BfArM - Federal Institute for Drugs and Medical Devices

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Pharmacovigilance

Monitoring safety. Averting danger.

The Pharmacovigilance Division continuously informs about adverse drug reactions and interactions related to the use of medicinal products which have become known and ensures that patients, medical doctors and other interested parties are made aware of existing risks as well as of possibilities to decrease them.

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News

Metamizole-containing medicinal products: risk of agranulocytosis - referral

Download_VeroeffentlichtAm_EN 2024.06.14

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.

Update of Direct Healthcare Professional Communication (DHPC) on Oncofolic 50 mg/ml solution for infusion/injection, strength 100 mg, 400 mg, 500 mg and 900 mg: Possible risk of visible particles in the solution, use of a filter

Download_VeroeffentlichtAm_EN 2024.05.27 Download_Angaben zum Download PDF, 296KB, File does not meet accessibility standards

The company medac GmbH informs that during the ongoing stability program visible particles have been found in the medicinal product Oncofolic 50 mg/ml solution for injection/infusion.

Direct Healthcare Professional Communication (DHPC) on Giapreza 2.5 mg/ml concentrate for preparation of infusion solution: potentially low fill vials and important information regarding instructions for use

Download_VeroeffentlichtAm_EN 2024.05.27 Download_Angaben zum Download PDF, 157KB, File does not meet accessibility standards

The company Paion Deutschland GmbH informs that in several hospitals in the USA vials of the medicinal product Giapreza have been detected that are not filled with the required volume.
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Risk information

All medicinal products are carefully monitored after having been placed on the EU market.

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Reporting risks

The sooner, more frequently, and in more detail the Federal Institute receives these reports (e.g. from physicians), the earlier warning signs can be detected and evaluated in order to take the necessary measures to protect the patients.

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Boards and committees

The BfArM is involved in the prevention of drug-associated risks, both nationally and internationally.

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PSURs

The obligations of Marketing Authorisation Holders (MAH) and pharmaceutical companies to submit regularly updated reports on the safety of medicinal products (Periodic Safety Update Report, called "PSUR" in the following) are laid down in Section 63d AMG and in Directive 2010/84/EU.

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Contact persons

Contact persons for Pharmacovigilance

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