BfArM - Federal Institute for Drugs and Medical Devices

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Dear Doctor Letter (Rote-Hand-Brief) on Ketoconazole HRA®: Risk of hepatotoxicity PDF, 842KB, File is accessible Date: 11. March 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ketoconazole

The company HRA Pharma is circulating information on the hepatotoxicity risk of its ketokonazole-containing medicinal product for treatment of endogenous Cushing's syndrome as well as on the measures to be taken prior to and during treatment.

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Medicinal products containing ambroxol and bromhexine: recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) and the Co-ordination group (CMDh) within a European safety review concerning the risk of hypersensitivity reactions Date: 10. March 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ambroxol | bromhexine

The BfArM issues information on a recommendation by the PRAC and the resulting majority decision by the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) within a European safety review in accordance with …

Neulasta®: Possibility of counterfeits being on the market Date: 06. March 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: pegfilgrastim

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) has received information via the "Land" authority ("Landesbehörde") of Bavaria and via the EU's Rapid Alert System (RAS) that …

Cialis®: Counterfeit medicinal products from Italy - Update Date: 24. February 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: tadalafil

The BfArM is reporting further information from the company Lilly as the marketing authorisation holder of the originator product.

Information on theft of the medicinal product Sildaristo® produced by Aristo Pharma GmbH in Berlin Date: 12. February 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: sildenafil

The State Office of Health and Social Affairs in Berlin ("Landesamt für Gesundheit und Soziales", LaGeSo) has informed the BfArM of the theft of the medicinal product Sildaristo®.

Polymyxin-based products (colistin, colistimethate sodium): realisation of the EU Commission's implementing decision Date: 30. January 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: colistin | colistimethate sodium

Based on the review of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the European Commission decided on 16 December 2014 to update the product informations of medicinal products containing …

Medicinal products containing testosterone: review of possible cardiac risks Date: 22. January 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: testosterone

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has reviewed the risk of cardiovascular diseases, particularly heart attacks, under treatment with testosterone.

Medicinal products containing ponatinib (Iclusig®): risk of blood vessel blockage Date: 15. January 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Ponatinib

With the publication of the decision of the European Commission on 15 January 2015, the risk assessment procedure for Iclusig® was completed.

Medicinal products containing valproate and related substances: risk of anomalies in neonates Date: 13. January 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valproate

On 19 November 2014, the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) decided unanimously based on the recommendations of the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment …

Medicinal products containing Estradiol for topical administration: realisation of the EU Commission's implementing decision Date: 09. January 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: estradiol

In its notice of 9 January 2015, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission C(2014)6030 of 19 August 2014