BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Search i

Search help

  • Enter one or more search terms in the search field. Upper and lower case are not relevant.
  • As soon as you have entered three letters in the search field, various search words will be suggested from which you can choose one.
  • If you are searching for a certain group of words, put these words in double quotes. The hits will then contain the words in the order you entered, e.g. "medicines for children".
  • Multiple search terms can also be combined with the Boolean operators AND and OR. When using the operator AND, the results contain the intersection of all search terms. When using the operator OR, the hits contain one of the search terms or only individual search terms. The result set is therefore significantly larger. Please note that these operators must be written in capital letters.
  • If you receive a (too) large number of hits as a result of your search, you can narrow it down by using filters. These filter options appear to the left of the search results and are subdivided into:

    • category (e.g. safety of medicinal products, medical devices, code systems)
    • format (e.g. download, risk information, DHPCs)
    • time interval (e.g. last 30 days, older than ...)
  • Selected filters can be removed individually or all at once ("Show all results").
  • By default, search results are sorted by relevance, but they can also be sorted chronologically ("Latest entries first" or "Oldest entries first").

Enter search term

819 results

Results per page: 10 20 30

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.

Information Letter on Doribax® 250 mg/500 mg (doripenem): Discontinuation and recall of stock in circulation PDF, 647KB, File is accessible Date: 05. March 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: doripenem

The company Janssen-Cilag GmbH points out that it will discontinue distribution of the medicinal product Doribax® 250 mg/500 mg (active substance: doripenem). The entire stock still on the market will be recalled on pharmacy level. This recall …

Information Letter on Isotonic Saline Solution Baxter, Clear-Flex plastic containers with Emoluer valves: Important safety information PDF, 197KB, File is accessible Date: 21. February 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: isotonic saline solution

The company Baxter Deutschland GmbH points out that Baxter has recently received an increased number of customer complaints referring to leakage of the Emoluer valves of Clear-Flex containers.

Information Letter on Olimel Peri/Olimel®: Reduction of maximal infusion rate per hour in children PDF, 552KB, File is accessible Date: 11. February 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: emulsion for infusion for parenteral nutrition

The company Baxter Deutschland GmbH points out that the posology given in the Package Leaflets and Summaries of Product Characteristics of Olimel Peri/Olimel nutrient solutions is to be altered with regard to the maximal infusion rate of …

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.

Dear Doctor Letter on Carbomedac 10 mg/ml® (carboplatin): Recall of batch A130069B due to insoluble particles PDF, 45KB, File is accessible Date: 06. February 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: carboplatin

The company Medac Gesellschaft für klinische Spezialpräparate m.b.H. points out that the a.m. batch of the medicinal product Carbomedac 10 mg/ml® is being recalled due to insoluble crystalline particles. The concentrate for solution for …

Dear Doctor Letter (Rote-Hand-Brief) on combined hormonal contraceptives, including information material: Risk of venous thromboembolic events PDF, 507KB, File is accessible Date: 03. February 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: gestagen components: chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, nomegestrol, norelgestromin, norgestimat

In coordination with the European Medicines Agency and the Federal Institute for Drugs and Medical Devices, the pharmaceutical manufacturers concerned are circulating information on new aspects of the risk of blood clots (venous thromboembolic …

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.

Information Letter on Zyvoxid® i.v. (linezolid): Limited supply PDF, 97KB, File is accessible Date: 27. January 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: linezolid

The company Pfizer Pharma GmbH is circulating information that with immediate effect the medicinal product Zyvoxid® i.v. is available to a limited extent.

Dear Doctor Letter (Rote-Hand-Brief) on Erivedge® (vismodegib): Labelling of the bottle and Package Leaflet PDF, 303KB, File is accessible Date: 20. January 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: vismodegib

Important information on the labelling of the bottle and the Package Leaflet as a precautionary measure to ensure safe administration.

Dear Doctor Letter (Rote-Hand-Brief) on Abraxane®: Quality issues PDF, 401KB, File is accessible Date: 17. January 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: paclitaxel

Information on quality issues in connection with the medicinal product Abraxane® for intravenous use. Visible particles were discovered in the infusion bag.