MYRELEZ Solution for injection Ref.[50169] Active ingredients: Lanreotide

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Amdipharm Limited, Temple Chambers, 3 Burlington Road, Dublin 4, Ireland

Product name and form

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.

Qualitative and quantitative composition

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.
Glacial acetic acid (for pH adjustment)

Pack sizes and marketing

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.

Marketing authorization holder

Amdipharm Limited, Temple Chambers, 3 Burlington Road, Dublin 4, Ireland

Marketing authorization dates and numbers

PA1142/039/001

Date of first authorisation: 23rd July 2021

Drugs

Drug Countries
MYRELEZ Estonia, Finland, Ireland, Lithuania, Poland

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