מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
ZINC OXIDE METHYL SALICYLATE OCTAFONIUM CHLORIDE PHENOL
Bayer Limited
ZINC OXIDE METHYL SALICYLATE OCTAFONIUM CHLORIDE PHENOL
6.55/3/0.3 %w/w
Ointment
Product not subject to medical prescription
Withdrawn
2012-11-30
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1410/046/001 Case No: 2043649 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to Transferred from PA0021/049/001. BAYER LIMITED THE ATRIUM, BLACKTHORN ROAD, DUBLIN 18, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product GERMOLENE OINTMENT 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 14/05/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/05/2010_ _CRN 2043649_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Germolene Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The ointment contains the following active substances: Zinc Oxide 6.55% w/w, Methyl Salicylate 3% w/w, Phenol 1.19% w/w and Octafonium Chloride 0.3% w/w. Excipients: Also contains wool fat (lanolin), 35.0% w/w For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment A pink smooth ointment with characteristic medicated odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an antiseptic and analgesic for the topical treatment of superficial skin trauma, nappy rash, sunburn and painful muscles. 4.2 POSOLOGY AND METHOD OF ADMINISTRAT קרא את המסמך השלם