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DepoCyte® 50 mg injectable suspension (liposomal cytarabine for intrathecal injection): Back on the market as of 1 August 2013
PDF, 175KB, File is accessible
Date: 25. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: liposomal cytarabine

As of 1 August 2013, DepoCyte® will be available again regularly on the German market.

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 …

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.

Dear Doctor Letter (Rote-Hand-Brief) on cyproterone acetate 2 mg/ethinylestradiol 35 µg PDF, 292KB, File is accessible Date: 12. June 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cyproterone acetate

Strengthening of warnings, new contraindications and updated indication.

Information Letter on CILEST® and PRAMINO® tablets: Recall of the entire stock from the market PDF, 337KB, File is accessible Date: 04. June 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ethinyl estradiol, norgestimate

The pharmaceutical manufacturer is sending out information on the recall of the entire stock of CILEST® and PRAMINO® from the market as both products are no longer available.

Dear Doctor Letter (Rote-Hand-Brief) on Samsca® (tolvaptan): liver injury PDF, 188KB, File is accessible Date: 23. May 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tolvaptan

Information for healthcare professionals regarding the potential risk of liver injury due to Samsca® (tolvaptan).

Information Letter on Nipruss® (sodium nitroprusside): recall all batches PDF, 944KB, File is accessible Date: 23. May 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sodium nitroprusside

As a precautionary measure and in co-ordination with the competent supervising authority, the company UCB Pharma GmbH is recalling all batches of Nipruss® dry substance for infusion after reconstitution (PZN 04746699).

Dear Doctor Letter (Rote-Hand-Brief) on Protelos® (strontium ranelate): Restriction of indication PDF, 301KB, File is accessible Date: 13. May 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: strontium ranelate

Recent data showing an increased risk of myocardial infarction have resulted in restrictions regarding the use of Protelos® (restricted indication, new contraindications and warnings).

Dear Doctor Letter (Rote-Hand-Brief) on Pletal® (cilostazol): New safety information PDF, 3MB, File is accessible Date: 02. May 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cilostazol

As the result of a review of the benefits and risks of cilostazol and in collaboration with the European Medicines Agency, the indications for medicinal products containing cilostazol have been restricted.

Dear Doctor Letter (Rote-Hand-Brief) on Tavor® pro injectione 2 mg solution for injection (lorazepam): Recall PDF, 119KB, File is accessible Date: 02. May 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lorazepam

Recall of Tavor® pro injectione 2 mg solution for injection due to possible contamination with glass splinters.

Increlex® 10 mg/ml solution for injection (mecasermin, recombinant human IGF-1): Temporary market shortage PDF, 208KB, File is accessible Date: 30. April 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mecasermin, recombinant human IGF-1

The company Ipsen Pharma GmbH is sending out information that the medicinal product Increlex® 10 mg/ml solution for injection will presumably be out of stock starting early August 2013. This shortage is due to manufacturing difficulties and …

Information Letter on CAELYX®: As of Monday 29 April 2013, supply with the medicinal product will return to normal PDF, 408KB, File is accessible Date: 23. April 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated liposomal doxorubicin

Janssen-Cilag is sending out information that the supply with CAELYX® 2 mg/ml concentrate for solution for infusion is returning to regular availability and that the "CAELYX® Managed Access Programme" is being terminated.

Dear Doctor Letter (Rote-Hand-Brief) on Thalidomide Celgene™ (thalidomide): Risk of second primary haematological malignancies PDF, 288KB, File is accessible Date: 08. April 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: thalidomide

The pharmaceutical manufacturer is sending out information on the risk of second primary haematological malignancies in patients treated with thalidomide.

Dear Doctor Letter (Rote-Hand-Brief) on INCIVO® (telaprevir): Occurrence of serious skin reactions PDF, 351KB, File is accessible Date: 08. April 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: telaprevir

The pharmaceutical manufacturer is sending out information on the occurrence of serious skin reactions associated with treatment with INCIVO®.