Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
MELOXICAM
Crookes Healthcare Ltd
7.5 Milligram
Tablets
2006-07-24
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0043/043/001 Case No: 2019779 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to CROOKES HEALTHCARE LTD 1 THANE ROAD WEST, NOTTINGHAM, NG2 3AA, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product GALOXIWAY 7.5 MG TABLETS The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 20/02/2008 until 23/07/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 06/03/2008_ _CRN 2019779_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Galoxiway 7.5 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains meloxicam 7.5 mg. Excipient: this product contains 43mg lactose per tablet. For excipients see section 6.1 3 PHARMACEUTICAL FORM Tablet Pale yellow coloured round tablet with a score line on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short-term symptomatic treatment of exacerbations of osteoarthrosis. Long-term symptomatic treatment of rheumatoid arthritis or ankylosing spondylitis. 4.2 POSOLOGY AND Citiți documentul complet