Pharmaceuticals - Community Register


List of referrals for human medicinal products

Tibolona Aristo

Product name: Tibolona Aristo
Also marketed in the EU under the name(s): Tibolon Aristo
INN: tibolone
Indication: Treatment of oestrogen deficiency symptoms in women more than one year after the menopause
Marketing Authorisation Holder: ArIsto Pharma GmbH


European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
06/03/2014 Referral EMEA/H/A-29/1389 (2014)1614 of 05/03/2014