Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Ireland
Eperzan 30 mg powder and solvent for solution for injection.
Eperzan 50 mg powder and solvent for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection. Powder: lyophilised white to yellow powder. |
Eperzan 30 mg powder and solvent for solution for injection: Each pen delivers 30 mg albiglutide per 0.5 ml dose following reconstitution.
Eperzan 50 mg powder and solvent for solution for injection: Each pen delivers 50 mg albiglutide per 0.5 ml dose following reconstitution.
Albiglutide is a recombinant fusion protein consisting of two copies of a 30-amino acid sequence of modified human glucagon-like peptide 1 genetically fused in series to human albumin.
Albiglutide is produced in Saccharomyces cerevisiae cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Albiglutide |
Albiglutide is an agonist of the GLP-1 receptor and augments glucose-dependent insulin secretion. Albiglutide also slows gastric emptying. |
| List of Excipients |
|---|
|
Powder for solution for injection: Sodium dihydrogen phosphate monohydrate Solvent: Water for injections |
Dual Chamber Cartridge (DCC) composed of a Type 1 glass barrel sealed with bromobutyl rubber stoppers and a bromobutyl rubber closure disc encased in a polypropylene snap on cap. Each cartridge is assembled into a disposable single use plastic pen injector (pen).
Each pen delivers a single 30 mg or 50 mg dose of Eperzan in a volume of 0.5 ml.
Pack sizes:
Carton of 4 single-dose pens and 4 pen needles.
Multipack containing 12 single-dose pens and 12 pen needles (3 packs of 4 pens and 4 needles).
Not all pack sizes may be marketed.
GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Ireland
EU/1/13/908/001
EU/1/13/908/002
EU/1/13/908/003
EU/1/13/908/004
Date of first authorisation: 21 March 2014
| Drug | Countries | |
|---|---|---|
| EPERZAN | Estonia, Lithuania |
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