Kliinilise uuringu otsus nr RKU-4/33

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

20.05.2024 nr RKU-4/33

OTSUS

Ravimi kliinilise uuringu loa andmiseks Euroopa Parlamendi ja nõukogu määruse (EL) nr

536/2014 (määrus (EL) 536/2014) alusel

Uuringu sponsor Novartis Pharma AG esitas 18.04.2024 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 Novartis Pharma AG loa ravimi kliinilise uuringu läbiviimiseks

vastavalt esitatud uuringuplaanile nr CLNA043A12202 järgmistel tingimustel:

uuringuplaani number: CLNA043A12202 (versioon 01 kuupäevaga 29. november 2021)

uuringu referentsnumber: 21-027

uuringu nimetus: „A 5- year randomized, double-blind, placebo-controlled, multi-center

study assessing the efficacy, safety, and tolerability of intra-articular regimens of LNA043

versus placebo in patients with symptomatic knee osteoarthritis (ONWARDS)“

uuringu sponsor: Novartis Pharma AG

uuritavate arv Eestis: 24

vastutavad uurijad ja uuringukeskused:

- Dr Ivo Valter, Center for Clinical and Basic Research AS, J. Pärna tn 4, 10128 Tallinn,

Eesti

- Dr Raili Müller, MediTrials OÜ, Mõisavahe tn 34c, 50708 Tartu, 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.

Alexander Kainz

Novartis Pharma AG

Roonstrasse 25 Gostenhof

90429 Nürnberg

SAKSAMAA

2 (2)

Lugupidamisega

(allkirjastatud digitaalselt)

Katrin Kiisk

Peadirektor

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

20.05.2024 nr RKU-4/33

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 Novartis Pharma AG on

18.04.2024 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 CLNA043A12202 under the following conditions:

protocol no: CLNA043A12202 (Version 01, dated November 29, 2021)

full title of the trial: A 5- year randomized, double-blind, placebo-controlled, multi-center

study assessing the efficacy, safety, and tolerability of intra-articular regimens of LNA043

versus placebo in patients with symptomatic knee osteoarthritis (ONWARDS)

sponsor of the trial: Novartis Pharma AG

number of subjects in Estonia: 24

principal investigators and study locations:

- Dr Ivo Valter, Center for Clinical and Basic Research AS, J. Pärna tn 4, 10128 Tallinn,

Estonia

- Dr Raili Müller, MediTrials OÜ, Mõisavahe tn 34c, 50708 Tartu, 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.

Alexander Kainz

Novartis Pharma AG

Roonstrasse 25 Gostenhof

90429 Nuremberg

GERMANY

2 (2)

(digitally signed)

Katrin Kiisk

Director General