Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: JANSSEN-CILAG INTERNATIONAL NV, Turnhoutseweg, 30, B-2340 Beerse, Belgium
EVRA 203 micrograms/24 hours + 33.9 micrograms/24 hours transdermal patch.
| Pharmaceutical Form |
|---|
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Transdermal patch. Thin, matrix-type transdermal patch consisting of three layers. The outside of the backing layer is beige and heat-stamped “EVRA”. |
Each 20 cm² transdermal patch contains 6 mg norelgestromin (NGMN) and 600 micrograms ethinyl estradiol (EE).
Each transdermal patch releases an average of 203 micrograms of NGMN and 33.9 micrograms of EE per 24 hours. Medicinal product exposure is more appropriately characterised by the pharmacokinetic profile (see section 5.2).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 17 alpha-Ethinylestradiol |
Ethinylestradiol is chemically and biologically identical to endogenous human oestradiol. It substitutes for the loss of estrogen production in menopausal women, and alleviates menopausal symptoms. Estrogens prevent bone loss following menopause or ovariectomy. |
|
| Norelgestromin |
|
| List of Excipients |
|---|
|
Backing layer: Low-density pigmented polyethylene outer layer Middle layer: Polyisobutylene/polybutene adhesive Third layer: Polyethylene terephthalate (PET) film |
A sachet is composed of four layers: a low-density polyethylene film (innermost layer), an aluminium foil, a low-density polyethylene film, and an outer layer of bleached paper.
Sachets are packaged in a cardboard carton. Every carton has 3, 9 or 18 EVRA transdermal patches in individual foil-lined sachets. Sachets are wrapped per three in a transparent perforated plastic film and packed in a cardboard carton.
Not all pack sizes may be marketed.
JANSSEN-CILAG INTERNATIONAL NV, Turnhoutseweg, 30, B-2340 Beerse, Belgium
EU/1/02/223/001
EU/1/02/223/002
EU/1/02/223/003
Date of first authorisation: 22 August 2002
Date of latest renewal: 22 August 2012
| Drug | Countries | |
|---|---|---|
| EVRA | Austria, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, United Kingdom, South Africa |
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