Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Ipsen Limited, 190 Bath Road, Slough, Berkshire, SL1 3XE, UK
Somatuline LA 30 mg, powder for suspension for injection.
| Pharmaceutical Form |
|---|
|
Powder for suspension for injection. Powder: a practically white lyophilisate with the presence of bubbles at the top. |
Each vial contains 30 mg of lanreotide, presented as lanreotide acetate.
After reconstitution with the solvent, 1 mL of suspension contains 15 mg lanreotide as lanreotide acetate.
Each vial contains 2.64 mg of sodium.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lanreotide |
Lanreotide is an octapeptide analogue of natural somatostatin. Like somatostatin, lanreotide is an inhibitor of various endocrine, neuroendocrine, exocrine and paracrine functions. |
| List of Excipients |
|---|
|
Lactide glycolide copolymer |
Powder in a vial (type I glass), with a rubber stopper (halogenobutyl) and cap (aluminium) and 2 mL solvent in an ampoule (type I glass).
Box of 1 vial, 1 ampoule, 1 syringe and 2 needles.
Box of 2 vials, 2 ampoules, 2 syringes and 4 needles.
Box of 6 vials, 6 ampoules, 6 syringes and 12 needles.
Not all pack sizes may be marketed.
Ipsen Limited, 190 Bath Road, Slough, Berkshire, SL1 3XE, UK
PL 34926/0004
Date of first authorisation: 26 January 1998
Date of latest renewal: 20 May 2004
| Drug | Countries | |
|---|---|---|
| SOMATULINE | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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