EMEA-001646-PIP01-14-M02

Key facts

Invented name
Epclusa
Active substance
  • Sofosbuvir
  • velpatasvir
Therapeutic area
Infectious diseases
Decision number
P/0150/2018
PIP number
EMEA-001646-PIP01-14-M02
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral formulation
Condition(s) / indication(s)
Treatment of chronic hepatitis C
Route(s) of administration
Oral use
Contact for public enquiries
Gilead Sciences International Ltd

E-mail: regulatory.pip@gilead.com
Tel. +44 (0)1223 897300

Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-001646-PIP01-14-M02
Compliance opinion date
26/02/2021
Compliance outcome
positive

Decision

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