This brand name is authorized in Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Italy, Japan, Mexico, Nigeria, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom, South Africa
The drug ZADITEN contains one active pharmaceutical ingredient (API):
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1
Ketotifen
UNII HBD503WORO - KETOTIFEN FUMARATE
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Ketotifen is a histamine H1-receptor antagonist. In vivo animal studies and in vitro studies suggest the additional activities of mast cell stabilisation and inhibition of infiltration, activation and degranulation of eosinophils. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| ZADITEN Eye drops, solution | Health Products Regulatory Authority (IE) | MPI, EU: SmPC | |
| ZADITEN Tablet | Health Products Regulatory Authority (IE) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| R06AX17 | Ketotifen | R Respiratory system → R06 Antihistamines for systemic use → R06A Antihistamines for systemic use → R06AX Other antihistamines for systemic use |
| S01GX08 | Ketotifen | 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) |
|---|---|---|
| Country: CA | Health Products and Food Branch | Identifier(s): 00577308, 00600784 |
| Country: EE | Ravimiamet | Identifier(s): 1606160 |
| Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 3400935607683, 3400935607744, 63616, 63619 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 056658, 551328, 569109, 599855 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 60067562, 67926980, 68070293 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 147650, 26645, 37777, 40278 |
| Country: HK | Department of Health Drug Office | Identifier(s): 10605, 45570, 48722, 50552 |
| Country: IE | Health Products Regulatory Authority | Identifier(s): 63214, 63281, 77402 |
| Country: IT | Agenzia del Farmaco | Identifier(s): 024574042 |
| Country: JP | 医薬品医療機器総合機構 | Identifier(s): 1319730Q1249, 1329705Q1298, 4490003M1263, 4490003Q1125, 4490003R1228 |
| Country: MX | Comisión Federal para la Protección contra Riesgos Sanitarios | Identifier(s): 358M90 |
| Country: NG | Registered Drug Product Database | Identifier(s): 04-0200 |
| Country: NL | Z-Index G-Standaard | Identifier(s): 14656515, 14858045 |
| Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 101850, 36587, 69221 |
| Country: NZ | Medicines and Medical Devices Safety Authority | Identifier(s): 11083, 12118 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100124911, 100272103 |
| Country: SG | Health Sciences Authority | Identifier(s): 07573P, 12209P |
| Country: TR | İlaç ve Tıbbi Cihaz Kurumu | Identifier(s): 8680177220023, 8681428010547, 8681428030552, 8699504570151, 8699504590203 |
| Country: ZA | Health Products Regulatory Authority | Identifier(s): 28/10.2.2/0550, 35/15.4/0076, M/10.2.2/278, M/10.2.2/279, Z/10.2.2/180 |
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