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Rivaroxaban

Rivaroxaban Patient Alert Card (download) Prescriber Guide (Download)

Fingolimod

Fingolimod Fingolimod Patient, Parent and Caregiver Guide (click to download) Fingolimod Pregnancy reminder card (click to download) Fingolimod_Prescriber’s Checklist (click to download)

ADMINISTRATIVE INSTRUCTION (HEALTH) NO.03/2026 ON SUPPLEMENTATION AND AMENDMENT OF ADMINISTRATIVE INSTRUCTION (HEALTH) NO. 01/2015 MARKETING AUTHORISATION FOR MEDICINAL PRODUCTS

In accordance with Article 16 of Law No. 04/L 190 on Medical Products and Devices (Official Gazette of the Republic of Kosovo /no.27/25 April 2014), Article 11, paragraph 1, subparagraph 1.5 of Law No.08/1-117 on the Government of the Republic of Kosovo, Article 9 paragraph 2 of the Government Regulation No.17/2024 (Official Gazette dated 21.06.2024) […]

Update for application for variation

In accordance with Article 15, paragraph 2 of Administrative Instruction (Health) No. 01/2024 on Variations of Medicinal Products, it is stipulated that the Guideline and the application are updated by AKPPM, while access to these documents is provided through the official website of AKPPM. Referring to the interpretation provided by the Legal Office of the […]

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