MHRA-102391-PIP01-26

Key Facts

Active Substance
Active Substance:
  • CABOTEGRAVIR
Invented Name
  • APRETUDE
  • Apretude 600 mg prolonged-release suspension for injection (PLGB 35728/0062)
  • Apretude 30 mg film-coated tablets (PLGB 35728/0061)
PIP Number MHRA-102391-PIP01-26
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for prolonged-release suspension for injection
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Prevention of human immunodeficiency virus (HIV-1) infection
Route(s) of administration
Route(s) of administration:
  • intramuscular
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):CABOTEGRAVIR.pdf
Published Date 23/07/2026