Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
HYDROCORTISONE SODIUM SUCCINATE
UCB Pharma Limited
2.5 Milligram
Buccal Tablet
1993-07-07
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0365/049/001 Case No: 2082431 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to UCB PHARMA LIMITED 208 BATH ROAD, SLOUGH, BERKSHIRE SL1 3WE, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product CORLAN, 2.5 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 10/05/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/05/2010_ _CRN 2082431_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Corlan 2.5mg Muco-Adhesive Buccal Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each muco-adhesive buccal tablet contains 2.5 mg Hydrocortisone as Hydrocortisone Sodium Succinate. Excipients: Each tablet contains 67.742mg lactose For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Mucoadhesive Buccal tablet White biconvex tablet engraved ‘Corlan Evans’ on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the local management of aphthous ulceration of the mouth. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults and children:_ One pellet four times daily. Corlan pellets should not be sucked, but Read the complete document