HALF CAPOZIDE 25/12.5 Milligram Tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

CAPTOPRIL HYDROCHLOROTHIAZIDE

제공처:

Bristol-Myers Squibb Pharmaceuticals Ltd

INN (국제 이름):

CAPTOPRIL HYDROCHLOROTHIAZIDE

복용량:

25/12.5 Milligram

약제 형태:

Tablets

처방전 유형:

Product subject to prescription which may be renewed (B)

승인 상태:

Withdrawn

승인 날짜:

0000-00-00

제품 특성 요약

IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0002/053/003
Case No: 2039075
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD
SWORDS, CO. DUBLIN, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
HALF CAPOZIDE 25MG/12.5MG 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 12/05/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/05/2009_
_CRN 2039075_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Half Capozide 25mg/12.5mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg captopril and 12.5 mg of hydrochlorothiazide.
Excipient(s): Each tablet contains 35.1 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to off-white, round, biconvex tablet, with a notch line on one side and engraved “SQUIBB 536” on the other
side.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
This fixed dose combination