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MIRVASO Gel (2018)

Active ingredients: Brimonidine

Product Name and Form

Mirvaso 3 mg/g gel.

Pharmaceutical form

Gel.

White to light yellow opaque aqueous gel.

Qualitative and Quantitative Composition

One gram of gel contains 3.3 mg of brimonidine, equivalent to 5 mg of brimonidine tartrate.

Excipient(s) with known effect: One gram of gel contains 1 mg methylparahydroxybenzoate (E218) and 55 mg propylene glycol (E1520).

For the full list of excipients, see section 6.1.

Chemical substance
Description
Brimonidine

Brimonidine is an alpha2-adrenergic receptor agonist that is 1000-fold more selective for the alpha2-adrenoceptor than the alpha1-adrenoreceptor. This selectivity results in no mydriasis and the absence of vasoconstriction in microvessels associated with human retinal xenografts.

List of excipients

Carbomer
Methylparahydroxybenzoate (E218)
Phenoxyethanol
Glycerol
Titanium dioxide
Propylene glycol (E1520)
Sodium hydroxide
Purified water

Pack sizes and Marketing

Tube of 2g: Polyethylene (PE)/Copolymer/Aluminium (Al)/Copolymer/Polyethylene (PE) polyfoil tubes with a high density polyethylene (HDPE) head and polyethylene (PE) child resistant closure

Tube of 10 g and 30g: Polyethylene (PE)/Copolymer/Aluminium (Al)/Copolymer/Polyethylene (PE) polyfoil tubes with a high density polyethylene (HDPE) head and polypropylene (PP) child resistant closure.

Pump of 30 g: Multidose container with airless pump system with child resistant closure. Polypropylene (PP)/Thermoplastic Polyolefin (TPO)/high density polyethylene (HDPE) and polypropylene (PP) child resistant closure.

Pack sizes: 1 tube of 2 g,10 g or 30 g; 1 pump of 30 g.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Galderma International, Tour Europlaza, 20 avenue André Prothin – La Défense 4, La Défense Cedex 92927, France

Date of first authorisation: 21 February 2014

Marketing authorization number:

Polyethylene (PE)/Copolymer/Aluminium (Al)/Copolymer/Polyethylene (PE) polyfoil tubes:

EU/1/13/904/004
EU/1/13/904/005
EU/1/13/904/006

Polypropylene (PP)/Thermoplastic Polyolefin (TPO)/high density polyethylene (HDPE) and polypropylene (PP) child resistant closure:

EU/1/13/904/007