|
|
Article: Serono Obtains First Designation Under New EC Regulation on Orphan Products.
- Article from:
- PR Newswire
- Article date:
- September 13, 2000
CopyrightCOPYRIGHT 2000 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
|
Application for European Marketing Authorization for Serostim(R)
to be Submitted by Year-End
GENEVA, Sept. 13 /PRNewswire/ --
Serono S.A. (SWX Swiss Exchange: SEO and NYSE: SRA) announced today that the European Commission has granted Orphan Medicinal Product (OMP) designation to Serono's recombinant human growth hormone product, Serostim(R), for the treatment of AIDS wasting. This is the first such designation under the new EC Regulation on orphan medicinal products which was passed in January 2000. Serono intends to submit an application for EU marketing authorization to the European Medicines Evaluation Agency (EMEA) by year-end.
...