Amaryl 2mg Tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Glimepiride

Disponible depuis:

Imbat Limited

Code ATC:

A10BB; A10BB12

DCI (Dénomination commune internationale):

Glimepiride

Dosage:

2 milligram(s)

forme pharmaceutique:

Tablet

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

Sulfonamides, urea derivatives; glimepiride

Statut de autorisation:

Authorised

Date de l'autorisation:

2008-04-11

Résumé des caractéristiques du produit

IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PPA1151/063/002
Case No: 2057218
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
AMARYL 2MG 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
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
Amaryl 2mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2mg glimepiride.
Excipient: lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from Italy:_
Green, oblong tablet marked with a smybol and ‘NMM’ and scored on
both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC