This brand name is authorized in Nigeria.
The drug TROFRINE contains a combination of these active pharmaceutical ingredients (APIs):
1
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UNII
N0A3Z5XTC6 - TROPICAMIDE
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Tropicamide is an anticholinergic which blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation thus dilating the pupil (mydriasis). |
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2
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UNII
04JA59TNSJ - PHENYLEPHRINE HYDROCHLORIDE
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Phenylephrine is a sympathomimetic agent with mainly direct effects on adrenergic receptors. It has predominantly alpha adrenergic activity and is without stimulating effects on the central nervous system. The sympathomimetic effect of phenylephrine produces vasoconstriction which in turn relieves nasal congestion. |
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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| B4-7805 | Eye drops | Trofrine Ophthalmic Solution SOL_DROPS 0.8%; 5% 1 x 5 mL (in plastic bottle) | Ophthalmic Solution 22 RNW-PP-294205 TROFRINE OPHTHALMIC SOLUTION TROPICAMIDE USP 0.8% w/v + PHENYLEPHRINE Hydrochloride USP 5%w//v Tropicamide USP 0.8%w/v, Phenylephrine Hydrochloride USP 5%w/v, Chlorobutanol BP 0.5%w/v (As preservative) Aqueous Base qs b4-7805 Drugs Imported Products 1x5ml Prescription Only Medicine (POM) 12/1/2022 LIN-KABS PHARMACEUTICAL LIMITED, 42, ZIK AVENUE FEGGE, ONITSHA 8094745001 linkabspharm.naf@gmail.com SUNWAYS ROHTO PHARMACEUTICAL PVT. LTD, 803/4/5 , G.I.D.C., DHOLKA, DIST. AHMEDABAD, GUJARAT 382225 INDIA., India | 27/07/2023 |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| S01FA56 | Tropicamide, combinations | S Sensory organs → S01 Ophthalmologicals → S01F Mydriatics and cycloplegics → S01FA Anticholinergics |
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 | B4-7805 |
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