21.03.2025 – Note on linguistic correction

We would like to point out that the German translation of Annex III of the Commission Implementing Decision should be corrected to the effect that the missing word ‘unter’ should be added in section 4.4 of the Summary of Product Characteristics (SPC). It should therefore read correctly: ‘Ebenso können die Symptome bei Patienten unter Antibiotikatherapie verschleiert werden".

The Federal Institute for Drugs and Medical Devices (BfArM) thus recommends implementing this correction with the next variation (as a type IA).

05.12.2024 - notice within the graduated plan procedure (“Stufenplanverfahren”)

The Federal Institute for Drugs and Medical Devices (BfArM) implements the implementing decision of the EU Commission of 22 November 2024, C(2024) 8439 (final), nationally by decision of 2 December 2024. The European risk assessment procedure for medicinal products containing metamizole in accordance with Article 107i of Directive 2001/83/EC is completed with the variation to the marketing authorisation.

When submitting the variation for adaptation to the referral, the SKNR 6536 listed in the notification and the keyword ‘medicinal products containing metamizole’ must be listed in the variation.

28.11.2024 - European Commission final decision

With the publication of the European Commission's decision, the risk assessment procedure according to Article 107i of Directive 2001/83/EC on medicinal products containing metamizole has been completed.

The Commission decision and its annexes can be found here:

20.09.2024 - CMDh position

CMDh recommends measures to minimise serious outcomes of known side effect with painkiller metamizole

On 18 September 2024, the CMDh endorsed the measures recommended by EMA’s safety committee, PRAC, to minimise the serious outcomes of agranulocytosis, a known side effect caused by the painkiller metamizole. Agranulocytosis involves a sudden and sharp decrease in granulocytes, a type of white blood cell, that can lead to serious or even fatal infections.

06.09.2024 - PRAC recommendation

Product information to be updated to raise awareness of known risk of agranulocytosis and facilitate its early detection and diagnosis

EMA’s safety committee, PRAC, has recommended measures to minimise the serious outcomes of agranulocytosis, a known side effect caused by the painkiller metamizole. Agranulocytosis involves a sudden and sharp decrease in granulocytes, a type of white blood cell, that can lead to serious or even fatal infections.

14.06.2024 – start of procedure

Review will look into risk of agranulocytosis, a sudden drop in white blood cells that can lead to serious infections, and measures to minimise it

EMA has started a review of medicines containing the painkiller metamizole following concerns that the measures in place to minimise the known risk of agranulocytosis may not be effective enough.

Further information

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