Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
LORMETAZEPAM
Meda Health Sales Ireland Limited
1.0 Milligram
Tablets
2008-05-02
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1332/026/001 Case No: 2050567 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to Transferred from PA0022/037/002. MEDA HEALTH SALES IRELAND LIMITED OFFICE 10, DUNBOYNE BUSINESS PARK, DUNBOYNE, CO. MEATH, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product LORAMET 1.0MG 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 02/05/2008 until 09/01/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 07/05/2008_ _CRN 2050567_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Loramet 1.0mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1.0 mg lormetazepam. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Circular, white uncoated tablets embossed ‘WYETH’ on one face ‘WY037’ on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the short term treatment of insomnia when it is disabling or subjecting the individual to extreme distress. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage and duration of therapy should be individualised. The lowest effective dose should be prescribed Прочитать полный документ