BfArM - Federal Institute for Drugs and Medical Devices

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Reporting form for communication of quality defects, batch recalls, and counterfeit drugs rtf, 38KB, File does not meet accessibility standards Date: 28. September 2010 Topics: Pharmakovigilanz Type: Form

Click here for the reporting form with which pharmaceutical companies can communicate quality defects, batch recalls and counterfeit drugs to the competent authority.

Information Letter on Vfend®: possible occurrence of squamous cell carcinomas of the skin PDF, 370KB, File is accessible Date: 27. September 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: voriconazole

Important safety-relevant information on the potential risk of the occurence of squamous cell carcinomas of the skin in patients taking Vfend® (voriconazole) as long-term treatment.

Anti-diabetics containing rosiglitazone: Order of discontinuation in Germany due to cardiovascular risks and Dear Doctor Letter (Rote-Hand-Brief) PDF, 238KB, File is accessible Date: 24. September 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: rosiglitazone

In a decision dated 23 September 2010, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the recall of anti-diabetics containing rosiglitazone from the trade chain in Germany down to the pharmacy level. Due to the necessity …

Information Letter on VFEND® PDF, 370KB, File is accessible Date: 23. September 2010 Topics: Pharmakovigilanz Type: Download

Acive substance: voriconazole

(Summary of Product Characteristics)

Main information on: Omniscan®, OptiMARK®, Magnevist®, MultiHance®, Primovist®, Vasovist®, Gadovist®, ProHance®, Dotarem® PDF, 44KB, File is accessible Date: 13. September 2010 Topics: Pharmakovigilanz Type: Download

Active substances: gadodiamide, gadoversetamide, gadopentetacid, gadobenacid, gadoxeracid, gadofosveset, gadobutrol, gadoteridol, gadoteracid

Information Letter regarding Relistor®: Occurrence of gastrointestinal perforations PDF, 2MB, File is accessible Date: 13. September 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: methylnaltrexone bromide

Important safety information on the occurrence of gastrointestinal perforations in patients who received RELISTOR® (active substance: methylnaltrexone bromide) for subcutaneous injection.
An information letter including the Fachinformation

Main information on contrast media containing gadolinium: Risk of nephrogenic systemic fibrosis (NSF) PDF, 44KB, File is accessible Date: 13. September 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: gadolinium

Summarising information on the risk of nephrogenic systemic fibrosis in association with the administratiion of gadolinium-containing contrast media.

Information Letter on Relistor® PDF, 2MB, File is accessible Date: 10. September 2010 Topics: Pharmakovigilanz Type: Download

Active Substance: methylnaltrexonbromide

(Summary of Product Characteristics)

Hormone Replacement Therapy (HRT): duration of gestagen addition in sequential HRT Date: 10. September 2010 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: gestagen

In a Notice (Bescheid) of 23 August 2010 relating to medicinal products for sequential HRT with gestagen addition on less than 12 days per treatment cycle, the BfArM ruled that the product information be supplemented. It is stated that there …

Angiotensin-receptor-antagonists: BfArM and EMA are assessing studies on the risk of cancer. Date: 13. August 2010 Topics: Pharmakovigilanz Type: Risk information

Active substance: angiotensin-receptor-antagonists

In June 2010 “Lancet Oncology“ published the results of a meta-analysis (Sipahi et al., 2010), in which the authors observed a slightly increased risk for new cases of cancer under angiotensin-receptor-antagonist therapies.