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
Mirvaso 3 mg/g gel.
Pharmaceutical Form |
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Gel. White to light yellow opaque aqueous gel. |
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 | 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 |
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Carbomer |
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.
Galderma International, Tour Europlaza, 20 avenue André Prothin – La Défense 4, La Défense Cedex 92927, France
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
Drug | Countries | |
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MIRVASO | Austria, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Netherlands, New Zealand, Poland, Singapore, United Kingdom, United States |
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