10.04.2015
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Viread: Possibility of counterfeits of the medicinal product in the legal supply chain in Germany
Active substance: tenofovir
The BfArM has received information that counterfeits of the centrally licensed medicinal product Viread 245 mg film-coated tablets are possibly on the market in Germany.
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07.04.2015
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Medicinal products containing dimethyl fumarate (Tecfidera®, Fumaderm®): Progressive multifocal leukoencephalopathy (PML) in connection with the administration of medicinal products containing dimethyl fumarate
Active substance: dimethyl fumarate
The BfArM issues information that in Germany up to now overall 9 cases of PML (progressive multifocal leukoencephalopathy) have been reported in connection with the administration of Fumaderm® and 2 cases in connection with the administration of Tecfidera®.
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27.03.2015
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Sofosbuvir: Arrhythmias as a possible interaction with other direct-acting antiviral agents (DAA) for the treatment of hepatitis C in combination with agents that could cause bradycardia (e.g. amiodarone)
Active substance: sofosbuvir
Signs of potential arrhythmias, especially the possibly life-threatening slowing of the heart rate (bradycardia), have become known especially due to case reports from France.
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27.03.2015
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Metformin: Update of Summaries of Product Characteristics/Package Leaflets regarding contraindication for patients with impaired renal function
Active substance: metformin
The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) issues information that the Summaries of Product Characteristics/Package Leaflets of medicinal products containing metformin have been updated with regard to the contraindication for patients with impaired renal function.
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06.03.2015
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Neulasta®: Possibility of counterfeits being on the market
Active substance: pegfilgrastim
The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) has received information via the "Land" authority ("Landesbehörde") of Bavaria and via the EU's Rapid Alert System (RAS) that counterfeits of the medicinal product Neulasta® have possibly reached Germany.
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24.02.2015
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Cialis®: Counterfeit medicinal products from Italy - Update
Active substance: tadalafil
The BfArM is reporting further information from the company Lilly as the marketing authorisation holder of the originator product.
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12.02.2015
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Information on theft of the medicinal product Sildaristo® produced by Aristo Pharma GmbH in Berlin
Active substance: sildenafil
The State Office of Health and Social Affairs in Berlin ("Landesamt für Gesundheit und Soziales", LaGeSo) has informed the BfArM of the theft of the medicinal product Sildaristo®.
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26.11.2014
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Counterfeit medicinal products in Spain
Active substance:
On 18 November 2014, the Spanish licensing authority Agencia Española de Medicamentos y Productos Sanitarios (AEMPS--Agencia Española de Medicamentos y Productos Sanitarios) issued information on initial findings on illegally traded medicinal products of Spanish origin.
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07.11.2014
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Tecfidera® (dimethyl fumarate): First case of progressive multifocal leukoencephalopathy (PML)
Active substance: dimethyl fumarate
At the request of the BfArM, the Pharmacovigilance Risk Assessment Committee (PRAC) discussed a fatal case of progressive multifocal leukoencephalopathy (PML) which was reported in a patient treated with Tecfidera® (dimethyl fumarate) at its meeting from 3 - 6 November 2014.
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15.09.2014
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Information on medicinal products traded illegally in Romania on the German market
Active substance: rituximab, trastuzumab
The Romanian medicines licensing authority (ANMDM) has informed the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institut (PEI) via the European Rapid Alert System that batches of 45 medicinal products traded by the Romanian wholesale distributor Chemomed are being recalled.
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17.06.2014
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Sutent® 25 mg and 50 mg hard capsules: BfArM issues warning regarding counterfeits of the medicinal product from Romania
Active substance: sunitinib
The Federal Institute for Medicinal Products and Medical Devices (BfArM) is circulating a warning against counterfeits of the 25 mg and 50 mg strengths of the cancer drug Sutent® produced by Pfizer. The counterfeits that are parallel imported can be identified based on visible differences in hard capsules and foil sealing of the plastic bottle.
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05.06.2014
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Rienso® (ferumoxytol): Risk of serious hypersensitivity reactions
Active substance: ferumoxytol
The EMA is in the process of evaluating all worldwide data available on serious hypersensitivity reactions in connection with administration of the medicinal product Rienso (ferumoxytol) which, however, is currently not being marketed in Germany.
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25.11.2013
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Iclusig®: Risk of blood clots
Active substance: ponatinib
The Committee for Medicinal Products for Human Use (CHMP) recommends updating the product information of the leukaemia medicine Iclusig® (ponatinib) to include new warnings in order to minimise the risk of a higher rate of blood clots.
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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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09.11.2012
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Diphenhydramine, doxylamine and dimenhydrinate: Over-the-counter first-generation H1-antihistamines in infants and young children
Active substance: diphenhydramine, doxylamine and dimenhydrinate
Children under the age of 3 years are especially at risk of experiencing adverse effects of first-generation H1-antihistamines. The BfArM points out that these medicinal products are only to be administered to infants and young children under strict adherence to the product informations and with special caution.
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