Key facts

Invented name
Maviret
Active Substance
  • glecaprevir
  • pibrentasvir
Therapeutic area
Infectious diseases
Decision number
P/0128/2019
PIP number
EMEA-001832-PIP01-15-M02
Pharmaceutical form(s)
  • 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

AbbVie Ltd

E-mail: paediatricteam@abbvie.com
Tel. +44(0) 1628925033

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-001832-PIP01-15-M02
Compliance opinion date
Compliance outcome
Positive

Decision

P/0128/2019: EMA decision of 17 April 2019 on the acceptance of a modification of an agreed paediatric investigation plan for glecaprevir / pibrentasvir (Maviret) (EMEA-001832-PIP01-15-M02)

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