26.06.2013
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Fumaderm® initial/Fumaderm® (fumaric acid derivatives): Avoiding the risk of opportunistic infections by adhering to regular laboratory controls and observing further warnings
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 the blood count (including differential blood counts) and the resulting therapeutic consequences.
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25.06.2013
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Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing tetrazepam (e.g. Musaril®): Ruling of suspension due to rare, serious skin reactions
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.
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24.06.2013
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Trobalt® (retigabine): Risk of pigmentary changes
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.
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20.06.2013
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Dear Doctor Letter (Rote-Hand-Brief) on Revlimid® (lenalidomide): Important aspects with regard to clinical use
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.
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14.06.2013
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Combined use of ACE-inhibitors, angiotensin II receptor antagonists or aliskiren: recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) within a European safety review
Active substances: ACE-inhibitors | angiotensin II receptor antagonists or aliskiren
The BfArM issues information on the PRAC recommendation within the European safety review according to Article 31 of Directive 2001/83/EC.
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12.06.2013
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Dear Doctor Letter (Rote-Hand-Brief) on cyproterone acetate 2 mg/ethinylestradiol 35 µg
Active substance: cyproterone acetate
Strengthening of warnings, new contraindications and updated indication.
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04.06.2013
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Information Letter on CILEST® and PRAMINO® tablets: Recall of the entire stock from the market
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.
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23.05.2013
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Dear Doctor Letter (Rote-Hand-Brief) on Samsca® (tolvaptan): liver injury
Active substance: tolvaptan
Information for healthcare professionals regarding the potential risk of liver injury due to Samsca® (tolvaptan).
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23.05.2013
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Information Letter on Nipruss® (sodium nitroprusside): recall all batches
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).
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13.05.2013
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Dear Doctor Letter (Rote-Hand-Brief) on Protelos® (strontium ranelate): Restriction of indication
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).
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02.05.2013
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Dear Doctor Letter (Rote-Hand-Brief) on Pletal® (cilostazol): New safety information
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.
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02.05.2013
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Dear Doctor Letter (Rote-Hand-Brief) on Tavor® pro injectione 2 mg solution for injection (lorazepam): Recall
Active substance: lorazepam
Recall of Tavor® pro injectione 2 mg solution for injection due to possible contamination with glass splinters.
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30.04.2013
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Increlex® 10 mg/ml solution for injection (mecasermin, recombinant human IGF-1): Temporary market shortage
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 the safety or efficacy of Increlex® already on the market is not affected.
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23.04.2013
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Information Letter on CAELYX®: As of Monday 29 April 2013, supply with the medicinal product will return to normal
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.
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08.04.2013
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Dear Doctor Letter (Rote-Hand-Brief) on Thalidomide Celgene™ (thalidomide): Risk of second primary haematological malignancies
Active substance: thalidomide
The pharmaceutical manufacturer is sending out information on the risk of second primary haematological malignancies in patients treated with thalidomide.
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