EMEA-001276-PIP01-12-M02

Key facts

Invented name
Sovaldi
Active substance
Sofosbuvir
Therapeutic area
Infectious diseases
Decision number
P/0172/2018
PIP number
EMEA-001276-PIP01-12-M02
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral solid dosage form
  • Age-appropriate oral liquid 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

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

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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