EMEA-002863-PIP01-20

Table of contents

Key facts

Active substance
(1R,3S,5R)-2-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromo-3- methylpyridin-2-yl)-5-methyl-2-azabicyclo[3.1.0]hexane-3-carboxamide (ALXN2050)
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0324/2021
PIP number
EMEA-002863-PIP01-20
Pharmaceutical form(s)
Capsule, hard
Condition(s) / indication(s)
Treatment of paroxysmal nocturnal haemoglobinuria
Route(s) of administration
Oral use
Contact for public enquiries
Alexion Europe SAS

E-mail: pip.enquiries.eu@alexion.com
Tel. +33 147103621

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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