BfArM - Federal Institute for Drugs and Medical Devices

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Dear Doctor Letter (Rote-Hand-Brief) on Uptravi® (selexipag): contraindication for concomitant administration of strong CYP2C8 inhibitors PDF, 804KB, File is accessible Date: 14. June 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: selexipag

The company Actelion Pharmaceuticals Deutschland GMBH is circulating information that a contraindication for concomitant administration of Uptravi® (selexipag) and strong inhibitors of CYP2C8 (e.g. gemfibrozil) has been introduced.

Epclusa® 400 mg/100 mg film-coated tablets (batch 15SFPD119): Counterfeit in German packaging offered to wholesaler Date: 18. May 2017 Topics: Pharmakovigilanz Type: Risk information

Active substance: sofosbuvir, velpatasvir

The Federal Institute for Drugs and Medical Devices (BfArM) reports that a counterfeit of the company Gilead's medicinal product Epclusa® 400 mg/100 mg film-coated tablets was offered to a wholesaler in Germany.

Direct-acting antivirals used for treating Hepatitis C: possible hepatitis B re-activation Date: 05. May 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: daclatasvir | dasabuvir | sofosbuvir/ledipasvir | simeprevir | sofosbuvir | ombitasvir/paritaprevir/ritonavir

The European Medicines Agency (EMA) confirms its recommendation for hepatitis B screening of all patients before starting treatment with direct-acting antiviral drugs for the treatment of hepatitis C

Dear Doctor Letter (Rote-Hand-Brief) on Cotellic® (cobimetinib): risk of haemorrhage and rhabdomyolysis PDF, 230KB, File is accessible Date: 24. April 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cobimetinib

The company Roche Pharma AG is sending out information on the risk of haemorrhage and rhabdomyolysis as well as new recommendations on dose modifications when taking Cotellic® (cobimetinib). Prior to initiating treatment, serum CPK and …

Information Letter on Trobalt® (retigabine): worldwide withdrawal PDF, 103KB, File is accessible Date: 24. April 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: retigabin

The company GlaxoSmithKline GmbH & CO KG is sending out information that as of the end of June 2017, all strengths of the medicinal product Trobalt® (retigabine) will be discontinued on a worldwide level and will thus cease to be …

Dienogest 2 mg and ethinylestradiol 0.03 mg for treatment of acne: use for treatment of acne possible if other specific treatments are not effective Date: 18. April 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: dienogest, ethinylestradiol

In its notice of 5 April 2017, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission C(2017) 2057 final of 22 March 2017. The European safety …

Medicinal products containing valproate: risks of use during pregnancy Date: 18. April 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valproate

In view of renewed discussions and assessments on a European level as well as current findings and discussions with scientific societies, the BfArM also considers it necessary to introduce a patient alert card as a further measure in addition …

Information letter on Clexane® (enoxaparin sodium): update of the information on the strength of the medicinal product, as well as on dosage recommendations and recommendations for use PDF, 2MB, File is accessible Date: 13. April 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: enoxaparin sodium

The company Sanofi-Aventis Deutschland GmbH is sending out information that the information on the effective strength of the medicinal product, the dosage recommendation for the treatment of deep vein thrombosis (DVT) and pulmonary embolism …

Dear Doctor Letter (Rote-Hand-Brief) on Fastjekt®/Fastjekt® Junior: recall of individual batches due to possible defects PDF, 297KB, File is accessible Date: 13. April 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Epinephrin

In coordination with the competent supervisory authority, the regional council ("Regierungspräsidium") in Darmstadt, the company Meda Pharma GmbH & Co. KG has initiated a voluntary recall of the listed batches of the adrenaline …

Renewed information on Erwinase® 10,000 IU/vial (crisantaspase): shortage and instructions for use for further batches 179a* and 180a* PDF, 260KB, File is accessible Date: 12. April 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: crisantaspase

The company Jazz Pharmaceuticals Germany GmbH is circulating information on the fact that, due to a temporary shortage, Erwinase® 10.000 I.U./vial powder for solution for injection is currently only available under consideration of the …