Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
PANCREAS POWDER
Abbott Healthcare Products Ltd
60.36mg Milligram
Granules Gastro-Resistant
2006-06-23
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0108/025/004 Case No: 2076132 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SOLVAY HEALTHCARE LIMITED MANSBRIDGE ROAD, WEST END, SOUTHAMPTON SO18 3JD, ENGLAND an authorisation, subject to the provisions of the said Regulations, in respect of the product CREON FOR CHILDREN 5000 GASTRO-RESISTANT GRANULES 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 09/02/2010 until 22/06/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 09/02/2010_ _CRN 2076132_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Creon for Children 5000 Gastro-resistant Granules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 mg of gastro-resistant granules (equivalent to one measuring spoonful) contains 60.12mg Pancreatin, containing the following pancreatic enzymes: Lipase 5,000 Ph. Eur. units Amylase 3,600 Ph. Eur. units Protease 200 Ph. Eur. units For excipients, see 6.1 3 PHARMACEUTICAL FORM Gastro resistant granules Round, light brown gastro-resistant granules 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of pancreatic exocrine insufficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Soma hati kamili