Kliinilise uuringu otsus nr RKU-4/84

Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477

06.11.2024 nr RKU-4/84

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.

Ida Bruun Kristensen

Odense University Hospital

J B Winsloews Vej 4

5000 Odense C

TAANI

2 (2)

Lugupidamisega

(allkirjastatud digitaalselt)

Katrin Kiisk

Peadirektor

Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477

06.11.2024 nr RKU-4/84

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.

Ida Bruun Kristensen

Odense University Hospital

J B Winsloews Vej 4

5000 Odense C

DENMARK

2 (2)

(digitally signed)

Katrin Kiisk

Director General