EMEA-001418-PIP02-15-M03 - paediatric investigation plan

Cabotegravir
PIPHuman

Key facts

Invented name
Vocabria
Active Substance
Cabotegravir
Therapeutic area
Infectious diseases
Decision number
P/0102/2022
PIP number
EMEA-001418-PIP02-15-M03
Pharmaceutical form(s)
  • Film-coated tablet
  • Prolonged-release suspension for injection
Condition(s) / indication(s)
Prevention of human immunodeficiency virus (HIV-1) infection
Route(s) of administration
  • Oral use
  • Intramuscular use
Contact for public enquiries

ViiV Healthcare UK Limited

E-mail: eu.paediatric-plans@gsk.com
Tel. +44 (0)208 990 3650

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-001418-PIP02-15-M03
Compliance opinion date
Compliance outcome
Positive

Decision

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