Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
SALMETEROL
B & S Healthcare
25 Microgram
Pressurised Inhalation Suspension
2006-08-25
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PPA1328/036/001 Case No: 2034068 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to B & S HEALTHCARE UNIT 4, BRADFIELD ROAD, RUISLIP, MIDDLESEX, HA4 0NU, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product SEREVENT INHALER, 25 MICROGRAMS, PRESSURISED INHALATION, SUSPENSION 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 26/03/2007 until 24/08/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/04/2007_ _CRN 2034068_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Serevent Inhaler, 25 Micrograms, pressurised inhalation, suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Pressurised metered-dose inhaler delivering 25 micrograms of salmeterol as salmeterol xinafoate with each actuation. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation, suspension _Product imported from Spain:_ Supplied in an aluminium can with metering valve and actuator 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ADULTS_ Salmeterol provides long-lasting (12 hour) bronchodilation in reversible airways obstruction due to asthma, chronic Прочитать полный документ