MHRA-100815-PIP01-22-M01 (update)

Key Facts

PIPS Key Facts
Active Substance	Active Substance: SIPONIMOD
Invented Name	Mayzent Mayzent Mayzent Mayzent Mayzent Mayzent Mayzent Mayzent Mayzent Mayzent Mayzent Mayzent Mayzent Mayzent Kiendra Mayzent Mayzent Mayzent Kiendra Mayzent Kiendra Mayzent Mayzent Mayzent Mayzent Mayzent Mayzent Kiendra Mayzent Mayzent Mayzent Mayzent Mayzent Mayzent
PIP Number	MHRA-100815-PIP01-22-M01 (update)
Pharmaceutical form(s)	Pharmaceutical form(s): Film-coated tablet
Therapeutic area	Therapeutic area: Neurology
Conditions / Indications	Conditions / Indications: Treatment of Multiple Sclerosis
Route(s) of administration	Route(s) of administration: Oral use
PIP applicant	Novartis Pharmaceuticals UK Limited Country United Kingdom Tel 02030895460 Email ramandeep.walia@novartis.com
Decision Type	Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check	Compliance Check No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document	Decision Document on a Paediatric Investigation Plan (PIP):SIPONIMOD.pdf
Published Date	25/05/2023