CELIPROLOL HYDROCHLORIDE 200 Milligram Film Coated Tablet

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

CELIPROLOL HYDROCHLORIDE

제공처:

Ranbaxy Ireland Limited

INN (International Name):

CELIPROLOL HYDROCHLORIDE

복용량:

200 Milligram

약제 형태:

Film Coated Tablet

처방전 유형:

Product subject to prescription which may be renewed (B)

승인 상태:

Withdrawn

승인 날짜:

2010-09-10

제품 특성 요약

IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0408/058/001
Case No: 2085471
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
RANBAXY IRELAND LIMITED
SPAFIELD, CORK ROAD, CASHEL, CO. TIPPERARY, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CELIPROLOL HYDROCHLORIDE, 200 MILLIGRAM
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 06/08/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 06/08/2010_
_CRN 2085471_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Celiprolol hydrochloride 200mg film coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg celiprolol hydrochloride.
_For a full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Film-coated tablet.
Yellow coloured, capsule shaped, biconvex film coated tablets, debossed with ‘200’ on one side of the breakline and a
deep breakline on the other side.
The tablet can be broken into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Celiprolol is indicated for the treatment of hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults: _The initial dose is 200 mg orally, taken once d