Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary
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. |
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 |
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.
Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary
EU/1/21/1565/001
EU/1/21/1565/002
Date of first authorisation: 16 July 2021
| Drug | Countries | |
|---|---|---|
| RYEQO | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom |
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