MIRVASO Gel Ref.[6613] Active ingredients: Brimonidine

Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Galderma International, Tour Europlaza, 20 avenue André Prothin – La Défense 4, La Défense Cedex 92927, France

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.

Active Ingredient
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.

And

Polyethylene (PE)/ Polyethylene (PE)/Copolymer/Aluminium (Al)/Polyethylene (PE)/Polyethylene high density (PEHD) and Linear low density polyethylene (LLDPE) polyfoil tubes with 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

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

Marketing authorization dates and numbers

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

Polyethylene (PE)/ Polyethylene (PE)/Copolymer/Aluminium (Al)/Polyethylene (PE)/Polyethylene high density (PEHD) and Linear low density polyethylene (LLDPE) polyfoil tubes:

EU/1/13/904/008
EU/1/13/904/009

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

EU/1/13/904/007

Date of first authorisation: 21 February 2014
Date of latest renewal: 22 November 2018

Drugs

Drug	Countries
MIRVASO	Austria, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Netherlands, New Zealand, Poland, Singapore, United Kingdom, United States

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