Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
DIHYDROCODEINE BITARTRATE
Galen Limited
30 Milligram
Tablets
2009-05-22
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1329/007/001 Case No: 2069929 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to GALEN LIMITED SEAGOE INDUSTRIAL ESTATE, CRAIGAVON, BT63 5UA, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product DF 118 TABLETS 30 MG 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 15/02/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 04/05/2010_ _CRN 2069929_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DF118 Tablets 30mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Excipients: also contains lactose monohydrate, 127.2 mg per tablet For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Biconvex round white uncoated tablet marked with ‘DF’ running horizontally and ‘118’ running vertically in a cross formation on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an analgesic in the relief of moderate to severe pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. ADULT DOSAGE: The usual dose is one tablet every four to six hours or as directed by the physician. DF118 i Perskaitykite visą dokumentą