Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
TEMAZEPAM
Meda Health Sales Ireland Limited
20mg Milligram
Tablets
2008-08-29
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1332/025/002 Case No: 2050275 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to Transferred from PA0022/026/004. 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 NORMISON 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 29/08/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/09/2008_ _CRN 2050275_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Normison 20 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg of temazepam. Excipient: Lactose monohydrate 120 mg per tablet For full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, to off-white, flat, bevel-edged tablets imprinted with “Wyeth” on one side and “WY” breakbar “041” on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Insomnia: The short term treatment of insomnia only when it is severe, disabling or subjecting the individual to extreme distress. Temazepam may be used as a pre- m Prečítajte si celý dokument