Navigation path

Pharmaceuticals - Community Register


Community 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 Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

   Public summary of scientific opinion    

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