The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Gencebok, intended for the treatment of primary apnoea of premature newborns. The applicant for this medicinal product is Gennisium Pharma. Gencebok will be available as 10 mg/ml solution for infusion.
The active substance of Gencebok is caffeine citrate, a xanthine derivative (ATC code: N06BC01) which acts through the adenosine receptors as a respiratory stimulant. The benefits with Gencebok are its ability to decrease the frequency of apnoeic episodes, increase respiratory rate and blood pH, decrease pCO2, and improve the function of the respiratory muscles in premature infants with recurrent apnoea. The most common side effects are related to central nervous system stimulation and include irritability, tachycardia and hypertension.