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819 results

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Information Letter on Carmubris® PDF, 239KB, File is accessible Date: 14. September 2012 Topics: Pharmakovigilanz Type: Download

Active substance: carmustine

Information Letter on Carmubris® powder and solution for infusion (carmustine, 100 mg): Overfilled vial found PDF, 239KB, File is accessible Date: 14. September 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: carmustine

In the course of routine stability testing, an overfilled vial was found in a specific batch of Carmubris®. Such overfilled vials pose a significant risk of overdosing patients.

Information Letter on Neupro®/Leganto® (rotigotine transdermal patch): New room-temperature stable formulation PDF, 203KB, File is accessible Date: 10. September 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: rotigotine

Licensing of improved formulation for Neupro®/Leganto® allowing storage at room temperature.

Information Letter on Neupro®/Leganto® PDF, 203KB, File is accessible Date: 10. September 2012 Topics: Pharmakovigilanz Type: Download

Active substance: rotigotine

Duogynon: Analysis of a retrospective case series does not show a causal association with birth defects, but it can also not be ruled out with certainty Date: 05. September 2012 Topics: Pharmakovigilanz Type: Risk information

Active substance:

The analytical results of a retrospective series of case-control studies yielding information on several types of birth defects in newborn babies in connection with the use of Duogynon during early pregnancy are now available to the BfArM.

Dear Doctor Letter (Rote-Hand-Brief) on Zostex® (brivudine): Potentially fatal interaction with 5-fluoropyrimidines PDF, 577KB, File is accessible Date: 03. September 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: brivudine

Important information to be observed: concomitant use of brivudine and 5-fluoropyrimidines (also in topical preparations and in combination medicinal products) is contraindicated due to the risk of potentially fatal interactions.

Dear Doctor Letter (Rote-Hand-Brief) on Tavanic® (levofloxacin) and generic medicinal products: Restriction of indications, new serious adverse reactions and precautions for use PDF, 601KB, File is accessible Date: 03. September 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: levofloxacin

In agreement with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), restrictions of indications and the inclusion of new serious adverse reactions as well as corresponding warnings in the product …

Rote-Hand-Brief on Zostex® PDF, 577KB, File is accessible Date: 31. August 2012 Topics: Pharmakovigilanz Type: Download

Active substance: brivudine

Rote-Hand-Brief on Tavanic® PDF, 601KB, File is accessible Date: 31. August 2012 Topics: Pharmakovigilanz Type: Download

Active substance:: levofloxacin

Additional information (available in German only):

Codeine: Genetic polymorphism - paediatric deaths Date: 30. August 2012 Topics: Pharmakovigilanz Type: Risk information

Active substance: codein

Recently, the U.S. licencing authority FDA reported three cases of death and one case of life-threatening respiratory depression following administration of codeine to children between 2 and 5 years of age. According to FDA statements the …