Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BECLOMETASONE DIPROPIONATE
Innovata Biomed Ltd
BECLOMETASONE DIPROPIONATE
100 mcg Microgram
Powder for Inhalation
Withdrawn
2008-12-18
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0486/002/002 Case No: 2050241 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to INNOVATA BIOMED LTD 1 MERE WAY, RUDDINGTON, NOTTINGHAM, NG11 6JS, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product CLICKHALER BECLOMETASONE 100 MICROGRAMS. INHALATION POWDER. 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 17/06/2008 until 29/10/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/06/2008_ _CRN 2050241_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clickhaler Beclometasone 100 micrograms. Inhalation powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered actuation of 2.6 mg contains 100 micrograms of beclometasone dipropionate and delivers 90 micrograms of beclometasone dipropionate. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Inhalation powder. White free-flowing powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Beclometasone Dipropionate is indicated for the control of persistent asthma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The product is intended for oral inhalation only. For optimum results Clickha Read the complete document