Information to marketing authorisation holders regarding variation applications after referral for topiramate-containing medicinal products
27.10.2023
The outcome of the referral procedure from 11 October 2023 relating to the medicinal products with active substance(s) topiramate approved in the Republic of Croatia is available on HALMED’s website, in the table at the 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 the corresponding annexes.
For additional information please send an e-mail to referal@halmed.hr.
