EU OKs Reinstatement of Aprotinin/Trasylol Marketing Authorizations
European Commission Approved Reinstatement of aprotinin/Trasylol® Marketing Authorisations in European Union
HOOFDDORP, The Netherlands, October 10, 2013 /PRNewswire/ --
Nordic Group announced today that the European Commission has approved the reinstatement of aprotinin marketing authorisations in European Union. This confirms the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) from May 2013, recommending these reinstatements. The recommendation took into account a full and independent review of the benefits and risks of aprotinin, which found that the results of the study, on which the suspension of aprotinin was based, were unreliable. Since 2007 Nordic has performed limited access programmes and is now looking forward to placing aprotinin in European markets according to national regulatory timelines.
The CHMP has recommended lifting the suspension for aprotinin in the indication: prophylactic use to reduce blood loss and blood transfusion in adult patients who are at high risk of major blood loss undergoing isolated cardiopulmonary bypass graft surgery (i.e., coronary artery bypass graft surgery that is not combined with other cardiovascular surgery). Aprotinin should only be used after careful consideration of the benefits and risks, and the consideration that alternative treatments are available. Aprotinin will be available to centres that perform cardiac surgery on cardiopulmonary bypass and that will participate in the aprotinin registry. Nordic (which was already marketing an aprotinin product) acquired rights to Trasylol® from Bayer in July 2012, worldwide excluding the United States. In September 2011, the marketing authorisation for aprotinin was reinstated in Canada.
About Nordic Group BV
The Nordic Group is a privately owned, fast growing, fully integrated, pan-European pharmaceutical company, with a strong focus on the development and commercialization of niche hospital and orphan products and services that cater to the specific needs of clients and patients. In addition to its direct sales and marketing presence in 16 European countries, operating under the name of Nordic Pharma and Nordic Drugs, the Nordic Group operates as well a number of specialized Pharmaceutical Services companies, specialized in product development, manufacturing, supply logistics, clinical studies and regulatory activities. These companies are operating under the name of Prague Clinical Services, QPharma, Disphar and Indeus. Since its creation, Nordic has enjoyed an average growth of 20% in revenues, and pursues its expansion through organic growth and strategic collaborations. Additional information can be obtained at http://www.nordicpharmagroup.com.
CONTACT: Contact at Nordic: Hans Schram, CEO, +33(0)1-70-37-63-93, firstname.lastname@example.org
Posted: October 2013