Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
METHYLPREDNISOLONE ACEPONATE
Intendis GmbH
0.1%w/w %w/w
Ointment
2007-07-27
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1407/001/003 Case No: 2042218 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to INTENDIS GMBH MAX-DOHRN-STR. 10, D-10589 BERLIN, GERMANY an authorisation, subject to the provisions of the said Regulations, in respect of the product ADVANTAN 0.1%W/W FATTY 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 03/04/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 09/07/2008_ _CRN 2042218_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Advantan 0.1% w/w Fatty Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1g fatty ointment contains 1 mg (0.1%) methylprednisolone aceponate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment White to yellowish fatty ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Topical treatment of corticosteroid sensitive dermatoses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION In general, the Advantan formulation appropriate to the skin condition is applied thinly once per day to the diseased areas of skin. In general, the duration of use should not exceed 12 weeks in adults and 4 weeks in children. 4.3 CONTRA Read the complete document