Cardicor 5mg Film-coated tablets

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Bisoprolol hemifumarate

Доступна с:

Imbat Limited

код АТС:

C07AB; C07AB07

ИНН (Международная Имя):

Bisoprolol hemifumarate

дозировка:

5 milligram(s)

Фармацевтическая форма:

Film-coated tablet

Тип рецепта:

Product subject to prescription which may be renewed (B)

Терапевтические области:

Beta blocking agents, selective; bisoprolol

Статус Авторизация:

Authorised

Дата Авторизация:

2008-05-02

Характеристики продукта

IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PPA1151/048/004
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, 5 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.
I
R
I
S
H
M
E
D
I
C
I
N
E
S
B
O
A
R
D
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_0_
_4_
_/_
_0_
_9_
_/_
_2_
_0_
_0_
_9_
_C_
_R_
_N_
_ _
_2_
_0_
_6_
_9_
_1_
_9_
_7_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cardicor 5mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Film-Coated Tablet contains 5mg 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 light yellow, heart-shaped, scored and Film-Coated.
4 CLINICAL PARTICULA