BfArM - Federal Institute for Drugs and Medical Devices

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819 results

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Dear Doctor Letter on Xyrem®: Risk of dosing errors PDF, 1MB, File is accessible Date: 12. August 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sodium oxybate

Risk of dosing errors with Xyrem® (sodium oxybate) because gramme (g) and milliliter (ml) are easily confused.

Rote-Hand-Brief on Xyrem® PDF, 1MB, File is accessible Date: 12. August 2010 Topics: Pharmakovigilanz Type: Download

Active substance: sodium oxybate

Dear Doctor Letter (Rote-Hand-Brief) regarding Ketoprofen, topical formulations PDF, 58KB, File is accessible Date: 09. August 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ketoprofen

Important safety information about the risk of photosensivity reactions in association with topical uses of Ketoprofen.

Rote-Hand-Brief on Ketoprofen
PDF, 58KB, File is accessible
Date: 05. August 2010 Topics: Pharmakovigilanz Type: Download

Active substance: ketoprofene

Rote-Hand-Brief on Cardioxane® PDF, 1MB, File is accessible Date: 26. July 2010 Topics: Pharmakovigilanz Type: Download

Active substance: dexrazoxane

Dear Doctor letter (Rote Hand Brief) on Cardioxane®: Secondary neoplasia in children PDF, 1MB, File is accessible Date: 26. July 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dexrazoxane

Important safety information on Cardioxane® (dexrazoxane) and increased risk for secondary neoplasia in children.

Rosiglitazone: The BfArM and the EMA emphasise restrictions in indications Date: 23. July 2010 Topics: Pharmakovigilanz Type: Risk information

Active substance: rosiglitazone

In July 2010 the CHMP at the EMA initiated assessment of new study results on the antidiabetic, rosiglitazone. The BfArM, like the CHMP, is repeating the advice that the long-existing restrictions in rosiglitazone indications should be …

Rosiglitazone: The EMA initiates assessment of new study results Date: 16. July 2010 Topics: Pharmakovigilanz Type: Risk information

Active substance: rosiglitazone

In July 2010 the CHMP at the EMA is assessing the recently published new study results on rosiglitazone (June 2010).

Rote-Hand-Brief on Invirase® PDF, 2MB, File is accessible Date: 15. July 2010 Topics: Pharmakovigilanz Type: Download

Active substance: saquinavir

Dear Doctor letter on Invirase®: QT-prolongations PDF, 2MB, File is accessible Date: 15. July 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: saquinavir

Additional safety information on the arrhythmogenic risk due to QT and PR interval prolongations in association with Invirase (saquinavir).

Rote-Hand-Brief on Perfalgan® PDF, 1MB, File is accessible Date: 14. July 2010 Topics: Pharmakovigilanz Type: Download

Active substance: paracetamol

Dear Doctor Letter on Perfalgan®: Inadvertent overdose in newborn babies and infants PDF, 1MB, File is accessible Date: 14. July 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: paracetamol i.v.

Important information on the risk of inadvertently overdosed intravenous infusion of paracetamol 10 mg/ ml to newborn babies and infants.

Rote-Hand-Brief on Temozolomid Hospira® PDF, 146KB, File is accessible Date: 12. July 2010 Topics: Pharmakovigilanz Type: Download

Active substance: temozolomide

Dear Doctor Letters on temozolomide: Recall Date: 09. July 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: temozolomide

For precautionary reasons the pharmaceutical companies will recall certain batches of temozolomide.

Rote-Hand-Brief on Temozolomid Hexal® PDF, 307KB, File is accessible Date: 09. July 2010 Topics: Pharmakovigilanz Type: Download

Active substance: temozolomide

Valproic acid/valproate: interaction with carbapenem Date: 17. June 2010 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valproic acid

The product information texts on all valproic acid or products containing valproates should include warnings about clinically relevant interactions with carbapenems (decreased valproate plasma concentration) to come up to the latest findings. …

Bufexamac-containing products for topical use Date: 05. May 2010 Topics: Pharmakovigilanz Type: Risk information

Active substance: bufexamac

A two-year period for selling bufexamac-containing products cannot be granted according to BfArM’s Feststellungsbescheid (ascertainment decision). Prior to the BfArM order the authorisation holders had abandoned their marketing authorisations …

Information Letter on Exelon® and Prometax® PDF, 97KB, File does not meet accessibility standards Date: 30. April 2010 Topics: Pharmakovigilanz Type: Download

Active substance: rivastigmine

Information Letter on Exelon® and Prometax® transdermal patches: incorrect administration and medication error PDF, 51KB, File is accessible Date: 29. April 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: rivastigmine

In association with the rivastigmine transdermal patches, Exelon® and Prometax®, cases of overdosage due to medication errors and incorrect administration have been reported.

Bufexamac products for topical use: Revocation of authorisations in the EU because of unfavourable benefit-risk ratio Date: 27. April 2010 Topics: Pharmakovigilanz Type: Risk information

Active substance: bufexamac

Assessment of medicinal products containing bufexamac for topical use in the authorised indications has revealed a negative overall benefit-risk ratio. Therefore the authorisations are revoked