Active substance: Leflunomide
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 20 mg milligram(s)
Max total dose: 14600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AK01 — -
Marketing authorisation: EU/1/99/118/007
MA holder: SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Leflunomide

SUB08424MIG · Substance

Active substance: Leflunomide
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 20 mg milligram(s)
Max total dose: 14600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Leflunomide

SUB08424MIG · Substance

Active substance: Leflunomide
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 20 mg milligram(s)
Max total dose: 14600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Arava 10 mg film-coated tablets

PRD479053 · Product

Active substance: Leflunomide
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 20 mg milligram(s)
Max total dose: 14600 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AK01 — -
Marketing authorisation: EU/1/99/118/004
MA holder: SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Benepali 50 mg solution for injection in pre-filled syringe

PRD3616090 · Product

Active substance: Etanercept
Substance synonyms: CHS-0214, ETANERCEPT (GENETICAL RECOMBINATION)
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 50 mg milligram(s)
Max total dose: 5200 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB01 — -
Marketing authorisation: EU/1/15/1074/001
MA holder: SAMSUNG BIOEPIS NL B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Benepali 50 mg solution for injection in pre-filled pen

PRD3616091 · Product

Active substance: Etanercept
Substance synonyms: CHS-0214, ETANERCEPT (GENETICAL RECOMBINATION)
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 50 mg milligram(s)
Max total dose: 5200 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB01 — -
Marketing authorisation: EU/1/15/1074/002
MA holder: SAMSUNG BIOEPIS NL B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Enbrel 50 mg solution for injection in pre-filled syringe

PRD6538802 · Product

Active substance: Etanercept
Substance synonyms: CHS-0214, ETANERCEPT (GENETICAL RECOMBINATION)
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 50 mg milligram(s)
Max total dose: 5200 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB01 — -
Marketing authorisation: EU/1/99/126/017
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Enbrel 25 mg solution for injection in pre-filled syringe

PRD6538806 · Product

Active substance: Etanercept
Substance synonyms: CHS-0214, ETANERCEPT (GENETICAL RECOMBINATION)
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 5200 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB01 — -
Marketing authorisation: EU/1/99/126/013
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Enbrel 50 mg solution for injection in pre-filled pen

PRD6538805 · Product

Active substance: Etanercept
Substance synonyms: CHS-0214, ETANERCEPT (GENETICAL RECOMBINATION)
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 50 mg milligram(s)
Max total dose: 5200 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB01 — -
Marketing authorisation: EU/1/99/126/019
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Enbrel 25 mg powder and solvent for solution for injection

PRD6538758 · Product

Active substance: Etanercept
Substance synonyms: CHS-0214, ETANERCEPT (GENETICAL RECOMBINATION)
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 5200 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB01 — -
Marketing authorisation: EU/1/99/126/005
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Enbrel 25 mg solution for injection in pre-filled pen

PRD6538804 · Product

Active substance: Etanercept
Substance synonyms: CHS-0214, ETANERCEPT (GENETICAL RECOMBINATION)
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 5200 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB01 — -
Marketing authorisation: EU/1/99/126/025
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Erelzi 25 mg solution for injection in pre-filled syringe.

PRD6806062 · Product

Active substance: Etanercept
Substance synonyms: CHS-0214, ETANERCEPT (GENETICAL RECOMBINATION)
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 5200 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB01 — -
Marketing authorisation: EU/1/17/1195/001
MA holder: SANDOZ GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Erelzi 50 mg solution for injection in pre-filled pen

PRD6806121 · Product

Active substance: Etanercept
Substance synonyms: CHS-0214, ETANERCEPT (GENETICAL RECOMBINATION)
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 50 mg milligram(s)
Max total dose: 5200 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB01 — -
Marketing authorisation: EU/1/17/1195/010
MA holder: SANDOZ GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Benepali 25 mg solution for injection in pre-filled syringe

PRD5343653 · Product

Active substance: Etanercept
Substance synonyms: CHS-0214, ETANERCEPT (GENETICAL RECOMBINATION)
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 25 mg milligram(s)
Max total dose: 5200 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB01 — -
Marketing authorisation: EU/1/15/1074/007
MA holder: SAMSUNG BIOEPIS NL B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Erelzi 50 mg solution for injection in pre-filled syringe.

PRD6060680 · Product

Active substance: Etanercept
Substance synonyms: CHS-0214, ETANERCEPT (GENETICAL RECOMBINATION)
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 50 mg milligram(s)
Max total dose: 5200 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L04AB01 — -
Marketing authorisation: EU/1/17/1195/005
MA holder: SANDOZ GMBH
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sint Maartenskliniek Stichting

Sponsor organisation: Sint Maartenskliniek Stichting
Address: Hengstdal 3
City: Ubbergen
Postcode: 6574 NA
Country: Netherlands

Scientific contact point

Organisation: Sint Maartenskliniek Stichting
Contact name: Researcher

Public contact point

Organisation: Sint Maartenskliniek Stichting
Contact name: Researcher

Locations

1 EU/EEA country · 4 investigational sites

By country

Country	MS status	Planned subjects	Sites
Netherlands	Authorised, recruitment pending	202	4
Rest of world	—	0	—

Investigational sites

Netherlands

4 sites · Authorised, recruitment pending

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Rheumatology, Dr. Molewaterplein 60, 3015 GJ, Rotterdam

Elisabeth-TweeSteden Ziekenhuis

Rheumatology, Hilvarenbeekse Weg 60, Netherlands, Tilburg

Reade revalidatie & reumatologie centrum te Amsterdam

Rheumatology, Admiraal Helfrichstraat 1, 1056 AA, Amsterdam

Sint Maartenskliniek Stichting

Rheumatology, Hengstdal 3, 6574 NA, Ubbergen

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 42 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Protocol 2026-525316-33-00	2
Protocol (for publication)	D1_Protocol 2026-525316-33-00 track changes	2
Protocol (for publication)	D4_EN-EN_Patient facing documents questionnaire RA-FQ	1
Protocol (for publication)	D4_NL-NL_Patient facing documents questionnaire EQ-5D-5L	1
Protocol (for publication)	D4_NL-NL_Patient facing documents questionnaire HAQ-DI	1
Protocol (for publication)	D4_NL-NL_Patient facing documents questionnaire iMTA-MCQ	1
Protocol (for publication)	D4_NL-NL_Patient facing documents questionnaire iMTA-PCQ	1
Protocol (for publication)	D4_NL-NL_Patient facing documents questionnaire MARS5	1
Protocol (for publication)	D4_NL-NL_Patient facing documents questionnaire NRS pain and fatigue	1
Protocol (for publication)	D4_NL-NL_Patient facing documents questionnaire PASS and transition	1
Protocol (for publication)	D4_NL-NL_Patient facing documents questionnaire RAID	1
Recruitment arrangements (for publication)	K1_Recruitment procedure	1
Subject information and informed consent form (for publication)	L1_NL-NL_SIS and ICF_2026-525316-33-00	3
Subject information and informed consent form (for publication)	L1_NL-NL_SIS and ICF_2026-525316-33-00 version 3 19-05-2026 track changes	3
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Adalimumab Amgevita	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Adalimumab Hukyndra	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Adalimumab Humira	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Adalimumab Hyrimoz	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Adalimumab Idacio	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Adalimumab Imraldi	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Adalimumab Yuflyma	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Certolizumab Cimzia	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Etanercept Benepali	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Etanercept Enbrel	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Etanercept Erelzi	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Golimumab Gobivaz	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Golimumab Simponi	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Infliximab Flixabi	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Infliximab Inflectra	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Infliximab Remicade	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Infliximab Remsima	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Infliximab Zessly	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Leflunomide Arava	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Methorexate Metoject	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Methotexate Injexate	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Methotrexaat Nordic	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Methotrexaat Sandoz	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Methotrexate Basitrin	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Methotrexate Ebetrex	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Methotrexate Emthexate	1
Synopsis of the protocol (for publication)	D1_ NL-NL_Protocol synopsis 2026-525316-33-00	1
Synopsis of the protocol (for publication)	D1_EN-EN_Protocol synopsis 2026-525316-33-00	1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2026-03-17	Netherlands	Acceptable 2026-06-09	2026-06-09

Discontinuation of disease-modifying anti-rheumatic drugs (DMARDs) in rheumatoid arthritis patients also using TNF inhibitors

Overview

Key facts

Trial design

Main objective

Secondary objectives 12

Conditions and MedDRA coding

Eligibility criteria

Inclusion criteria 6

Exclusion criteria 7

Endpoints

Primary endpoints 1

Secondary endpoints 22

Investigational products

Test 107

Sponsors and contacts

Sint Maartenskliniek Stichting

Scientific contact point

Public contact point

Locations

By country

Investigational sites

Results and documents

Documents 42 files

Application history

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