Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Ipsen Limited, 190 Bath Road, Slough, Berkshire, SL1 3XE, UK
Somatuline Autogel 60 mg, solution for injection in a pre-filled syringe.
Somatuline Autogel 90 mg, solution for injection in a pre-filled syringe.
Somatuline Autogel 120 mg, solution for injection in a pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection in a pre-filled syringe. White to pale yellow semi-solid formulation. |
Lanreotide (I.N.N.), 60 mg, 90 mg or 120 mg (as acetate).
Each pre-filled syringe contains a supersaturated solution of lanreotide acetate corresponding to 0.246 mg lanreotide base/mg of solution, which ensures an actual injection dose of 60 mg, 90 mg or 120 mg of lanreotide, respectively.
For excipients, see 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 |
|---|
|
Water for injection |
Somatuline Autogel is supplied in a pre-filled syringe (polypropylene) fitted with an automatic safety system with a plunger stopper (bromobutyl rubber) and a needle (stainless steel) covered by a plastic cap.
Each ready to use pre-filled syringe is placed into a plastic tray and packed in a laminated pouch and a cardboard box.
Box of one 0.5 ml pre-filled syringe with one needle (1.2 mm x 20 mm).
Ipsen Limited, 190 Bath Road, Slough, Berkshire, SL1 3XE, UK
PL 34926/0005 (Somatuline Autogel 60 mg)
PL 34926/0006 (Somatuline Autogel 90 mg)
PL 34926/0007 (Somatuline Autogel 120 mg)
Date of first authorisation: 16 October 2001
Date of latest renewal: 07 April 2009
| 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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