TOBREX

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Israel, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United States, South Africa

Active ingredients

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

1 Tobramycin UNII VZ8RRZ51VK - TOBRAMYCIN

Tobramycin is an aminoglycoside antibiotic produced by Streptomyces tenebrarius. It acts primarily by disrupting protein synthesis leading to altered cell membrane permeability, progressive disruption of the cell envelope and eventual cell death. It is bactericidal at concentrations equal to or slightly greater than inhibitory concentrations. Read about Tobramycin

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
TOBREX 0.3% Ophthalmic ointment	FDA, National Drug Code (US)	MPI, US: SPL/Old
TOBREX 0.3% Ophthalmic solution	FDA, National Drug Code (US)	MPI, US: SPL/Old

Medicine classification

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

ATC code	Group title	Classification
S01AA12	Tobramycin	S Sensory organs → S01 Ophthalmologicals → S01A Antiinfectives → S01AA Antibiotics
Discover more medicines within S01AA12

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 2328M, 2329N, 5569D, 5570E
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 500903701164311, 500903702179310
Country: CA	Health Products and Food Branch	Identifier(s): 00513962, 00614254
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 26.213-03-05
Country: EE	Ravimiamet	Identifier(s): 1012543, 1150120, 1730821, 1870589, 1870758
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 57593, 57594
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 015638
Country: FR	Base de données publique des médicaments	Identifier(s): 61621356, 67299307
Country: HK	Department of Health Drug Office	Identifier(s): 17292, 19904
Country: HR	Agencija za lijekove i medicinske proizvode	Identifier(s): HR-H-257802614, HR-H-904981713
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6848, 756
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1012608, 1016300, 1021386, 1066396, 1074798, 1076195, 1076968, 1079721, 1080369, 1082816, 1082817, 1087031, 1088699, 1091108
Country: MT	Medicines Authority	Identifier(s): MA1249/02901, MA1249/02902
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 74M83, 95M83
Country: NG	Registered Drug Product Database	Identifier(s): A4-1975
Country: NL	Z-Index G-Standaard	Identifier(s): 12557676
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 18376, 22373
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 3295, 3296
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100067053, 100165376, 100247619, 100267651, 100268260, 100277796, 100304895, 100305268, 100306463, 100316020, 100324930, 100325638, 100327519, 100343607, 100344535, 100344558, 100345463, 100357940, 100359695, 100362131, 100363107, 100384256, 100391552, 100394556, 100396615, 100423105, 100438176, 100438880, 100438897, 100440776, 100441592, 100442019, 100442048, 100447643, 100447650, 100448772, 100451790, 100452556, 100463217, 100468125
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W63542001, W63543001
Country: SG	Health Sciences Authority	Identifier(s): 04451P, 04722P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 10283391, 1028341
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699504440522, 8699504612110
Country: US	FDA, National Drug Code	Identifier(s): 0065-0643, 0065-0644
Country: ZA	Health Products Regulatory Authority	Identifier(s): P/15.1/205, P/15.1/58