MHRA-101287-PIP01-23

Key Facts

Active Substance
  • SUMATRIPTAN
  • NAPROXEN SODIUM
Invented Name
  • Suvexx 85 mg/500 mg film-coated tablets
  • FI, DK, HU, NO, SE: Nomigrin EE, LT, LV: Migsun PL: Frimig Duo
PIP Number MHRA-101287-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablets
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of migraine headaches
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):SUMATRIPTANNAPROXEN SODIUM.pdf
Published Date 30/04/2024