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Dear Doctor Letter (Rote-Hand-Brief) on Pedea® (ibuprofen as solution for injection): Shortage PDF, 401KB, File is accessible Date: 22. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ibuprofen

A temporary shortage in the supply of the medicinal product Pedea® for treatment of a haemodynamically significant patent ductus arteriosus Botalli in preterm newborn infants less than 34 weeks of gestational age has arisen due to the …

PlasmaVolume Redibag® by the company Baxter: Voluntary recall of the medicinal product PDF, 116KB, File is accessible Date: 18. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydroxyethyl starch

The marketing authorisation holder Baxter is circulating information that its medicinal product PlasmaVolume Redibag® (active substance: hydroxyethyl starch (HES)) is being recalled voluntarily from the market and requests to stop using this …

Information Letter on Zofran® (ondansetron) and generic medicinal products: Risk of QTc prolongation PDF, 548KB, File is accessible Date: 18. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ondansetron

This communication contains updated information regarding intravenous use of ondansetron for prevention and treatment of chemotherapy-induced nausea, retching and vomiting (CINV), as well as new recommendations for repeated administration and …

Medicinal products containing diclofenac: Cardiovascular risks PDF, 249KB, File is accessible Date: 16. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: diclofenac

The marketing authorisation holders of systemically acting medicinal products containing diclofenac are sending out information that new contraindications and warnings for these medicinal products have been decided following the Europe-wide …

List of medicines under additional monitoring Date: 15. July 2013 Topics: Pharmakovigilanz Type: Article

List of medicines under additional monitoring

Medicinal products containing codeine for treatment of pain in children: Key messages from the PRAC for consideration Date: 11. July 2013 Topics: Pharmakovigilanz Type: Risk information

Active substance: codeine

At its June meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) issued a document with key messages that should be considered when using medicinal products containing codeine for pain relief in children.

Fumaderm® initial/Fumaderm® (fumaric acid derivatives): Avoiding the risk of opportunistic infections by adhering to regular laboratory controls and observing further warnings PDF, 679KB, File is accessible Date: 26. June 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fumaric acid derivatives

The company Biogen Idec GmbH points out that it is absolutely necessary when using the medicinal products Fumaderm® initial/Fumaderm® to observe the warnings given in the Summary of Product Characteristics with regard to regular monitoring of …

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing tetrazepam (e.g. Musaril®): Ruling of suspension due to rare, serious skin reactions PDF, 331KB, File is accessible Date: 25. June 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tetrazepam

The company Sanofi-Aventis Deutschland GmbH is sending out information that the marketing authorisations for medicinal products containing tetrazepam (e.g. Musaril®) have been suspended in the EU.

Trobalt® (retigabine): Risk of pigmentary changes PDF, 343KB, File is accessible Date: 24. June 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: retigabine

The company GlaxoSmithKline is sending out information that treatment with the medicinal product Trobalt® can lead to pigmentary changes of eye tissues, including the retina, as well as of the skin, lips and/or nails.

Dear Doctor Letter (Rote-Hand-Brief) on Revlimid® (lenalidomide): Important aspects with regard to clinical use PDF, 260KB, File is accessible Date: 20. June 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lenalidomide

Celgene Europe Ltd. is sending out information on important aspects regarding the clinical use of Revlimid® (lenalidomide) for which a further indication was recently licenced.