This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Estonia, Finland, France, Hong Kong SAR China, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Nigeria, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.
The drug BETOPTIC contains one active pharmaceutical ingredient (API):
1
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UNII
6X97D2XT0O - BETAXOLOL HYDROCHLORIDE
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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. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| Betoptic Eye Drops Solution | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) | |
| BETOPTIC Eye drops, suspension | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| S01ED02 | Betaxolol | S Sensory organs → S01 Ophthalmologicals → S01E Antiglaucoma preparations and miotics → S01ED Beta blocking agents |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 2825Q, 5544T |
| BR | Câmara de Regulação do Mercado de Medicamentos | 500900501172314, 526517090091403 |
| CA | Health Products and Food Branch | 01908448 |
| EE | Ravimiamet | 1034042 |
| ES | Centro de información online de medicamentos de la AEMPS | 61015 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 061275, 098582, 423434 |
| FR | Base de données publique des médicaments | 60100877 |
| GB | Medicines & Healthcare Products Regulatory Agency | 13842, 13844, 142101, 16194, 181547 |
| HK | Department of Health Drug Office | 35281 |
| HR | Agencija za lijekove i medicinske proizvode | HR-H-709311743 |
| JP | 医薬品医療機器総合機構 | 1319733Q1072 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1002498 |
| MT | Medicines Authority | MA1249/00801 |
| MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 107M93 |
| NG | Registered Drug Product Database | 04-1568 |
| NL | Z-Index G-Standaard | 13741926, 14051907 |
| NL | Z-Index G-Standaard, PRK | 37001, 46205 |
| NZ | Medicines and Medical Devices Safety Authority | 4635, 4636 |
| PL | Rejestru Produktów Leczniczych | 100010001, 100010018, 100255719, 100255731, 100262671, 100342217, 100399565, 100456318 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W69082001 |
| SG | Health Sciences Authority | 04716P, 05837P |
| TN | Direction de la Pharmacie et du Médicament | 21313011, 6643041, 6643042 |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699839611475, 8699839611482 |
| US | FDA, National Drug Code | 0065-0246 |
| ZA | Health Products Regulatory Authority | 28/15.4/0716, S/15.4/371 |
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