BfArM - Federal Institute for Drugs and Medical Devices

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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.

Counterfeits of the medicinal product VELCADE® 3.5 mg powder for solution for injection discovered in Germany Date: 14. August 2017 Topics: Pharmakovigilanz Type: Risk information

Active substance: bortezomib

The Federal Institute for Drugs and Medical Devices (BfArM) is issuing information on counterfeits of the medicinal product VELCADE 3.5 mg powder for solution for injection by Janssen-Cilag International NV, Belgium which were was found in …

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 …

Counterfeits of the medicinal product Xeplion® 150 mg extended-release suspension for injection (batches GFB4D00_BG-RO and GEB3Z00_BG-RO) have reached the German market (including amendments of 2 August 2017, 28 July 2017 and 26 July 2017) Date: 02. August 2017 Topics: Pharmakovigilanz Type: Risk information

Active substance: paliperidon

The Federal Institute for Drugs and Medical Devices (BfArM) has received new information on a further batch concerned in the case of counterfeits of the medicinal product Xeplion 150 mg extended-release suspension for injection (active …

Omnitrope® 15 mg / 1.5 ml solution for injection (somatropin) Batch EL9738: Counterfeit being offered in German packaging Date: 18. July 2017 Topics: Pharmakovigilanz Type: Risk information

Active substance: somatropin

The Federal Institute for Drugs and Medical Devices (BfArM) refers to counterfeits of the medicinal product Omnitrope® 15 mg / 1.5 ml solution for injection by the company Sandoz reported in France, Denmark and Mexico. The medicinal product …

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 …

Marketing authorisations based on studies conducted by the company Micro Therapeutic Research Labs in India: suspension of marketing authorisations Date: 13. July 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: various

In a notice dated 13 July 2017, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the provisional suspension of generic marketing authorisations based on clinical trials conducted by the company Micro Therapeutic Research …

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 …

Symbioflor 2: recommendations of the Committee for Medicinal Products for Human Use regarding further use and restrictions of use Date: 04. July 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: escherichia coli

In its review of Symbioflor 2, the European Medicines Agency EMA has concluded that the medicinal product can continue to be used for treatment of irritable bowel syndrome in adults. However, it should no longer be taken to treat so-called …