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

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.

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

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

Marketing authorization dates and numbers

EU/1/03/252/001-002

Date of first authorisation: 27 May 2003

Date of last renewal: 27 May 2008

Drugs

Drug
Countries
Austria, Australia, Brazil, Canada, Cyprus, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Poland, United Kingdom