LIVIAL 1.25 MG CAPSULES
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
21-05-2024
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Active ingredient:
TIBOLONE
Available from:
Organon (Ireland) Limited
Dosage:
1.25mg Milligram
Pharmaceutical form:
Capsules Hard
Authorization date:
2007-03-16
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0061/018/002
Case No: 2036545
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ORGANON (IRELAND) LIMITED
DRYNAM ROAD, SWORDS, CO. DUBLIN, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
LIVIAL 1.25 MG CAPSULES
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 08/06/2007 until 15/03/2012.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/06/2007_
_CRN 2036545_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Livial 1.25 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 1.25mg of tibolone
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Hard gelatin capsule with white, opaque body and light blue, opaque cap coded with “MK” above “5” and the Organon
logo.
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 women at high risk of future fractures who are
intolerant of, or contraindicated for, other medicinal products approved for
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