This brand name is authorized in United States. It is also authorized in Austria, Croatia, Cyprus, Estonia, Finland, Hong Kong SAR China, Ireland, Lithuania, Netherlands, Poland, Singapore, South Africa, Spain, Tunisia, Turkey.
The drug EMADINE contains one active pharmaceutical ingredient (API):
1
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UNII
42MB94QOSM - EMEDASTINE DIFUMARATE
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Emedastine is a potent selective and topically effective histamine H1 antagonist. In vivo topical ocular administration of emedastine produces a concentration-dependent inhibition of histamine-stimulated conjunctival vascular permeability. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| Emadine 0.05% w/v, Eye drops, Solution | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) | |
| EMADINE Eye drops, solution | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| S01GX06 | Emedastine | 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) |
|---|---|---|
| EE | Ravimiamet | 1042850, 1078107, 1209585, 1209596 |
| ES | Centro de información online de medicamentos de la AEMPS | 98095001 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 008903, 527523 |
| HK | Department of Health Drug Office | 45710 |
| IE | Health Products Regulatory Authority | 22514 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1006275, 1006276, 1027965, 1027966 |
| NL | Z-Index G-Standaard | 14270226 |
| NL | Z-Index G-Standaard, PRK | 52469 |
| PL | Rejestru Produktów Leczniczych | 100095256 |
| SG | Health Sciences Authority | 14381P |
| TN | Direction de la Pharmacie et du Médicament | 1903021 |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699839611451 |
| US | FDA, National Drug Code | 0065-0325 |
| ZA | Health Products Regulatory Authority | 34/15.4/0037 |
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