Information to marketing authorisation holders regarding variation applications after referral for azithromycin-containing medicinal products for systemic use
18.09.2025
The outcome of the referral procedure from 8 September 2025, relating to the azithromycin-containing medicinal products for systemic use approved in the Republic of Croatia, is available on HALMED’s website, in the table at the following link https://www.halmed.hr/en/Lijekovi/Arbitrazni-postupci-PSUSA-postupci-i-PRAC-signali-upute-za-prijavu-izmjena-/Upute-nositeljima-odobrenja-za-prijavljivanje-izmjena-koje-su-posljedica-arbitraznog-postupka-referral/.
Marketing authorisation holders are obliged to act in accordance with the conditions specified in the decision and its corresponding annexes.
For additional information, please send an e-mail to referal@halmed.hr.
