This brand name is authorized in Nigeria.
The drug ORCHAZID contains a combination of these active pharmaceutical ingredients (APIs):
1
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UNII
HBD503WORO - KETOTIFEN FUMARATE
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Ketotifen is a histamine H1-receptor antagonist. In vivo animal studies and in vitro studies suggest the additional activities of mast cell stabilisation and inhibition of infiltration, activation and degranulation of eosinophils. |
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2
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UNII
F5UM2KM3W7 - BENZALKONIUM CHLORIDE
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3
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UNII
PDC6A3C0OX - GLYCERIN
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Glycerol has uses as a hyperosmotic, osmotic diuretic, and ophthalmic agent. It may be used as an eye drop in the treatment of glaucoma to reduce intraocular pressure, as a solution or suppository for short-term treatment of constipation, to evacuate the bowel prior to a colonoscopy, and in some ocular surgeries. It may be given intravenously to reduce pressure inside the brain and used externally on the skin as a moisturizer. |
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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| B4-0049 | Solution/Drops | ORCHAZID OPHTHALMIC SOLUTION SOL_DROPS 0.345mg; 0.1mg; 21.25mg 1X5ML | 60 RNW-PP-335657 ORCHAZID OPHTHALMIC SOLUTION KETOTIFEN HYDROGEN FUMARATE KETOTIFEN HYDROGEN FUMARATE 0.345MG, BENZALKONIUM CHLORIDE 0.1MG, GLYCEROL 21.25MG, 1 M SODIUM HYDROCHLORIDE -075 (TO PH OF ABOUT 5.3), WATER FOR INJECTION QS B4-0049 Drugs Imported Products 1X5ML Prescription Only Medicine (POM) 8/10/2023 SMART WAY PHARMA LTD IKEJA, OBAFEMI AWOLOWO WAY,IKEJA LAGOS IKEJA LAGOS 8052632719 smartwaypharm@outlook.com ORCHIDIA PHARM INDUSTRIES SAE, NO(15)-BLK(12011), NORTH INDUSTRIAL ZONE, EXTENSION EL-OBOUR CITY, EGYPT, Egypt | 30/11/2023 |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| S01GX08 | Ketotifen | S Sensory organs → S01 Ophthalmologicals → S01G Decongestants and antiallergics → S01GX Other antiallergics |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| NG | Registered Drug Product Database | B4-0049 |
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