ORGOVYX Film-coated tablet Ref.[50889] Active ingredients: Relugolix

Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039 Barcelona, Spain

Product name and form

Orgovyx 120 mg film-coated tablets.

Pharmaceutical Form
Film-coated tablet. Light red, almond-shaped, film-coated tablet (11 mm [length] × 8 mm [width]) with “R” on one side and “120” on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 120 mg of relugolix.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Relugolix	Relugolix is a nonpeptide GnRH receptor antagonist that competitively binds to GnRH receptors in the anterior pituitary gland preventing native GnRH from binding and signalling the secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). Consequently, the production of testosterone from the testes is reduced.

List of Excipients
Mannitol (E421) Sodium starch glycolate (E468) Hydroxypropyl cellulose (E463) Magnesium stearate (E572) Hypromellose (E464) Titanium dioxide (E171) Iron oxide red (E172) Carnauba wax (E903)

Pack sizes and marketing

Orgovyx film-coated tablets are supplied in a bottle. Each high-density polyethylene (HDPE) bottle contains 30 film-coated tablets and a desiccant and is closed with a child-resistant induction seal polypropylene (PP) cap.

Pack sizes of 30 and 90 (3 packs of 30) film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039 Barcelona, Spain

Marketing authorization dates and numbers

EU/1/22/1642/001
EU/1/22/1642/002

Date of first authorisation: 29 April 2022

Drugs

Drug	Countries
ORGOVYX	Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Romania, United States

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