Key facts

Invented name
Vosevi
Active Substance
  • Sofosbuvir
  • velpatasvir
  • voxilaprevi
Therapeutic area
Infectious diseases
Decision number
P/0006/2020
PIP number
EMEA-001822-PIP01-15-M01
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral solid dosage form
Condition(s) / indication(s)
Treatment of chronic hepatitis C
Route(s) of administration
Oral use
Contact for public enquiries

Gilead Sciences Ireland UC

E-mail: regulatory.pip@gilead.com
Tel. +44 1223897300

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-001822-PIP01-15-M01
Compliance opinion date
Compliance outcome
Positive

Decision

P/0006/2020: EMA decision of 6 January 2020 on the acceptance of a modification of an agreed paediatric investigation plan for sofosbuvir / velpatasvir / voxilaprevir (Vosevi), (EMEA-001822-PIP01-15-M01)

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