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Pharmaceuticals - Community Register

  

List of referrals for human medicinal products

Betavert N and associated names

Product name: Betavert N and associated names
Also marketed in the EU under the name(s): Vertimen, Vertisan
INN: betahistine dihydrochloride
Indication: Betahistine is indicated for the treatment of Menière’s syndrome, symptoms of which may include vertigo (often associated with nausea and/or vomiting), tinnitus and hearing loss.
Marketing Authorisation Holder: Hennig Arzneimittel GmbH & Co. KG

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
03/06/2009 Referral EMEA/H/A-29/1094 (2009)4399 of 02/06/2009