Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
1,021
Countries
19
Sites
81
Reversal of anticoagulation effect in patients on a FXa inhibitor (apixaban, rivaroxaban, or edoxaban) who require urgent surgery or procedure, and who have a major risk of bleeding.
To assess the ability of andexanet to achieve effective intraoperative hemostasis when compared to usual care
Key facts
- Sponsor
- Astrazeneca AB, Astrazeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- completed 14 Jun 2024
- Decision date (initial)
- 2024-01-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AstraZeneca AB
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To assess the ability of andexanet to achieve effective intraoperative hemostasis when compared to usual care
Secondary objectives 2
- To assess the ability of andexanet to rapidly reverse the anticoagulation effect of FXa inhibitors by reduction of anti FXa activity when compared to usual care at the start of surgery or procedure
- To assess the ability of andexanet to sustainably reverse the anticoagulation effect of FXa inhibitors by reduction of anti FXa activity when compared to usual care at 2 h post start of surgery or procedure
Conditions and MedDRA coding
Reversal of anticoagulation effect in patients on a FXa inhibitor (apixaban, rivaroxaban, or edoxaban) who require urgent surgery or procedure, and who have a major risk of bleeding.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10042613 | Surgical and medical procedures | 25 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Surgery or Procedure and Study Intervention Period In the andexanet group patients will receive andexanet alfa as IV bolus followed by an infusion. In the usual care group patients will receive treatment based on the Investigator’s discretion, according to regional, local/institutional guidelines or practices.
|
Randomised Controlled | None | Andexanet Treatment Group: In the andexanet group patients will receive andexanet alfa as IV bolus followed by an infusion. Usual Care Treatment Group: In the usual care group patients will receive treatment based on the Investigator’s discretion, according to regional, local/institutional guidelines or practices. |
|
| 2 | Follow-up Period There will be 4 follow-up visits over a duration of approximately 30 days.
|
Not Applicable | None | ||
| 3 | Follow-up Visit for patients with positive anti-andexanet antibody test Patients with a positive anti-andexanet antibody response at Day 30 should have a follow-up anti andexanet antibody test approximately 120 days post-surgery or procedure.
|
Not Applicable | None |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration, Paul-Ehrlich-Institut, Pharmaceuticals And Medical Devices Agency
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- The patient requires, in the opinion of the Investigator, urgent surgery or procedure and requires reversal of direct oral FXa inhibition
- The patient requires urgent surgery or procedure within 12 hours of informed consent
- The patient requires urgent surgery or procedure that is expected to be associated with a high risk of bleeding or bleeding to occur into a critical organ
- The patient has taken an oral FXa inhibitor (such as apixaban, rivaroxaban, or edoxaban) within 15 hours or more, prior to start of surgery or procedure
- Female patients of childbearing potential must have a negative pregnancy test at Screening
- Willingness to use highly effective methods of contraception (for male and female patients who are fertile)
Exclusion criteria 12
- The patient requires surgeries or procedures that have a very low chance of causing significant, uncontrollable bleeding, such as small skin procedures, cataract surgery, and minor dental procedures
- The patient has acute life-threatening bleeding at the time of Screening
- The patient will undergo a surgery or procedure which will require the use of heparin
- Patient who is not expected to live for more than three months due to other health problems or has specifically requested not to be resuscitated if their heart stops beating
- Prior to screening, the patient had either experienced low platelet count due to heparin use with or without blood clots or had a genetic condition that affects blood clotting
- Patient has acute decompensated heart failure, cardiogenic shock, sepsis, or septic shock at the time of Screening
- Patient has history of heparin-induced thrombocytopenia (with or without thrombosis) or inherited coagulopathy (eg, anti-thrombin III deficiency, anti-phospholipid antibody syndrome, protein C/S deficiency, Factor V Leiden) at the time of Screening
- Previously diagnosed with a bleeding disorder (eg, platelet function disorder, hemophilia, Von Willebrand disease, or coagulation factor deficiency)
- Prior known hypersensitivity to andexanet alfa
- Use of andexanet alfa 30 days prior to Screening
- Patient diagnosed with dementia
- Any prohibited medication as determined in the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Effective intraoperative hemostasis
Secondary endpoints 2
- Change in anti-FXa activity from baseline to start of surgery or procedure
- Change in anti-FXa activity from baseline to 2 h post start of surgery or procedure
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Ondexxya 200 mg powder for solution for infusion
PRD9745329 · Product
- Active substance
- Andexanet Alfa
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V03AB38 — -
- Marketing authorisation
- EU/1/18/1345/001
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 14
SCP68630841 · ATC
- Active substance
- Apixaban
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AF02 — APIXABAN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP70719484 · ATC
- Active substance
- Lactose Monohydrate
- Substance synonyms
- LACTOSE HYDRATE
- Route of administration
- ORAL USE
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 30 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AF01 — RIVAROXABAN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1162790 · ATC
- Active substance
- Protamine Hydrochloride
- Substance synonyms
- PROTAMINE HCL
- Route of administration
- UNKNOWN USE
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V03AB14 — PROTAMINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP2107137 · ATC
- Active substance
- Etamsylate
- Substance synonyms
- Etamsilate, ETHAMSYLATE, ETAMSILATE
- Route of administration
- UNKNOWN USE
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B02BX01 — ETAMSYLATE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
B02BD · Product
- Pharmaceutical form
- PHF00190MIG
- Route of administration
- UNKNOWN USE
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B02BD — BLOOD COAGULATION FACTORS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP20125780 · ATC
- Active substance
- Tranexamic Acid
- Substance synonyms
- LB1148, 4-(AMINOMETHYL)CYCLOHEXANE-1-CARBOXYLIC ACID, AMCA, TRANS-AMCHA
- Route of administration
- UNKNOWN USE
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B02AA02 — TRANEXAMIC ACID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP4332463 · ATC
- Active substance
- Aminocaproic Acid
- Route of administration
- UNKNOWN USE
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B02AA01 — AMINOCAPROIC ACID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP2015928 · ATC
- Active substance
- Human Fibrinogen
- Substance synonyms
- FIBRINOGEN, HUMAN
- Route of administration
- UNKNOWN USE
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B02BB01 — FIBRINOGEN, HUMAN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
V07AB · Product
- Pharmaceutical form
- PHF00017MIG
- Route of administration
- UNKNOWN USE
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP157889 · ATC
- Active substance
- Potassium Chloride
- Route of administration
- UNKNOWN USE
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05AX01 — ERYTHROCYTES
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP210486 · ATC
- Route of administration
- UNKNOWN USE
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B02AA03 — AMINOMETHYLBENZOIC ACID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
B05A · Product
- Active substance
- Blood and Related Products
- Pharmaceutical form
- -
- Authorisation status
- Authorised
- ATC code
- B05A — BLOOD AND RELATED PRODUCTS
- Marketing authorisation
- -
- Paediatric formulation
- No
B05AX · Product
- Active substance
- Other blood products
- Pharmaceutical form
- -
- Authorisation status
- Authorised
- ATC code
- B05AX — Other blood products
- Marketing authorisation
- -
- Paediatric formulation
- No
SCP257594 · ATC
- Active substance
- Edoxaban
- Route of administration
- ORAL USE
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AF03 — EDOXABAN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Astrazeneca AB
- Sponsor organisation
- Astrazeneca AB
- Address
- Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- Astrazeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Public contact point
- Organisation
- Astrazeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Excelya Greece CRO Single Member S.A. ORG-100009224
|
Vrilissia, Greece | On site monitoring, Other, Code 2 |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 14, Code 2, Code 5, Data management, E-data capture, Code 8 |
Astrazeneca AB
- Sponsor organisation
- Astrazeneca AB
- Address
- Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- Astrazeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Public contact point
- Organisation
- Astrazeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Excelya Greece CRO Single Member S.A. ORG-100009224
|
Vrilissia, Greece | On site monitoring, Other, Code 2 |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 14, Code 2, Code 5, Data management, E-data capture, Code 8 |
Locations
19 EU/EEA countries · 81 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 10 | 1 |
| Belgium | Ended | 29 | 4 |
| Bulgaria | Ended | 50 | 10 |
| Czechia | Ended | 15 | 4 |
| Denmark | Ended | 11 | 1 |
| Estonia | Ended | 30 | 3 |
| France | Ended | 16 | 3 |
| Germany | Ended | 56 | 8 |
| Greece | Ended | 10 | 4 |
| Hungary | Ended | 50 | 5 |
| Ireland | Ended | 9 | 2 |
| Italy | Ended | 78 | 8 |
| Lithuania | Ended | 14 | 3 |
| Poland | Ended | 14 | 5 |
| Portugal | Ended | 20 | 4 |
| Romania | Ended | 7 | 3 |
| Slovakia | Ended | 3 | 1 |
| Slovenia | Ended | 4 | 2 |
| Spain | Ended | 41 | 10 |
| Rest of world
Israel, Korea, Republic of, Switzerland, Japan, United Kingdom, Canada, Australia, Thailand, Argentina, United States, Malaysia, Georgia, Colombia, New Zealand, Serbia, Taiwan, Singapore, Mexico, Brazil, China
|
— | 554 | — |
Investigational sites
UZ Leuven
0503: Cardiovascular diseases, Herestraat 49, 3000, Leuven
Algemeen Stedelijk Ziekenhuis Campus Aalst
0502: Cardiology, Merestraat 80, 9300, Aalst
Algemeen Ziekenhuis Groeninge
0504: Dept of Anesthesia, President Kennedylaan 4, 8500, Kortrijk
Universitair Ziekenhuis Gent
0501: Gastrointestinal surgery, Corneel Heymanslaan 10, 9000, Gent
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Hristo Botev AD
0907: Department – Surgery, Bulevard Vtori Yuni 66, 3000, Vratsa
Mbal Lyulin EAD
0905: Department of Orthopedics and Traumatology, Anesthesiology department, Lyulin 6, Ulitsa D-R Petir Dertliev 81, Sofiya
University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd.
0908: Department – Surgery, Ulitsa Komatevsko Shose 79, 4004, Plovdiv
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
0901: "Department of Orthopedics and Traumatology, Anesthesiology department", Bulevard Peshtersko Shose 66, 4002, Plovdiv
Multiprofile Hospital For Active Treatment Sveti Nikolay Chuditvorets EOOD
0902: "Vascular surgery, orthopedic surgery and anesthesiology department", Ulitsa Todor Kableshkov 2, 3600, Lom
University Hospital Queen Govanna
0904: "Department of Orthopedics and Traumatology", Ulitsa Byalo More 8, 1527, Sofiya
University Multidisciplinary Hospital for Active Treatment Prof. Dr. Alexander Tchirkov EAD
0903: "Vascular and Endovascular Surgery Clinic", Bulevard Pencho Slaveykov 52a, 1431, Sofiya
Multidisciplinary Hospital For Active Treatment Haskovo AD
0910: Department – Surgery, Bulevard Siedinenie 49, 6304, Haskovo
MBAL Dr. Ivan Seliminski - Sliven AD
0909: Department for intensive care, Bulevard Hristo Botev 1, 8801, Sliven
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
0906: Septic Surgery, Krasno Selo, Bulevard Gen Totleben 21, Sofiya
Fakultni Nemocnice Brno
1904: Chirurgicka klinika, Jihlavska 340/20, Bohunice, Brno
Vseobecna Fakultni Nemocnice V Praze
1903: I. Chirurgicka klinika, U Nemocnice 499/2, Nove Mesto, Prague 2
Krajska zdravotni a.s.
1901: Klinika anesteziologie, perioperacni a intenzivni mediciny, Socialni Pece 3316/12a, Severni Terasa, Usti Nad Labem
Fakultni Nemocnice Kralovske Vinohrady
1902: Chirurgicka klinika, Srobarova 1150/50, Vinohrady, Prague 10
Bispebjerg Hospital
2001: Department of Anaesthesia and Intensive Care, Bispebjerg Bakke 23, 2400, Copenhagen Nv
Sihtasutus Ida-Viru Keskhaigla
2102: general surgey, Ilmajaama Tn 12, Ahtme Linnaosa, Kohtla-Jarve Linn
Tartu University Hospital
2103: Hematology-Oncology Clinic, A006, L. Puusepa Tn 8, Tartu Linn
Louna-Eesti Haigla AS
2104, Meegomae Village, 65526, Voru
Centre Hospitalier De Cholet
2303: Service d'Anesthésie, 1 Rue De Marengo, 49300, Cholet
Centre Hospitalier Universitaire De Nantes
2301: Service d'Anesthésie et réanimations chirurgicales, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Nimes
2302: Service Anesthésie-Réanimation Pôle ARDU, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Marienhaus Klinikum Mainz GmbH
2603: Klinik für Innere Medizin 1, An Der Goldgrube 11, Oberstadt, Mainz
Rostock University Medical Center
2604: Neurochirurgie, Schillingallee 35, Hansaviertel, Rostock
Technische Universitat Dresden
2601: Center for Vascular diseases, Fetscherstrasse 74, Johannstadt-Nord, Dresden
BG Klinikum Bergmannstrost Halle gGmbH
2608: Neurochirurgie, Merseburger Strasse 165, Damaschkestrasse, Halle (Saale)
Universitaetsklinikum Aachen AöR
2607: Anaesthesiologie, Pauwelsstrasse 30, 52074, Aachen
Marien Hospital Herne -Universitaetsklinikum der Ruhr-Universitaet Bochum
2609:Klinik für Anästhesiologie, operative Intensivmedizin, Schmerz- und Palliativmedizin, Hoelkeskampring 40, 44625, Herne
BG Unfallklinik Murnau gGmbH
2602: BG Unfallklinik Murnau gGmbH, Professor-Kuentscher-Strasse 8, 82418, Murnau A. Staffelsee
Universitaetsklinikum Schleswig-Holstein
2605: Universitätsklinikum Schleswig-Holstein Campus Lübeck, Ratzeburger Allee 160, 23538, Lübeck
Ippokratio General Hospital Of Thessaloniki
3001: Cardiology Department, Konstadinoupoleos 49, 546 42, Thessaloniki
General University Hospital Of Larissa
3003: Anaesthesiology Department, P. O. Box 1425, 411 10, Larissa
University General Hospital Attikon
3004: Intensive Care Unit, Rimini Street 1, 124 62, Athens
Henry Dunant Hospital Center
3002: 7th Orthopaedic Department, 107 Mesogeion Avenue, 115 26, Athens
University Of Pecs
3301:Sebészeti Klinika, Ifjusag Utja 13, 7624, Pecs
University Of Debrecen
3304:Aneszteziológiai és Intenzív Terápiás Klinika, Moricz Zsigmond Korut 22, 4032, Debrecen
Semmelweis University
3305:I.sz. Sebészeti Klinika, Ulloi Ut 78, 1082, Budapest
Zala Megyei Szent Rafael Korhaz
3302:Aneszteziológiai és Intenzív Terápiás Osztály, Zrinyi Miklos Utca 1, 8900, Zalaegerszeg
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
3303:Központi Aneszteziológiai és Intenzív Betegellátó Osztály, Seregelyesi Ut 3, 8000, Szekesfehervar
Mater Misericordiae University Hospital
3901: Haematology, Eccles Street, D07 R2WY, Dublin 7
St Vincent's University Hospital
3902: Intensive Care Unit, Nutley Lane Donnybrook, Elm Park, Dublin 4
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
4101: Pronto Soccorso e Medicina d’Urgenza, Viale Luigi Borri 57, 21100, Varese
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo
4108: SC Medicina Generale II, Via Antonio Di Rudini' 8, 20142, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4104: UOC Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica, Largo Francesco Vito 1, 00168, Rome
Humanitas Research Hospital
4114: U.O. Centro Trombosi e Malattie Emorragiche, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliera Papa Giovanni XXIII
4102: SC Ortopedia e Traumatologia, Piazza Oms 1, 24127, Bergamo
Fondazione Policlinico Universitario Campus Bio-Medico
4113: UOC Anestesia e Rianimazione, Via Alvaro Del Portillo N 200, 00128, Rome
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
4106: SC Neurochirurgia- Dipartimento Chirurgico, Via Venezia 16, 15121, Alexandria
Azienda Ospedale-Universita Padova
4103: UOSD Malattie Trombotiche ed Emorragiche, Via Nicolo' Giustiniani 2, 35128, Padova
Vilniaus universiteto ligonine Santaros klinikos VšĮ
4603, Santariskiu G. 2, Vilniaus M. Sav., Vilnius
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
4601, Eiveniu G. 2, Kauno M. Sav., Kaunas
Lietuvos sveikatos mokslu universiteto Kauno ligonine
4602, Laisves Al. 17, Kauno M. Sav., Kovno
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
5704: Kliniczny Oddział Chirurgii Urazowo Ortopedyczne, Ul. Dr. K. Jaczewskiego 8, 20-954, Lublin
Uniwersytecki Szpital Kliniczny Im Wojskowej Akademii Medycznej Centralny Szpital Weteranow
5705: Klinika Ortopedii, Ul. Stefana Zeromskiego 113, 90-549, Lodz
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
5703: Klinika Ortopedii z Pododdziałem Ortopedii Dziecięcej, Ul. Pomorska Nr 251, 92-213, Lodz
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
5702: Oddział Ortopedii i Traumatologii Narządu Ruchu, Os. Zlotej Jesieni 1, 31-826, Cracow
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im Prof. Tadeusza Sokolowskiego Pomorskiego Uniwersytetu Medycznego W Szczecinie
5701: Klinika Ortopedii Traumatologii i Onkologii Narządu Ruchu, Ul. Unii Lubelskiej 1, 71-252, Szczecin
Centro Hospitalar Universitario De Lisboa Norte E.P.E.
5804: Oncologia, Avenida Professor Egas Moniz, 1649-035, Lisbon
Hospital Professor Doutor Fernando Fonseca E.P.E.
5802: Oftalmologia, Itinerario Complementar 19 Acesso Ao Hospital 19, 2720-276, Amadora
Hospital Da Senhora Da Oliveira Guimaraes E.P.E.
5803: Pediatrics, Rua Dos Cuteleiros De Guimaraes, 4835-044, Guimaraes
Centro Hospitalar Universitario De Santo Antonio E.P.E.
5801: Hematologia Clinica, Largo Professor Abel Salazar, 4050-011, Porto
Institutul Clinic Fundeni
6101:ICU, Soseaua Fundeni 258, 022328, Bucharest
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
6102:ATI, Bulevardul Liviu Rebreanu 156, 300723, Timisoara
Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu
6103:Cardiovascular ICU dept 1, Soseaua Fundeni 258, 022328, Bucharest
Narodny Onkologicky Ustav
6701: Klinika onkohematologie, Klenova 1, Nove Mesto, Bratislava
University Medical Center Ljubljana
6802: Department of Anaesthesiology and Surgical Intensive Care, Zaloska Cesta 2, 1000, Ljubljana
Splosna Bolnisnica Celje
6801: Department of Anesthesiology, Oblakova Ulica 5, 3000, Celje
Hospital Universitario Infanta Leonor
7001: Hematología, Avenida Gran Via Del Este 80, 28031, Madrid
Bellvitge University Hospital
7009: Anestesia, Carrer De La Feixa Llarga Sn, 08907, L'hospitalet De Llobregat
Hospital Clinic De Barcelona
7008: Medicina Interna, Calle Villarroel 170, 08036, Barcelona
Hospital Costa Del Sol
7003: TRAUMATOLOGIA, Terreno Autovia Mediterraneo A-7 S/n, 29603, Marbella
Hospital Universitario Del Vinalopo
7006: Hematología, Calle Tonico Sansano Mora 14, 03293, Elche
Hospital Arnau De Vilanova De Valencia
7005: Hematología, Calle De San Clemente 12, 46015, Valencia
Hospital Clinico Universitario De Valencia
7010: Anestesiología y Reanimación, Avenida Blasco Ibanez 17, 46010, Valencia
University Hospital Virgen Del Rocio S.L.
7002: Aparato Digestivo, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Y Politecnico La Fe
7007: Anestesiología y Reanimación, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Virgen De La Macarena
7004: Cirugía General y Aparato Digestivo, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-30 | Germany | Acceptable 2024-01-10
|
2024-01-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-02-19 | Germany | Acceptable 2024-01-10
|
2024-02-19 |