SILKIS Ointment Ref.[8062] Active ingredients: Calcitriol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS, UK

Product name and form

Silkis 3 micrograms per g ointment.

Pharmaceutical Form

Ointment.

White, translucent ointment.

Qualitative and quantitative composition

One gram of ointment contains 3 micrograms of calcitriol (INN).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Calcitriol

Calcitriol is the most active known form of vitamin D3 in stimulating intestinal calcium transport. In physiological amounts it augments the intestinal absorption of calcium and phosphate and plays a significant part in the regulation of bone mineralisation.

List of Excipients

Liquid paraffin
White soft paraffin
Alpha-tocopherol

Pack sizes and marketing

The product is packaged in collapsible aluminium tubes coated internally with an epoxy – phenolic resin and fitted with a white high density polyethylene or polypropylene screw cap.

Tubes contain either 15, 30 or 100g of ointment.

Not all pack sizes may be marketed.

Marketing authorization holder

Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS, UK

Marketing authorization dates and numbers

PL 10590/0047

10.07.1995/09.02.2004

Drugs

Drug Countries
SILKIS Canada, Spain, Finland, France, Hong Kong, Ireland, Netherlands, Singapore, United Kingdom

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