Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
SOMAVERT 10 mg powder and solvent for solution for injection.
SOMAVERT 15 mg powder and solvent for solution for injection.
SOMAVERT 20 mg powder and solvent for solution for injection.
SOMAVERT 25 mg powder and solvent for solution for injection.
SOMAVERT 30 mg powder and solvent for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection (powder for injection). The powder is white to slightly off-white. |
SOMAVERT 10 mg powder and solvent for solution for injection: One vial contains 10 mg of pegvisomant. After reconstitution, 1 ml of solution contains 10 mg of pegvisomant.*
Excipient with known effect: The 10 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder.
SOMAVERT 15 mg powder and solvent for solution for injection: One vial contains 15 mg of pegvisomant. After reconstitution, 1 ml of solution contains 15 mg of pegvisomant.*
Excipient with known effect: The 15 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder.
SOMAVERT 20 mg powder and solvent for solution for injection: One vial contains 20 mg of pegvisomant. After reconstitution, 1 ml of solution contains 20 mg of pegvisomant.*
Excipient with known effect: The 20 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder.
SOMAVERT 25 mg powder and solvent for solution for injection: One vial contains 25 mg of pegvisomant. After reconstitution, 1 ml of solution contains 25 mg of pegvisomant.*
Excipient with known effect: The 25 mg strength of the medicinal product contains 0.5 mg of sodium per vial of powder.
SOMAVERT 30 mg powder and solvent for solution for injection: One vial contains 30 mg of pegvisomant. After reconstitution, 1 ml of solution contains 30 mg of pegvisomant.*
Excipient with known effect: The 30 mg strength of the medicinal product contains 0.6 mg of sodium per vial of powder.
* produced in Escherichia coli cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pegvisomant |
Pegvisomant is an analogue of human growth hormone that has been genetically modified to be a growth hormone receptor antagonist for the treatment of adult patients with acromegaly. Pegvisomant is highly selective for the GH receptor, and does not cross-react with other cytokine receptors, including prolactin. |
| List of Excipients |
|---|
|
Powder: Glycine Solvent: Water for Injections |
10 mg or 15 mg or 20 mg or 25 mg or 30 mg of pegvisomant in powder in a vial (type I flint glass) with a stopper (chlorobutylrubber) and 1 ml solvent (water for injections) in a pre-filled syringe (type I borosilicate glass) with a plunger stopper (bromobutyl rubber) and a tip cap (bromobutyl rubber). The colour of the protective plastic cap is specific to the strength of the product.
SOMAVERT 10 mg and 15 mg: Pack size of 30 vials, pre-filled syringes and safety needles.
SOMAVERT 20 mg, 25 mg and 30 mg: Pack sizes of 1 and 30 vial(s), pre-filled syringe(s) and safety needle(s)
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
EU/1/02/240/001 10 mg 30 vials
EU/1/02/240/002 15 mg 30 vials
EU/1/02/240/004 20 mg 1 vial
EU/1/02/240/003 20 mg 30 vials
EU/1/02/240/009 25 mg 1 vial
EU/1/02/240/010 25 mg 30 vials
EU/1/02/240/011 30 mg 1 vial
EU/1/02/240/012 30 mg 30 vials
Date of first authorization: 13 November 2002
Date of latest renewal: 20 September 2007
| Drug | Countries | |
|---|---|---|
| SOMAVERT | Austria, Australia, Brazil, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom |
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