BfArM - Federal Institute for Drugs and Medical Devices

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Information letter on medicinal products containing codeine as liquid dosage forms by UCB Pharma GmbH: Recall Date: 13. November 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: codein

The company UCB Pharma GmbH is circulating information on the recall of medicinal products containing codeine as liquid dosage forms.

Information letter on Xofigo® (radium 223 dichloride): Temporary shortage of the medicinal product and special temporary preparation instructions. PDF, 75KB, File is accessible Date: 07. November 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: radium-223-dichlorid

The company Bayer Vital GmbH is circulating information on a worldwide temporary shortage of the medicinal product Xofigo® as recently produced batches did not pass routine quality checks prior to release.

Information Letter on Xofigo® (radium 223 dichloride): Temporary shortage of the medicinal product PDF, 2MB, File is accessible Date: 05. November 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: radium-223-dichlorid

The company Bayer Vital GmbH is circulating information on a worldwide temporary shortage of the medicinal product Xofigo® as recently produced batches did not pass routine quality checks prior to release.

Dear Doctor Letter (Rote-Hand-Brief) on Beofenac® (aceclofenac): New contraindications and warnings PDF, 1MB, File is accessible Date: 28. October 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: aceclofenac

The company Almirall Hermal GmbH is circulating information that treatment with aceclofenac - similar to that with diclofenac and selective COX-2 inhibitors - is associated with an increased risk of arterial thrombotic events.

Information Letter on Buccolam®: Recall due to a potential quality defect PDF, 793KB, File is accessible Date: 09. October 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: midazolam

The company ViroPharma GmbH issues information on the recall of the medicinal product Buccolam®. During a routine inspection at the manufacturing site, the potential risk of a cross-contamination with another medicinal product produced at the …

Safety relevant information on Beta interferons: Risk of thrombotic microangiopathy and nephrotic syndrome PDF, 286KB, File is accessible Date: 20. August 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: interferon beta

In accord with the European Medicines Agency (EMA) and the marketing authorisation holders, the BfArM issues important safety information regarding the treatment of multiple sclerosis with medicinal products containing interferon beta.

Dear Doctor Letter (Rote-Hand-Brief) on domperidone: serious cardiac side effects PDF, 369KB, File is accessible Date: 20. August 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: domperidone

After conclusion of the European safety review of medicinal products containing domperidone, the marketing authorisation holders are circulating a joint Dear Doctor Letter with information on safety measures to minimise cardiac risks.

Amsidyl® (active substance amsacrine) 75 MG concentrate for solution for infusion
(PZN 07131886) – Information on the shortage of Amsidyl after detection of GMP deficiencies during manufacture PDF, 454KB, File is accessible Date: 21. July 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Amsacrine

The pharmaceutical entrepreneur has issued information on a lack of availability of Amsidyl® until presumably 2015 due to the GMP deficiencies determined at the manufacturing site.

Information Letter on Velcade 3.5 MG (PZN 00822831) – Further information regarding the precautionary recall of a batch of Velcade (DELSC01) PDF, 269KB, File is accessible Date: 16. July 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Bortezomib

As a follow-up to the already published precautionary recall of a batch of Velcade®, the pharmaceutical manufacturer has compiled further information.

Dantrolene sodium (DANTROLEN i.v.®): Use of filter needles to draw up reconstituted solution from new stock until further notice PDF, 1MB, File is accessible Date: 27. June 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dantrolene sodium

The company Norgine GmbH is circulating information that some vials of dantrolene sodium for intravenous use after reconstitution may contain visible particles of the active substance.