Cardicor 3.75mg Film-coated tablets

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Bisoprolol hemifumarate

Disponível em:

Imbat Limited

Código ATC:

C07AB; C07AB07

DCI (Denominação Comum Internacional):

Bisoprolol hemifumarate

Dosagem:

3.75 milligram(s)

Forma farmacêutica:

Film-coated tablet

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Área terapêutica:

Beta blocking agents, selective; bisoprolol

Status de autorização:

Authorised

Data de autorização:

2008-05-02

Características técnicas

IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PPA1151/048/003
Case No: 2069197
The Irish Medicines Board in exercise of the powers conferred on it by
the above mentioned Regulations hereby grants to
IMBAT LIMITED
UNIT L2
,
NORTH RING BUSINESS PARK
,
SANTRY
,
DUBLIN 9
an authorisation, subject to the provisions of the said Regulations,
in respect of the product
CARDICOR, 3.75 MILLIGRAM
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
26/08/2009
.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cardicor 3.75mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Film-Coated 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 and the UK:_
Each tablet is off-white, heart-shaped, scored and Film-Coated.
4 CLINICAL PAR