Information to marketing authorisation holders regarding variation applications after referral for medicinal products which contain the active substance finasteride or dutasteride
11.09.2025
The outcome of the referral procedure from 22 August 2025, relating to the medicinal products with active substance(s) finasteride or dutasteride 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 the corresponding annexes.
For additional information, please send an e-mail to referal@halmed.hr.
