Basic Information
SIMBRINZA EYE DROPS, SUSPENSION 10 MG/ML + 2 MG/ML
SUSPENSION, STERILE
Regulatory Information
SIN15085P
September 6, 2016
Prescription Only
Therapeutic
OPHTHALMIC
August 10, 2023
May 30, 2025
Company Information
Active Ingredients
Strength: 10 mg/mL
Strength: 2 mg/ml
Detailed Information
Contraindications
**4.3. Contraindications** - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or to sulphonamides (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_), - Patients receiving monoamine oxidase (MAO) inhibitor therapy (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_), - Patients on antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin) (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_), - Patients with severe renal impairment (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_), - Patients with hyperchloraemic acidosis, - Neonates and infants younger than 2 years old (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Indication Information
**4.1. Therapeutic indications** SIMBRINZA® eye drops contains brinzolamide, a carbonic anhydrase (CA-II) inhibitor, and brimonidine tartrate, an alpha-2 adrenergic agonist. Decrease of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).