CREON FOR CHILDREN 5000 GASTRO-RESISTANT GRANULES
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
PANCREAS POWDER
Available from:
Abbott Healthcare Products Ltd
Dosage:
60.36mg Milligram
Pharmaceutical form:
Granules Gastro-Resistant
Authorization date:
2006-06-23
Summary of Product characteristics
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
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