TOBRAMYCIN WKT, TOBRAMYCIN WOCKHARDT (Wockhardt Bio Pty Ltd)
Product name
TOBRAMYCIN WKT, TOBRAMYCIN WOCKHARDT
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
180 working days (255)
Active ingredients
tobramycin
Registration type
New generic medicine
Indication
TOBRAMYCIN WKT, TOBRAMYCIN WOCKHARDT (solution for inhalation) is indicated for the management of cystic fibrosis patients with P. aeruginosa infections. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 ≤ 25% or ≥ 80% predicted at screening, or patients colonised with Burkholderia cepacia.