26.08.2013
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Dear Doctor Letter (Rote-Hand-Brief) on Neupogen® (filgrastim) and Neulasta® (pegfilgrastim): Risk of capillary leak syndrom
Active substance: filgrastim
The marketing authorisation holder Amgen GmbH is circulating information on an adverse effect, the capillary leak syndrome (CLS), associated with the treatment of patients with cancer and/or healthy donors with Neupogen® (filgrastim) or Neulasta® (pegfilgrastim).
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23.08.2013
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Diane® 35 and generic drugs: risk of thromboembolic events
Active substance: cyproterone acetate/ethinylestradiol
In a notice dated 8 August 2013, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the European Commission's implementing decision on medicinal products containing the combination cyproterone acetate/ethinylestradiol.
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22.08.2013
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Information Letter on oral ketoconazole-containing medicinal products (Nizoral® tablets): Suspension of marketing authorisation due to serious liver damage
Active substance: ketoconazole
After an EU-wide review of the risk of hepatotoxicity under ketoconazole for treatment of fungal infections, the EMA recommends the suspension of the marketing authorisation for Nizoral® tablets (oral ketoconazole-containing medicinal products) in the EU.
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15.08.2013
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Zyvoxid® 2 mg/ml solution for injection (linezolid): Temporary shortage
Active substance: linezolid
The company Pfizer Pharma GmbH is circulating information that the medicinal product Zyvoxid® 2 mg/ml solution for injection can currently not be supplied. This shortage is the result of manufacturing problems of one of the external manufacturers.
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09.08.2013
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Mucosolvan® Solution for injection (ambroxol hydrochloride)
Active substance: ambroxol hydrochloride
Information on mixing with commercially available 5% glucose solution for infusion.
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07.08.2013
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LInformation Letter on Roferon®-A (interferon alfa-2a)
Active substance: interferon alfa-2a
The marketing authorisation holder Roche Pharma is circulating an information letter on a temporary shortage in the supply of Roferon®-A due to relocation of the production site.
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02.08.2013
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Information Letter on PegIntron® (peginterferon alfa-2b)
Active substance: peginterferon alfa-2b
Information on the correct use of the new pre-filled injection pen.
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31.07.2013
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Dear Doctor Letter (Rote-Hand-Brief) on Erivedge® (vismodegib)
Active substance: vismodegib
Important information for safe use, including information on contraceptive programmes.
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30.07.2013
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Information Letter on VOTRIENT® (pazopanib)
Active substance: pazopanib
Important change to frequency of serum liver test monitoring for hepatotoxicity.
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25.07.2013
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DepoCyte® 50 mg injectable suspension (liposomal cytarabine for intrathecal injection): Back on the market as of 1 August 2013
Active substance: liposomal cytarabine
As of 1 August 2013, DepoCyte® will be available again regularly on the German market.
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22.07.2013
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Dear Doctor Letter (Rote-Hand-Brief) on Pedea® (ibuprofen as solution for injection): Shortage
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 development of visible particles in the ampoules.
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18.07.2013
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PlasmaVolume Redibag® by the company Baxter: Voluntary recall of the medicinal product
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 solution for infusion.
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18.07.2013
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Information Letter on Zofran® (ondansetron) and generic medicinal products: Risk of QTc prolongation
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 for dosing in the elderly.
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16.07.2013
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Medicinal products containing diclofenac: Cardiovascular risks
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 evaluation of cardiovascular safety.
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11.07.2013
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Medicinal products containing codeine for treatment of pain in children: Key messages from the PRAC for consideration
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.
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