ALMIRAL Suppositories Ref.[28120] Active ingredients: Diclofenac

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Almiral 50 mg suppositories.

Almiral 100 mg suppositories.

Pharmaceutical Form

Suppositories.

Almiral suppositories are white, smooth, homogenous, torpedo-shaped suppositories, for rectal administration.

Qualitative and quantitative composition

Almiral suppositories contain either 50 mg or 100 mg of 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

Hard fat.

Pack sizes and marketing

Almiral suppositories 100 mg and 50 mg are presented in aluminium blisters of ten suppositories in an outer carton.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Almiral suppositories 50mg: 11763
Almiral suppositories 100mg: 11764

Almiral suppositories 50mg: 2.7.1988/15.10.2013
Almiral suppositories 100mg: 2.7.1988/19.10.2010

Drugs

Drug Countries
ALMIRAL Cyprus, Estonia, Hong Kong, Malta, Romania, Singapore

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