Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
IPRATROPIUM BROMIDE
PCO Manufacturing
IPRATROPIUM BROMIDE
500/2 Microgram/ML
Nebuliser Solution
Withdrawn
2008-12-31
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA0465/173/002 Case No: 2054664 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PCO MANUFACTURING LIMITED UNIT 10, ASHBOURNE BUSINESS PARK, RATH, ASHBOURNE, CO. MEATH, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product ATROVENT UDVS 500MICROGRAM/2ML NEBULISER SOLUTION 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 20/10/2008 until 08/01/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/10/2008_ _CRN 2054664_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atrovent ® UDVs ® 500 micrograms/2ml Nebuliser solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each single dose unit contains 0.025% w/v ipratropium bromide (monohydrate) i.e. 500 micrograms in 2 ml. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Nebuliser Solution. Product imported from the UK: Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ATROVENT 250 UDVs, 1 ml and ATROVENT UDVs, 2 ml are indicated for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease and, when used concomitantly with inhale Přečtěte si celý dokument