SOMATULINE LA Powder for suspension for injection Ref.[8586] Active ingredients: Lanreotide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Ipsen Limited, 190 Bath Road, Slough, Berkshire, SL1 3XE, UK

Product name and form

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.

Qualitative and quantitative composition

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
Lactic glycolic copolymer
Mannitol (E421)
Carmellose sodium (E466)
Polysorbate 80 (E433)

Pack sizes and marketing

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.

Marketing authorization holder

Ipsen Limited, 190 Bath Road, Slough, Berkshire, SL1 3XE, UK

Marketing authorization dates and numbers

PL 34926/0004

Date of first authorisation: 26 January 1998

Date of latest renewal: 20 May 2004

Drugs

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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