Key facts

Invented name
  • Harvoni
  • 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 oral solid dosage form
  • Age-appropriate dosage form, other
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 date
Compliance procedure number
EMEA-C-001411-PIP01-12-M04
Compliance opinion date
Compliance outcome
Positive

Decision

P/0063/2017: EMA decision of 17 March 2017 on the acceptance of a modification of an agreed paediatric investigation plan for sofosbuvir / ledipasvir (Harvoni), (EMEA-001411-PIP01-12-M04)

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