BfArM - Federal Institute for Drugs and Medical Devices

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442 results

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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®.

Information Letter on Vfend®: possible occurrence of squamous cell carcinomas of the skin PDF, 370KB, File is accessible Date: 27. September 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: voriconazole

Important safety-relevant information on the potential risk of the occurence of squamous cell carcinomas of the skin in patients taking Vfend® (voriconazole) as long-term treatment.

Anti-diabetics containing rosiglitazone: Order of discontinuation in Germany due to cardiovascular risks and Dear Doctor Letter (Rote-Hand-Brief) PDF, 238KB, File is accessible Date: 24. September 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: rosiglitazone

In a decision dated 23 September 2010, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the recall of anti-diabetics containing rosiglitazone from the trade chain in Germany down to the pharmacy level. Due to the necessity …

Information Letter regarding Relistor®: Occurrence of gastrointestinal perforations PDF, 2MB, File is accessible Date: 13. September 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: methylnaltrexone bromide

Important safety information on the occurrence of gastrointestinal perforations in patients who received RELISTOR® (active substance: methylnaltrexone bromide) for subcutaneous injection.
An information letter including the Fachinformation

Main information on contrast media containing gadolinium: Risk of nephrogenic systemic fibrosis (NSF) PDF, 44KB, File is accessible Date: 13. September 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: gadolinium

Summarising information on the risk of nephrogenic systemic fibrosis in association with the administratiion of gadolinium-containing contrast media.

Dear Doctor Letter on Xyrem®: Risk of dosing errors PDF, 1MB, File is accessible Date: 12. August 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sodium oxybate

Risk of dosing errors with Xyrem® (sodium oxybate) because gramme (g) and milliliter (ml) are easily confused.

Dear Doctor Letter (Rote-Hand-Brief) regarding Ketoprofen, topical formulations PDF, 58KB, File is accessible Date: 09. August 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ketoprofen

Important safety information about the risk of photosensivity reactions in association with topical uses of Ketoprofen.

Dear Doctor letter (Rote Hand Brief) on Cardioxane®: Secondary neoplasia in children PDF, 1MB, File is accessible Date: 26. July 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dexrazoxane

Important safety information on Cardioxane® (dexrazoxane) and increased risk for secondary neoplasia in children.

Dear Doctor letter on Invirase®: QT-prolongations PDF, 2MB, File is accessible Date: 15. July 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: saquinavir

Additional safety information on the arrhythmogenic risk due to QT and PR interval prolongations in association with Invirase (saquinavir).

Dear Doctor Letter on Perfalgan®: Inadvertent overdose in newborn babies and infants PDF, 1MB, File is accessible Date: 14. July 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: paracetamol i.v.

Important information on the risk of inadvertently overdosed intravenous infusion of paracetamol 10 mg/ ml to newborn babies and infants.

Dear Doctor Letters on temozolomide: Recall Date: 09. July 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: temozolomide

For precautionary reasons the pharmaceutical companies will recall certain batches of temozolomide.

Information Letter on Exelon® and Prometax® transdermal patches: incorrect administration and medication error PDF, 51KB, File is accessible Date: 29. April 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: rivastigmine

In association with the rivastigmine transdermal patches, Exelon® and Prometax®, cases of overdosage due to medication errors and incorrect administration have been reported.

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.

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.

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®.

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®: 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.

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).

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 (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 (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® 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®