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818 results

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Dear Doctor Letter (Rote-Hand-Brief) on Dianeal®, Extraneal®, Nutrineal®: Risk of occurrence of aseptic peritonitis
PDF, 44KB, File is accessible
Date: 26. January 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: peritoneal dialysis solutions

New information on the possible presence of endotoxins in batches of the peritoneal dialysis solutions Dianeal®, Extraneal®, and Nutrineal® and the associated increased risk of occurrence of aseptic peritonitis.

Rote-Hand-Brief on Dianeal®, Extraneal®, Nutrineal® PDF, 64KB, File is accessible Date: 25. January 2011 Topics: Pharmakovigilanz Type: Download

peritoneal dialysis solution

Dear Doctor Letter (Rote-Hand-Brief) on Multaq® (dronedarone): Severe liver injury
PDF, 146KB, File is accessible
Date: 24. January 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dronedarone

Important safety-relevant information on the occurrence of severe liver injury and on necessary control tests.

Rote-Hand-Brief on Cubicin® PDF, 2MB, File is accessible Date: 21. January 2011 Topics: Pharmakovigilanz Type: Download

Active substance: daptomycine

Dear Doctor Letter (Rote-Hand-Brief) on Cubicin® (daptomycin): Cases of eosinophilic pneumonia
PDF, 2MB, File is accessible
Date: 21. January 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: daptomycin

Important safety information on the connection between Cubicin® (daptomycin) and eosinophilic pneumonia.

Rote-Hand-Brief on Multaq® PDF, 146KB, File is accessible Date: 21. January 2011 Topics: Pharmakovigilanz Type: Download

Active substance: dronedarone

Dear Doctor Letter (Rote-Hand-Brief) on Vistide® (cidofovir): Serious adverse reactions following off-label use
PDF, 145KB, File is accessible
Date: 13. January 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cidofovir

Call for reporting of all suspected cases of adverse drug reactions in association with the use of Vistide®.

Rote-Hand-Brief on Vistide® PDF, 145KB, File is accessible Date: 13. January 2011 Topics: Pharmakovigilanz Type: Download

Active substance: cidofovir

Dear Doctor Letter (Rote-Hand-Brief) on Dianeal®, Extraneal®, Nutrineal®: Risk of occurrence of aseptic peritonitis PDF, 65KB, File is accessible Date: 27. December 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: peritoneal dialysis solution

Increased endotoxin concentrations which lead to an increased risk of occurrence of aseptic peritonitis have been found in batches of the peritoneal dialysis solutions Dianeal®, Extraneal® and Nutrineal®.

Dear Doctor Letter (Rote-Hand-Brief) on Revlimid® (lenalidomide): Occurrence of venous and arterial thromboembolic events PDF, 1MB, File is accessible Date: 27. December 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lenalidomide

Important safety-relevant information on the occurrence of venous and arterial thromboembolic events associated with Revlimid® (lenalidomide).

Dear Doctor Letter (Rote-Hand-Brief) on Thelin® (sitaxentan): Withdrawal from the market PDF, 108KB, File is accessible Date: 27. December 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sitaxentan

Withdrawal of Thelin® (sitaxentan) from the market due to unpredictable progression of serious hepatic impairment.

Rote-Hand-Brief on Revlimid® PDF, 1MB, File is accessible Date: 21. December 2010 Topics: Pharmakovigilanz Type: Download

Active substance: lenalidomide

Rote-Hand-Brief on Thelin® PDF, 125KB, File is accessible Date: 21. December 2010 Topics: Pharmakovigilanz Type: Download

Active substance: sitaxentan

SSRIs, venlafaxine and mirtazapine and the risk of Persistent Pulmonary Hypertension in Neonates (PPHN) - Final SPC and PL wording agreed by the PhVWP in March 2010 PDF, 32KB, File is accessible Date: 20. December 2010 Topics: Pharmakovigilanz Type: Download

SSRIs, venlafaxine and mirtazapine and the risk of Persistent Pulmonary Hypertension in Neonates (PPHN)

Fluoxetine and the risk of Congenital Malformations - Final SPC and PL wording Agreed by the PhVWP in March 2010 PDF, 13KB, File is accessible Date: 20. December 2010 Topics: Pharmakovigilanz Type: Download

Fluoxetine and the risk of Congenital Malformations

Rote-Hand-Brief on Dianeal®, Extraneal®, Nutrineal® PDF, 65KB, File is accessible Date: 20. December 2010 Topics: Pharmakovigilanz Type: Download

peritoneal dialysis solution

Rote-Hand-Brief on Nplate® PDF, 2MB, File is accessible Date: 15. December 2010 Topics: Pharmakovigilanz Type: Download

Active substance: romiplostim

Dear Doctor Letter (Rote-Hand-Brief) on Nplate® (romiplostim): Possible risk of thrombotic/thromboembolic events PDF, 2MB, File is accessible Date: 15. December 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: romiplostin

Important safety-relevant information for medical experts regarding the revised dose adjustment in patients with immune thrombocytopenic purpura (ITP) as well as the warnings for administration in ITP patients with hepatic impairment.

Thelin® (sitaxentan): intended withdrawal from the market Date: 14. December 2010 Topics: Pharmakovigilanz Type: Risk information

Active substance: sitaxentan

The pharmaceutical company Pfizer has informed the BfArM that it intends to withdraw Thelin® (sitaxentan) from the market.

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.