TOBI

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Estonia, Finland, France, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, South Africa, Spain, Turkey, UK.

Active ingredients

The drug TOBI 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  
 TOBI Podhaler Inhalation powder, hard capsule MPI, EU: SmPC European Medicines Agency (EU)

Medicine classification

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

ATC Group Classification
J01GB01 Tobramycin J Antiinfectives for systemic use → J01 Antibacterials for systemic use → J01G Aminoglycoside antibacterials → J01GB Other aminoglycosides
Discover more medicines within J01GB01

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 10066T, 10074F, 5442K
BR Câmara de Regulação do Mercado de Medicamentos 526513030077514, 541519110016417
CA Health Products and Food Branch 02239630, 02365154
EE Ravimiamet 1553879, 1553880, 1553891
ES Centro de información online de medicamentos de la AEMPS 10652002, 63689
FI Lääkealan turvallisuus- ja kehittämiskeskus 003861, 586241
FR Base de données publique des médicaments 60565723, 65832685
GB Medicines & Healthcare Products Regulatory Agency 195371, 41252
IE Health Products Regulatory Authority 88370, 88373, 88882
IL מִשְׂרַד הַבְּרִיאוּת 4922, 6965
IT Agenzia del Farmaco 034767018
JP 医薬品医療機器総合機構 6123700G1026
LT Valstybinė vaistų kontrolės tarnyba 1061964, 1061965, 1061966
MT Medicines Authority MA1507/02201
MX Comisión Federal para la Protección contra Riesgos Sanitarios 161M2004
NL Z-Index G-Standaard 14675595
NL Z-Index G-Standaard, PRK 59986, 98248
NZ Medicines and Medical Devices Safety Authority 15591, 9549
PL Rejestru Produktów Leczniczych 100315203
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W68686001, W68686002, W68686003
TR İlaç ve Tıbbi Cihaz Kurumu 8698856520685
US FDA, National Drug Code 0078-0494, 0078-0630, 49502-346
ZA Health Products Regulatory Authority A40/20.1.1/0522

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