# Eiropas Savienības C 101/2020

| | ISSN 1977-0952 |
| --- | --- |
| Eiropas Savienības
  Oficiālais Vēstnesis | C 101 |
| | |
| Izdevums latviešu valodā | Informācija un paziņojumi | 63. gadagājums2020. gada 27. marts |

ISSN 1977-0952

Eiropas Savienības

Oficiālais Vēstnesis

C 101

Izdevums latviešu valodā

Informācija un paziņojumi

63. gadagājums2020. gada 27. marts

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| Saturs | Lappuse |
| --- | --- |
| | IV   Paziņojumi |
| | EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI |
| | Eiropas Komisija |
| 2020/C 101/01 | Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2020. gada 1. februāra līdz 2020. gada 29. februārim(Publicēts saskaņā ar 13. vai 38. pantu Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004) | 1 |

Saturs

Lappuse

IV   Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

2020/C 101/01

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2020. gada 1. februāra līdz 2020. gada 29. februārim(Publicēts saskaņā ar 13. vai 38. pantu Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004)

(Publicēts saskaņā ar 13. vai 38. pantu Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004)

1

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| LV | |
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LV

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IV Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

| 27.3.2020 | LV | Eiropas Savienības Oficiālais Vēstnesis | C 101/1 |
| --- | --- | --- | --- |

27.3.2020

LV

Eiropas Savienības Oficiālais Vēstnesis

C 101/1

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Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2020. gada 1. februāra līdz 2020. gada 29. februārim

(Publicēts saskaņā ar 13. vai 38. pantu Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004 (1))

(2020/C 101/01)

—   Tirdzniecības atļaujas izsniegšana (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemtas

| Lēmuma datums | Zāļu nosaukums | INN (starptautiskais nepatentētais nosaukums) | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Farmaceitiskā forma | AĶT kods (Anatomiski ķīmiski terapeitiskais kods) | Paziņojuma datums |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 13.2.2020. | Amsparity | adalimumab | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/19/1415 | Šķīdums injekcijai | L04AB04 | 17.2.2020. |
| 13.2.2020. | Azacitidine Accord | Azacitidīns | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | EU/1/19/1413 | Pulveris injekciju suspensijas pagatavošanai | L01BC07 | 17.2.2020. |
| 13.2.2020. | Beovu | brolucizumabs | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/19/1417 | Šķīdums injekcijai | S01LA06 | 17.2.2020. |
| 13.2.2020. | Dexmedetomidine Accord | dexmedetomidinum | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | EU/1/19/1418 | Koncentrāts infūziju šķīduma pagatavošanai | N05CM18 | 17.2.2020. |
| 13.2.2020. | Recarbrio | imipenēms/cilastatīns/relebaktāms | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/19/1420 | Pulveris infūziju šķīduma pagatavošanai | J01DH56 | 17.2.2020. |

Lēmuma datums

Zāļu nosaukums

INN (starptautiskais nepatentētais nosaukums)

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Farmaceitiskā forma

AĶT kods (Anatomiski ķīmiski terapeitiskais kods)

Paziņojuma datums

13.2.2020.

Amsparity

adalimumab

Pfizer Europe MA EEIG

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

EU/1/19/1415

Šķīdums injekcijai

L04AB04

17.2.2020.

13.2.2020.

Azacitidine Accord

Azacitidīns

Accord Healthcare S.L.U.

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

EU/1/19/1413

Pulveris injekciju suspensijas pagatavošanai

L01BC07

17.2.2020.

13.2.2020.

Beovu

brolucizumabs

Novartis Europharm Limited

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

EU/1/19/1417

Šķīdums injekcijai

S01LA06

17.2.2020.

13.2.2020.

Dexmedetomidine Accord

dexmedetomidinum

Accord Healthcare S.L.U.

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

EU/1/19/1418

Koncentrāts infūziju šķīduma pagatavošanai

N05CM18

17.2.2020.

13.2.2020.

Recarbrio

imipenēms/cilastatīns/relebaktāms

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/19/1420

Pulveris infūziju šķīduma pagatavošanai

J01DH56

17.2.2020.

—   Tirdzniecības atļaujas grozīšana (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemtas

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 4.2.2020. | Ceprotin | Takeda Manufacturing Austria AG
  Industriestraße 67, 1221 Wien, Österreich | EU/1/01/190 | 6.2.2020. |
| 4.2.2020. | CONTROLOC Control | Takeda GmbH
  Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland | EU/1/09/515 | 6.2.2020. |
| 4.2.2020. | ellaOne | Laboratoire HRA Pharma
  200 avenue de Paris, 92320 Chatillon, France | EU/1/09/522 | 6.2.2020. |
| 4.2.2020. | Ivabradine Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | EU/1/17/1190 | 6.2.2020. |
| 4.2.2020. | Lacosamide Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/17/1230 | 6.2.2020. |
| 4.2.2020. | LIFMIOR | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/16/1165 | 6.2.2020. |
| 4.2.2020. | Mekinist | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/931 | 6.2.2020. |
| 4.2.2020. | PANTOZOL Control | Takeda GmbH
  Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland | EU/1/09/517 | 6.2.2020. |
| 4.2.2020. | Suboxone | Indivior Europe Limited
  27 Windsor Place, Dublin 2, Ireland | EU/1/06/359 | 6.2.2020. |
| 4.2.2020. | Ucedane | Eurocept International B.V.
  Trapgans 5, 1244 RL Ankeveen, Nederland | EU/1/17/1202 | 6.2.2020. |
| 4.2.2020. | Ziagen | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/99/112 | 6.2.2020. |
| 4.2.2020. | Zoely | Theramex Ireland Limited
  3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland | EU/1/11/690 | 6.2.2020. |
| 6.2.2020. | Aranesp | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/01/185 | 10.2.2020. |
| 6.2.2020. | Bronchitol | Pharmaxis Europe Limited
  108 Q House, Furze Road, Sandyford Dublin 18, D18AY29, Ireland | EU/1/12/760 | 10.2.2020. |
| 6.2.2020. | Fasenra | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/17/1252 | 10.2.2020. |
| 6.2.2020. | 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 | 10.2.2020. |
| 6.2.2020. | Jardiance | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/930 | 10.2.2020. |
| 6.2.2020. | Neuraceq | Life Radiopharma Berlin GmbH
  Max-Planck-Straße 4, 12489 Berlin, Deutschland | EU/1/13/906 | 10.2.2020. |
| 6.2.2020. | SOMAC Control | Takeda GmbH
  Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland | EU/1/09/516 | 10.2.2020. |
| 6.2.2020. | Vokanamet | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/918 | 10.2.2020. |
| 10.2.2020. | Inhixa | Techdow Pharma Netherlands B.V.
  Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland | EU/1/16/1132 | 12.2.2020. |
| 11.2.2020. | Alimta | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/04/290 | 13.2.2020. |
| 11.2.2020. | ALPROLIX | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | EU/1/16/1098 | 13.2.2020. |
| 11.2.2020. | Entecavir Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/17/1211 | 13.2.2020. |
| 11.2.2020. | OCALIVA | Intercept Pharma International Limited
  Ormond Building, 31 – 36 Ormond Quay Upper, Dublin 7, Ireland | EU/1/16/1139 | 13.2.2020. |
| 11.2.2020. | Orkambi | Vertex Pharmaceuticals (Ireland) Limited
  28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland | EU/1/15/1059 | 13.2.2020. |
| 11.2.2020. | Pemetrexed Fresenius Kabi | Fresenius Kabi Deutschland GmbH
  Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland | EU/1/16/1115 | 13.2.2020. |
| 11.2.2020. | Rebetol | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/99/107 | 13.2.2020. |
| 11.2.2020. | Symkevi | Vertex Pharmaceuticals (Ireland) Limited
  28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland | EU/1/18/1306 | 13.2.2020. |
| 11.2.2020. | Zeffix | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/99/114 | 13.2.2020. |
| 11.2.2020. | Zevalin | Ceft Biopharma s.r.o
  Trtinova 260/1 Cakovice, 196 00 Praha 9, Česká republika | EU/1/03/264 | 13.2.2020. |
| 12.2.2020. | Zoledronic acid Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/12/800 | 14.2.2020. |
| 13.2.2020. | Aimovig | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/18/1293 | 17.2.2020. |
| 13.2.2020. | Bosulif | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/13/818 | 17.2.2020. |
| 13.2.2020. | Brineura | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, Ireland | EU/1/17/1192 | 17.2.2020. |
| 13.2.2020. | Dificlir | Astellas Pharma Europe B.V.
  Sylviusweg 62, 2333 BE Leiden, Nederland | EU/1/11/733 | 17.2.2020. |
| 13.2.2020. | Duloxetine Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/15/1010 | 17.2.2020. |
| 13.2.2020. | Ebixa | H. Lundbeck A/S
  Ottiliavej 9, 2500 Valby, Danmark | EU/1/02/219 | 17.2.2020. |
| 13.2.2020. | IBRANCE | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/16/1147 | 17.2.2020. |
| 13.2.2020. | Mvasi | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/17/1246 | 17.2.2020. |
| 13.2.2020. | Quinsair | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/14/973 | 17.2.2020. |
| 13.2.2020. | Sprycel | Bristol-Myers Squibb Pharma EEIG
  Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland | EU/1/06/363 | 17.2.2020. |
| 13.2.2020. | Tamiflu | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/02/222 | 17.2.2020. |
| 13.2.2020. | Ventavis | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/03/255 | 17.2.2020. |
| 17.2.2020. | Adempas | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/907 | 19.2.2020. |
| 17.2.2020. | Atripla | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/07/430 | 19.2.2020. |
| 17.2.2020. | Eliquis | Bristol-Myers Squibb/Pfizer EEIG
  Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland | EU/1/11/691 | 19.2.2020. |
| 17.2.2020. | Sifrol | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/97/050 | 19.2.2020. |
| 17.2.2020. | Suliqua | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/16/1157 | 19.2.2020. |
| 17.2.2020. | Tacforius | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/17/1244 | 2.3.2020. |
| 17.2.2020. | Vyndaqel | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/11/717 | 19.2.2020. |
| 18.2.2020. | Zypadhera | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/08/479 | 20.2.2020. |
| 21.2.2020. | Cholib | Mylan IRE Healthcare Ltd
  Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland | EU/1/13/866 | 25.2.2020. |
| 21.2.2020. | Cometriq | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/13/890 | 25.2.2020. |
| 21.2.2020. | Docetaxel Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/12/769 | 25.2.2020. |
| 21.2.2020. | Eptifibatide Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | EU/1/15/1065 | 25.2.2020. |
| 21.2.2020. | Holoclar | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/14/987 | 25.2.2020. |
| 21.2.2020. | Imfinzi | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/18/1322 | 18.2.2020. |
| 21.2.2020. | Lyrica | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/04/279 | 25.2.2020. |
| 21.2.2020. | Mirapexin | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/97/051 | 25.2.2020. |
| 21.2.2020. | Resolor | Shire Pharmaceuticals Ireland Limited
  Block 2 & 3 Miesian Plaza, 50-58 Baggot Street Lower, D02 Y754 Dublin 2, Ireland | EU/1/09/581 | 25.2.2020. |
| 21.2.2020. | Trelegy Ellipta | GlaxoSmithKline Trading Services Limited
  Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland | EU/1/17/1236 | 25.2.2020. |
| 21.2.2020. | Voriconazole Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | EU/1/13/835 | 25.2.2020. |
| 21.2.2020. | Zalasta | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/07/415 | 25.2.2020. |
| 21.2.2020. | Zyprexa | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/96/022 | 25.2.2020. |
| 21.2.2020. | Zyprexa Velotab | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/99/125 | 25.2.2020. |
| 24.2.2020. | Docetaxel Kabi | Fresenius Kabi Deutschland GmbH
  Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland | EU/1/12/770 | 26.2.2020. |
| 24.2.2020. | Lixiana | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/15/993 | 26.2.2020. |
| 24.2.2020. | Slenyto | RAD Neurim Pharmaceuticals EEC SARL
  4 rue de Marivaux, 75002 Paris, France | EU/1/18/1318 | 26.2.2020. |
| 25.2.2020. | Aripiprazole Mylan Pharma | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/15/1005 | 27.2.2020. |
| 28.2.2020. | Advagraf | Astellas Pharma Europe B.V.
  Sylviusweg 62, 2333 BE Leiden, Nederland | EU/1/07/387 | 3.3.2020. |
| 28.2.2020. | Bexsero | GlaxoSmithKline Vaccines S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/12/812 | 3.3.2020. |
| 28.2.2020. | Cuprymina | A.C.O.M. -ADVANCED CENTER ONCOLOGY MACERATA -S.R.L.
  Località Cavallino, 39 A/B 62010 Montecosaro (MC), Italia | EU/1/12/784 | 3.3.2020. |
| 28.2.2020. | Hetlioz | Vanda Pharmaceuticals Germany GmbH
  Franzoesische Strasse 12, Mitte, Berlin 10117, Deutschland | EU/1/15/1008 | 3.3.2020. |
| 28.2.2020. | Januvia | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/07/383 | 3.3.2020. |
| 28.2.2020. | Ledaga | Helsinn Birex Pharmaceuticals Ltd.
  Damastown, Mulhuddart, Dublin 15, Ireland | EU/1/16/1171 | 3.3.2020. |
| 28.2.2020. | Modigraf | Astellas Pharma Europe B.V.
  Sylviusweg 62, 2333 BE Leiden, Nederland | EU/1/09/523 | 3.3.2020. |
| 28.2.2020. | Pegfilgrastim Mundipharma | Mundipharma Corporation (Ireland) Limited
  Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland | EU/1/19/1409 | 3.3.2020. |
| 28.2.2020. | Pemetrexed Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | EU/1/15/1071 | 3.3.2020. |
| 28.2.2020. | Pemetrexed Lilly | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/15/1034 | 3.3.2020. |
| 28.2.2020. | Simponi | Janssen Biologics B.V.
  Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/09/546 | 3.3.2020. |
| 28.2.2020. | Voncento | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | EU/1/13/857 | 3.3.2020. |
| 28.2.2020. | Xerava | Tetraphase Pharmaceuticals Ireland Limited
  10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland | EU/1/18/1312 | 3.3.2020. |
| 28.2.2020. | Xeristar | Esteve Pharmaceuticals S.A.
  Passeig de la Zona Franca, 109, 08038 Barcelona, España | EU/1/04/297 | 3.3.2020. |
| 28.2.2020. | Xolair | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/05/319 | 3.3.2020. |
| 28.2.2020. | Zoledronic acid Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/13/834 | 3.3.2020. |
| 28.2.2020. | Zydelig | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/14/938 | 3.3.2020. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

4.2.2020.

Ceprotin

Takeda Manufacturing Austria AG

Industriestraße 67, 1221 Wien, Österreich

EU/1/01/190

6.2.2020.

4.2.2020.

CONTROLOC Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/515

6.2.2020.

4.2.2020.

ellaOne

Laboratoire HRA Pharma

200 avenue de Paris, 92320 Chatillon, France

EU/1/09/522

6.2.2020.

4.2.2020.

Ivabradine Accord

Accord Healthcare S.L.U.

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

EU/1/17/1190

6.2.2020.

4.2.2020.

Lacosamide Accord

Accord Healthcare S.L.U.

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

EU/1/17/1230

6.2.2020.

4.2.2020.

LIFMIOR

Pfizer Europe MA EEIG

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

EU/1/16/1165

6.2.2020.

4.2.2020.

Mekinist

Novartis Europharm Limited

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

EU/1/14/931

6.2.2020.

4.2.2020.

PANTOZOL Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/517

6.2.2020.

4.2.2020.

Suboxone

Indivior Europe Limited

27 Windsor Place, Dublin 2, Ireland

EU/1/06/359

6.2.2020.

4.2.2020.

Ucedane

Eurocept International B.V.

Trapgans 5, 1244 RL Ankeveen, Nederland

EU/1/17/1202

6.2.2020.

4.2.2020.

Ziagen

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/99/112

6.2.2020.

4.2.2020.

Zoely

Theramex Ireland Limited

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

EU/1/11/690

6.2.2020.

6.2.2020.

Aranesp

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/01/185

10.2.2020.

6.2.2020.

Bronchitol

Pharmaxis Europe Limited

108 Q House, Furze Road, Sandyford Dublin 18, D18AY29, Ireland

EU/1/12/760

10.2.2020.

6.2.2020.

Fasenra

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1252

10.2.2020.

6.2.2020.

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

10.2.2020.

6.2.2020.

Jardiance

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/930

10.2.2020.

6.2.2020.

Neuraceq

Life Radiopharma Berlin GmbH

Max-Planck-Straße 4, 12489 Berlin, Deutschland

EU/1/13/906

10.2.2020.

6.2.2020.

SOMAC Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/516

10.2.2020.

6.2.2020.

Vokanamet

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/918

10.2.2020.

10.2.2020.

Inhixa

Techdow Pharma Netherlands B.V.

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

EU/1/16/1132

12.2.2020.

11.2.2020.

Alimta

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/04/290

13.2.2020.

11.2.2020.

ALPROLIX

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/16/1098

13.2.2020.

11.2.2020.

Entecavir Accord

Accord Healthcare S.L.U.

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

EU/1/17/1211

13.2.2020.

11.2.2020.

OCALIVA

Intercept Pharma International Limited

Ormond Building, 31 – 36 Ormond Quay Upper, Dublin 7, Ireland

EU/1/16/1139

13.2.2020.

11.2.2020.

Orkambi

Vertex Pharmaceuticals (Ireland) Limited

28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland

EU/1/15/1059

13.2.2020.

11.2.2020.

Pemetrexed Fresenius Kabi

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland

EU/1/16/1115

13.2.2020.

11.2.2020.

Rebetol

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/99/107

13.2.2020.

11.2.2020.

Symkevi

Vertex Pharmaceuticals (Ireland) Limited

28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland

EU/1/18/1306

13.2.2020.

11.2.2020.

Zeffix

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/99/114

13.2.2020.

11.2.2020.

Zevalin

Ceft Biopharma s.r.o

Trtinova 260/1 Cakovice, 196 00 Praha 9, Česká republika

EU/1/03/264

13.2.2020.

12.2.2020.

Zoledronic acid Hospira

Pfizer Europe MA EEIG

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

EU/1/12/800

14.2.2020.

13.2.2020.

Aimovig

Novartis Europharm Limited

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

EU/1/18/1293

17.2.2020.

13.2.2020.

Bosulif

Pfizer Europe MA EEIG

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

EU/1/13/818

17.2.2020.

13.2.2020.

Brineura

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, Ireland

EU/1/17/1192

17.2.2020.

13.2.2020.

Dificlir

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/11/733

17.2.2020.

13.2.2020.

Duloxetine Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/1010

17.2.2020.

13.2.2020.

Ebixa

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/02/219

17.2.2020.

13.2.2020.

IBRANCE

Pfizer Europe MA EEIG

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

EU/1/16/1147

17.2.2020.

13.2.2020.

Mvasi

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/17/1246

17.2.2020.

13.2.2020.

Quinsair

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/973

17.2.2020.

13.2.2020.

Sprycel

Bristol-Myers Squibb Pharma EEIG

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

EU/1/06/363

17.2.2020.

13.2.2020.

Tamiflu

Roche Registration GmbH

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

EU/1/02/222

17.2.2020.

13.2.2020.

Ventavis

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/03/255

17.2.2020.

17.2.2020.

Adempas

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/907

19.2.2020.

17.2.2020.

Atripla

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/07/430

19.2.2020.

17.2.2020.

Eliquis

Bristol-Myers Squibb/Pfizer EEIG

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

EU/1/11/691

19.2.2020.

17.2.2020.

Sifrol

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/97/050

19.2.2020.

17.2.2020.

Suliqua

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/16/1157

19.2.2020.

17.2.2020.

Tacforius

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/17/1244

2.3.2020.

17.2.2020.

Vyndaqel

Pfizer Europe MA EEIG

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

EU/1/11/717

19.2.2020.

18.2.2020.

Zypadhera

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/08/479

20.2.2020.

21.2.2020.

Cholib

Mylan IRE Healthcare Ltd

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

EU/1/13/866

25.2.2020.

21.2.2020.

Cometriq

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/13/890

25.2.2020.

21.2.2020.

Docetaxel Accord

Accord Healthcare S.L.U.

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

EU/1/12/769

25.2.2020.

21.2.2020.

Eptifibatide Accord

Accord Healthcare S.L.U.

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

EU/1/15/1065

25.2.2020.

21.2.2020.

Holoclar

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/987

25.2.2020.

21.2.2020.

Imfinzi

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1322

18.2.2020.

21.2.2020.

Lyrica

Pfizer Europe MA EEIG

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

EU/1/04/279

25.2.2020.

21.2.2020.

Mirapexin

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/97/051

25.2.2020.

21.2.2020.

Resolor

Shire Pharmaceuticals Ireland Limited

Block 2 & 3 Miesian Plaza, 50-58 Baggot Street Lower, D02 Y754 Dublin 2, Ireland

EU/1/09/581

25.2.2020.

21.2.2020.

Trelegy Ellipta

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/17/1236

25.2.2020.

21.2.2020.

Voriconazole Accord

Accord Healthcare S.L.U.

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

EU/1/13/835

25.2.2020.

21.2.2020.

Zalasta

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/07/415

25.2.2020.

21.2.2020.

Zyprexa

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/96/022

25.2.2020.

21.2.2020.

Zyprexa Velotab

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/99/125

25.2.2020.

24.2.2020.

Docetaxel Kabi

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland

EU/1/12/770

26.2.2020.

24.2.2020.

Lixiana

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/15/993

26.2.2020.

24.2.2020.

Slenyto

RAD Neurim Pharmaceuticals EEC SARL

4 rue de Marivaux, 75002 Paris, France

EU/1/18/1318

26.2.2020.

25.2.2020.

Aripiprazole Mylan Pharma

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/1005

27.2.2020.

28.2.2020.

Advagraf

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/07/387

3.3.2020.

28.2.2020.

Bexsero

GlaxoSmithKline Vaccines S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/12/812

3.3.2020.

28.2.2020.

Cuprymina

A.C.O.M. -ADVANCED CENTER ONCOLOGY MACERATA -S.R.L.

Località Cavallino, 39 A/B 62010 Montecosaro (MC), Italia

EU/1/12/784

3.3.2020.

28.2.2020.

Hetlioz

Vanda Pharmaceuticals Germany GmbH

Franzoesische Strasse 12, Mitte, Berlin 10117, Deutschland

EU/1/15/1008

3.3.2020.

28.2.2020.

Januvia

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/383

3.3.2020.

28.2.2020.

Ledaga

Helsinn Birex Pharmaceuticals Ltd.

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/16/1171

3.3.2020.

28.2.2020.

Modigraf

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/09/523

3.3.2020.

28.2.2020.

Pegfilgrastim Mundipharma

Mundipharma Corporation (Ireland) Limited

Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland

EU/1/19/1409

3.3.2020.

28.2.2020.

Pemetrexed Accord

Accord Healthcare S.L.U.

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

EU/1/15/1071

3.3.2020.

28.2.2020.

Pemetrexed Lilly

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1034

3.3.2020.

28.2.2020.

Simponi

Janssen Biologics B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/09/546

3.3.2020.

28.2.2020.

Voncento

CSL Behring GmbH

Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland

EU/1/13/857

3.3.2020.

28.2.2020.

Xerava

Tetraphase Pharmaceuticals Ireland Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

EU/1/18/1312

3.3.2020.

28.2.2020.

Xeristar

Esteve Pharmaceuticals S.A.

Passeig de la Zona Franca, 109, 08038 Barcelona, España

EU/1/04/297

3.3.2020.

28.2.2020.

Xolair

Novartis Europharm Limited

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

EU/1/05/319

3.3.2020.

28.2.2020.

Zoledronic acid Accord

Accord Healthcare S.L.U.

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

EU/1/13/834

3.3.2020.

28.2.2020.

Zydelig

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/14/938

3.3.2020.

—   Tirdzniecības atļaujas izņemšana no aprites (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004)

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 11.2.2020. | Picato | LEO Laboratories Ltd
  285 Cashel Road, Crumlin, Dublin 12, Ireland | EU/1/12/796 | 13.2.2020. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

11.2.2020.

Picato

LEO Laboratories Ltd

285 Cashel Road, Crumlin, Dublin 12, Ireland

EU/1/12/796

13.2.2020.

—   Tirdzniecības atļaujas grozīšana (38. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemtas

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 4.2.2020. | Clevor | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/2/17/222 | 6.2.2020. |
| 11.2.2020. | Halagon | Emdoka bvba
  J. Lijsenstraat 16, 2321 Hoogstraten, België | EU/2/16/201 | 13.2.2020. |
| 11.2.2020. | Meloxidyl | Ceva Santé Animale
  10 avenue de La Ballastière, 33500 Libourne, France | EU/2/06/070 | 13.2.2020. |
| 11.2.2020. | Oxyglobin | OPK Biotech Netherlands BV
  Teleportboulevard 140, 1043 EJ Amsterdam, Nederland | EU/2/99/015 | 14.2.2020. |
| 11.2.2020. | Palladia | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/100 | 13.2.2020. |
| 17.2.2020. | Zulvac 1 Bovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/130 | 19.2.2020. |
| 17.2.2020. | Zulvac 1 Ovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/131 | 19.2.2020. |
| 18.2.2020. | Emdocam | Emdoka bvba
  J. Lijsenstraat 16, 2321 Hoogstraten, België | EU/2/11/128 | 20.2.2020. |
| 18.2.2020. | Zycortal | Dechra Regulatory B.V.
  Handelsweg 25, 5531 AE Bladel, Nederland | EU/2/15/189 | 20.2.2020. |
| 26.2.2020. | Porcilis ColiClos | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/12/141 | 28.2.2020. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

4.2.2020.

Clevor

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/17/222

6.2.2020.

11.2.2020.

Halagon

Emdoka bvba

J. Lijsenstraat 16, 2321 Hoogstraten, België

EU/2/16/201

13.2.2020.

11.2.2020.

Meloxidyl

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/06/070

13.2.2020.

11.2.2020.

Oxyglobin

OPK Biotech Netherlands BV

Teleportboulevard 140, 1043 EJ Amsterdam, Nederland

EU/2/99/015

14.2.2020.

11.2.2020.

Palladia

Zoetis Belgium S.A.

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

EU/2/09/100

13.2.2020.

17.2.2020.

Zulvac 1 Bovis

Zoetis Belgium S.A.

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

EU/2/11/130

19.2.2020.

17.2.2020.

Zulvac 1 Ovis

Zoetis Belgium S.A.

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

EU/2/11/131

19.2.2020.

18.2.2020.

Emdocam

Emdoka bvba

J. Lijsenstraat 16, 2321 Hoogstraten, België

EU/2/11/128

20.2.2020.

18.2.2020.

Zycortal

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/15/189

20.2.2020.

26.2.2020.

Porcilis ColiClos

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/12/141

28.2.2020.

—   Tirdzniecības atļaujas izņemšana no aprites (38. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004)

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 18.2.2020. | Zulvac 1 Bovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/130 | 20.2.2020. |
| 18.2.2020. | Zulvac 1 Ovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/131 | 20.2.2020. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

18.2.2020.

Zulvac 1 Bovis

Zoetis Belgium S.A.

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

EU/2/11/130

20.2.2020.

18.2.2020.

Zulvac 1 Ovis

Zoetis Belgium S.A.

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

EU/2/11/131

20.2.2020.

Ikvienam, kurš vēlas apskatīt publisko novērtējuma ziņojumu par attiecīgajām zālēm un ar tām saistītos lēmumus, jāsazinās ar:

| European Medicines Agency |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| NETHERLANDS |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

---

(1)  OV L 136, 30.4.2004, 1. lpp.

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