BfArM - Federal Institute for Drugs and Medical Devices

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Use of valproate (and related substances) during pregnancy: recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) within a European safety review Date: 10. October 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valproate

The BfArM issues information on the PRAC's recommendation within a European safety review according to Article 31 of Directive 2001/83/EC.

Information Letter on Buccolam®: Recall due to a potential quality defect PDF, 793KB, File is accessible Date: 09. October 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: midazolam

The company ViroPharma GmbH issues information on the recall of the medicinal product Buccolam®. During a routine inspection at the manufacturing site, the potential risk of a cross-contamination with another medicinal product produced at the …

Information on medicinal products traded illegally in Romania on the German market Date: 15. September 2014 Topics: Pharmakovigilanz Type: Risk information

Active substance: rituximab, trastuzumab

The Romanian medicines licensing authority (ANMDM) has informed the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institut (PEI) via the European Rapid Alert System that batches of 45 medicinal products traded by …

Domperidone: realisation of the EU Commission's implementing decision Date: 11. September 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: domperidone

In its notice of 8 September 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission C(2014)5113. The European safety review according to …

Medicinal products containing zolpidem: risks to impairment of driving ability, attention and ability to react Date: 25. August 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: zolpidem

By decision of 22 August 2014, the Federal Institute for Drugs and Medical Devices (BfArM) implements the corresponding implementing decision of the EU Commission of 23 June 2014 on zolpidem-containing medicinal products. The Implementing …

Safety relevant information on Beta interferons: Risk of thrombotic microangiopathy and nephrotic syndrome PDF, 286KB, File is accessible Date: 20. August 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: interferon beta

In accord with the European Medicines Agency (EMA) and the marketing authorisation holders, the BfArM issues important safety information regarding the treatment of multiple sclerosis with medicinal products containing interferon beta.

Dear Doctor Letter (Rote-Hand-Brief) on domperidone: serious cardiac side effects PDF, 369KB, File is accessible Date: 20. August 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: domperidone

After conclusion of the European safety review of medicinal products containing domperidone, the marketing authorisation holders are circulating a joint Dear Doctor Letter with information on safety measures to minimise cardiac risks.

Methadone-containing drugs, with povidone (as pharmaceutical excipient): severe side effects due to misuse Date: 25. July 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Methadone

The BfArM issues information on the unanimous consensus of the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) to suspend the marketing authorisation of oral methadone solutions containing high molecular …

Amsidyl® (active substance amsacrine) 75 MG concentrate for solution for infusion
(PZN 07131886) – Information on the shortage of Amsidyl after detection of GMP deficiencies during manufacture
PDF, 454KB, File is accessible
Date: 21. July 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Amsacrine

The pharmaceutical entrepreneur has issued information on a lack of availability of Amsidyl® until presumably 2015 due to the GMP deficiencies determined at the manufacturing site.

Information Letter on Velcade 3.5 MG (PZN 00822831) – Further information regarding the precautionary recall of a batch of Velcade (DELSC01) PDF, 269KB, File is accessible Date: 16. July 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Bortezomib

As a follow-up to the already published precautionary recall of a batch of Velcade®, the pharmaceutical manufacturer has compiled further information.