BENTIFEN Eye Drops Solution 0.25 Mg/Ml
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
KETOTIFEN FUMARATE
Available from:
Novartis Pharmaceuticals UK Ltd
Dosage:
0.25 Mg/Ml
Pharmaceutical form:
Eye Drops Solution
Authorization date:
2005-03-24
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)
PA0013/113/001
Case No: 2037810
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
NOVARTIS PHARMACEUTICALS UK LTD
FRIMLEY BUSINESS PARK, FRIMLEY, CAMBERLEY, SURREY, GU16 7SR, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
BENTIFEN 0.25 MG/ML EYE DROPS SOLUTION
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 11/12/2007 until 29/06/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 04/01/2008_
_CRN 2037810_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BENTIFEN 0.25 mg/ml, eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains 0.345 mg ketotifen fumarate corresponding to 0.25 mg ketotifen.
Each drop contains 8.5 microgram ketotifen fumarate.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
Clear, colourless to faintly yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of seasonal allergic conjunctivitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults, elderly and children (age 3 and older): one drop of BENTIFEN into the conjunctival sac
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