CHMP extends approval of tobramycin as a hybrid medicine Tobramycin PARI for infection in cystic fibrosis.- PARI Pharma.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tobramycin PARI (tobramycin), from PARI Pharma GmbH, intended for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis. Tobramycin PARI will be available as a 170 mg nebuliser solution. Tobramycin PARI represents an alternative treatment option for cystic fibrosis patients with chronic P.aeruginosa lung infections.

It is a hybrid medicine of TOBI Nebuliser solution which has been authorised in the EU since 10 December 1999. Tobramycin PARI contains the same active substance as TOBI Nebuliser solution, but has a different strengthand is used with a different nebuliser device, allowing it to be inhaled over a shorter period. The most common side effects are cough and dysphonia. The full indication is: "Tobramycin PARI is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF).Consideration should be given to official guidance on the appropriate use of antibacterial agents".