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SOLARAZE Gel (2019)

Active ingredients: Diclofenac

Product Name and Form

Solaraze 3%, gel.

Pharmaceutical form

Gel.

A clear, transparent, colourless or pale yellow gel.

Qualitative and Quantitative Composition

Each gram contains 30 mg diclofenac sodium (3% w/w).

For the full list of excipients, see section 6.1.

Chemical substance
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

Sodium hyaluronate
Benzyl alcohol
Macrogol monomethyl ether 350
Purified water

Pack sizes and Marketing

The product is supplied in an epoxy-phenolic lined sealed aluminium tube with a white polypropylene screw on cap with a pierced tip, in 25 g, 50 g, 60 g, 90 g and 100 g sizes.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Almirall, S.A., Ronda General Mitre, 151, 08022 Barcelona, Spain

1 September 2000 / 25 July 2007

Marketing authorization number:

PL 16973/0012