Combino Pharm presents a new business opportunity with the product Tobramycin for inhalation.
Product description: Tobramycin Solution for inhalation.
Reference product: Tobi® (Novartis).
Therapeutical indication: Management of cystic fibrosis patients with P. aeruginosa.
Presentation: Ampoule blow-fill-seal 300mg/5ml.
Highlights:
- Dossier available for submission
- Alternative formulation
Patent status – EU: Ready to be launched/commercialised/marketed.
Regulatory Details:
- The product is produced in a EU manufacturing site
- The dossier has been approved in the EU and CCP is available from PT and ES
Regulatory strategy: Dossier completed with granted MAs in PT and ES through DCP.