BfArM - Federal Institute for Drugs and Medical Devices

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819 results

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Information Letter on acitretin and teratogenicity: Extension of the contraception period and the prohibition of blood donation after end of therapy PDF, 98KB, File is accessible Date: 08. November 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: acitretin

In an Information Letter, the companies Dermapharm and Puren Pharma point out the extension of the contraception period and the prohibition of blood donation up to three years after discontinuation of therapy with acitretin.

Metformin for treatment of type 2 diabetes: use is extended to patients with moderately reduced kidney function Date: 03. November 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: metformin

As of 14 October 2016 and based on a European safety review, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended further lowering the limit of the creatinine clearance above which …

Medicinal products containing hydroxyethyl starch (HES): review of the risk-benefit ratio Date: 18. October 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: hydroxyethyl starch

In its notice of 12 October 2016, the BfArM has ruled suspension of the marketing authorisations until 1 November 2017. This notice is not legally enforceable. It is currently permitted to place the medicinal products on the market.

Information letter on emergency hormonal contraceptives (e.g. Postinor®): New recommendations for women taking CYP3A4 inducers PDF, 93KB, File does not meet accessibility standards Date: 26. September 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: levonorgestrel

The company Gedeon Richter Pharma GmbH is circulating new recommendations for women taking liver enzyme inducers. Active substances that trigger such an induction include e.g. preparations containing St. John's wort, rifampicin, certain HIV

3-Bromopyruvate (3-BP): Prescription requirement Date: 14. September 2016 Topics: Pharmakovigilanz Type: Risk information

Active substance: 3-Bromopyruvate

Medicinal products for human use with effects not generally known in medical science only to be dispensed upon prescription by a physician.

Dear Doctor Letter (Rote-Hand-Brief) on GlucaGen® HypoKit (glucagon hydrochloride): Batch recall due to quality defect Date: 07. September 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: glucagon hydrochloride

The company Novo Nordisk Pharma GmbH is circulating information that 3 batches of the GlucaGen® HypoKit are being recalled in Germany.

Renewed information on Erwinase® 10,000 IU/vial (crisantaspase): Shortage and instructions for use for further batches 174aG116 and 177aG116 PDF, 303KB, File is accessible Date: 26. August 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: crisantaspase

In connection with the import of Erwinase® from The United Kingdom, the company Jazz Pharmaceuticals Germany GmbH is circulating information on the fact that a 5 μm filter needle is to be used when administering batches 174aG116 and 177aG116.

Dear Doctor Letter (Rote-Hand-Brief) on Zydelig® (Idelalisib): Updated recommendations following conclusion of the safety data evaluation PDF, 600KB, File is accessible Date: 23. August 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: idelalisib

The company Gilead Sciences GmbH is circulating information on the updated indication of idelalisib as first-line treatment of patients with chronic lymphocytic leukaemia (CLL) and on risk minimisation measures for prevention of infections.

Viread 245 mg and Truvada 200 mg: Counterfeit medicinal products discovered Date: 20. July 2016 Topics: Pharmakovigilanz Type: Risk information

Active substance: tenofovi rdisoproxil, emtricitabine

The Federal Institute for Drugs and Medical Devices (BfArM) warns that counterfeits of the medicinal products Viread 245 mg film-coated tablets and Trudava 200 mg film-coated tablets have been discovered in several European countries.

Arcoxia® (etoricoxib): Altered dosage recommendations for patients with rheumatoid arthritis and ankylosing spondylitis (Bekhterev's disease) PDF, 902KB, File is accessible Date: 19. July 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: etoricoxib

The company MSD is circulating information on altered dosage recommendations for the medicinal product Arcoxia®.