Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
SIMBRINZA 10 mg/mL + 2 mg/mL eye drops, suspension.
| Pharmaceutical Form |
|---|
|
Eye drops, suspension (eye drops). White-to-off-white uniform suspension, pH 6.5 (approximately). |
1 mL of suspension contains 10 mg of brinzolamide and 2 mg of brimonidine tartrate equivalent to 1.3 mg of brimonidine.
Excipient with known effect: Each mL of suspension contains 0.03 mg of benzalkonium chloride.
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. |
|
| Brinzolamide |
Brinzolamide is an inhibitor of carbonic anhydrase II (CA-II). Carbonic anhydrase (CA) is an enzyme found in many tissues of the body, including the eye. Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases aqueous humour secretion resulting in a reduction in intraocular pressure (IOP) which is a major risk factor in the pathogenesis of optic nerve damage and glaucomatous visual field loss. |
| List of Excipients |
|---|
|
Benzalkonium chloride |
8 mL round, opaque, low density polyethylene (LDPE) bottles with a LDPE dropper tip and white polypropylene screw cap containing 5 mL suspension.
Carton containing 1 or 3 bottles.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/14/933/001-002
Date of first authorisation: 18 July 2014
Date of last renewal: 20 February 2019
| Drug | Countries | |
|---|---|---|
| SIMBRINZA | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Mexico, Nigeria, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
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