BfArM - Federal Institute for Drugs and Medical Devices

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Methotrexate: dosing errors

Active substance: methotrexate

25.11.2019 - Notice within the graduated plan procedure ("Stufenplanverfahren")

The Federal Institute for Drugs and Medical Devices (BfArM) is implementing the corresponding implementing decision of the European Commission C(2019) 7680 final of 21 October 2019 by decision of 20 November 2019.

23.08.2019 - CHMP opinion

New measures to avoid potentially fatal dosage errors with methotrexate in inflammatory diseases

EMA has recommended new measures to prevent serious and potentially fatal dosing errors in methotrexate for the treatment of inflammatory diseases such as rheumatoid arthritis, psoriasis and Crohn's disease.

12.07.2019 - PRAC recommendation

PRAC recommends new measures to avoid dosing errors with methotrexate

13.04.2019 - Procedure started

The Federal Institute for Drugs and Medical Devices (BfArM) issues information on the initiation of a safety review by the European Medicines Agency (EMA) to review the risk of dosing errors with methotrexate.

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):

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