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Pharmaceuticals - Community Register

  

List of referrals for human medicinal products

Tibocina and associated names

Product name: Tibocina and associated names
Also marketed in the EU under the name(s): Tibolinia, 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-29/1390 (2014)1622 of 05/03/2014