FML-NEO LIQUIFILM
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
04-05-2024
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Active ingredient:
NEOMYCIN SULFATE FLUOROMETHOLONE
Available from:
Allergan Pharmaceuticals Ireland
Dosage:
1/5 Mg/Ml
Pharmaceutical form:
Eye Drops Suspension
Authorization date:
1976-05-18
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)
PA0148/020/001
Case No: 2053297
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ALLERGAN PHARMACEUTICALS IRELAND
CASTLEBAR ROAD, WESTPORT, CO. MAYO, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
FML-NEO LIQUIFILM 1MG/ML + 5 MG/ML EYE DROPS, SUSPENSION
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 12/08/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/08/2008_
_CRN 2053297_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
FML-NEO Liquifim 1 mg/ml + 5 mg/ml eye drops, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Eye drops, suspension
White to slightly straw-coloured microfine suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FML-NEO is indicated for use in the following situations:
In the treatment of infectious conjunctivitis due to organisms sensitive to neomycin.
For the treatment of corneal and anterior segment inflammatory disorders which may be threatened with, or
complicated by, organisms sensitive to neomycin.
Prophylactically following removal of foreign bodies, as
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