REMETHAN Gel Ref.[28322] Active ingredients: Diclofenac

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Remethan 1% gel.

Pharmaceutical Form

Gel.

White, soft, homogeneous cream like gel.

Qualitative and quantitative composition

Remethan gel contains 1% w/w diclofenac diethylamine.

1 g gel contains diclofenac diethylamine equivalent to 10 mg diclofenac sodium.

Excipient(s) with known effect:

20 g gel contain 1 g of propylene glycol.

50g gel contain 2.5 g of propylene glycol.

100 g gel contain 5 g of propylene glycol.

For the full list of excipients, see section 6.1.

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

Triethanolamine
Carbomer
Cetomacrogol 1000
Cetiol LC
Isopropyl alcohol
Liquid paraffin
Propylene glycol
Perfume
Purified water

Pack sizes and marketing

Aluminium tube. Pack-sizes of 20 g, 50 g and 100 g.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

14630

Date of first authorization: 10 February 1994
Date of latest renewal: 29 September 2010

Drugs

Drug Countries
REMETHAN Albania, Cyprus, Hong Kong, Malta, Singapore

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