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Register of orphan medicinal products


Product information

(S)-{8-fluoro-2-2[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)-phenyl]-3,4-dihydro-4-quinazolinyl} acetic acid

EU orphan designation number: EU/3/11/849   
Active ingredient: (S)-{8-fluoro-2-2[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)-phenyl]-3,4-dihydro-4-quinazolinyl} acetic acid
Indication: Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity deemed at risk
Sponsor: Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name PREVYMIS on 8/01/2018 with the number EU/1/17/1245

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
19/04/2011 Orphan designation EMA/OD/090/10 (2011)2836 of 15/04/2011
19/03/2013 Transfer of orphan designation EMA/OD/090/10/T/01 (2013)1714 of 15/03/2013
27/06/2018 Transfer of orphan designation EMA/OD/090/10/T/02 (2018)4102 of 25/06/2018