Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
TEMAZEPAM
Orion Corporation
20 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) PA1327/006/002 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 20 MG 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 20 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains temazepam 20 mg. Excipients: contains 144.6mg lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Round, white to pale yellow, flat, bevelled-edged tablet with a scoreline on one face. 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 Insomnia. Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. For premedication prior to minor surgery or other relat Đọc toàn bộ tài liệu