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819 results

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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