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443 results

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Information letter regarding Anemet® 200 mg tablets (dolasetron): Discontinuation of production PDF, 143KB, File is accessible Date: 26. April 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dolasetron

Due to the risk of arrhythmias in connection with the administration of Anemet® 200 mg tablets to adults for prevention and treatment of nausea and vomiting associated with cytostatic chemotherapy, the pharmaceutical manufacturer has renounced …

Dear Doctor Letter (Rote-Hand-Brief) on Thalidomide Celgene™ (thalidomide): Occurrence of thromboembolic events PDF, 129KB, File is accessible Date: 21. April 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: thalidomide

Important information on the occurrence of thromboembolic events associated with Thalidomide Celgene™ (thalidomide).

Information letter on Thyrogen® (thyrotropin alfa): Supply shortage due to a manufacturing issue and temporary treatment recommendations from the EMA PDF, 59KB, File is accessible Date: 11. April 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: thyrotropin alfa

An information letter on the treatment recommendations has been sent to attending physicians and pharmacies concerned.

Information letter on Onsenal® (celecoxibe): Company-led drug withdrawal for the indication "familial adenomatous polyposis" (FAP) PDF, 2MB, File is accessible Date: 08. April 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: celecoxibe

Important information on the company-led drug withdrawal of Onsenal® (celecoxibe) for the indication familial adenomatous polyposis.

Dear Doctor Letter (Rote-Hand-Brief) on Revlimid® (lenalidomide): Potential risk of second primary tumours PDF, 389KB, File is accessible Date: 01. April 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lenalidomide

Important information on the potential risk of second primary tumours in patients treated with Revlimid® (lenalidomide).

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.

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 …

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®.