RYEQO Film-coated tablet Ref.[51659] Active ingredients: Estradiol Norethisterone Relugolix

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary

Product name and form

Ryeqo 40 mg/1 mg/0.5 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Light yellow to yellow, round film-coated tablet of 8 mm with “415” on one side and plain-faced on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 40 mg relugolix, 1 mg estradiol (as hemihydrate), and 0.5 mg norethisterone acetate.

Excipient with known effect: Each film-coated tablet contains approximately 80 mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Estradiol

Estradiol, is chemically and biologically identical to endogenous human estradiol. It substitutes for the loss of oestrogen production in menopausal women, and alleviates menopausal symptoms. Oestrogens prevent bone loss following menopause or ovariectomy.

Norethisterone

Norethisterone has progestational actions similar to those of progesterone, but is a more potent inhibitor of ovulation and has weak oestrogenic and androgenic properties. It is used to treat a number of disorders of the menstrual cycle.

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

Lactose monohydrate
Mannitol (E421)
Sodium starch glycolate
Hydroxypropylcellulose (E463)
Magnesium stearate (E572)
Hypromellose type 2910 (E464)
Titanium dioxide (E171)
Triacetin (E1518)
Iron oxide yellow (E172)

Pack sizes and marketing

Ryeqo tablets are packaged in high-density polyethylene (HDPE) bottles with desiccant and closed with an induction-sealed child-resistant polypropylene cap. Each bottle contains 28 tablets.

Pack sizes:

One bottle (28 tablets)
Three bottles (84 tablets).

Not all pack sizes may be marketed.

Marketing authorization holder

Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary

Marketing authorization dates and numbers

EU/1/21/1565/001
EU/1/21/1565/002

Date of first authorisation: 16 July 2021

Drugs

Drug Countries
RYEQO Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.