BioAlliance Pharma Announces the Registration of Sitavig® in European Countries
12/21/2012 9:06:17 AM
PARIS--(BUSINESS WIRE)--Regulatory News: BioAlliance Pharma SA (Euronext Paris - BIO) (Paris:BIO), an innovative Company dedicated to the development of orphan oncology products and to supportive care products, announces the approval of Sitavig® (acyclovir LauriadTM) for the treatment of recurrent labial herpes in 8 European countries*. The decentralized procedure, with Sweden as Reference Member State, ended with a positive opinion for these first 8 countries. Each country will now issue a national marketing authorization in the coming weeks. Besides, BioAlliance Pharma plans to pursue the submission of the registration dossier in other European countries as soon as the first quarter of 2013. The evaluation by the Agencies should then last 4 to 6 months.