Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Amdipharm Limited, Temple Chambers, 3 Burlington Road, Dublin 4, Ireland
Myrelez 60 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection in a prefilled syringe. White to pale yellow semi-solid formulation practically free of foreign particles. |
Lanreotide (I.N.N.), 60 mg (as acetate).
Each prefilled 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 of lanreotide.
For the 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 |
|---|
|
Water for injections. |
Myrelez is supplied in a pre-filled syringe (polypropylene with thermoplastic elastomer rubber plunger stopper sealed with polypropylene cap) placed in a plastic tray and sealed inside an aluminum pouch and a separately packed automatic single use needle-safe device. Both are packaged inside a cardboard box.
Box of one 0.5 mL syringe with one co-packaged safety needle (1.2 mm x 20 mm).
Multipack with 3 boxes, each containing one 0.5 mL syringe with one co-packaged safety needle (1.2 mm x 20 mm).
Not all pack sizes may be marketed.
Amdipharm Limited, Temple Chambers, 3 Burlington Road, Dublin 4, Ireland
PA1142/039/001
Date of first authorisation: 23rd July 2021
| Drug | Countries | |
|---|---|---|
| MYRELEZ | Estonia, Finland, Ireland, Lithuania, Poland |
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