ADOCAM FOR DOGS
Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Produktets egenskaber
(SPC)
18-05-2024
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Aktiv bestanddel:
MELOXICAM (MICRONISED)
Tilgængelig fra:
Niche Generics Limited
ATC-kode:
QM01AC06
Dosering:
1.5 Mg/Ml
Lægemiddelform:
Oral Suspension
Terapeutisk gruppe:
N.S.A.I.D
Terapeutisk område:
Canine
Autorisation dato:
2008-06-20
Produktets egenskaber
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA:10776/001/001
Case No: 7003545
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:
NICHE GENERICS LIMITED
1 THE CAM CENTRE, WILBURY WAY, HERTFORDSHIRE SG4 0TW, UNITED KINGDOM
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:
ADOCAM 1.5 MG/ML ORAL SUSPENSION 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 Part 2 of the said Schedule.
This authorisation,unless previously revoked, shall continue in force from 20/06/2008 to 19/06/2013.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 15/07/2008_
_CRN 7003545_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Adocam 1.5 mg/ml Oral Suspension for Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of product contains:
Active substance(s):
Meloxicam 1.5 mg (equivalent to 0.05 mg per drop)
Excipient(s):
Sodium benzoate 1.5 mg (equivalent to 0.05 mg per drop)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension
The product is a pale yellow viscous suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dog
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Alleviation of inflammation and p
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