Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
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. |
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 Solvent: Water for Injections |
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
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
EU/1/03/252/001
Date of first authorisation: 27 May 2003
Date of latest renewal: 27 May 2008
| 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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