LIVIAL Tablets 2.5 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
22-06-2024
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Active ingredient:
TIBOLONE
Available from:
McDowell Pharmaceuticals
Dosage:
2.5 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2009-11-06
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PPA1473/033/001
Case No: 2061423
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
MCDOWELL PHARMACEUTICALS
4 ALTONA ROAD, LISBURN, N. IRELAND, BT27 5QB
an authorisation, subject to the provisions of the said Regulations, in respect of the product
LIVIAL 2.5 MG TABLETS
The particulars of which are set out in Part I and Part II of 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 06/11/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 17/11/2009_
_CRN 2061423_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Livial 2.5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5mg of tibolone.
Excipients: also includes lactose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from the UK:_
White, round and flat tablets with bevelled edges and a diameter of 6mm and coded “MK” above “2” on one side and
“Organon” and a star on the reverse side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of estrogen deficiency symptoms in postmenopausal women, more than one year after menopause.
Second line therapy for prevention of osteoporosis in postmenopausal
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