LEVONELLE Tablets 1500 Microgram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
28-04-2024
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Active ingredient:
LEVONORGESTREL
Available from:
Medimpex (UK) Limited
Dosage:
1500 Microgram
Pharmaceutical form:
Tablets
Authorization date:
2006-02-03
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0818/004/002
Case No: 2059506
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
MEDIMPEX (UK) LIMITED
127 SHIRLAND ROAD, LONDON W9 2EP, ENGLAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
LEVONELLE 1500 MICROGRAM TABLET
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 13/06/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/06/2010_
_CRN 2059506_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levonelle 1500 microgram Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The tablet contains 1500 microgram of levonorgestrel
Excipients: Contains Lactose Monohydrate 142.5mg
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Tablet
The tablet is round and white with an impressed mark of "G00" on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration: One tablet should be taken as soon as possible, preferably within 12 hours, and no later than 72
hours after
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