Date: 2011-12-19
Type of information: Granting of a Market Authorisation in the EU
Product name: Eviplera®
Compound: fixed dose combination of emtricitabine, rilpivirine and tenofovir disoproxil
Therapeutic area: Infectious diseases
Action mechanism: All three substances act by inhibition of HIV-1 reverse transcriptase, an enzyme needed for replication of the virus; rilpivirine hydrochloride is a non-nucleoside reverse transcriptase.
Company: Gilead Sciences (USA)
Disease: HIV-1 infection
Latest news: * On 22 September 2011, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Eviplera®, 200 mg of emtricitabine, 25 mg of rilpivirine (as hydrochloride) and 245 mg of tenofovir disoproxil (as fumarate) film-coated tablet, intended for the treatment of human immunodeficiency virus-1 (HIV-1) infection.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2011-11-28
Favourable opinion UE: 2011-09-22
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
