Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
MELOXICAM (MICRONISED)
Niche Generics Limited
QM01AC06
1.5 Mg/Ml
Oral Suspension
N.S.A.I.D
Canine
2008-06-20
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 Read the complete document