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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)