BfArM - Federal Institute for Drugs and Medical Devices

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818 results

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Information Letter on Mircera® PDF, 1MB, File is accessible Date: 26. March 2012 Topics: Pharmakovigilanz Type: Download

Active substance: methoxy-polyethylenglycol-epoetin beta

Information Letter on Vfend® PDF, 47KB, File is accessible Date: 12. March 2012 Topics: Pharmakovigilanz Type: Download

Active substance: voriconazole

Information Letter on Vfend® 200 mg powder for solution for infusion (voriconazole): Temporary shortage PDF, 47KB, File is accessible Date: 12. March 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: voriconazole

It is recommended to limit the use of the product to patients without alternative treatment options. An information letter with treatment recommendations has been circulated to treating physicians and pharmacies concerned.

Information Letter on Onglyza® PDF, 183KB, File is accessible Date: 08. March 2012 Topics: Pharmakovigilanz Type: Download

Active substance: saxagliptin

Additional information (available in German only):

Information Letter on Onglyza® (saxagliptin): Risk of serious hypersensitivity reactions and acute pancreatitis PDF, 183KB, File is accessible Date: 08. March 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: saxagliptin

The pharmaceutical manufacturer issues information on important new findings on the use of Onglyza® (saxagliptin) and the related risk of serious hypersensitivity reactions and acute pancreatitis.

Information Letter on Halaven® (eribulin): Danger of dosing errors PDF, 58KB, File is accessible Date: 05. March 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: eribulin

Danger of dosing errors due to the fact that the dose is stated differently in the EU compared to several other regions and in some publications.

Information Letter on Halaven® PDF, 58KB, File is accessible Date: 05. March 2012 Topics: Pharmakovigilanz Type: Download

Active substance: eribulin

Rote-Hand-Brief on Rasilez®, Rasilez HCT® and Rasilamlo® PDF, 87KB, File is accessible Date: 27. February 2012 Topics: Pharmakovigilanz Type: Download

Active substance: aliskiren

Dear Doctor Letter (Rote-Hand-Brief) on Rasilez®, Rasilez HCT® and Rasilamlo® (aliskiren): New contraindications and warnings in connection with the use of aliskiren-containing medicines PDF, 87KB, File is accessible Date: 27. February 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: aliskiren

Important information on new contraindications and warnings in connection with the use of aliskiren-containing medicinal products in combination with inhibitors of the angiotensin converting enzyme (ACE inhibitors) or angiotensin receptor …

Dear Doctor Letter (Rote-Hand-Brief) on Victrelis (boceprevir): Drug interactions with ritonavir-boosted HIV protease inhibitors PDF, 100KB, File is accessible Date: 24. February 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: boceprevir

In co-ordination with the European Medicines Agency (EMA) the pharmaceutical entrepreneur is circulating information on new findings on drug interactions between boceprevir, a recently licensed oral inhibitor of the hepatitis C virus …

Rote-Hand-Brief on Victrelis® PDF, 100KB, File is accessible Date: 24. February 2012 Topics: Pharmakovigilanz Type: Download

Active substance: boceprevir

Final SmPC and PL wording agreed by the PhVWP December 2011 PDF, 44KB, File is accessible Date: 14. February 2012 Topics: Pharmakovigilanz Type: Download

Final SmPC and PL wording agreed by the PhVWP December 2011

Ukrain: New findings with regard to detrimental effects of the medicinal product Date: 09. February 2012 Topics: Pharmakovigilanz Type: Risk information

Active substance:

In the course of recent findings, the BfArM has extended its assessment of the medicinal product Ukrain and now classifies Ukrain as an unsafe medicinal product.

Final SmPC and PL wording agreed by the PhVWP in September 2011 PDF, 59KB, File is accessible Date: 03. February 2012 Topics: Pharmakovigilanz Type: Download

Final SmPC and PL wording agreed by the PhVWP in September 2011

Final SmPC and PL wording Agreed by PhVWP in June 2011 PDF, 487KB, File is accessible Date: 03. February 2012 Topics: Pharmakovigilanz Type: Download

Final SmPC and PL wording Agreed by PhVWP in June 2011

Information Letter on Mircera® PDF, 886KB, File is accessible Date: 02. February 2012 Topics: Pharmakovigilanz Type: Download

Active substance: methoxy-polyethylenglycol-epoetin beta

Information Letter on Mircera® (methoxy polyethylene glycol-epoetin beta): Impending supply failure, note on switching to alternative treatments PDF, 1MB, File is accessible Date: 02. February 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: methoxy polyethylene glycol-epoetin beta

An information letter with treatment recommendations has been circulated to treating physicians and pharmacies concerned.

Information Letter on Mircera® (methoxy polyethylene glycol-epoetin beta): Possible shortages: Note on switching to alternative treatments PDF, 886KB, File is accessible Date: 02. February 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: methoxy polyethylene glycol-epoetin beta

An information letter with treatment recommendations has been circulated to treating physicians and pharmacies concerned.

Dear Doctor Letter (Rote-Hand-Brief) on Gilenya® (fingolimod): Increased cardiovascular monitoring at the beginning of treatment PDF, 638KB, File is accessible Date: 27. January 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

Important additional recommendations regarding a more intense monitoring of cardiovascular functions at the beginning of treatment with Gilenya® (fingolimod) in patients with relapsing-remitting multiple sclerosis.

Rote-Hand-Brief on Gilenya® PDF, 638KB, File is accessible Date: 26. January 2012 Topics: Pharmakovigilanz Type: Download

Active substance: fingolimod

Dear Doctor Letter (Rote-Hand-Brief) on Velcade® (bortezomib): Intravenous injection is the only correct route of administration PDF, 127KB, File is accessible Date: 16. January 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: bortezomib

The only licensed route of administration of Velcade® (1 mg, 3.5 mg, powder for solution for injection) is via intravenous injection. Velcade® must not be administered in any other manner.

Rote-Hand-Brief on Velcade® 1 mg, 3.5 mg, powder for solution for injection PDF, 127KB, File is accessible Date: 13. January 2012 Topics: Pharmakovigilanz Type: Download

Active substance: bortezomib

Citalopram and risk of QT prolongation - Final SmPC and PL wording agreed by the PhVWP in October 2011 PDF, 48KB, File is accessible Date: 10. January 2012 Topics: Pharmakovigilanz Type: Download

Citalopram - SmPC und PL Texte

Rote-Hand-Brief on Rasilez®, Rasilez HCT® and Rasilamlo® PDF, 72KB, File is accessible Date: 05. January 2012 Topics: Pharmakovigilanz Type: Download

Active substance: aliskiren

Dear Doctor Letter (Rote-Hand-Brief) on Rasilez®, Rasilez HCT® and Rasilamlo® (aliskiren): Potential risks of cardiovascular or renal adverse events PDF, 72KB, File is accessible Date: 05. January 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: aliskiren

Important information on potential risks of cardiovascular or renal adverse events in patients with type 2 diabetes and renal impairment and/or cardiovascular diseases who are being treated with medicinal products containing aliskiren.

Rote-Hand-Brief on Hexvix® PDF, 668KB, File is accessible Date: 29. December 2011 Topics: Pharmakovigilanz Type: Download

Active substance: hexaminolevulinate hydrochloride

Dear Doctor Letter (Rote-Hand-Brief) on UVADEX™: Visual inspection of vials prior to administration PDF, 57KB, File is accessible Date: 29. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance:

Therakos Europe advises healthcare professionals to visually inspect the UVADEX™ vials prior to administration in order to exclude particle contamination. Furthermore, suspected cases of sepsis should be reported along with the numbers of the …

Dear Doctor Letter (Rote-Hand-Brief) on Hexvix®: Visual inspection of vials prior to administration PDF, 668KB, File is accessible Date: 29. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hexaminolevulinate hydrochloride

Ipsen Pharma GmbH advises healthcare professionals to visually inspect the Hexvix® vials prior to administration in order to exclude particle contamination. Furthermore, suspected cases of sepsis should be reported along with the numbers of …

Rote-Hand-Brief on UVADEX PDF, 57KB, File is accessible Date: 27. December 2011 Topics: Pharmakovigilanz Type: Download

Active substance: methoxsalen

Rote-Hand-Brief on Virazole® PDF, 104KB, File is accessible Date: 23. December 2011 Topics: Pharmakovigilanz Type: Download

Active substance: ribavirin