CATHATE 1.25 Milligram Tablets

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

ESTROGENS CONJUGATED

Mevcut itibaren:

John Wyeth & Brother Limited

INN (International Adı):

ESTROGENS CONJUGATED

Doz:

1.25 Milligram

Farmasötik formu:

Tablets

Yetkilendirme durumu:

Withdrawn

Yetkilendirme tarihi:

2007-10-05

Ürün özellikleri

IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0022/068/002
Case No: 2026843
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
JOHN WYETH & BROTHER LIMITED
HUNTERCOMBE LANE SOUTH, TAPLOW, MAIDENHEAD, BERKSHIRE SL6 0PH, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CATHATE 1.25 MILLIGRAM 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 24/11/2006 until 18/09/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 25/11/2006_
_CRN 2026843_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cathate* Tablets 1.25mg Coated Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cathate tablets contain 1.25 mg Conjugated Estrogens.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet
A white coloured, oval coated tablet printed '1.25' in black.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cathate is indicated for hormone replacement therapy (HRT) for estrogen deficiency symptoms in menopausal and
postmenopausal women.
Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or
contraindicated for, other medicinal products appro