SODIUM CROMOGLICATE 2 %w/v Eye Drops Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CROMOGLICATE SODIUM

Available from:

Norton Healthcare Limited T/A IVAX Pharmaceuticals UK

INN (International Name):

CROMOGLICATE SODIUM

Dosage:

2 %w/v

Pharmaceutical form:

Eye Drops Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Withdrawn

Authorization date:

2013-04-26

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)
PA0282/059/002
Case No: 2061679
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
NORTON HEALTHCARE LIMITED T/A IVAX PHARMACEUTICALS UK
REGENT HOUSE, 5-7 BROADHURST GARDENS, SWISS COTTAGES, LONDON NW6 3RZ, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
SODIUM CROMOGLICATE 2% W/V EYE DROPS
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 19/02/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 19/02/2009_
_CRN 2061679_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Cromoglicate 2% w/v Eye Drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml contains Sodium Cromoglicate 2% w/v.
Excipients: also includes benzalkonium chloride solution 0.01% w/v.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution (Eye Drops).
A clear colourless sterile eye drops solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief and treatment of acute allergic conjunctivitis such as hay fever, chronic allergic conjunctivitis and vernal
keratoconjunctivitis. Sodium cromoglicate i