Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DIAZEPAM
Roche Products Ltd
2 Milligram
Tablets
1977-04-01
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0050/017/001 Case No: 2033456 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ROCHE PRODUCTS LTD 6 FALCON WAY, SHIRE PARK, WELWYN GARDEN CITY, AL7 1TW, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product VALIUM 2 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 14/05/2007. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/07/2007_ _CRN 2033456_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Valium 2 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg Diazepam. Excipients: Also contains 100mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Round, white tablet with “ROCHE” imprinted on one face and a single break-bar on the other. 2 The tablet can be divided into equal halves to facilitate dosing. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Anxiety. 2. Insomnia. Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. 3. In the control of muscle spasm including that ass Read the complete document