SOLACUTAN Gel Ref.[27901] Active ingredients: Diclofenac

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Mibe Pharma UK Ltd, 4 Coleman Street, 6th Floor; London, United Kingdom, EC2R 5AR

Product name and form

Solacutan 3% gel.

Pharmaceutical Form

Gel.

Clear, transparent, colourless to yellowish.

Qualitative and quantitative composition

Each gram of gel contains 30 mg diclofenac sodium.

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

Sodium hyaluronate
Macrogol 400
Benzyl alcohol
Purified water

Pack sizes and marketing

Aluminium tube with original sealing membrane and internal protective lacquer and HDPE screw cap.

10 g gel
25 g gel
26 g gel
30 g gel
50 g gel
60 g gel
90 g gel

Not all pack sizes may be marketed.

Marketing authorization holder

Mibe Pharma UK Ltd, 4 Coleman Street, 6th Floor; London, United Kingdom, EC2R 5AR

Marketing authorization dates and numbers

PL 49452/0001

09.02.2017

Drugs

Drug Countries
SOLACUTAN Austria, Spain, Italy, Poland, United Kingdom

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