BfArM - Federal Institute for Drugs and Medical Devices

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442 results

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Information letter on ERWINASE ® 10,000 IU/vial powder for solution for injection: precautionary measures when administering ERWINASE vials from batches 181a* and 182a* Date: 14. August 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: asparaginase

Due to shortage, ERWINASE® 10,000 IU/vial powder for solution for injection is currently only available under consideration of the provisions of Section 73 (3) AMG.

Information letter on Trisenox® (arsenic trioxide): import from third country in order to avert shortages Date: 03. August 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: arsenix trioxide

The company Teva GmbH is circulating information on the fact that due to problems in the manufacture of Trisenox there will be a shortage on the European market during mid/late August 2017. However, these manufacturing issues do not affect the …

Arixtra® (fondaparinux sodium): shortage following interrupted production due to a minor defect affecting the needle guard PDF, 248KB, File is accessible Date: 18. July 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fondaparinux sodium

The company Aspen Pharma Trading Limited is circulating information on the fact that a minor defect affecting the needle guard of some Arixtra syringes has led to quarantine of several batches and interrupted production.

Dear Doctor Letter (Rote-Hand-Brief) on Imbruvica® (ibrutinib): risk of hepatitis B re-activation PDF, 490KB, File is accessible Date: 18. July 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ibrutinib

The company Janssen-Cilag GmbH is circulating information on the fact that cases of hepatitis B virus (HBV) re-activation have occurred during treatment with Imbruvica®. Therefore, patients should be examined with regard to HBV infection prior …

Introduction of a patient alert card for medicinal products containing valproate and related substances Date: 13. July 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: valproate and related substances

In a notice dated 10 April 2017, the Federal Institute for Drugs and Medical Devices (BfArM) ruled the introduction of a patient alert card for medicinal products containing valproate as a supplementary risk minimisation measure. The companies …

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.

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 …

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 …