ZOELY Film-coated tablet Ref.[50593] Active ingredients: Estradiol Nomegestrol

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

Product name and form

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.

Qualitative and quantitative composition

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
Microcrystalline cellulose (E460)
Crospovidone (E1201)
Talc (E553b)
Magnesium stearate (E572)
Colloidal anhydrous silica

Tablet coat (white active film-coated tablets):

Polyvinyl alcohol (E1203)
Titanium dioxide (E171)
Macrogol 3350
Talc (E553b)

Tablet coating (yellow placebo film-coated tablets):

Polyvinyl alcohol (E1203)
Titanium dioxide (E171)
Macrogol 3350
Talc (E553b)
Yellow iron oxide (E172)
Black iron oxide (E172)

Pack sizes and marketing

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.

Marketing authorization holder

Theramex Ireland Limited, 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

Marketing authorization dates and numbers

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

Drugs

Drug Countries
ZOELY Austria, Cyprus, Estonia, Spain, Finland, France, Ireland, Israel, Lithuania, Mexico, Netherlands, Poland, Romania, United Kingdom, South Africa

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