Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Theramex Ireland Limited, 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland
Zoely 2.5 mg/1.5 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). The active tablet is white, round and coded ‘ne’ on both sides. The placebo tablet is yellow, round and coded ‘p’ on both sides. |
Each white active tablet contains 2.5 mg nomegestrol acetate and 1.5 mg estradiol (as hemihydrate).
Each yellow placebo tablet does not contain active substances.
Excipients with known effect:
Each white active tablet contains 57.7 mg of lactose monohydrate.
Each yellow placebo tablet contains 61.8 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. |
|
| Nomegestrol |
|
| List of Excipients |
|---|
|
Tablet core (white active and yellow placebo film-coated tablets): Lactose monohydrate Tablet coat (white active film-coated tablets): Polyvinyl alcohol (E1203) Tablet coating (yellow placebo film-coated tablets): Polyvinyl alcohol (E1203) |
PVC/aluminium blister containing 28 film-coated tablets (24 white active tablets and 4 yellow placebo tablets).
Pack sizes: 28, 84, 168 and 364 film-coated tablets.
Not all pack sizes may be marketed.
Theramex Ireland Limited, 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland
EU/1/11/690/001
EU/1/11/690/002
EU/1/11/690/003
EU/1/11/690/004
Date of first authorisation: 27 July 2011
Date of latest renewal: 10 May 2021
| Drug | Countries | |
|---|---|---|
| ZOELY | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Mexico, Netherlands, Poland, Romania, United Kingdom, South Africa |
© 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.
