14.07.2016
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Information letter on Etopophos® 100-/1000 mg (etoposide): Shortage and procedure for ordering
Active substance: etoposide
The company Bristol-Myers Squibb GmbH & Co. KGaA is circulating information regarding the shortage of Etopophos® 100-/1000 mg.
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14.07.2016
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Acitretin and teratogenicity: Extension of the period of pregnancy prevention to 3 years after end of treatment
Active substance: Acitretin
The BfArM issues information on the result of the European PSUR worksharing procedure for the active substance acitretin. It was determined that the current 2-year period of pregnancy prevention after end of treatment is not sufficient and must therefore be extended to 3 years.
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15.07.2016
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Zydelig® for treatment of chronic lymphocytic leukaemia and follicular lymphoma: PRAC recommendation
Active substance: idelalisib
The BfArM issues information on the recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC) for physicians and patients in order to make use of the medicinal product Zydelig® as safe as possible.
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18.07.2016
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Dear Doctor Letter (Rote-Hand-Brief) on Noxafil® (posaconazole): Tablets and oral suspension are not interchangeable
Active substance: posaconazole
The company MSD is circulating information on the broad-spectrum antimycotic Noxafil® with regard to the use of different pharmaceutical forms.
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19.07.2016
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Arcoxia® (etoricoxib): Altered dosage recommendations for patients with rheumatoid arthritis and ankylosing spondylitis (Bekhterev's disease)
Active substance: etoricoxib
The company MSD is circulating information on altered dosage recommendations for the medicinal product Arcoxia®.
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20.07.2016
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Viread 245 mg and Truvada 200 mg: Counterfeit medicinal products discovered
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.
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23.08.2016
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Dear Doctor Letter (Rote-Hand-Brief) on Zydelig® (Idelalisib): Updated recommendations following conclusion of the safety data evaluation
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.
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26.08.2016
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Renewed information on Erwinase® 10,000 IU/vial (crisantaspase): Shortage and instructions for use for further batches 174aG116 and 177aG116
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.
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07.09.2016
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Dear Doctor Letter (Rote-Hand-Brief) on GlucaGen® HypoKit (glucagon hydrochloride): Batch recall due to quality defect
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.
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14.09.2016
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3-Bromopyruvate (3-BP): Prescription requirement
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.
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26.09.2016
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Information letter on emergency hormonal contraceptives (e.g. Postinor®): New recommendations for women taking CYP3A4 inducers
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 medicines or antiepileptic agents.
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18.10.2016
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Medicinal products containing hydroxyethyl starch (HES): review of the risk-benefit ratio
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.
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03.11.2016
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Metformin for treatment of type 2 diabetes: use is extended to patients with moderately reduced kidney function
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 metformin is contraindicated.
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08.11.2016
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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
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.
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08.11.2016
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Dear Doctor Letter (Rote-Hand-Brief) on Revlimid® (lenalidomide): New important information on reactivation of virus infections
Active substance: lenalidomide
The company Celgene GmbH is circulating information that cases of virus reactivation after treatment with lenalidomide have been reported.
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