BfArM - Federal Institute for Drugs and Medical Devices

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819 results

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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.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing dihydroergotoxine: Restriction of indications PDF, 99KB, File is accessible Date: 27. March 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dihydroergotoxine

The company Sigma-Tau Arzneimittel GmbH is circulating information that there are several indications for which medicinal products with the active substance dihydroergotoxine must no longer be prescribed in the future.

Granocyte® (lenograstim): Risk of capillary leak syndrome PDF, 309KB, File is accessible Date: 20. March 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lenograstim

The company Chugai Pharma Marketing is circulating information on the occurrence of capillary leak syndrome (CLS) following administration of lenogastrim (as also in the case of other G-CSF products) in patients undergoing chemotherapy, as …

Dear Doctor Letter (Rote-Hand-Brief) on Protelos® (strontium ranelate): Restriction of indication and recommendations for controls during administration PDF, 917KB, File is accessible Date: 11. March 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: strontium ranelate

The company Servier Deutschland GmbH is circulating information that use of Protelos is now restricted to the treatment of severe osteoporosis in postmenopausal women and adult men with a high risk of fractures who cannot be treated with other …

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.

Information letter on Isotonic Saline Solution Baxter, Clear-Flex plastic containers with Emoluer valves: Recall due to leakage PDF, 91KB, File is accessible Date: 07. March 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: isotonic saline

In addition to the safety information of 18 February 2014, the company Baxter Deutschland GmbH is circulating information on the recall of several batches of the medicinal product Isotonic Saline Solution Baxter.

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.