Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Pifeltro   
Auth. number : EU/1/18/1332
Active substance : doravirine
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J05 - Antivirals for systemic use
Pharmacological subgroup: J05A - Agents affecting the virus directly
Chemical subgroup: J05AG - Non-nucleoside reverse transcriptase inhibitors
Chemical substance: J05AG06 - doravirine
(See WHO ATC Index)
Indication: Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults infected with HIV 1 without past or present evidence of resistance to the NNRTI class.
Marketing Authorisation Holder: Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
27/11/2018 Centralised - Authorisation EMEA/H/C/4747 (2018)7983 of 22/11/2018
28/02/2019 Centralised - Variation EMEA/H/C/4747/II/01