Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
TEMAZEPAM
Orion Corporation
10 Milligram
Tablets
2006-06-30
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1327/006/001 Case No: 2062149 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ORION CORPORATION ORIONINTIE 1, FIN-02200 ESPOO, FINLAND an authorisation, subject to the provisions of the said Regulations, in respect of the product TENOX 10MG TABLETS 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 15/04/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/04/2009_ _CRN 2062149_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tenox 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg of temazepam. Excipients: contains 72.3mg lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet A white to pale yellow round, flat scored, bevelled edge, uncoated tablet with 7mm diameter. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a hypnotic for the short-term management of insomnia only when it is severe, disabling or subjecting the individual to extreme distress. For premedication prior to minor surgery o Przeczytaj cały dokument