MHRA-100074-PIP01-21

Key Facts

Active Substance
Active Substance:
  • GABAPENTIN
Invented Name
Gralise
PIP Number MHRA-100074-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Prolonged-release tablets
Therapeutic area
  • Neurology
  • Pain
Conditions / Indications
Conditions / Indications:
  • Treatment of Postherpetic Neuralgia
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(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):GABAPENTIN.pdf
Published Date 17/12/2021