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Fuzeon 90 mg/ml powder and solvent for solution for injection (2010)

Active ingredients: Enfuvirtide

Product Name and Form

Fuzeon 90 mg/ml powder and solvent for solution for injection.

Pharmaceutical form

Powder and solvent for solution for injection.

White to off-white lyophilised powder.

Qualitative and Quantitative Composition

Each vial contains 108 mg enfuvirtide.

Each ml of reconstituted solution contains 90 mg enfuvirtide.

For a full list of excipients, see section 6.1.

Chemical substance
Description
Enfuvirtide

Enfuvirtide is a member of the therapeutic class called fusion inhibitors. It is an inhibitor of the structural rearrangement of HIV-1 gp41 and functions by specifically binding to this virus protein extracellularly thereby blocking fusion between the viral cell membrane and the target cell membrane, preventing the viral RNA from entering into the target cell.

List of excipients

Powder:

Sodium carbonate
Mannitol
Sodium hydroxide
Hydrochloric Acid

Solvent:

Water for Injections

Pack sizes and Marketing

Powder

Vial: 3 ml vial, colourless glass type 1

Closure: lyophilisate stopper, rubber (latex free)

Seal: aluminum seal with flip-off cap

Solvent

Vial: 2 ml vial, colourless glass type 1

Closure: rubber stopper (latex free)

Seal: aluminum seal with flip-off cap

Pack sizes

Pack 1:

60 vials powder for solution for injection

60 vials solvent

60 3 ml syringes

60 1 ml syringes

180 alcohol swabs

Pack 2:

60 vials powder for solution for injection

60 vials solvent

Marketing authorization holder
Authorization dates

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Date of first authorisation: 27 May 2003

Date of last renewal: 27 May 2008

Marketing authorization number:

EU/1/03/252/001-002