CARDICOR 3.75 Milligram Film Coated Tablet

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

BISOPROLOL HEMIFUMARATE

Tilgjengelig fra:

B & S Healthcare

INN (International Name):

BISOPROLOL HEMIFUMARATE

Dosering :

3.75 Milligram

Legemiddelform:

Film Coated Tablet

Resept typen:

Product subject to prescription which may be renewed (B)

Autorisasjon status:

Withdrawn

Autorisasjon dato:

0000-00-00

Preparatomtale

IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PPA1328/013/006
Case No: 2074374
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
B & S HEALTHCARE
UNIT 4, BRADFIELD ROAD, RUISLIP, MIDDLESEX, HA4 0NU, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CARDICOR 3.75MG FILM-COATED 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 12/03/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 21/03/2010_
_CRN 2074374_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cardicor 3.75mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 3.75mg bisoprolol hemifumarate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from _Italy:
Off-white, heart-shaped, scored and film-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors,
and diuretics, and optionally cardiac glycosides (for additional information see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Sta