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442 results

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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 …

Dantrolen i.v.: packages no longer contains water for injection PDF, 220KB, File is accessible Date: 22. March 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dantrolene

The company Norgine GmbH is circulating information that as of April 2017 (the 12 vial pack) or May 2017 (the 36 vial pack), packages of Dantrolen i.v. newly placed on the market no longer contain water for injection. Care must be taken that …

Dear Doctor Letter (Rote-Hand-Brief) on Viread® 204 mg film-coated tablet: incorrect dosage information in previous Summaries of Product Characteristics PDF, 242KB, File is accessible Date: 15. March 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tenofovir disoproxil

The company Gilead Sciences GmbH is circulating information on incorrect dosage information in the Summaries of Product Characteristics of Viread 204 mg film-coated tablets.

Dear Doctor Letter (Rote-Hand-Brief) on Viridal® 40 µg powder and solvent for injection: recall due to membrane defects PDF, 1MB, File is accessible Date: 06. March 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Alprostadil

The company UCB Pharma GmbH is circulating information on a voluntary recall of the medicinal product Viridal® due to defective membranes of the glass cartridges.

Information Letter on Erwinase® 10.000 IU/vial, powder for solution for injection: information on temporary shortage PDF, 261KB, File is accessible Date: 31. January 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 …

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.

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 …

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.

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.