BfArM - Federal Institute for Drugs and Medical Devices

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SGLT2 inhibitors: initiation of a European safety review to evaluate the risk of diabetic ketoacidosis Date: 16. June 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: canagliflozin | dapagliflozin | empagliflozin

The BfArM issues information on the initiation of a European safety review according to Article 20 of Regulation (EC) No. 726/2004 regarding SGLT2 inhibitors.

Hydroxyzine: effects on heart rhythm Date: 20. May 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: hydroxyzine

The Co-ordination group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has unanimously decided further measures to minimise the risk of arrhythmias.

Quinine for nocturnal leg cramps (Limptar® N): BfArM's notice regarding changes of the product informations within a national graduated plan procedure ("Stufenplanverfahren"), including a restriction of the indication, amongst others due to the risk of severe blood count changes (thrombocytopenias) Date: 02. April 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: quinine

The BfArM issues information on a national graduated plan procedure ("Stufenplanverfahren") regarding the active substance quinine for the indication nocturnal leg cramps.

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 …

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

Marketing authorisations based on studies conducted by GVK Biosciences in India: suspension of marketing authorisation Date: 09. December 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: various

In a notice dated 8 December 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the suspension of several marketing authorisations that were based on a clinical trial conducted by GVK Biosciences in India.