TOBRADEX

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

Active ingredients

The drug TOBRADEX contains a combination of these active pharmaceutical ingredients (APIs):

1	Dexamethasone UNII 7S5I7G3JQL - DEXAMETHASONE
	Dexamethasone is a synthetic glucocorticoid; it combines high anti-inflammatory effects with low mineralocorticoid activity. It has an approximately 7 times greater anti-inflammatory potency than prednisolone, another commonly prescribed corticosteroid. At high doses it reduces the immune response.
	Read more about Dexamethasone
2	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 more about Tobramycin

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
TOBRADEX Ophthalmic ointment	MPI, US: SPL/Old	FDA, National Drug Code (US)
TOBRADEX Ophthalmic suspension	MPI, US: SPL/Old	FDA, National Drug Code (US)
TOBRADEX Eye drops, suspension	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
S01CA01	Dexamethasone and antiinfectives	S Sensory organs → S01 Ophthalmologicals → S01C Antiinflammatory agents and antiinfectives in combination → S01CA Corticosteroids and antiinfectives in combination
Discover more medicines within S01CA01

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
BR	Câmara de Regulação do Mercado de Medicamentos	500903401160319, 500903402175311
CA	Health Products and Food Branch	00778907, 00778915
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	1070-MEE-0615, 26.015-10-04
EE	Ravimiamet	1124266, 1150276
ES	Centro de información online de medicamentos de la AEMPS	61575
FR	Base de données publique des médicaments	66302120
GB	Medicines & Healthcare Products Regulatory Agency	140063, 146719, 162763, 37483
HK	Department of Health Drug Office	33403, 33404
HR	Agencija za lijekove i medicinske proizvode	HR-H-813846689, HR-H-942799697
LT	Valstybinė vaistų kontrolės tarnyba	1007700, 1074800, 1080370, 1080500, 1081607, 1082310, 1089623
MT	Medicines Authority	MA1249/02801, MA1249/02802
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	161M91, 228M92
NG	Registered Drug Product Database	B4-3477
Switch country to Nigeria in order to find specific presentations of TOBRADEX
NL	Z-Index G-Standaard	13627759, 13627767
NL	Z-Index G-Standaard, PRK	86614, 86622
NZ	Medicines and Medical Devices Safety Authority	5239
PL	Rejestru Produktów Leczniczych	100108415, 100324857, 100325644, 100330467, 100335520, 100335536, 100344950, 100345500, 100359873, 100362125, 100398005, 100403982, 100420058, 100420874, 100426813, 100426954, 100429875, 100441758, 100443208, 100448186, 100451652
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W63594001, W63595001
SG	Health Sciences Authority	04309P, 04438P
TN	Direction de la Pharmacie et du Médicament	10283381, 10283382
TR	İlaç ve Tıbbi Cihaz Kurumu	8699504710168
US	FDA, National Drug Code	0065-0647, 0065-0648, 0065-0652, 0078-0876
ZA	Health Products Regulatory Authority	X/15.3/91, X/15.3/92