EMEA-001411-PIP01-12-M04

Key facts

Invented name
Harvoni
Active substance
  • Sofosbuvir
  • ledipasvir
Therapeutic area
Infectious diseases
Decision number
P/0063/2017
PIP number
EMEA-001411-PIP01-12-M04
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate dosage form, other
  • 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 International Ltd.
United Kingdom
Tel. +44 (0)1223 897300
Fax +44 (0)1223897284
E-mail: regulatory.pip@gilead.com
Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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