NORBET 0.25MG TABLETS FOR DOGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
10-05-2024
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Active ingredient:
BETAMETHASONE
Available from:
Norbrook Laboratories Limited
ATC code:
QH02AB01
Dosage:
0.25 mg/tablet
Pharmaceutical form:
Tablets
Therapeutic group:
Corticosteroid
Therapeutic area:
Canine
Authorization date:
1995-02-17
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10999/058/001
Case No: 7006651
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:
NORBET 0.25MG TABLETS FOR DOGS
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 16/02/2010.
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 22/05/2010_
_CRN 7006651_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Norbet 0.25mg Tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each tablet contains 0.25 mg Betamethasone
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
A small white tablet.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Norbet Tablets are specifically indicated for the treatment of canine allergic dermatoses
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