ELANTAN LA HARD
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
ISOSORBIDE MONONITRATE
Available from:
UCB (Pharma) Ireland Limited
Dosage:
50 Milligram
Pharmaceutical form:
Prolonged Release Capsules
Authorization date:
2009-06-12
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0891/011/002
Case No: 2086513
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
UCB (PHARMA) IRELAND LIMITED
UNITED DRUG HOUSE, MAGNA DRIVE, MAGNA BUSINESS PARK, CITYWEST ROAD, DUBLIN 24, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ELANTAN LA 50 MG PROLONGED RELEASE CAPSULES, HARD
the particulars of which are set out in 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 28/07/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/07/2010_
_CRN 2086513_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Elantan LA 50 mg Prolonged Release Capsules, hard.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release hard capsule contains 50 mg isosorbide mononitrate.
Excipients: Each prolonged release hard capsule contains 13.42 mg lactose monohydrate and approximately 16-24
mg sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release capsule, hard (prolonged release capsule).
Size 3 hard gelatin opaque capsules. Brown capsule cap and flesh coloured body, containing white to beige
odourless pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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