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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30.08.2012
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Codeine: Genetic polymorphism - paediatric deaths
Active substance: codein
Recently, the U.S. licencing authority FDA reported three cases of death and one case of life-threatening respiratory depression following administration of codeine to children between 2 and 5 years of age. According to FDA statements the three children who died were "ultra-rapid" metabolisers, the fourth child was an "extensive" metaboliser.
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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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14.08.2017
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Counterfeits of the medicinal product VELCADE® 3.5 mg powder for solution for injection discovered in Germany
Active substance: bortezomib
The Federal Institute for Drugs and Medical Devices (BfArM) is issuing information on counterfeits of the medicinal product VELCADE 3.5 mg powder for solution for injection by Janssen-Cilag International NV, Belgium which were was found in Germany at the parallel distributor EuroPharma hvd medical GmbH in the Saarland.
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02.08.2017
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Counterfeits of the medicinal product Xeplion® 150 mg extended-release suspension for injection (batches GFB4D00_BG-RO and GEB3Z00_BG-RO) have reached the German market (including amendments of 2 August 2017, 28 July 2017 and 26 July 2017)
Active substance: paliperidon
The Federal Institute for Drugs and Medical Devices (BfArM) has received new information on a further batch concerned in the case of counterfeits of the medicinal product Xeplion 150 mg extended-release suspension for injection (active substance: paliperidone) by Janssen-Cilag. The presentation of this batch is likewise Romanian/Bulgarian.
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26.03.2020
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COVID-19: beware of falsified medicines from unregistered websites
Active substance: diverse
The BfArM and the EMA advise the public not to purchase medicines from unauthorised websites or other vendors trying to take advantage of the fears and concerns of the public.
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28.01.2011
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Dexrazoxane: Referral procedure for clarification of a potentially increased risk of secondary cancers
Active substance: dexrazoxane
In the course of a graduated plan procedure, stage II, the BfArM announces the initiation of a referral procedure in accordance with Article 31 of Directive 2001/83/EC.
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16.04.2010
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Dextromethorphane (DXM): Growing number of reports on misuse in 2009. Pharmacies are recommended to sell with caution.
Active substance: dextromethorphane
In 2009 the BfArM received a noticeably increased number of reports on (suspected) misuse of dextromethorphane products compared with previous years.
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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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22.05.2018
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Dolutegravir (Tivicay®, Triumeq®): New study suggests risk of birth defects in babies born to women who were treated for HIV infection
Active substance: dolutegravir
The European Medicines Agency (EMA) is currently evaluating preliminary results from a study which found 4 cases of birth defects.
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22.07.2011
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Dronedarone: EMA renews information on the benefit-risk assessment of Multaq®
Active substance: dronedarone
The European Medicines Agency is currently reviewing the benefit-risk balance of the antiarrhythmic agent dronedarone (Multaq®). New study data (PALLAS study) indicate a significantly increased risk of cardiovascular adverse events in patients with permanent atrial fibrillation due to treatment with dronedarone. In January 2011 the CHMP already initiated a procedure to review the benefit-risk balance following reports of severe liver injury including hepatic failure due to dronedarone.
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05.09.2012
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Duogynon: Analysis of a retrospective case series does not show a causal association with birth defects, but it can also not be ruled out with certainty
Active substance:
The analytical results of a retrospective series of case-control studies yielding information on several types of birth defects in newborn babies in connection with the use of Duogynon during early pregnancy are now available to the BfArM.
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05.04.2011
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EMA announcement on possible radioactivity of medicinal products manufactured in Japan
Active substance:
The BfArM calls attention to the public announcement made by the European Medicines Agency (EMA) in co-ordination with the European licensing authorities following the radiation leak from the Fukushima Daiichi nuclear power plant in Japan.
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24.11.2011
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EMA recommends suspension of marketing authorisation for all medicinal products containing buflomedil
Active substance: buflomedil
The Committee for Medicinal Products on Human Use (CHMP) of the European Medicines Agency (EMA) has completed its review of the benefit/risk balance of buflomedil and has come to a negative conclusion. The EMA recommends that all marketing authorisations for medicines containing buflomedil should be suspended throughout the Member States of the EU.
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18.05.2017
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Epclusa® 400 mg/100 mg film-coated tablets (batch 15SFPD119): Counterfeit in German packaging offered to wholesaler
Active substance: sofosbuvir, velpatasvir
The Federal Institute for Drugs and Medical Devices (BfArM) reports that a counterfeit of the company Gilead's medicinal product Epclusa® 400 mg/100 mg film-coated tablets was offered to a wholesaler in Germany.
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