BETAMOX 400 MG TABLETS

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

AMOXICILLIN TRIHYDRATE

Saatavilla:

Norbrook Laboratories Limited

ATC-koodi:

QJ01CA04

INN (Kansainvälinen yleisnimi):

AMOXICILLIN TRIHYDRATE

Annos:

400 Milligram

Lääkemuoto:

Tablets

Prescription tyyppi:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeuttinen ryhmä:

Bovine

Terapeuttinen alue:

amoxicillin

Käyttöaiheet:

Antibacterial

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

1987-10-01

Valmisteyhteenveto

IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA:
10999/014/001
Case No: 7003347
The Irish Medicines Board in exercise of the powers conferred on it by
Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby
grants to:
NORBROOK LABORATORIES LIMITED
STATION WORKS
,
CAMLOUGH ROAD
,
CO. DOWN BT35 6JP
an authorisation, subject to the provisions of the said Regulations
and the general conditions of the attached authorisation, in respect
of the
Veterinary Medicinal Product:
BETAMOX 400 MG TABLETS
The particulars of which are set out in Part 1 and Part 2 of the said
Schedule. The authorisation is also subject to any special conditions
as may
be specified in the said Schedule.
The authorisation, unless previously revoked, shall continue in force
from
30/09/2007
.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: From this date of effect, this authorisation replaces any
previous authorisation in respect of this product which is now null
and void.)
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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Betamox 400 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Amoxicillin Trihydrate 0.460 g equivalent to
400.00 mg amoxicil