IMODIUM

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

LOPERAMIDE HYDROCHLORIDE

Prieinama:

Imbat Limited

ATC kodas:

A07DA03

INN (Tarptautinis Pavadinimas):

LOPERAMIDE HYDROCHLORIDE

Dozė:

2 Milligram

Vaisto forma:

Capsules Hard

Recepto tipas:

Product subject to prescription which may be renewed (B)

Gydymo sritis:

loperamide

Autorizacija statusas:

Authorised

Leidimo data:

2008-02-01

Prekės savybės

IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PPA1151/060/001
Case No: 2073853
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
IMODIUM 2MG CAPSULES
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
23/11/2009
.
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
Imodium 2mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 2 mg of loperamide hydrochloride.
Excipients: lactose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
_Product imported from the UK_
Gelatin capsules with an opaque green cap marked with ‘Imodium’
and an opaque dark grey body marke