Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
MIRTAZAPINE
McDowell Pharmaceuticals
MIRTAZAPINE
15 Milligram
Orodispersible Tablet
Product subject to prescription which may not be renewed (A)
Withdrawn
2010-06-02
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1473/025/001 Case No: 2059703 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MCDOWELL PHARMACEUTICALS 4 ALTONA ROAD, LISBURN, N. IRELAND, BT27 5QB an authorisation, subject to the provisions of the said Regulations, in respect of the product ZISPIN SOLTAB 15MG ORODISPERSIBLE 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 24/04/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/04/2009_ _CRN 2059703_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zispin SolTab 15mg, orodispersible tablet. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 15mg of mirtazapine Excipients: Aspartame (E951) and sucrose For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Orodispersible tablet _Product imported from the United Kingdom:_ Round, white, standard bevelled-edge tablets marked with a code on one side TZ/1 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Episode of major depression. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The tablet should be taken orally. The tablet will rapidly disintegrate and can be swallowed without water Læs hele dokumentet