ESTELLE Tablets 75/20 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
GESTODENE ETHINYLESTRADIOL
Available from:
Clonmel Healthcare Ltd
Dosage:
75/20 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2007-09-21
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0126/170/001
Case No: 2077080
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
CLONMEL HEALTHCARE LIMITED
WATERFORD ROAD, CLONMEL, CO. TIPPERARY, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ESTELLE 20 MICROGRAMS/75 MICROGRAMS COATED TABLETS
the particulars of which are set out in the attached Schedule. The authorisation is also subject to the general conditions as may be specified in
the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 30/06/2010 until 20/09/2012.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 30/06/2010_
_CRN 2077080_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Estelle 20 micrograms/75 micrograms Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 micrograms ethinylestradiol and 75 micrograms gestodene.
Excipients:
contains 38 mg lactose monohydrate and 20 mg sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet.
White, round, biconvex sugar coated tablets, both sides are without imprinting.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_How to take Estelle:_
The tablets should be taken in the order indicated on the package, every day at app
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