EMEA-001024-PIP01-10-M02

Key facts

Invented name
Nuwiq and associated names
Active substance
  • Human-cell-line recombinant human factor VIII (human-cl rhFVIII)
  • Human Coagulation Factor VIII (rDNA)
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0014/2020
PIP number
EMEA-001024-PIP01-10-M02
Pharmaceutical form(s)
Powder and solvent for solution for injection
Condition(s) / indication(s)
Treatment of haemophilia A (congenital factor-VIII deficiency)
Route(s) of administration
Intravenous use
Contact for public enquiries
Octapharma Pharmazeutika Produktionsges.m.b.H

E-mail: sigurd.knaub@octapharma.ch
Tel. +41 554512141

Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-001024-PIP01-10-M02
Compliance opinion date
26/03/2021
Compliance outcome
positive

Decision

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