EMA — authorised 22 November 2018
- Marketing authorisation holder: MERCK SHARP & DOHME B.V.
- Status: approved
🇪🇺 Pifeltro in European Union
EMA authorised Pifeltro on 22 November 2018
Marketing authorisations
EMA — authorised 22 November 2018
- Application: EMEA/H/C/004747
- Marketing authorisation holder: Merck Sharp & Dohme B.V.
- Local brand name: Pifeltro
- Indication: Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with HIV 1 without past or present evidence of resistance to the NNRTI class.
- Status: approved
Pifeltro in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in European Union
Frequently asked questions
Is Pifeltro approved in European Union?
Yes. EMA authorised it on 22 November 2018; EMA authorised it on 22 November 2018.
Who is the marketing authorisation holder for Pifeltro in European Union?
MERCK SHARP & DOHME B.V. holds the EU marketing authorisation.