BfArM - Federal Institute for Drugs and Medical Devices

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819 results

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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.