BfArM - Federal Institute for Drugs and Medical Devices

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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

Anlage zur Anhörung vom 02.08.2007 (Public Assessment Report) PDF, 189KB, File does not meet accessibility standards Date: 09. August 2007 Topics: Pharmakovigilanz Type: Download

Anlage zur Anhörung vom 02.08.2007

Public Statement des Committee on Herbal Medicinal Products (HMPC) vom 8. Juli 2006 PDF, 187KB, File does not meet accessibility standards Date: 29. December 2006 Topics: Pharmakovigilanz Type: Download

HMPC public statement – assessment of case reports connected to herbal medicinal products containing Cimicifuga root, 22. Mai 2006

Assessment of Case Reports des Committee on Herbal Medicinal Products (HMPC) vom 8. Juli 2006 PDF, 237KB, File does not meet accessibility standards Date: 29. December 2006 Topics: Pharmakovigilanz Type: Download

Assessment of case reports connected to herbal medicinal products containing Cimicifugae racemosae rhizoma (Black Cohosh, root), EMEA/HMPC/26258/2006, 8. Juli 2006

Public Statement der EMEA vom 18. Juli 2006 PDF, 74KB, File does not meet accessibility standards Date: 29. December 2006 Topics: Pharmakovigilanz Type: Download

Cimicifuga Public Statement

Safety of Long Acting Beta Agonists (LABA) (salmeterol ; formoterol) Date: 06. September 2006 Topics: Pharmakovigilanz Type: Risk information

Active substance: Salmeterol, Formoterol

Important Safety Information Date: 09. May 2006 Topics: Pharmakovigilanz Type: Risk information

Active substance: Paroxetine

Questions and answers on Paroxetine Date: 08. May 2006 Topics: Pharmakovigilanz Type: Risk information