البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
ISOTRETINOIN
Roche Products Ltd
5 mg Milligram
Capsules, Soft
1983-04-19
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0050/053/002 Case No: 2073238 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ROCHE PRODUCTS LTD 6 FALCON WAY, SHIRE PARK, WELWYN GARDEN CITY, AL7 1TW, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product ROACCUTANE, 5 MG MILLIGRAM 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 03/11/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 04/11/2009_ _CRN 2073238_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Roaccutane 5 mg soft capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each soft capsule contains 5 mg isotretinoin Excipients: Contains soya bean oil (refined, hydrogenated and partially hydrogenated), arachis oil and sorbitol (E420). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsules, soft 5 mg capsules: Oval, opaque, pale red-violet and white capsules imprinted with R5 in black ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe forms of acne (such as nodular or conglobate acne or acne at risk of permanent scarring) resistant to adequate courses of standard therap اقرأ الوثيقة كاملة