MHRA-100213-PIP01-21-M04 (update)

Key Facts

PIPS Key Facts
Active Substance	Active Substance: RAVULIZUMAB
Invented Name	Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris
PIP Number	MHRA-100213-PIP01-21-M04 (update)
Pharmaceutical form(s)	Pharmaceutical form(s): Solution for injection. Concentrate for solution for infusion.
Therapeutic area	Therapeutic area: Haematology-Hemostaseology
Conditions / Indications	Conditions / Indications: Treatment of Paroxysmal Nocturnal Haemoglobinuria
Route(s) of administration	Subcutaneous use intravenous
PIP applicant	Alexion Europe SAS Country France Tel 02087446600 Email ukieregulatory@astrazeneca.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):RAVULIZUMAB.pdf
Published Date	24/06/2024