Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Recordati Rare Diseases, Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92800, Puteaux, France
Signifor 10 mg powder and solvent for suspension for injection.
Signifor 20 mg powder and solvent for suspension for injection.
Signifor 30 mg powder and solvent for suspension for injection.
Signifor 40 mg powder and solvent for suspension for injection.
Signifor 60 mg powder and solvent for suspension for injection.
| Pharmaceutical Form |
|---|
|
Powder and solvent for suspension for injection (powder for injection). Powder: slightly yellowish to yellowish powder. |
Signifor 10 mg powder and solvent for suspension for injection: One vial contains 10 mg pasireotide (as pasireotide pamoate).
Signifor 20 mg powder and solvent for suspension for injection: One vial contains 20 mg pasireotide (as pasireotide pamoate).
Signifor 30 mg powder and solvent for suspension for injection: One vial contains 30 mg pasireotide (as pasireotide pamoate).
Signifor 40 mg powder and solvent for suspension for injection: One vial contains 40 mg pasireotide (as pasireotide pamoate).
Signifor 60 mg powder and solvent for suspension for injection: One vial contains 60 mg pasireotide (as pasireotide pamoate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pasireotide |
Pasireotide is a novel cyclohexapeptide, injectable somatostatin analogue. Pasireotide exerts its pharmacological activity via binding to somatostatin receptors. Somatostatin receptors are expressed in many tissues, especially in neuroendocrine tumours in which hormones are excessively secreted, including ACTH in Cushing’s disease. |
| List of Excipients |
|---|
|
Powder: Poly(D,L-lactide-co-glycolide) (50-60:40-50) Solvent: Carmellose sodium |
Powder: brownish vial (glass) with rubber stopper (chlorobutyl rubber), containing the active substance (pasireotide).
Solvent: colourless pre-filled syringe (glass) with front and plunger stopper (chlorobutyl rubber), containing 2 ml solvent. Unit packs (all strengths): each unit pack contains a blister tray with one injection kit (one vial and, in a separate sealed section, one pre-filled syringe, one vial adapter and one safety-engineered needle for injection).
Multipacks (40 mg and 60 mg strengths only): each multipack contains 3 intermediate cartons, each containing a blister tray with one injection kit (one vial and, in a separate sealed section, one pre-filled syringe, one vial adapter and one safety engineered needle for injection).
Not all pack sizes or strengths may be marketed.
Recordati Rare Diseases, Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92800, Puteaux, France
Signifor 10 mg powder and solvent for suspension for injection: EU/1/12/753/018
Signifor 20 mg powder and solvent for suspension for injection: EU/1/12/753/013
Signifor 30 mg powder and solvent for suspension for injection: EU/1/12/753/019
Signifor 40 mg powder and solvent for suspension for injection: EU/1/12/753/014-015
Signifor 60 mg powder and solvent for suspension for injection: EU/1/12/753/016-017
Date of first authorisation: 24 April 2012
Date of latest renewal: 18 November 2016
| Drug | Countries | |
|---|---|---|
| SIGNIFOR | Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
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