Ida Bruun Kristensen
Odense University Hospital
J B Winsloews Vej 4 06.11.2024 nr RKU-4/84
5000 Odense C
TAANI
OTSUS
Ravimi kliinilise uuringu loa andmiseks Euroopa Parlamendi ja nõukogu määruse (EL) nr
536/2014 (määrus (EL) 536/2014) alusel
Uuringu sponsor Odense University Hospital esitas 04.10.2024 Ravimiametile taotluse ravimi
kliinilise uuringu teostamiseks määruse (EL) 536/2014 artikli 5 (1) ja ravimiseaduse (RavS) §
991 lõikes 1 sätestatud tingimustel.
Tuginedes määruse (EL) 536/2014 artiklile 8, hindamisaruande I ja II osaga hõlmatud aspekte
hinnates, otsustab Ravimiamet ravimiseaduse § 996 lg 1 punkti 1 ja lõike 3 alusel
anda uuringu sponsorile Odense University Hospital loa ravimi kliinilise uuringu
läbiviimiseks vastavalt esitatud uuringuplaanile nr SABLe järgmistel tingimustel:
uuringuplaani number: SABLe_(versioon 2.2, kuupäevaga 5. jaanuar 2023)
uuringu referentsnumber: 21-050
uuringu nimetus: „Selinexor with alternating bortezomib or lenalidomide plus
dexamethasone in transplant ineligible newly diagnosed multiple myeloma patients (SABLe):
An Investigator Sponsored Trial“
uuringu sponsor: Odense University Hospital
uuritavate arv Eestis: 9
vastutavad uurijad ja uuringukeskused:
- Dr Diana Loigom, sihtasutus Põhja-Eesti Regionaalhaigla, J. Sütiste tee 19, 13419
Tallinn, Eesti
Vaide käesolevale otsusele saab esitada Ravimiametile 30 päeva jooksul arvates otsuse
teatavaks tegemisest vastavalt haldusmenetluse seaduse § 71 lõikele 1. Kui otsuse saaja soovib
otsust vaidlustada halduskohtus, võib ta vastavalt halduskohtumenetluse seadustiku § 7 lõikele
1 ja § 46 lõikele 1 esitada kaebuse otsuse peale Tartu Halduskohtule 30 päeva jooksul otsuse
teatavaks tegemisest arvates.
Nooruse 1 / 50411 Tartu / 737 4140 /
[email protected] / www.ravimiamet.ee / Registrikood 70003477
Lugupidamisega
(allkirjastatud digitaalselt)
Katrin Kiisk
Peadirektor
2 (2)
Ida Bruun Kristensen
Odense University Hospital
J B Winsloews Vej 4 06.11.2024 nr RKU-4/84
5000 Odense C
DENMARK
DECISION
to grant authorisation for clinical trial on the basis of Regulation (EU) No 536/2014 of the
European Parliament and of the council
State Agency of Medicines has received the application from sponsor Odense University
Hospital on 04.10.2024 to conduct a clinical trial under the conditions stipulated in Regulation
(EU) No 536/2014 art 5 (1) and § 991 (1) of Estonian Medicinal Products Act (MPA).
Based on art 8 of Regulation (EU) No 536/2014, considering the aspects covered by Part I and
Part II of the assessment report, on the basis of § 996 section 1 p 1 and (3) of Medicinal Product
Act
State Agency of Medicines has decided to give the approval to conduct the clinical study
protocol no SABLe under the following conditions:
protocol no: SABLe (Version 2.2, dated January 05, 2023)
full title of the trial: Selinexor with alternating bortezomib or lenalidomide plus
dexamethasone in transplant ineligible newly diagnosed multiple myeloma patients (SABLe):
An Investigator Sponsored Trial
sponsor of the trial: Odense University Hospital
number of subjects in Estonia: 9
principal investigators and study locations:
- Dr Diana Loigom, North Estonia Medical Centre Foundation, J. Sütiste tee 19, 13419
Tallinn, Estonia
The addressee may file a challenge with State Agency of Medicines within 30 days as of the
day when the addressee became or should have become aware of the decision as prescribed in
Code of Administrative Procedure § 71(1). If the addressee wishes to have the decision to
annulled by the administrative court, he or she may submit a complaint to the Tartu
Administrative Court as prescribed in § 7(1) and § 46(1) of the Code of Administrative Court
Procedure within 30 days after the date on which the decision was notified to the applicant.
Nooruse 1 / 50411 Tartu / 737 4140 /
[email protected] / www.ravimiamet.ee / Registrikood 70003477
(digitally signed)
Katrin Kiisk
Director General
2 (2)