FORTINOL LA
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
CARTEOLOL HYDROCHLORIDE
Available from:
Chauvin Pharmaceuticals Limited
Dosage:
2 %w/v
Pharmaceutical form:
Eye Drops Prolonged Rel.
Authorization date:
2004-12-03
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)
PA0118/048/002
Case No: 2043927
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
CHAUVIN PHARMACEUTICALS LIMITED
106 LONDON ROAD, KINGSTON-UPON-THAMES, SURREY, KT2 6TN, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
FORTINOL LA 2 %W/V EYE DROPS PROLONGED REL.
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 28/11/2007.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/11/2007_
_CRN 2043927_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fortinol LA 2%, Eye drops, prolonged-release.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Carteolol hydrochloride: 2 g per 100 ml (1 ml eye drops, prolonged release contains Carteolol hydrochloride 20 mg).
Excipient: benzalkonium chloride solution (10 mg/100 ml).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, prolonged-release.
Clear and light brown yellow solution
.
The pH is between 6 and 7, compatible with the pH of the tears.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
o
Intraocular hypertension.
o
Chronic open-angle glaucoma.
4.2 POSOLOGY A
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