GHRYVELIN Granules for oral suspension Ref.[28093] Active ingredients: Macimorelin

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Consilient Health Limited, 5th Floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland

Product name and form

GHRYVELIN 60 mg granules for oral suspension in sachet.

Pharmaceutical Form

Granules for oral suspension in sachet.

White to off-white granules.

Qualitative and quantitative composition

Each sachet contains 60 mg macimorelin (as acetate). 1 mL of the reconstituted suspension contains 500 micrograms macimorelin.

Excipient(s) with known effect:

Contains lactose monohydrate 1,691.8 mg per sachet.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Macimorelin

Macimorelin is an orally available peptidomimetic with growth hormone (GH) secretagogue activity similar to ghrelin. Macimorelin stimulates GH release by activating growth hormone secretagogue receptors (GHSR) present in the pituitary and hypothalamus.

List of Excipients

Lactose monohydrate
Colloidal anhydrous silica
Crospovidone type A
Saccharin sodium dihydrate
Sodium stearyl fumarate

Pack sizes and marketing

One LDPE/Alu/LDPE/paper sachet containing 1,817 mg granules placed in cardboard box.

Each cardboard box contains 1 sachet.

Marketing authorization holder

Consilient Health Limited, 5th Floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland

Marketing authorization dates and numbers

EU/1/18/1337/001

Date of first registration: 11 January 2019

Drugs

Drug Countries
GHRYVELIN Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania

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