EMEA-001296-PIP01-12-M04

Table of contents

Key facts

Invented name
Adynovi
Active substance
rurioctocog alfa pegol
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0302/2021
PIP number
EMEA-001296-PIP01-12-M04
Pharmaceutical form(s)
Powder and solvent for solution for injection
Condition(s) / indication(s)
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)
Route(s) of administration
Intravenous use
Contact for public enquiries
Baxalta Innovations GmbH

E-mail: medinfoEMEA@takeda.com
Tel. +44 (0)3333 000181

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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