DAVLIET Capsules Hard 10 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
16-04-2024
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Active ingredient:
OMEPRAZOLE
Available from:
Volkspharma GmbH
Dosage:
10 Milligram
Pharmaceutical form:
Capsules Hard
Authorization date:
2008-05-30
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)
PA1499/001/001
Case No: 2071132
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
VOLKSPHARMA GMBH
AUGUST-WESSELS-STR. 5, AUGSBURG, D-86154, GERMANY
an authorisation, subject to the provisions of the said Regulations, in respect of the product
DAVLIET, 10 MILLIGRAM
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 07/12/2009 until 31/05/2012.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 07/12/2009_
_CRN 2071132_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Davliet 10 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10 mg of Omeprazole
Also contains sucrose.
For a full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Capsule hard, with gastro-resistant granules.
Opaque red cap and opaque orange body, containing white to beige granules.
Size 3 capsule marked with O10.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Duodenal ulcers
•
Benign gastric ulcers
•
Reflux oesophagitis
•
Maintenance treatment of reflux oesophagitis to prevent relapse
•
Zollinger-Ellison syndrome
•
Treatment of NSAID (Non Steroid Anti Inflammatory Drug) related
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