RABEPRAZOLE LICONSA
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
RABEPRAZOLE SODIUM
Available from:
Laboratorios LICONSA, S.A.
Dosage:
10 Milligram
Pharmaceutical form:
Tablets Gastro-Resistant
Authorization date:
2009-09-11
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)
PA1239/006/001
Case No: 2050301
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
LABORATORIOS LICONSA, S.A.
GRAN VIA CARLOS III, 98, 7TH FLOOR, E-08028 BARCELONA, SPAIN
an authorisation, subject to the provisions of the said Regulations, in respect of the product
RABEPRAZOLE LICONSA 10 MG GASTRO-RESISTANT TABLETS
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 11/09/2009 until 10/09/2014.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 11/09/2009_
_CRN 2050301_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rabeprazole Liconsa 10 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 10 mg rabeprazole sodium, equivalent to 9.42 mg of rabeprazole.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
Pink, film-coated, biconvex tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rabeprazole Liconsa gastro-resistant tablets are indicated for treatment of:
Active duodenal ulcer
Active benign gastric ulcer
Symptomatic erosive or ulcerative gastro-oesophageal reflux disease (GORD)
Gastro-oesop
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