This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Ecuador, Estonia, France, Hong Kong SAR China, Ireland, Netherlands, New Zealand, Poland, Singapore, Spain, Turkey, UK.
The drug ACULAR contains one active pharmaceutical ingredient (API):
1
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UNII
4EVE5946BQ - KETOROLAC TROMETHAMINE
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Ketorolac is a non-steroidal anti-inflammatory agent demonstrating analgesic and anti-inflammatory activity. Ketorolac inhibits the cyclo-oxygenase enzyme essential for biosynthesis of prostaglandins. Ketorolac has been shown to reduce prostaglandin levels in the aqueous humour after topical ophthalmic administration. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| ACULAR Eye drops, solution | 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 | |
|---|---|---|
| S01BC05 | Ketorolac | S Sensory organs → S01 Ophthalmologicals → S01B Antiinflammatory agents → S01BC Antiinflammatory agents, non-steroids |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| BR | Câmara de Regulação do Mercado de Medicamentos | 501000101176310, 501006201131318, 501006202136313, 501007301170313, 501007302177311, 501007303173311 |
| CA | Health Products and Food Branch | 01968300, 02248722 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 27-947-03-08 |
| EE | Ravimiamet | 1006120 |
| ES | Centro de información online de medicamentos de la AEMPS | 61690 |
| FR | Base de données publique des médicaments | 63866361 |
| GB | Medicines & Healthcare Products Regulatory Agency | 138242, 140407, 161342, 36933 |
| HK | Department of Health Drug Office | 57634 |
| IE | Health Products Regulatory Authority | 10336, 13023, 13045 |
| NL | Z-Index G-Standaard | 13641751 |
| NL | Z-Index G-Standaard, PRK | 34436 |
| NZ | Medicines and Medical Devices Safety Authority | 2905 |
| PL | Rejestru Produktów Leczniczych | 100135085 |
| SG | Health Sciences Authority | 11189P |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699490561027 |
| US | FDA, National Drug Code | 0023-2181, 0023-9277 |
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