ALOMIDE ALLERGY 0.1% W/V EYE DROPS, SOLUTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
LODOXAMIDE
Available from:
Alcon Laboratories (UK) Ltd
Dosage:
0.1 %w/v
Pharmaceutical form:
Eye Drops Solution
Authorization date:
2003-06-03
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0290/063/002
Case No: 2080568
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ALCON LABORATORIES (UK) LTD
PENTAGON PARK, BOUNDARY WAY, HEMEL HEMPSTEAD, HERTFORDSHIRE HP2 7UD, ENGLAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ALOMIDE ALLERGY 0.1% W/V EYE DROPS, SOLUTION
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 06/07/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 06/07/2010_
_CRN 2080568_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alomide Allergy 0.1% w/v Eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains 0.1% w/v lodoxamide as lodoxamide trometamol.
Excipient: contains 0.007% w/v benzalkonium chloride as benzalkonium chloride solution.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution (eye drops).
A clear colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Alomide is indicated in the treatment of the ocular signs and symptoms of allergic conjunctivitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children (4 years and above): One or two drops
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