BfArM - Federal Institute for Drugs and Medical Devices

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443 results

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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.