BfArM - Federal Institute for Drugs and Medical Devices

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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.

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.

Ambroxol and bromhexine: start of a European safety review in accordance with Article 31 of Directive 2001/83/EC Date: 11. April 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ambroxol | bromhexine

The BfArM issues information on the initiation of a European safety review according to Article 31 of Directive 2001/83/EC. This procedure was initiated at the request of the Belgian Federal Agency for Medicines and Health Products.

Combined hormonal contraceptives: realisation of the EU Commission's implementing decisions Date: 03. April 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: combined hormonal contraceptives

In its notice of 31 March 2014, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the corresponding implementing decisions of the EU Commission K(2014)307 of 16 January 2014.

Medicinal products containing pelargonium: risk of liver damage Date: 31. March 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: pelargonium

After having conducted a hearing within a graduated plan ("Stufenplan") procedure, the BfArM has now issued a notice regarding the risk of liver damage due to medicinal products containing pelargonium root.

Medicinal products containing diacerein: recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) within a European safety review Date: 07. March 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: diacerein

The BfArM issues information on the PRAC's recommendation within the re-examination procedure following a European safety review in accordance with Article 31 of Directive 2001/83/EC.

Medicinal products containing domperidone: recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) within a European safety review Date: 07. March 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: domperidone

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

Iron-containing medicinal products for parenteral use: realisation of the EU Commission's implementing decision Date: 07. February 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: iron

In its notice of 18 December 2013, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the implementing decision of the European Commission regarding iron-containing medicinal products for parenteral use.

Flupirtine: restrictions in the use of flupirtine-containing medicines Date: 27. January 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: flupirtine

In its notice of 18 December 2013, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the implementing decision of the European Commission regarding medicinal products with the active substance flupirtine.

Quinine (Limptar® N): hearing under the graduated plan procedure ("Stufenplanverfahren"), stage II Date: 20. December 2013 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: quinine

In its letter dated 19 December 2013, the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) has initiated a written hearing regarding the risk of serious haematological …