দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
POVIDONE-IODINE
Medlock Medical Ltd
POVIDONE-IODINE
10 %w/w
Impregnated Dressing
Withdrawn
2012-06-25
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA1175/002/015 Case No: 2037610 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to Transferred from PA0696/002/005. MEDLOCK MEDICAL LTD TUBITON HOUSE, MEDLOCK STREET, OLDHAM, OL1 3HS, ENGLAND an authorisation, subject to the provisions of the said Regulations, in respect of the product BETADINE ANTISEPTIC TULLE 250 MG IMPREGNATED DRESSING 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 08/06/2007. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/06/2007_ _CRN 2037610_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betadine Antiseptic Tulle 250 mg Impregnated Dressing 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dressing is impregnated with 2.5 g of gel containing 250 mg povidone iodine equivalent to 10% w/w. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Impregnated dressing. 10 x 10cm gauze dressing impregnated with a golden brown gel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an antiseptic dressing for the management of cutaneous traumatic lesions and ulcers. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical use only. Apply as required to the affected area, সম্পূর্ণ নথি পড়ুন