BfArM - Federal Institute for Drugs and Medical Devices

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Dear Doctor Letter (Rote-Hand-Brief) on TYGACIL® (tigecycline): Restrictions in all indications PDF, 44KB, File is accessible Date: 17. March 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tigecycline

Important information on restrictions in all indications of TYGACIL® (tigecycline) due to increased mortality observed in clinical trials.

Rote-Hand-Brief on Tygacil® PDF, 44KB, File is accessible Date: 17. March 2011 Topics: Pharmakovigilanz Type: Download

Active substance: tigecycline

Rote-Hand-Brief on Zerit® PDF, 419KB, File is accessible Date: 09. March 2011 Topics: Pharmakovigilanz Type: Download

Active substance: stavudine

Dear Doctor Letter (Rote-Hand-Brief) on ZERIT® (stavudine): Restricted indications PDF, 419KB, File is accessible Date: 09. March 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: stavudine

Important information on restrictions in the indications of ZERIT® (stavudine) due to potentially serious adverse reactions.

Dear Doctor Letter (Rote-Hand-Brief) on Anemet 100 mg i.v.® (dolasetron): Renunciation of marketing authorisation PDF, 90KB, File is accessible Date: 18. February 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dolasetron

Due to the risk of arrhythmias in connection with the intravenous administration of dolasetron to adults for treatment of nausea and vomiting associated with cytostatic chemotherapy, the pharmaceutical manufacturer has renounced this marketing …

Dear Doctor Letter (Rote-Hand-Brief) on Vigil® (modafinil): Restricted indication and important safety information PDF, 104KB, File is accessible Date: 11. February 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: modafinil

A safety review by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has lead to a restriction of the indications of Vigil® (modafinil) to adults with excessive sleepiness associated with …

Rote-Hand-Brief on Anemet® PDF, 90KB, File is accessible Date: 10. February 2011 Topics: Pharmakovigilanz Type: Download

Active substance: dolasetrone

Rote-Hand-Brief on Vigil® PDF, 104KB, File is accessible Date: 07. February 2011 Topics: Pharmakovigilanz Type: Download

Active substance: modafinil

Dexrazoxane: Referral procedure for clarification of a potentially increased risk of secondary cancers Date: 28. January 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance: dexrazoxane

In the course of a graduated plan procedure, stage II, the BfArM announces the initiation of a referral procedure in accordance with Article 31 of Directive 2001/83/EC.

Dear Doctor Letter (Rote-Hand-Brief) on Octenisept® (octenidine hydrochloride, phenoxyethanol): Swelling and tissue damage following irrigation under pressure PDF, 2MB, File is accessible Date: 27. January 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: octenidine hydrochloride, phenoxyethanol

Warning against incorrect use of Octenisept®.