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Document 52024XC03355

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2024 to 30 April 2024 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)

PUB/2024/456

OJ C, C/2024/3355, 31.5.2024, ELI: http://data.europa.eu/eli/C/2024/3355/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

ELI: http://data.europa.eu/eli/C/2024/3355/oj

European flag

Official Journal
of the European Union

EN

C series

C/2024/3355

31.5.2024

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2024 to 30 April 2024

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council  (1) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council  (2) )

(C/2024/3355)

—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

19.4.2024

Apremilast Accord

apremilast

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/24/1796

Film-coated tablet

L04AA32

23.4.2024

19.4.2024

CARVYKTI

ciltacabtagene autoleucel

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/22/1648

Dispersion for infusion

L01XL05

22.4.2024

19.4.2024

Celldemic

Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures)

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland

EU/1/24/1806

Suspension for injection in pre-filled syringe (injection).

J07BB02

22.4.2024

19.4.2024

Filspari

Sparsentan

Vifor France S.A.

Tour Franklin La Defense 8, 100-101 Terrasse Boieldieu, 92042 Paris La Defense Cedex, France

EU/1/23/1788

Film-coated tablet

C09XX01

23.4.2024

19.4.2024

Incellipan

Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures)

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland

EU/1/24/1807

Suspension for injection

J07BB02

23.4.2024

19.4.2024

Nintedanib Accord

nintedanib

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/24/1803

Capsule, soft

L01EX09

24.4.2024

19.4.2024

Pyzchiva

ustekinumab

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/24/1801

Concentrate for solution for injection

Solution for injection

L04AC05

24.4.2024

19.4.2024

Tizveni

tislelizumab

BeiGene Ireland Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

EU/1/24/1797

Concentrate for solution for infusion

 

22.4.2024

19.4.2024

Voydeya

danicopan

Alexion Europe SAS

103-105 rue Anatole France, 92300 Levallois-Perret, France

EU/1/24/1792

Film-coated tablet

L04AJ09

25.4.2024

19.4.2024

ZYNYZ

retifanlimab

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/24/1800

Concentrate for solution for infusion

L01FF10

24.4.2024

22.4.2024

Dimethyl fumarate Accord

dimethyl fumarate

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/24/1811

Gastro-resistant capsule, hard

L04AX07

24.4.2024

22.4.2024

Dimethyl fumarate Mylan

dimethyl fumarate

Mylan Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

EU/1/24/1814

Gastro-resistant capsule, hard

L04AX07

22.4.2024

22.4.2024

Dimethyl fumarate Neuraxpharm

dimethyl fumarate

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69, 08970 Sant Joan Despí - Barcelona, España

EU/1/24/1810

Gastro-resistant capsule, hard

L04AX07

22.4.2024

22.4.2024

Emblaveo

aztreonam / avibactam

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/24/1808

Powder for concentrate for solution for infusion

J01DF51

22.4.2024

—   Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

5.4.2024

Alofisel

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/17/1261

8.4.2024

5.4.2024

Clopidogrel/Acetylsalicylic acid Viatris

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/19/1395

8.4.2024

5.4.2024

Entecavir Viatris

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/17/1227

8.4.2024

5.4.2024

Epidyolex

Jazz Pharmaceuticals Ireland Ltd

5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland

EU/1/19/1389

8.4.2024

5.4.2024

Febuxostat Viatris

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/17/1194

8.4.2024

5.4.2024

Lacosamide UCB

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/19/1383

8.4.2024

5.4.2024

Lokelma

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1173

8.4.2024

5.4.2024

Lorviqua

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/19/1355

8.4.2024

5.4.2024

Orkambi

Vertex Pharmaceuticals (Ireland) Limited

Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland

EU/1/15/1059

8.4.2024

5.4.2024

Perjeta

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/13/813

8.4.2024

9.4.2024

Anagrelide Viatris

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/17/1256

10.4.2024

9.4.2024

Clopidogrel/Acetylsalicylic acid Viatris

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/19/1395

10.4.2024

9.4.2024

Drovelis

Gedeon Richter Plc.

Gyömrői út 19-21, 1103 Budapest, Magyarország

EU/1/21/1547

11.4.2024

9.4.2024

Entecavir Viatris

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/17/1227

10.4.2024

9.4.2024

Febuxostat Viatris

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/17/1194

10.4.2024

9.4.2024

Inhixa

Techdow Pharma Netherlands B.V.

Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland

EU/1/16/1132

15.4.2024

9.4.2024

Orfadin

Swedish Orphan Biovitrum International AB

112 76 Stockholm, Sverige

EU/1/04/303

11.4.2024

9.4.2024

Posaconazole Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/19/1379

10.4.2024

9.4.2024

Posaconazole AHCL

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/19/1380

10.4.2024

9.4.2024

Prasugrel Viatris

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/18/1273

10.4.2024

9.4.2024

Zalasta

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/07/415

15.4.2024

9.4.2024

Zeposia

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/20/1442

10.4.2024

9.4.2024

Zoonotic Influenza Vaccine Seqirus

Seqirus S.r.l.

Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italia

EU/1/23/1761

10.4.2024

11.4.2024

Fingolimod Mylan

Mylan Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

EU/1/21/1573

15.4.2024

15.4.2024

Moventig

Grünenthal GmbH

Zieglerstraße 6, 52078, Aachen, Deutschland

EU/1/14/962

17.4.2024

15.4.2024

Talzenna

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/19/1377

16.4.2024

19.4.2024

Atazanavir Mylan

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/16/1091

22.4.2024

19.4.2024

Biktarvy

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/18/1289

22.4.2024

19.4.2024

Bimzelx

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/21/1575

23.4.2024

19.4.2024

Dupixent

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/17/1229

23.4.2024

19.4.2024

Emtricitabine/Tenofovir disoproxil Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/16/1148

22.4.2024

19.4.2024

Gilenya

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/11/677

23.4.2024

19.4.2024

Jentadueto

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/12/780

22.4.2024

19.4.2024

Koselugo

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1552

22.4.2024

19.4.2024

Lamivudine Teva Pharma B.V.

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/596

22.4.2024

19.4.2024

Leqvio

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/20/1494

23.4.2024

19.4.2024

Lunsumio

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/22/1649

22.4.2024

19.4.2024

Lyxumia

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/12/811

22.4.2024

19.4.2024

Mounjaro

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/22/1685

22.4.2024

19.4.2024

Onglyza

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/09/545

22.4.2024

19.4.2024

Palynziq

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland

EU/1/19/1362

22.4.2024

19.4.2024

Pandemic influenza vaccine H5N1 AstraZeneca

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1089

22.4.2024

19.4.2024

Pluvicto

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/22/1703

26.4.2024

19.4.2024

Potactasol

Actavis Group PTC ehf.

Dalshraun 1, 220 Hafnarfjörður, Íceland

EU/1/10/660

23.4.2024

19.4.2024

Pramipexole Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/08/490

22.4.2024

19.4.2024

Qtern

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1108

22.4.2024

19.4.2024

Rivastigmine Actavis

Actavis Group PTC ehf.

Dalshraun 1, 220 Hafnarfjörður, Íceland

EU/1/11/693

25.4.2024

19.4.2024

Sivextro

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/991

22.4.2024

19.4.2024

Spedra

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Luxembourg

EU/1/13/841

23.4.2024

19.4.2024

Tecartus

Kite Pharma EU B.V.

Tufsteen 1, 2132 NT Hoofddorp, Nederland

EU/1/20/1492

22.4.2024

19.4.2024

Teriflunomide Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/22/1693

24.4.2024

19.4.2024

Twinrix Adult

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/96/020

24.4.2024

19.4.2024

Twinrix Paediatric

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/97/029

24.4.2024

19.4.2024

Ultomiris

Alexion Europe SAS

103-105 Rue Anatole France, 92300 Levallois-Perret, France

EU/1/19/1371

29.4.2024

19.4.2024

Xeplion

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/11/672

22.4.2024

19.4.2024

Xtandi

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/13/846

25.4.2024

25.4.2024

Ambirix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/02/224

26.4.2024

25.4.2024

BYANNLI

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1453

26.4.2024

25.4.2024

Colobreathe

Essential Pharma Limited

Vision Exchange Building, Triq it-Territorjals, Zone 1, Central Business District, Birkirkara CBD 1070, Malta

EU/1/11/747

30.4.2024

25.4.2024

Granpidam

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/16/1137

26.4.2024

25.4.2024

Kalydeco

Vertex Pharmaceuticals (Ireland) Limited

Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland

EU/1/12/782

26.4.2024

25.4.2024

Krazati

Bristol Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland

EU/1/23/1744

6.5.2024

25.4.2024

Levetiracetam Actavis Group

Actavis Group PTC ehf.

Dalshraun 1, 220 Hafnarfjörður, Íceland

EU/1/11/738

26.4.2024

25.4.2024

Lydisilka

Estetra SRL

Rue Saint Georges 5-7, 4000 Liège, Belgique

EU/1/21/1548

26.4.2024

25.4.2024

LysaKare

Advanced Accelerator Applications

8-10 Rue Henri Sainte-Claire Deville, 92500 Rueil-Malmaison, France

EU/1/19/1381

26.4.2024

25.4.2024

Onivyde pegylated liposomal

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/16/1130

30.4.2024

25.4.2024

Yselty

Theramex Ireland Limited

3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

EU/1/21/1606

29.4.2024

29.4.2024

Luxturna

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/18/1331

1.5.2024

29.4.2024

Retsevmo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/20/1527

6.5.2024

29.4.2024

Xerava

PAION Deutschland GmbH

Heussstraße 25, 52078 Aachen, Deutschland

EU/1/18/1312

6.5.2024

—   Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

19.4.2024

Telmisartan Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/719

22.4.2024

—   Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

8.4.2024

Alcort

hydrocortisone aceponate

NEXTMUNE ITALY S.R.L.

Via G.B. Benzoni 50, 26020 Palazzo Pignano (CR), Italia

EU/2/24/306

Cutaneous spray, solution

QD07AC16

9.4.2024

8.4.2024

Lexylan

cefalexin

Emdoka

John Lijsenstraat 16, 2321 Hoogstraten, België

EU/2/24/308

Suspension for injection

QJ01DB01

10.4.2024

9.4.2024

DIVENCE PENTA

Bovine viral diarrhoea (subunit), bovine parainfluenza 3 virus (inactivated), bovine respiratory syncytial virus and bovine herpesvirus type 1 (live) vaccine

Laboratorios Hipra, S.A.

Avda. La Selva, 135, 17170 Amer (Girona), España

EU/2/24/307

Lyophilisate and solvent for solution for injection

QI02AH

10.4.2024

25.4.2024

Lotimax

lotilaner

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/24/311

Chewable tablet

QP53BE04

29.4.2024

—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

8.4.2024

Aivlosin

ECO Animal Health Europe Limited

6th Floor, South Bank House, Barrow Street, Dublin 4, D04 TR29, Ireland

EU/2/04/044

12.4.2024

8.4.2024

Chanhold

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/19/236

15.4.2024

8.4.2024

Daxocox

Ecuphar NV

Legeweg 157-i, 8020 Oostkamp, België

EU/2/21/270

9.4.2024

8.4.2024

Draxxin

Zoetis Belgium

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/03/041

10.4.2024

8.4.2024

Incurin

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/00/018

11.4.2024

9.4.2024

Aivlosin

ECO Animal Health Europe Limited

6th Floor, South Bank House, Barrow Street, Dublin 4, D04 TR29, Ireland

EU/2/04/044

12.4.2024

9.4.2024

Lydaxx

VETOQUINOL S.A.

Magny-Vernois, 70200 Lure, France

EU/2/20/253

10.4.2024

9.4.2024

OvuGel

Vetoquinol S.A.

Magny-Vernois, 70200 Lure, France

EU/2/20/260

10.4.2024

9.4.2024

Strangvac

Intervacc AB

Vastertorpsvagen 135, 129 44 Hagersten, Sverige

EU/2/21/274

10.4.2024

11.4.2024

Tulissin

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/20/252

12.4.2024

25.4.2024

Halocur

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/99/013

26.4.2024

25.4.2024

Nobilis IB Primo QX

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/14/174

29.4.2024

25.4.2024

PREVEXXION RN+HVT+IBD

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/20/255

30.4.2024

25.4.2024

Purevax RCP

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/052

29.4.2024

25.4.2024

Senvelgo

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/23/305

29.4.2024

25.4.2024

Tulaven

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/20/251

26.4.2024

29.4.2024

Coliprotec F4/F18

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/16/202

30.4.2024

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

(1)   OJ L 136, 30.4.2004, p. 1.

(2)   OJ L 4, 7.1.2019, p. 43.

ELI: http://data.europa.eu/eli/C/2024/3355/oj

ISSN 1977-091X (electronic edition)

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