TOBREX

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

Active ingredients

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

1
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 more about Tobramycin

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

ATC Group 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)
AU Pharmaceutical Benefits Scheme 2328M, 2329N, 5569D, 5570E
BR Câmara de Regulação do Mercado de Medicamentos 500903701164311, 500903702179310
CA Health Products and Food Branch 00513962, 00614254
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 26.213-03-05
EE Ravimiamet 1012543, 1150120, 1730821, 1870589, 1870758
ES Centro de información online de medicamentos de la AEMPS 57593, 57594
FI Lääkealan turvallisuus- ja kehittämiskeskus 015638
FR Base de données publique des médicaments 61621356, 67299307
HK Department of Health Drug Office 17292, 19904
HR Agencija za lijekove i medicinske proizvode HR-H-257802614, HR-H-904981713
IL מִשְׂרַד הַבְּרִיאוּת 6848, 756
LT Valstybinė vaistų kontrolės tarnyba 1012608, 1016300, 1021386, 1066396, 1074798, 1076195, 1076968, 1079721, 1080369, 1082816, 1082817, 1087031, 1088699, 1091108
MT Medicines Authority MA1249/02901, MA1249/02902
MX Comisión Federal para la Protección contra Riesgos Sanitarios 74M83, 95M83
NG Registered Drug Product Database A4-1975
Switch country to Nigeria in order to find specific presentations of TOBREX
NL Z-Index G-Standaard 12557676
NL Z-Index G-Standaard, PRK 18376, 22373
NZ Medicines and Medical Devices Safety Authority 3295, 3296
PL Rejestru Produktów Leczniczych 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
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W63542001, W63543001
SG Health Sciences Authority 04451P, 04722P
TN Direction de la Pharmacie et du Médicament 10283391, 1028341
TR İlaç ve Tıbbi Cihaz Kurumu 8699504440522, 8699504612110
US FDA, National Drug Code 0065-0643, 0065-0644
ZA Health Products Regulatory Authority P/15.1/205, P/15.1/58

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