VOLTAROL OPTHA MULTIDOSE Eye drops solution Ref.[6793] Active ingredients: Diclofenac

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2014  Publisher: Laboratoires Thea, 12, rue Louis-Blรฉriot, 63017 Clermont-Ferrand Cedex 2, France

Product name and form

Voltarol Ophtha Multidose 0.1% Eye Drops.

Pharmaceutical Form

Eye drops solution.

Qualitative and quantitative composition

Contains diclofenac sodium 1mg/ml.

Active Ingredient Description
Diclofenac

Diclofenac is a non-steroidal anti-inflammatory drug. The mechanism of action of diclofenac in AK may be related to the inhibition of the cycloxygenase pathway leading to reduced prostaglandin E2 (PGE2) synthesis. In addition, immunohistochemistry (IHC) from skin biopsies ac revealed that the clinical effects of diclofenac in AK are primarily due to anti-inflammatory, anti-angiogenic and possibly anti-proliferative effects and apoptosis-inducing mechanisms.

List of Excipients

Benzalkonium chloride
Disodium edetate
Hydroxypropyl ฮณ-cyclodextrin
Hydrochloric acid
Propylene glycol
Trometamol
Tyloxapol
Water for injections

Pack sizes and marketing

5ml white LDPE bottle with LDPE dropper and HDPE closure.

Marketing authorization holder

Laboratoires Thea, 12, rue Louis-Blรฉriot, 63017 Clermont-Ferrand Cedex 2, France

Marketing authorization dates and numbers

PL 20162/0017

22/08/2002 / 26/02/2009

Drugs

Drug Countries
VOLTAROL Estonia, Ireland, Malta, United Kingdom

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