BfArM - Federal Institute for Drugs and Medical Devices

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Oral bromocriptine-containing medicines: indicated in the prevention or suppression of physiological lactation post-partum Date: 28. November 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: bromocriptine

In its notice of 27 November 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission of 30 October 2014 regarding medicinal products containing …

Medicinal products that affect the renin-angiotensin(-aldosterone) system (RAS/RAAS): realisation of the EU Commission's implementing decision Date: 13. November 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ACE-Hemmer | Angiotensin-II-Rezeptor-Antagonisten | Aliskiren

In its notice of 31 October 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision (2014) 6371 of the EU Commission.

Levonorgestrel- and ulipristal acetate-containing medicines for emergency contraception: influence of body weight/BMI on efficacy/bioavailability Date: 07. November 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: levonorgestrel | ulipristal acetate

In its notice of 5 November 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision C(2014)7147of the EU Commission.

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.

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 …

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 …

Medicinal product Corlentor®/Procoralan® (ivabradine): Initiation of a European safety review Date: 27. June 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ivabradine

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

Strontium ranelate containing medicinal products: risk of cardiavascular side effects Date: 19. May 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: strontium ranelate

The BfArM issues information on the implementing decision of the Commission within a European safety review in accordance with Article 20 of Regulation (EC-European Community) No. 726/2004.

Medicinal products containing metoclopramide: realisation of the EU Commission's implementing decision Date: 15. April 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: metoclopramide

On 20 December 2013, the European Commission decided that high dose medicinal products containing metoclopramide should be removed from the market.