Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark
Dovobet 50 microgram/g + 0.5 mg/g gel.
| Pharmaceutical Form |
|---|
|
Gel. An almost clear, colourless to slightly off-white gel. |
One gram of gel contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).
Excipient with known effect: Butylhydroxytoluene (E321) 160 micrograms/g gel.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Betamethasone |
Betamethasone is a glucocorticoid which is about eight to ten times as active as prednisolone on a weight-for-weight basis. Betamethasone has anti-inflammatory, antipruritic, and vasoconstrictive properties. |
|
| Calcipotriol |
Calcipotriol is a derivative of vitamin D for topical use on psoriasis. It probably works by suppressing keratinization. Advantage of substance or absence of odor and non-coloring of clothing. |
| List of Excipients |
|---|
|
Paraffin, liquid |
Bottles: High-density polyethylene bottles with a low-density polyethylene nozzle and a high-density polyethylene screw cap.
The bottles are placed in cartons.
Pack sizes: 15 g, 30 g, 60 g, 80 g, 2 × 60 g, 2 × 80 g and 3 × 60 g.
Applicator: The Applicator consists of a polypropylene cartridge (with a high-density polyethylene plunger and screw cap), an
applicator head (polypropylene outer casing, polyoxymethylene lever and thermoplastic elastomer nozzle) and polypropylene
cover. The cartridge, applicator head and cover are assembled prior to use. The cartridge(s), applicator head(s) and cover(s) are
placed in a carton.
Pack sizes: 60 g (equivalent to 68 ml) and 2 × 60 g (equivalent to 2 × 68 ml)
Not all pack sizes may be marketed.
LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark
PA1025/001/002
Date of first authorisation: 12th September 2008
Date of last renewal: 1st October 2015
| Drug | Countries | |
|---|---|---|
| DOVOBET | Canada, Cyprus, Ireland, Italy, Japan, Netherlands, United Kingdom, South Africa |
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