FUZEON Powder and solvent for solution for injection Ref.[8773] Active ingredients: Enfuvirtide

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany

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.

Excipient with known effect: sodium. Contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

For the full list of excipients, see section 6.1.

Active Ingredient 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: aluminium seal with flip-off cap

Powder:

Vial: 2 ml vial, colourless glass type 1

Closure: rubber stopper (latex free)

Seal: aluminium seal with flip-off cap

Pack sizes:

60 vials powder for solution for injection
60 vials solvent
60 3 ml syringes
60 1 ml syringes
180 alcohol swabs

Marketing authorization holder

Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany

Marketing authorization dates and numbers

EU/1/03/252/001

Date of first authorisation: 27 May 2003

Date of latest renewal: 27 May 2008

Drugs

Drug Countries
FUZEON Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Lithuania, Mexico, Poland, Romania, United Kingdom

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