BETOPTIC

This brand name is authorized in Austria, Australia, Brazil, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

Active ingredients

The drug BETOPTIC contains one active pharmaceutical ingredient (API):

1 Betaxolol
UNII 6X97D2XT0O - BETAXOLOL HYDROCHLORIDE

Betaxolol is a cardioselective Beta1 receptor blocker which, when applied topically to the eye, lowers intraocular pressure. It is thought to produce this effect by reducing the rate of production of aqueous humour.

Read about Betaxolol

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
Betoptic Eye Drops Solution Medicines & Healthcare Products Regulatory Agency (GB) MPI, EU: SmPC
BETOPTIC Eye drops, suspension Medicines & Healthcare Products Regulatory Agency (GB) MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
S01ED02 Betaxolol S Sensory organs → S01 Ophthalmologicals → S01E Antiglaucoma preparations and miotics → S01ED Beta blocking agents
Discover more medicines within S01ED02

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: AU Pharmaceutical Benefits Scheme Identifier(s): 2825Q, 5544T
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 500900501172314, 526517090091403
Country: CA Health Products and Food Branch Identifier(s): 01908448
Country: EE Ravimiamet Identifier(s): 1034042
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 61015
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 061275, 098582, 423434
Country: FR Base de données publique des médicaments Identifier(s): 60100877
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 13842, 13844, 142101, 16194, 181547
Country: HK Department of Health Drug Office Identifier(s): 35281
Country: HR Agencija za lijekove i medicinske proizvode Identifier(s): HR-H-709311743
Country: JP 医薬品医療機器総合機構 Identifier(s): 1319733Q1072
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1002498
Country: MT Medicines Authority Identifier(s): MA1249/00801
Country: MX Comisión Federal para la Protección contra Riesgos Sanitarios Identifier(s): 107M93
Country: NL Z-Index G-Standaard Identifier(s): 13741926, 14051907
Country: NL Z-Index G-Standaard, PRK Identifier(s): 37001, 46205
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 4635, 4636
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100010001, 100010018, 100255719, 100255731, 100262671, 100342217, 100399565, 100456318
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W69082001
Country: SG Health Sciences Authority Identifier(s): 04716P, 05837P
Country: TN Direction de la Pharmacie et du Médicament Identifier(s): 21313011, 6643041, 6643042
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699839611475, 8699839611482
Country: US FDA, National Drug Code Identifier(s): 0065-0246
Country: ZA Health Products Regulatory Authority Identifier(s): 28/15.4/0716, S/15.4/371

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