NOROCLOX DC INTRAMAMMARY SUSPENSION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
07-06-2024
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Active ingredient:
CLOXACILLIN BENZATHINE
Available from:
Norbrook Laboratories Limited
ATC code:
QJ51CF02
INN (International Name):
CLOXACILLIN BENZATHINE
Dosage:
500 Milligram
Pharmaceutical form:
intramammary Suspension
Prescription type:
POM
Therapeutic group:
Bovine
Therapeutic area:
Cloxacillin
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
1987-10-01
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10999/012/001
Case No: 7003191
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, NEWRY, 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:
NOROCLOX DC INTRAMAMMARY SUSPENSION
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 18/02/2009_
_CRN 7003191_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Noroclox DC Intramammary Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each syringe contains:
Active Substance
Cloxacillin (as Benzathine Salt) 500 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Intramammary Suspension. An off-white suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cows
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For routine use in cows at drying-off to treat existin
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