Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE
Ergha Healthcare Ltd
1/2 Milligram
Tablets
2005-07-29
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0966/009/005 Case No: 2027193 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ERGHA HEALTHCARE LTD DAMASTOWN, MULHUDDART, DUBLIN 15 an authorisation, subject to the provisions of the said Regulations, in respect of the product HYRAZ 1 MG AND 2 MG TABLETS. TITRATION PACK. 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 28/06/2007 until 28/07/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/06/2007_ _CRN 2027193_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hyraz 1 mg and 2 mg Tablets. Titration pack 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg or 2 mg Terazosin (as terazosin hydrochloride dihydrate). For excipients see 6.1 3 PHARMACEUTICAL FORM Tablet. 1 mg: White to off-white, round, flat tablet, embossed with ‘93’ on one side and ‘760’ on the other side. 2 mg: A mottled yellow round, flat tablet with beveled edges, embossed with ‘93’ on one side and ‘761’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Terazosin is a selective blocker of post-junctional alpha-1-adrenoreceptors, well absorbed after oral dosing, metaboli Baca dokumen lengkap