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 0.3 mg solution for injection.
Signifor 0.6 mg solution for injection.
Signifor 0.9 mg solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear, colourless solution. |
Signifor 0.3 mg solution for injection: One ampoule of 1 ml contains 0.3 mg pasireotide (as pasireotide diaspartate).
Signifor 0.6 mg solution for injection: One ampoule of 1 ml contains 0.6 mg pasireotide (as pasireotide diaspartate).
Signifor 0.9 mg solution for injection: One ampoule of 1 ml contains 0.9 mg pasireotide (as pasireotide diaspartate).
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 |
|---|
|
Mannitol |
One-point-cut colourless, type I glass ampoule containing 1 ml of solution.
Each ampoule is packed in a cardboard tray which is placed in an outer box.
Packs containing 6 ampoules or multipacks containing 18 (3 × 6), 30 (5 × 6) or 60 (10 × 6) ampoules.
Not all pack sizes may be marketed.
Recordati Rare Diseases, Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92800, Puteaux, France
Signifor 0.3 mg solution for injection: EU/1/12/753/001-004
Signifor 0.6 mg solution for injection: EU/1/12/753/005-008
Signifor 0.9 mg solution for injection: EU/1/12/753/009-0012
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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