Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BISACODYL
Imbat Limited
10 Milligram
Suppositories
2007-06-22
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1151/045/002 Case No: 2076834 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to IMBAT LIMITED UNIT L2, NORTH RING BUSINESS PARK, SANTRY, DUBLIN 9 an authorisation, subject to the provisions of the said Regulations, in respect of the product DULCOLAX 10MG SUPPOSITORIES 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 20/05/2010 until 21/06/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/05/2010_ _CRN 2076834_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dulcolax 10mg Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains 10 mg of bisacodyl. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suppository _Product imported from Greece_ Smooth, white torpedo-shaped suppositories 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For evacuation of the colon in constipation and in preparation for radiological investigations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _1. IN CONSTIPATION:_ Adults and Children over 10 years: One 10mg suppository to be administered in the morning. Children under 10 years: One 5mg suppository to be admi Read the complete document