BfArM - Federal Institute for Drugs and Medical Devices

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818 results

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Dear Doctor Letter (Rote-Hand-Brief) on Kepivance®: Restriction of indication PDF, 2MB, File is accessible Date: 20. April 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: palifermin

Indication for Kepivance® restricted to patients exposed to radiotherapy and chemotherapy for conditioning prior to autologous stem cell transplantation.

Dextromethorphane (DXM): Growing number of reports on misuse in 2009. Pharmacies are recommended to sell with caution. Date: 16. April 2010 Topics: Pharmakovigilanz Type: Risk information

Active substance: dextromethorphane

In 2009 the BfArM received a noticeably increased number of reports on (suspected) misuse of dextromethorphane products compared with previous years.

Antragsformular Variation Statine doc, 115KB, File does not meet accessibility standards Date: 07. April 2010 Topics: Pharmakovigilanz Type: Download

Antragsformular Variation Statine

Formblatts Änderungsanzeige Statine doc, 67KB, File does not meet accessibility standards Date: 07. April 2010 Topics: Pharmakovigilanz Type: Download

Formblatts Änderungsanzeige Statine

PhVWP Report PDF, 63KB, File does not meet accessibility standards Date: 07. April 2010 Topics: Pharmakovigilanz Type: Download

Pharmacovigilance Working Party Report

Yasmin® and venous thrombosis: Update of product information Date: 29. March 2010 Topics: Pharmakovigilanz Type: Risk information

Active substance: drospirenone

Data from two studies into the risk of venous thromboembolic incidents due to the use of combined oral contraceptives containing drospirenone, have been evaluated by the Pharmacovigilance Working Party of the European Medicines Agency EMA.

Tamoxifen: Interaction with SSRIs (selective serotonin reuptake inhibitors) Date: 18. March 2010 Topics: Pharmakovigilanz Type: Risk information

Active substance: tamoxifen

A Canadian cohort study showed that the SSRI, paroxetin, may decrease the effect of tamoxifen in a hormone therapy of mamma carcinoma (BMJ 2010; 340:c693). Concomitant administration of tamoxifen and paroxetin was found to increase breast …

Rote-Hand-Brief on REGRANEX® PDF, 79KB, File does not meet accessibility standards Date: 15. March 2010 Topics: Pharmakovigilanz Type: Download

Active substance: becaplermine

Dear Doctor Letter (Rote-Hand-Brief) on REGRANEX®: Extension of existing contraindications PDF, 79KB, File is accessible Date: 15. March 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: becaplermin

REGRANEX® (active substance: becaplermin) contraindicated for patients with malign diseases.

Rote-Hand-Brief on Aclasta® PDF, 143KB, File does not meet accessibility standards Date: 12. March 2010 Topics: Pharmakovigilanz Type: Download

Active substance: zoledronic acid

Dear Doctor Letter (Rote-Hand-Brief) on Aclasta®: Reports on renal dysfunction and renal failure PDF, 143KB, File is accessible Date: 12. March 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: zoledronic acid

Additional safety information on reports on renal dysfunction and renal failure with Aclasta®.

Reporting form for adverse drug reactions (ADR) PDF, 363KB, File does not meet accessibility standards Date: 23. February 2010 Topics: Pharmakovigilanz Type: Form

If you have observed an adverse drug reaction that you wish to report, please use the form provided here in the table. ADR s can also be reported online. Since the scientific assessment of reported events requires specialised medical information, the

Circular Letter about Protopic® PDF, 304KB, File does not meet accessibility standards Date: 08. February 2010 Topics: Pharmakovigilanz Type: Download

Active substance: tacrolimus

Information Letter on Protopic®: Recommendation to monitor maintenance therapy PDF, 304KB, File is accessible Date: 08. February 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tacrolimus

Important information on the safety of Protopic® Salbe (containing 0.03% or 0.1% tacrolimus) and recommendation to monitor maintenance therapy

Information Letter on Keppra® PDF, 1MB, File does not meet accessibility standards Date: 01. February 2010 Topics: Pharmakovigilanz Type: Download

Active substance: levetiracetame

Information Letter on Keppra®: Changed dose recommendations PDF, 1MB, File is accessible Date: 01. February 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: levetiracetam

Changed dose recommendations for use in children and adults are valid.

Rote-Hand-Brief on Reductil® PDF, 716KB, File does not meet accessibility standards Date: 25. January 2010 Topics: Pharmakovigilanz Type: Download

Active substance: sibutramine

Sibutramin-containing medicines: Suspension of marketing authorisation because of increased risk for cardiovascular events PDF, 329KB, File is accessible Date: 25. January 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sibutramin

The BfArM wishes to inform the public that the suspension of marketing authorisation for sibutramin-containing medicines is considered necessary by the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA).

Sibutramin: New Study Data under Evaluation Date: 18. December 2009 Topics: Pharmakovigilanz Type: Risk information

Active substance: sibutramin

The Committee for Human Medicinal Products (CHMP) at the European Medicines Agency (EMA) is currently concerned with a risk evaluation of sibutramin. The re-evaluation was prompted by the preliminary results of a large long-time study …

Rote-Hand-Brief on Fluorescein Alcon®10% PDF, 2MB, File does not meet accessibility standards Date: 15. December 2009 Topics: Pharmakovigilanz Type: Download

Active substance: fluoresceine sodium

Alcon Pharma GmbH recalls batches 160621F to 165639F in Germany. A Rote-Hand-Brief with attachment will be circulated

Rote-Hand-Brief (Dear Doctor Letter) on Fluorescein Alcon® 10 %: Batch Recall Date: 15. December 2009 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fluorescein-sodium

Alcon Pharma GmbH recalls batches 160621F to 165639F in Germany. A Rote-Hand-Brief with attachment will be circulated.

Rote-Hand-Brief on Fluorescein Alcon®10%
PDF, 1MB, File does not meet accessibility standards
Date: 02. November 2009 Topics: Pharmakovigilanz Type: Download

Active substance: fluoresceine sodium

The Institute for Drugs and Medical Devices (BfArM) advises the strict observance of the updated warnings and precautions in the expert information (SPC) on Fluorescein Alcon® 10%. A Rote-Hand-Brief …

Rote-Hand-Brief (Dear Doctor Letter) on Fluorescein Alcon® 10 % PDF, 1MB, File is accessible Date: 02. November 2009 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fluorescein sodium

For immediate attention: The BfArM advises the strict observance of the warnings and precautions in the information for medical professionals. A Rote-Hand-Brief with attachment will be circulated.

Rote-Hand-Brief on Intelence®
PDF, 143KB, File does not meet accessibility standards
Date: 19. October 2009 Topics: Pharmakovigilanz Type: Download

Active substance: etravirine

The Institute for Drugs and Medical Devices (BfArM) advises the urgent observance of updated warnings and precautions in expert information (SPC). A Rote-Hand-Brief (Dear Doctor Letter) dealing with the …

Rote-Hand-Brief (Dear Doctor Letter) on INTELENCE® PDF, 143KB, File is accessible Date: 19. October 2009 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: etravirin

For immediate attention: The BfArM advises the strict observance of the warnings and precautions in the information for medical professionals. A Rote-Hand-Brief informing about the changes will be circulated.

Information Letter on Tasigna®
active substance: nilotinib
PDF, 915KB, File does not meet accessibility standards
Date: 15. September 2009 Topics: Pharmakovigilanz Type: Download

Active substance: nilotinib

The Federal Institute for Drugs and Medical Devices (BfArM) requests consideration of the Information letter concerning the medicinal product Tasigna® (active substance: nilotinib)

Information Letter on Tasigna® PDF, 770KB, File does not meet accessibility standards Date: 15. September 2009 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: nilotinib

The Federal Institute for Drugs and Medical Devices (BfArM) requests consideration of the Information letter concerning the medicinal product Tasigna®

Assessment Report der Pharmacovigilance Working Party (PhVWP), aktualisierte Fassung PDF, 140KB, File does not meet accessibility standards Date: 04. July 2008 Topics: Pharmakovigilanz Type: Download

Assessment Report der Pharmacovigilance Working Party (PhVWP)

Anlage 3 zur Anhörung vom 19. Dezember 2007 PDF, 24KB, File does not meet accessibility standards Date: 21. December 2007 Topics: Pharmakovigilanz Type: Download

Anlage 3 zur Anhörung vom 19. Dezember 2007

Anlage 1 zur Anhörung vom 19. Dezember 2007 PDF, 23KB, File does not meet accessibility standards Date: 21. December 2007 Topics: Pharmakovigilanz Type: Download

Anlage 1 zur Anhörung vom 19. Dezember 2007