Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
CALCIPOTRIOL ANHYDROUS
Rowex Ltd
0.05 mg/g
Ointment
2007-07-13
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0711/093/001 Case No: 2042715 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ROWEX LTD BANTRY, CO. CORK, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product CALCIL 50 MICROGRAMS/G 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 21/08/2008 until 12/07/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/09/2008_ _CRN 2042715_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calcil 50 micrograms/g Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of ointment contains 0.05 mg (is equal to 50 micrograms) of calcipotriol. Excipient: Propylene glycol 10 mg/g For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment White to off-white ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Calcil is indicated for the topical treatment of mild to moderately severe psoriasis (psoriasis vulgaris). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults:_ As monotherapy Calcil should be applied to the affected skin once or twice daily. At the beginning of treatment, twice daily application is Διαβάστε το πλήρες έγγραφο