BfArM - Federal Institute for Drugs and Medical Devices

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819 results

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Dear Doctor Letter (Rote-Hand-Brief) on Sutent®: Possible risk of osteonecrosis of the jaw PDF, 44KB, File is accessible Date: 10. December 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sunitinibe

Important safety-relevant information on the potential risk of osteonecrosis of the jaw in cancer patients treated with sunitinibe (Sutent®) associated with concomitant or previous administration of bisphosphonates.

Rote-Hand-Brief on Sutent® PDF, 44KB, File does not meet accessibility standards Date: 03. December 2010 Topics: Pharmakovigilanz Type: Download

Active substance: sunitinibe

Medicinal products containing isotretinoin for oral administration: Risk of severe skin reactions, adherence to contraceptive measures Date: 22. November 2010 Topics: Pharmakovigilanz Type: Risk information

Active substance: isotretinoin

The BfArM considers it necessary to add information on the risk of severe skin reactions to the product informations of medicinal products containing isotretinoin. This information was compiled by the Pharmacovigilance Working Party (PHVWP) of …

Tamoxifen: Interaction with CYP2D6 inhibitors Date: 04. November 2010 Topics: Pharmakovigilanz Type: Risk information

Active substance: tamoxifen

Concomitant administration of tamoxifen and strong inhibitors of the cytochrome P450 2D6 enzyme (CYP2D6) should be avoided, as a resulting reduced efficacy of tamoxifen cannot be excluded.

Information Letter on Sabril®: MRI findings reveal brain anomalies and motion disorders PDF, 47KB, File is accessible Date: 29. October 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: vigabatrine

During the ongoing safety monitoring of Sabril® (vigabatrine), case reports on MRI findings of brain anomalies and motion disorders were analysed.

Information Letter on Axura® and Ebixa®: Overdosage due to administration errors PDF, 55KB, File is accessible Date: 29. October 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: memantine hydrochloride

Information for medical experts regarding overdosage due to administration errors of the medicinal products Axura® und Ebixa® containing memantine hydrochloride.

Rote-Hand-Brief (Dear Doctor Letter) regarding Leflunomid medac® laboratory tests PDF, 474KB, File is accessible Date: 29. October 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: leflunomide

Correction of the information on laboratory tests to be performed when administering Leflunomid medac®.

Rote-Hand-Brief on Leflunomid medac® PDF, 474KB, File does not meet accessibility standards Date: 18. October 2010 Topics: Pharmakovigilanz Type: Download

Active substance: leflunomide

Information Letter on Axura® and Ebixa® PDF, 55KB, File is accessible Date: 15. October 2010 Topics: Pharmakovigilanz Type: Download

Active substance: memantine hydrochloride

Information Letter on Sabril® PDF, 47KB, File does not meet accessibility standards Date: 04. October 2010 Topics: Pharmakovigilanz Type: Download

Active substance: vigabatrine

(Summary of Product Characteristics)

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.