MHRA-102232-PIP01-25

Key Facts

Active Substance
Active Substance:
  • Napazimone
Invented Name
Not yet available
PIP Number MHRA-102232-PIP01-25
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral liquid dosage form
Therapeutic area
Therapeutic area:
  • Other: Genetic mitochondrial abnormalities NEC
Conditions / Indications
Conditions / Indications:
  • Treatment of primary mitochondrial disease
Route(s) of administration
  • Oral use
  • Gastric use
PIP applicant
  • Pharming Technologies B.V.
  • Country Netherlands
  • Tel +31715247400
  • Email info@pharming.com
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):Napazimone.pdf
Published Date 01/05/2026