LACHEN, Switzerland - Tuesday, May 31st 2011 [ME NewsWire]
(BUSINESS WIRE)-- On 30 May 2011 The European Commission adopted the EMA's recommendation of 14 April 2011 revised on May 12, 2011 to lift the suspension of the marketing authorization of octagam® and octagam®10%, thus allowing both products back on the European markets.
On 14 April 2011 revised on May 12, 2011 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended to lift the EU-wide suspension of the marketing authorizations of both octagam® and octagam®10% which has been in place since October 4,2010. This recommendation was based on the safeguards and an action implemented by Octapharma and is subject to certain conditions.
For every batch to be released onto the market, Octapharma will carry out a Thrombin generation assay to measure substances that can cause thromboembolic events. Additionally, post-marketing studies will be implemented in order to confirm the safety of the product.
Octapharma was and is committed to provide their stakeholders with a family of IVIG preparations that offers the best possible value to patients and healthcare professionals and consequently manufactures octagam® and octagam® 10% according to the latest state of research in plasma fractionation.
The long term experience with the use of octagam® over 17 years and octagam®10% in over two years in the EU confirms the brand characteristics in terms of quality and tolerability.
About octagam®
octagam® is a liquid, 5% (50 mg/mL) immune globulin (human) solution for intravenous administration (IVIG) which is currently registered in about 60 countries, including the USA and the EU.
In the EU and other countries it is indicated for the use in: primary humoral immunodeficiency (PI); myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; in children with congenital AIDS who have repeated bacterial infections; immune thrombocytopenic purpura (ITP) in children or adults at high risk of bleeding or prior to surgery to correct the platelet count; Guillain Barré syndrome; Kawasaki disease.
About octagam®10%:
octagam®10% is a liquid, 10% (100 mg/mL) immune globulin (human) solution for intravenous administration (IVIG) which is currently registered mainly in European countries, where it is indicated for the use in: primary humoral immunodeficiency (PI); myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; in children with congenital AIDS who have repeated bacterial infections; immune thrombocytopenic purpura (ITP) in children or adults at high risk of bleeding or prior to surgery to correct the platelet count; Guillain Barré syndrome; Kawasaki disease. octagam®10% is the 10% version of octagam® (50 mg/mL) which was first launched in 1995.
About Octapharma
Octapharma AG is headquartered in Lachen, Switzerland and is an independent, global provider of pharmaceutical human proteins for life-threatening diseases. Its core business is the development, production and sale of high quality human proteins including plasma derivatives and recombinant products. The company was founded in 1983 and since then has grown to over 4,000 employees. Today it has 38 subsidiaries and representative offices in over 80 countries with state-of-the-art production facilities in Austria, France, Germany, Sweden and Mexico.
Contacts
Octapharma AG
Corinne Landolt
Corporate Communications
+41-(55)-451-21-36
Corinne.Landolt@octapharma.com
No comments:
Post a Comment