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.