- Marketing authorisation of Intratect 100 g/l (10%) under the European Decentralised Procedure
- Marketing of the new product possible in 18 other European countries in addition to Germany
- Market introduction in Germany expected from January 2013
DREIEICH, Germany I October 24, 2012 I Today, Biotest obtained marketing authorisation under the European Decentralised Procedure (DCP) for the 10% intravenous Intratect (100 g/l) immunoglobulin solution. 19 European countries are involved in this marketing authorisation procedure. According to European guidelines, the marketing authorisation applies for the treatment of primary immunodeficiency syndromes (PID), hypogammaglobulinaemia, primary immune thrombocytopenia (ITP), Gulllain-Barré syndrome (GBS) and Kawasaki syndrome. Intratect 10% will be available for the German market from January 2013 on. It will be introduced gradually in other countries.
The marketing authorisation of Intratect 10% by the relevant European authorities is based on the results of a clinical multicentre study carried out in Europe. Its main focus was to study the pharmacokinetics, tolerability and safety of the new product in patients with primary immunodeficiency syndrome. The pharmacokinetics and the side-effects observed of Intratect 10% are similar to Intratect 5% (50 g/l), which has been in the market for some time.
The Intratect products are Premium Immunoglobulin (IVIG) products for Biotest. Intratect 5% is especially designed for delicate patients where time is not the determining decision factor. Intratect 10% is especially designed for the more robust patients tolerating the 10% solution.
About Intratect 100 g/l (10%)
Intratect 10% is a polyvalent immunoglobulin G preparation from human blood plasma for intravenous administration (IVIG). The ready-to-use solution is suitable for replacement therapy in primary and secondary antibody deficiency syndromes and also for immunomodulation in autoimmune diseases such as ITP, GBS and Kawasaki syndrome. The dosage and duration of the treatment depends on the indication and the severity of the disease.
The manufacturing of Intratect 10% and 5% is a state of the art production process to ensure highest quality and virus safety.
The sugarfree infusion solution is suitable for patients with diabetes or sugar intolerance. Intratect 10% can be stored for two years at up to 25°C (room temperature).
About primary immune deficiencies
Primary immune deficiencies (PID) belong to a group of more than 150 functional disorders, which affect cells, tissue and proteins of the immune system. People with PID have an inadequately functioning immune system and are therefore more prone to infections. In these patients, who are often children, treatment with antibiotics is not sufficient to successfully control severe, recurring infections. Without adequate immunoglobulin G replacement, organ dysfunction and an increased risk of tumours or autoimmune diseases occur in the long term.
It is estimated that 10 million people worldwide are affected by PID.
SOURCE: Biotest
Post Views: 92
- Marketing authorisation of Intratect 100 g/l (10%) under the European Decentralised Procedure
- Marketing of the new product possible in 18 other European countries in addition to Germany
- Market introduction in Germany expected from January 2013
DREIEICH, Germany I October 24, 2012 I Today, Biotest obtained marketing authorisation under the European Decentralised Procedure (DCP) for the 10% intravenous Intratect (100 g/l) immunoglobulin solution. 19 European countries are involved in this marketing authorisation procedure. According to European guidelines, the marketing authorisation applies for the treatment of primary immunodeficiency syndromes (PID), hypogammaglobulinaemia, primary immune thrombocytopenia (ITP), Gulllain-Barré syndrome (GBS) and Kawasaki syndrome. Intratect 10% will be available for the German market from January 2013 on. It will be introduced gradually in other countries.
The marketing authorisation of Intratect 10% by the relevant European authorities is based on the results of a clinical multicentre study carried out in Europe. Its main focus was to study the pharmacokinetics, tolerability and safety of the new product in patients with primary immunodeficiency syndrome. The pharmacokinetics and the side-effects observed of Intratect 10% are similar to Intratect 5% (50 g/l), which has been in the market for some time.
The Intratect products are Premium Immunoglobulin (IVIG) products for Biotest. Intratect 5% is especially designed for delicate patients where time is not the determining decision factor. Intratect 10% is especially designed for the more robust patients tolerating the 10% solution.
About Intratect 100 g/l (10%)
Intratect 10% is a polyvalent immunoglobulin G preparation from human blood plasma for intravenous administration (IVIG). The ready-to-use solution is suitable for replacement therapy in primary and secondary antibody deficiency syndromes and also for immunomodulation in autoimmune diseases such as ITP, GBS and Kawasaki syndrome. The dosage and duration of the treatment depends on the indication and the severity of the disease.
The manufacturing of Intratect 10% and 5% is a state of the art production process to ensure highest quality and virus safety.
The sugarfree infusion solution is suitable for patients with diabetes or sugar intolerance. Intratect 10% can be stored for two years at up to 25°C (room temperature).
About primary immune deficiencies
Primary immune deficiencies (PID) belong to a group of more than 150 functional disorders, which affect cells, tissue and proteins of the immune system. People with PID have an inadequately functioning immune system and are therefore more prone to infections. In these patients, who are often children, treatment with antibiotics is not sufficient to successfully control severe, recurring infections. Without adequate immunoglobulin G replacement, organ dysfunction and an increased risk of tumours or autoimmune diseases occur in the long term.
It is estimated that 10 million people worldwide are affected by PID.
SOURCE: Biotest
Post Views: 92
