EMEA-000428-PIP01-08-M03

Table of contents

Key facts

Invented name
NovoEight
Active substance
turoctocog alpha
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0207/2016
PIP number
EMEA-000428-PIP01-08-M03
Pharmaceutical form(s)
Powder and solvent for solution for injection
Condition(s) / indication(s)
Treatment of hereditary factor-VIII deficiency
Route(s) of administration
Intravenous use
Contact for public enquiries
Novo Nordisk A/S

Denmark
Tel. +45 44448888
E-mail: paediatrics@novonordisk.com

Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000428-PIP01-08-M03
Compliance opinion date
26/04/2019
Compliance outcome
positive

Decision

Related content

How useful was this page?

Add your rating