ZADITEN

This brand name is authorized in Austria, Canada, Cyprus, Estonia, Finland, France, Hong Kong SAR China, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Nigeria, Poland, Singapore, South Africa, Spain, Turkey, UK.

Active ingredients

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

1	Ketotifen UNII HBD503WORO - KETOTIFEN FUMARATE
	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.
	Read more about Ketotifen

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ZADITEN Tablet	MPI, EU: SmPC	Health Products Regulatory Authority (IE)
ZADITEN Eye drops, solution	MPI, EU: SmPC	Health Products Regulatory Authority (IE)

Medicine classification

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

ATC Group		Classification
R06AX17	Ketotifen	R Respiratory system → R06 Antihistamines for systemic use → R06A Antihistamines for systemic use → R06AX Other antihistamines for systemic use
Discover more medicines within R06AX17
S01GX08	Ketotifen	S Sensory organs → S01 Ophthalmologicals → S01G Decongestants and antiallergics → S01GX Other antiallergics
Discover more medicines within S01GX08

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
CA	Health Products and Food Branch	00577308, 00600784
EE	Ravimiamet	1606160
ES	Centro de información online de medicamentos de la AEMPS	3400935607683, 3400935607744, 63616, 63619
FI	Lääkealan turvallisuus- ja kehittämiskeskus	056658, 551328, 569109, 599855
FR	Base de données publique des médicaments	60067562, 67926980, 68070293
GB	Medicines & Healthcare Products Regulatory Agency	147650, 26645, 37777, 40278
HK	Department of Health Drug Office	10605, 45570, 48722, 50552
IE	Health Products Regulatory Authority	63214, 63281, 77402
IT	Agenzia del Farmaco	024574042
JP	医薬品医療機器総合機構	1319730Q1249, 1329705Q1298, 4490003M1263, 4490003Q1125, 4490003R1228
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	358M90
NG	Registered Drug Product Database	04-0200
NL	Z-Index G-Standaard	14656515, 14858045
NL	Z-Index G-Standaard, PRK	101850, 36587, 69221
NZ	Medicines and Medical Devices Safety Authority	11083, 12118
PL	Rejestru Produktów Leczniczych	100124911, 100272103
SG	Health Sciences Authority	07573P, 12209P
TR	İlaç ve Tıbbi Cihaz Kurumu	8680177220023, 8681428010547, 8681428030552, 8699504570151, 8699504590203
ZA	Health Products Regulatory Authority	28/10.2.2/0550, 35/15.4/0076, M/10.2.2/278, M/10.2.2/279, Z/10.2.2/180