DGAP-News: Biotest AG
/ Key word(s): Regulatory Approval
30.11.2021 / 07:00
The issuer is solely responsible for the content of this announcement.
Biotest receives approval for Intratect(R) in France
Dreieich, 30 November 2021 Biotest AG today announces the marketing authorisation in France for the human intravenous immunoglobulin preparation Intratect(R), which is manufactured and marketed by Biotest in two concentrations (50 g/l and 100 g/l). The regulatory process (Repeat Use Procedure) and the approval of Intratect(R) in France were completed in a very short time.
Intratect(R) is an important component of Biotest’s portfolio with over 50 approvals worldwide. The broad spectrum of indications includes substitution therapy for primary and secondary immunodeficiency diseases as well as immunomodulation for primary immunothrombocytopenia, Guillain-Barré syndrome, Kawasaki syndrome, chronic inflammatory demyelinating polyradiculoneuropathy and multifocal motor neuropathy.
Due to a shortage of human intravenous immunoglobulin preparations in France, Biotest has already been marketing Intratect(R) in both concentrations since spring 2021 on the basis of a national exemption. “We are very pleased that we can now further expand the marketing of Intratect(R) on the basis of a regular marketing authorisation in France” emphasises Henrik Oehme, Head of Region Middle East, Africa & France, “with the approval of Intratect(R), there is now another human intravenous immunoglobulin preparation in France, which helps to ensure a continuous supply of this vital preparation for patients.”
The demand for immunoglobulin preparations in France is approximately 10 tonnes per year. “We thank the French authorities for their cooperation in partnership, which allows us to make our contribution to the supply of patients in France”, says Dr Olivier Samama, Managing Director of Biotest France SAS.
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com
Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201
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