BfArM - Federal Institute for Drugs and Medical Devices

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107 results

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Diclofenac: realisation of the EU Commission's implementing decision Date: 06. December 2013 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: diclofenac

Based on the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) and on the position of the Coordination Group (CMDh), the European Commission decided on 25 September 2013 to adapt …

Use of valproate (and related substances) during pregnancy: initiation of a European safety review Date: 15. October 2013 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valproate

At the request of Great Britain, the European Medicines Agency (EMA) has initiated a review procedure in accordance with Article 31 of Directive 2001/83/EC regarding valproate, valproic acid and related substances.

Diane® 35 and generic drugs: risk of thromboembolic events Date: 23. August 2013 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: cyproterone acetate/ethinylestradiol

In a notice dated 8 August 2013, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the European Commission's implementing decision on medicinal products containing the combination cyproterone acetate/ethinylestradiol.

Combined use of ACE-inhibitors, angiotensin II receptor antagonists or aliskiren: recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) within a European safety review Date: 14. June 2013 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ACE-inhibitors | angiotensin II receptor antagonists or aliskiren

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

Tredaptive®, Pelzont®, Trevaclyn® (niacin/laropiprant): start of a review procedure in accordance with Article 20 of Regulation (EC) No. 726/2004 Date: 02. January 2013 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: niacin | laropiprant

The European Medicines Agency (EMA) has initiated a review procedure regarding the lipid-lowering drugs Tredaptive®/Pelzont®/Trevaclyn® after the MAH of the medicinal products had published preliminary results of a large, long-term study.

Hormone Replacement Therapy (HRT): duration of gestagen addition in sequential HRT Date: 10. September 2010 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: gestagen

In a Notice (Bescheid) of 23 August 2010 relating to medicinal products for sequential HRT with gestagen addition on less than 12 days per treatment cycle, the BfArM ruled that the product information be supplemented. It is stated that there …

Valproic acid/valproate: interaction with carbapenem Date: 17. June 2010 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valproic acid

The product information texts on all valproic acid or products containing valproates should include warnings about clinically relevant interactions with carbapenems (decreased valproate plasma concentration) to come up to the latest findings. …