XALATAN

This brand name is authorized in United States. It is also authorized in Australia, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Germany, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, Nigeria, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

Active ingredients

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

1
UNII 6Z5B6HVF6O - LATANOPROST
 

The active substance latanoprost, a prostaglandin F analogue, is a selective prostanoid FP receptor agonist which reduces the intraocular pressure (IOP) by increasing the outflow of aqueous humour. Reduction of the IOP in man starts about three to four hours after administration and maximum effect is reached after eight to twelve hours.

 
Read more about Latanoprost

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 XALATAN Ophthalmic solution MPI, US: SPL/PLR FDA, National Drug Code (US)
 XALATAN Eye drops, solution MPI, EU: SmPC Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

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

ATC Group Classification
S01EE01 Latanoprost S Sensory organs → S01 Ophthalmologicals → S01E Antiglaucoma preparations and miotics → S01EE Prostaglandin analogues
Discover more medicines within S01EE01

Authorization and marketing

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

Country Identification scheme Identifier(s)
AU Pharmaceutical Benefits Scheme 5552F, 8243W
BR Câmara de Regulação do Mercado de Medicamentos 552820060069217
CA Health Products and Food Branch 02231493
DE Bundesinstitut für Arzneimittel und Medizinprodukte 00721047, 00721136, 00721219, 04385037, 04385043, 04385089, 06148169, 09537351, 09537368, 10073520, 10073537, 10073543, 10090375, 10090381, 10090398, 10218668, 10268212, 10268229, 10268235, 10710151, 10710168, 10817593, 10817618, 10817624, 11874392, 11874400, 11874417, 14018570, 15863586, 16527620
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 29697-03-11
EE Ravimiamet 1041196, 1078095
ES Centro de información online de medicamentos de la AEMPS 61756, BE183967
FI Lääkealan turvallisuus- ja kehittämiskeskus 124735, 124743
FR Base de données publique des médicaments 60047271
GB Medicines & Healthcare Products Regulatory Agency 13819, 139791, 147628, 164478
HK Department of Health Drug Office 42158
HR Agencija za lijekove i medicinske proizvode HR-H-173193826
IE Health Products Regulatory Authority 53420, 53473
IL מִשְׂרַד הַבְּרִיאוּת 3815
IT Agenzia del Farmaco 033219015, 044895011, 046107013
JP 医薬品医療機器総合機構 1319739Q1037
LT Valstybinė vaistų kontrolės tarnyba 1003206, 1082998
MT Medicines Authority MA1396/01101, PI770/15001A
MX Comisión Federal para la Protección contra Riesgos Sanitarios 043M98
NG Registered Drug Product Database 04-4198
NL Z-Index G-Standaard 14145332
NL Z-Index G-Standaard, PRK 48216
PL Rejestru Produktów Leczniczych 100085967, 100373620
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W67251001, W67251002
SG Health Sciences Authority 09549P
TN Direction de la Pharmacie et du Médicament 10803081, 4143011
TR İlaç ve Tıbbi Cihaz Kurumu 8699759610015
US FDA, National Drug Code 0013-8303
ZA Health Products Regulatory Authority 31/15.4/0614

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.