BETAMOX 400 MG TABLETS
Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Karakteristik produk
(SPC)
09-05-2024
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Bahan aktif:
AMOXICILLIN TRIHYDRATE
Tersedia dari:
Norbrook Laboratories Limited
Kode ATC:
QJ01CA04
INN (Nama Internasional):
AMOXICILLIN TRIHYDRATE
Dosis:
400 Milligram
Bentuk farmasi:
Tablets
Jenis Resep:
POM
Kelompok Terapi:
Bovine
Area terapi:
Amoxicillin
Indikasi Terapi:
Antibacterial
Status otorisasi:
Authorised
Tanggal Otorisasi:
1987-10-01
Karakteristik produk
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.)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 31/07/2008_
_CRN 7003347_
_page number: 1_
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 amoxicillin.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Tablet. White to off-white oblong scored tablet
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Calves
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Betamox 400 mg Tablets are indicated for the treatment of
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