BfArM - Federal Institute for Drugs and Medical Devices

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Information Letter on Kyprolis® 30 mg vial (carfilzomib): Recall due to possible cracks in the glass of the vials PDF, 29KB, File is accessible Date: 21. December 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: carfilzomib

The company Amgen is circulating information on a voluntary recall of the medicinal product Kyprolis® 30 mg vial.

Recall of the medicinal product Tranexamsäure Carino 100 mg/ml, 5 ml ampoules, 5x5 ml solution for injection, PZN 10816978 batch designation: 013024 due to mix-up with Urapidil-25 mg-Carino ampoules PDF, 18KB, File is accessible Date: 20. December 2016 Topics: Pharmakovigilanz Type: Risk information

Active substance: tranexamic acid

The Federal Institute for Drugs and Medical Devices (BfArM) calls attention to the recall of batch 013024 of the medicinal product Tranexamsäure Carino 100 mg/ml by the company Carinopharm GmbH.

Information letter on Ammonaps® (sodium phenylbutyrate) tablets and granules: Treatment only if no alternative is available
PDF, 422KB, File is accessible
Date: 13. December 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sodium phenylbutyrate

In view of failings found in the manufacturing site of Ammonaps® (sodium phenylbutyrate) the company Swedish Orphan Biovitrum International AB (Sobi) is circulating information on temporary precautionary measures regarding treatment with …

Injectable allergy medications containing methylprednisolone that include traces of cows' milk proteins: risk of allergic reactions Date: 06. December 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: methylprednisolone

At the request of Croatia, the European Medicines Agency EMA has initiated a review procedure on 1 December 2016. It concerns injectable medicinal products with the active substance methylprednisolone that additionally contain lactose from …

Dear Doctor Letter (Rote-Hand-Brief) on oral solutions containing levetiracetam: Risk of overdosage due to medication errors PDF, 97KB, File is accessible Date: 21. November 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: levetiracetam

In several cases, oral administration of levetiracetam solutions (100 mg/ml) resulted in accidental (up to 10-fold) overdosage, especially in children aged 11 years and younger.

Marketing authorisations based on studies conducted by the company Alkem Laboratories Ltd. in India: suspension of marketing authorisation Date: 14. November 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Riluzol

In a notice dated 13 October 2016, the Federal Institute for Drugs and Medical Devices (BfArM) ruled the provisional suspension of a generic marketing authorisation that was based on a clinical trial conducted by the company Alkem Laboratories

Information Letter on Erwinase® 10.000 IU/vial, powder for solution for injection: Information on temporary shortages PDF, 38KB, File is accessible Date: 14. November 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Crisantaspase

The company Jazz Pharmaceuticals Germany GmbH is circulating information on the fact that over a period of 4 to 5 weeks there will be temporary shortages as regards new orders of Erwinase®.

Dear Doctor Letter (Rote-Hand-Brief) on Otezla® (apremilast): New important information on suicidal thoughts or behaviour PDF, 713KB, File is accessible Date: 08. November 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: apremilast

The company Celgene GmbH is circulating information regarding occasional cases of suicidal thoughts or behaviour that have been reported from clinical trials and after introduction to the market.

Dear Doctor Letter (Rote-Hand-Brief) on Revlimid® (lenalidomide): New important information on reactivation of virus infections PDF, 335KB, File is accessible Date: 08. November 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lenalidomide

The company Celgene GmbH is circulating information that cases of virus reactivation after treatment with lenalidomide have been reported.

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.