MHRA-100098-PIP01-21-M02 (update)

Key Facts

Active Substance
Active Substance:
  • ATALUREN
Invented Name
Translarna
PIP Number MHRA-100098-PIP01-21-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Granules for oral suspension
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of dystrophinopathy
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
  • PTC Therapeutics International Limited
  • Country Ireland
  • Tel +35319068700
  • Email medinfo@ptcbio.com
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
07/09/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100098-PIP01-21-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):ATALUREN.pdf
Published Date 19/12/2023