NOVOSEVEN Powder and solvent for solution for injection Ref.[9448] Active ingredients: Coagulation factor VIIa

The solvent of NovoSeven is provided in either a vial or in a pre-filled syringe. Not all presentations may be marketed.

The NovoSeven 1 mg (50 KIU)/NovoSeven 2 mg (100 KIU) package contains either:

• 1 vial (2 ml) with white powder for solution for injection
• 1 vial (2 ml) with solvent for reconstitution

or

• 1 vial (2 ml) with white powder for solution for injection
• 1 pre-filled syringe (3 ml) with solvent for reconstitution
• 1 plunger rod
• 1 vial adapter, with an integrated particle filter with a pore size of 25 micrometer.

The NovoSeven 5 mg (250 KIU)/NovoSeven 8 mg (400 KIU) package contains either:

• 1 vial (12 ml) with white powder for solution for injection
• 1 vial (12 ml) with solvent for reconstitution

or

• 1 vial (12 ml) with white powder for solution for injection
• 1 pre-filled syringe (10 ml) with solvent for reconstitution
• 1 plunger rod
• 1 vial adapter, with an integrated particle filter with a pore size of 25 micrometer.

Vial: Type I glass vial closed with a chlorobutyl rubber stopper, covered with an aluminium cap. The closed vial is equipped with a polypropylene tamper-evident snap-off cap.

Pre-filled syringe: Type I glass barrel with a polypropylene backstop and bromobutyl rubber plunger. The syringe cap consists of bromobutyl rubber and polypropylene tamper evident seal.

Plunger rod: made of polypropylene.

Novo Nordisk A/S, Novo Allé, DK-2880, Bagsværd, Denmark

NovoSeven 1 mg (50 KIU):

EU/1/96/006/004
EU/1/96/006/008

NovoSeven 2 mg (100 KIU):

EU/1/96/006/005
EU/1/96/006/009

NovoSeven 5 mg (250 KIU):

EU/1/96/006/006
EU/1/96/006/010

NovoSeven 8 mg (400 KIU):

EU/1/96/006/007
EU/1/96/006/011

Date of first authorisation: 23 February 1996
Date of latest renewal: 23 February 2006