Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
ZINC OXIDE
Medlock Medical Ltd
15 %w/w
Impregnated Dressing
2006-11-10
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1175/012/001 Case No: 2062971 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MEDLOCK MEDICAL LTD TUBITON HOUSE, MEDLOCK STREET, OLDHAM, OL1 3HS, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product STERIPASTE 15%W/W MEDICATED PASTE BANDAGE 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 26/07/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/09/2009_ _CRN 2062971_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Steripaste 15% w/w Medicated Paste Bandage 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Zinc Oxide 15% w/w. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Impregnated dressing Bandage with serrated edges evenly impregnated with white opaque, homogeneous paste, packed in heat-sealed sachets of laminated foil in cartons. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of venous ulcers where sensitisation has been a problem. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS, CHILDREN AND THE ELDERLY Frequency of dressing changes is at the discretion of the responsible Lestu allt skjalið