DICLOFENAC SODIUM MULTIDOSE 0.1% EYE DROPS

Active substance: DICLOFENAC SODIUM

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S & M Medical Ltd
Chemilines House, Alperton Lane, Wembley, Middlesex HA0 1DX
telephone: +44 (0)20 8799 7600 EXT 733 facsimile: +44 (0)20 8799 7619
e-mail: minal.kesarkar@chemilines.com
Ref: 2007090603LA

Mr. Noor Uddin
PLPI Team Leader,
Room 11-150,
MHRA,
Market Towers,
1 Nine Elms Lane,
London, SW8 5NQ.

06 September 2007

Dear Noor,
PLPI 19488/0698 – Voltarol Eye Drops
Further to our telephone conversation on 4 September 2007 please find the enclosed
documents as you requested.
The enclosed amended MLA form, labels and Patient Information Leaflet are textually
identical to the mock-up for the above application.
I confirm that the leaflet will be made available in formats appropriate for blind and partially
sighted people.
I confirm that the text and any diagram in the mock-up PIL is exactly the same as that in the
final draft version.
If you need any further information or amendments to be made please contact me.

With kind regards,
Dr. Tam Cilgi,
Regulatory Affairs Manager
encl

Registered in England No 04364679

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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