EMEA-000185-PIP01-08-M05

Key facts

Invented name
NovoThirteen
Active substance
catridecacog
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0001/2013
PIP number
EMEA-000185-PIP01-08-M05
Pharmaceutical form(s)
Powder and solvent for solution for injection
Condition(s) / indication(s)
Treatment of congenital factor-XIII A-subunit deficiency
Route(s) of administration
Intravenous use
Contact for public enquiries
Novo Nordisk A/S

E-mail: paediatrics@novonordisk.com
Tel. +45 4444 8888

Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000185-PIP01-08-M05
Compliance opinion date
16/12/2016
Compliance outcome
positive

Decision

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