# Službeni list C 349/28.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 349 |
| | |
| Hrvatsko izdanje | Informacije i objave | Godište 61.28 rujna 2018. |

ISSN 1977-1088

Službeni list

Europske unije

C 349

Hrvatsko izdanje

Informacije i objave

Godište 61.28 rujna 2018.

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| Sadržaj | Stranica |
| --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2018/C 349/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. kolovoza 2018. do 31. kolovoza 2018.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 1 |
| 2018/C 349/02 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. kolovoza 2018. do 31. kolovoza 2018.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ) | 14 |

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2018/C 349/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. kolovoza 2018. do 31. kolovoza 2018.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

1

2018/C 349/02

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. kolovoza 2018. do 31. kolovoza 2018.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ)

(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ)

14

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| HR | |
| --- | --- |

HR

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IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 28.9.2018 | HR | Službeni list Europske unije | C 349/1 |
| --- | --- | --- | --- |

28.9.2018

HR

Službeni list Europske unije

C 349/1

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Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. kolovoza 2018. do 31. kolovoza 2018.

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (1))

(2018/C 349/01)

| — | Izdavanje odobrenja za stavljanje u promet (članak 13. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno |
| --- | --- |

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Izdavanje odobrenja za stavljanje u promet (članak 13. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | INN (medunarodni nezašticeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 23.8.2018. | Duzallo | alopurinol/lesinurad | Grünenthal GmbH
  Zieglerstraße 6, 52078, Aachen, Deutschland | EU/1/18/1300 | Filmom obložena tableta | M04AA51 | 27.8.2018. |
| 23.8.2018. | Kymriah | tisagenlekleucel | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/18/1297 | Disperzija za infuziju | Pending | 27.8.2018. |
| 23.8.2018. | Mepsevii | vestronidaze alfa | Ultragenyx Germany GmbH
  Friedrichstraße 191, 10117 Berlin, Deutschland | EU/1/18/1301 | Koncentrat za otopinu za infuziju | A16AB18 | 27.8.2018. |
| 23.8.2018. | Vyxeos | daunorubicin/citarabin | Jazz Pharmaceuticals Ireland Ltd
  5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland | EU/1/18/1308 | Prašak za koncentrat za otopinu za infuziju | L01XY01 | 27.8.2018. |
| 23.8.2018. | Yescarta | aksikaptagen ciloleucel | Kite Pharma EU B.V.
  Science Park 408, 1098 XH Amsterdam, Nederland | EU/1/18/1299 | Disperzija za infuziju | L01X | 27.8.2018. |
| 27.8.2018. | Onpattro | patisirana | Alnylam Netherlands B.V.
  Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland | EU/1/18/1320 | Koncentrat za otopinu za infuziju | Pending | 29.8.2018. |
| 27.8.2018. | Ulipristal Acetate Gedeon Richter | ulipristalacetat | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/18/1309 | Tableta | G03XB02 | 29.8.2018. |
| 31.8.2018. | Cablivi | kaplacizumab | Ablynx N.V.
  Technologiepark 21, 9052 Zwijnaarde, België | EU/1/18/1305 | Prašak i otapalo za otopinu za injekciju | B01AX07 | 4.9.2018. |
| 31.8.2018. | Nerlynx | neratinib | Puma Biotechnology, Ltd.
  11th Floor, Whitefriars, Lewins Mead, Bristol, BS1 2NT, United Kingdom | EU/1/18/1311 | Filmom obložena tableta | L01XE45 | 4.9.2018. |
| 31.8.2018. | VEYVONDI | vonikog alfa | Baxalta Innovations GmbH
  Industriestraße 67, 1221 Wien, Österreich | EU/1/18/1298 | Prašak i otapalo za otopinu za injekciju | B02BD10 | 4.9.2018. |

Datum odluke

Naziv lijeka

INN (medunarodni nezašticeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

23.8.2018.

Duzallo

alopurinol/lesinurad

Grünenthal GmbH

Zieglerstraße 6, 52078, Aachen, Deutschland

EU/1/18/1300

Filmom obložena tableta

M04AA51

27.8.2018.

23.8.2018.

Kymriah

tisagenlekleucel

Novartis Europharm Limited

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

EU/1/18/1297

Disperzija za infuziju

Pending

27.8.2018.

23.8.2018.

Mepsevii

vestronidaze alfa

Ultragenyx Germany GmbH

Friedrichstraße 191, 10117 Berlin, Deutschland

EU/1/18/1301

Koncentrat za otopinu za infuziju

A16AB18

27.8.2018.

23.8.2018.

Vyxeos

daunorubicin/citarabin

Jazz Pharmaceuticals Ireland Ltd

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

EU/1/18/1308

Prašak za koncentrat za otopinu za infuziju

L01XY01

27.8.2018.

23.8.2018.

Yescarta

aksikaptagen ciloleucel

Kite Pharma EU B.V.

Science Park 408, 1098 XH Amsterdam, Nederland

EU/1/18/1299

Disperzija za infuziju

L01X

27.8.2018.

27.8.2018.

Onpattro

patisirana

Alnylam Netherlands B.V.

Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland

EU/1/18/1320

Koncentrat za otopinu za infuziju

Pending

29.8.2018.

27.8.2018.

Ulipristal Acetate Gedeon Richter

ulipristalacetat

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/18/1309

Tableta

G03XB02

29.8.2018.

31.8.2018.

Cablivi

kaplacizumab

Ablynx N.V.

Technologiepark 21, 9052 Zwijnaarde, België

EU/1/18/1305

Prašak i otapalo za otopinu za injekciju

B01AX07

4.9.2018.

31.8.2018.

Nerlynx

neratinib

Puma Biotechnology, Ltd.

11th Floor, Whitefriars, Lewins Mead, Bristol, BS1 2NT, United Kingdom

EU/1/18/1311

Filmom obložena tableta

L01XE45

4.9.2018.

31.8.2018.

VEYVONDI

vonikog alfa

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/18/1298

Prašak i otapalo za otopinu za injekciju

B02BD10

4.9.2018.

| — | Izmjena odobrenja za stavljanje u promet (članak 13. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno |
| --- | --- |

—

Izmjena odobrenja za stavljanje u promet (članak 13. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 2.8.2018. | Avonex | Biogen Netherlands B.V.
  Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | EU/1/97/033 | 6.8.2018. |
| 2.8.2018. | Bosulif | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/13/818 | 6.8.2018. |
| 2.8.2018. | Cetrotide | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/99/100 | 6.8.2018. |
| 2.8.2018. | Conbriza | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/09/511 | 6.8.2018. |
| 2.8.2018. | Dexdor | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/11/718 | 6.8.2018. |
| 2.8.2018. | DUAVIVE | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/14/960 | 6.8.2018. |
| 2.8.2018. | Fampyra | Biogen Netherlands B.V.
  Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | EU/1/11/699 | 6.8.2018. |
| 2.8.2018. | Insulin lispro Sanofi | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Pariz, France | EU/1/17/1203 | 6.8.2018. |
| 2.8.2018. | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 6.8.2018. |
| 2.8.2018. | Kyntheum | Leo Pharma A/S
  Industriparken 55, 2750 Ballerup, Danmark | EU/1/16/1155 | 6.8.2018. |
| 2.8.2018. | Onglyza | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/09/545 | 6.8.2018. |
| 2.8.2018. | Otezla | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/14/981 | 6.8.2018. |
| 2.8.2018. | Rapamune | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/01/171 | 6.8.2018. |
| 2.8.2018. | ReFacto AF | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/99/103 | 6.8.2018. |
| 2.8.2018. | Siklos | Addmedica
  37 rue de Caumartin, 75009 Pariz, France | EU/1/07/397 | 6.8.2018. |
| 2.8.2018. | Temomedac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/09/605 | 6.8.2018. |
| 2.8.2018. | Tepadina | ADIENNE S.r.l.
  Via Galileo Galilei 19, 20867 Caponago (MB), Italia | EU/1/10/622 | 6.8.2018. |
| 2.8.2018. | Tysabri | Biogen Netherlands B.V.
  Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | EU/1/06/346 | 6.8.2018. |
| 2.8.2018. | Zoledronic acid Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/834 | 6.8.2018. |
| 3.8.2018. | Accofil | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/14/946 | 7.8.2018. |
| 3.8.2018. | Brimica Genuair | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/14/963 | 7.8.2018. |
| 3.8.2018. | Crixivan | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/96/024 | 7.8.2018. |
| 3.8.2018. | Duaklir Genuair | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/14/964 | 7.8.2018. |
| 3.8.2018. | Duloxetine Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/15/1010 | 7.8.2018. |
| 3.8.2018. | Inlyta | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/12/777 | 7.8.2018. |
| 3.8.2018. | Inovelon | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/06/378 | 7.8.2018. |
| 3.8.2018. | Memantin Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/880 | 7.8.2018. |
| 3.8.2018. | Numient | Amneal Pharma Europe Ltd
  70 Sir John Rogerson’s Quay, Dublin 2, Ireland | EU/1/15/1044 | 7.8.2018. |
| 3.8.2018. | Ribavirin Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/10/634 | 7.8.2018. |
| 3.8.2018. | Tadalafil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/14/961 | 7.8.2018. |
| 3.8.2018. | Vyndaqel | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/11/717 | 7.8.2018. |
| 6.8.2018. | GONAL-f | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/95/001 | 8.8.2018. |
| 8.8.2018. | Bortezomib Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/16/1114 | 10.8.2018. |
| 8.8.2018. | Brinavess | Correvio
  15 rue du Bicentenaire, 92800 Puteaux, France | EU/1/10/645 | 10.8.2018. |
| 8.8.2018. | CANCIDAS | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/01/196 | 10.8.2018. |
| 8.8.2018. | Cubicin | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/05/328 | 10.8.2018. |
| 8.8.2018. | Januvia | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/07/383 | 10.8.2018. |
| 8.8.2018. | Lymphoseek | Norgine B.V.
  Hogehilweg 7, 1101 CA Amsterdam, Nederland | EU/1/14/955 | 10.8.2018. |
| 8.8.2018. | Sivextro | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/991 | 10.8.2018. |
| 8.8.2018. | Tesavel | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/07/435 | 10.8.2018. |
| 8.8.2018. | Thalidomide Celgene | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/08/443 | 10.8.2018. |
| 8.8.2018. | Torisel | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/07/424 | 10.8.2018. |
| 13.8.2018. | Ivabradine Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/16/1144 | 15.8.2018. |
| 13.8.2018. | Komboglyze | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/11/731 | 15.8.2018. |
| 13.8.2018. | Orbactiv | Rempex London Ltd
  115L Milton Park, Abingdon, Oxfordshire, OX14 4SA, United Kingdom | EU/1/15/989 | 15.8.2018. |
| 13.8.2018. | Xyrem | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/05/312 | 15.8.2018. |
| 20.8.2018. | Cholib | Mylan IRE Healthcare Ltd
  Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland | EU/1/13/866 | 22.8.2018. |
| 20.8.2018. | Lenvima | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/15/1002 | 22.8.2018. |
| 20.8.2018. | Luveris | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/00/155 | 22.8.2018. |
| 20.8.2018. | Pergoveris | Merck Europe B.V.
  Gustav Mahlerplein 102, lto Toren, 1082 MA Amsterdam, Nederland | EU/1/07/396 | 22.8.2018. |
| 20.8.2018. | Xelevia | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/07/382 | 22.8.2018. |
| 23.8.2018. | Abilify | Otsuka Pharmaceutical Netherlands B.V.
  Herikerbergweg 292, 1101 CT, Amsterdam, Nederland | EU/1/04/276 | 28.8.2018. |
| 23.8.2018. | Aranesp | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/01/185 | 27.8.2018. |
| 23.8.2018. | Arixtra | Aspen Pharma Trading Limited
  3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland | EU/1/02/206 | 27.8.2018. |
| 23.8.2018. | Beromun | BELPHARMA s.a.
  2, Rue Albert 1er, L-1117, Luxembourg, Luxembourg | EU/1/99/097 | 27.8.2018. |
| 23.8.2018. | Biktarvy | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/18/1289 | 27.8.2018. |
| 23.8.2018. | Blincyto | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1047 | 27.8.2018. |
| 23.8.2018. | CABOMETYX | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/16/1136 | 27.8.2018. |
| 23.8.2018. | Entyvio | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/14/923 | 27.8.2018. |
| 23.8.2018. | Evicel | Omrix Biopharmaceuticals N.V.
  Leonardo Da Vincilaan 15, 1831 Diegem, België | EU/1/08/473 | 27.8.2018. |
| 23.8.2018. | Firazyr | Shire Pharmaceuticals Ireland Limited
  Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland | EU/1/08/461 | 27.8.2018. |
| 23.8.2018. | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/945 | 27.8.2018. |
| 23.8.2018. | Intelence | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/08/468 | 27.8.2018. |
| 23.8.2018. | Kalydeco | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/12/782 | 28.8.2018. |
| 23.8.2018. | Lemtrada | Sanofi Belgium
  Leonardo Da Vincilaan 19, B-1831 Diegem, België | EU/1/13/869 | 28.8.2018. |
| 23.8.2018. | LIFMIOR | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/16/1165 | 28.8.2018. |
| 23.8.2018. | Nivestim | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/10/631 | 27.8.2018. |
| 23.8.2018. | Opsumit | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/13/893 | 27.8.2018. |
| 23.8.2018. | Orkambi | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/15/1059 | 28.8.2018. |
| 23.8.2018. | Parsabiv | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/16/1142 | 27.8.2018. |
| 23.8.2018. | Pixuvri | CTI Life Sciences Ltd
  Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom | EU/1/12/764 | 28.8.2018. |
| 23.8.2018. | Ristaben | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/10/621 | 28.8.2018. |
| 23.8.2018. | RoActemra | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/08/492 | 27.8.2018. |
| 23.8.2018. | Somavert | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/02/240 | 27.8.2018. |
| 23.8.2018. | Sovaldi | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/894 | 27.8.2018. |
| 23.8.2018. | Steglujan | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/18/1266 | 27.8.2018. |
| 23.8.2018. | Strimvelis | Orchard Therapeutics (Netherlands) B.V.
  Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland | EU/1/16/1097 | 27.8.2018. |
| 23.8.2018. | Temodal | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/98/096 | 28.8.2018. |
| 23.8.2018. | Venclyxto | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/16/1138 | 27.8.2018. |
| 23.8.2018. | Xagrid | Shire Pharmaceuticals Ireland Limited
  Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland | EU/1/04/295 | 25.8.2018. |
| 23.8.2018. | Xarelto | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/08/472 | 27.8.2018. |
| 27.8.2018. | ABILIFY MAINTENA | Otsuka Pharmaceutical Europe Ltd
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/13/882 | 29.8.2018. |
| 27.8.2018. | BYDUREON | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/11/696 | 29.8.2018. |
| 27.8.2018. | Cinryze | Shire Services BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/688 | 29.8.2018. |
| 27.8.2018. | Coagadex | Bio Products Laboratory Ltd
  Dagger Lane, Elstree, Hertfordshire WD6 3BX, United Kingdom | EU/1/16/1087 | 29.8.2018. |
| 27.8.2018. | Cometriq | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/13/890 | 29.8.2018. |
| 27.8.2018. | Filgrastim Hexal | Hexal AG
  Industriestraße 25, 83607 Holzkirchen, Deutschland | EU/1/08/496 | 29.8.2018. |
| 27.8.2018. | Fulvestrant Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/17/1253 | 29.8.2018. |
| 27.8.2018. | Lojuxta | Amryt Pharmaceuticals DAC
  90 Harcourt Street, Dublin 2, Ireland | EU/1/13/851 | 29.8.2018. |
| 27.8.2018. | Mekinist | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/931 | 29.8.2018. |
| 27.8.2018. | Nucala | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/15/1043 | 29.8.2018. |
| 27.8.2018. | Rasilez HCT | Noden Pharma DAC
  D’Olier Chambers, 16 A D’Olier Street, Dublin 2, Ireland | EU/1/08/491 | 29.8.2018. |
| 27.8.2018. | Tafinlar | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/13/865 | 29.8.2018. |
| 27.8.2018. | Varuby | TESARO U.K. Limited
  55 Baker Street, London W1U 7EU, United Kingdom | EU/1/17/1180 | 29.8.2018. |
| 27.8.2018. | Victoza | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/09/529 | 29.8.2018. |
| 27.8.2018. | Vokanamet | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/918 | 29.8.2018. |
| 27.8.2018. | Xarelto | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/08/472 | 29.8.2018. |
| 27.8.2018. | Zarzio | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/08/495 | 29.8.2018. |
| 28.8.2018. | Fluenz Tetra | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/13/887 | 30.8.2018. |
| 28.8.2018. | Steglatro | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/18/1267 | 30.8.2018. |
| 31.8.2018. | Abseamed | Medice Arzneimittel Pütter GmbH & Co KG
  Kuhloweg 37, 58638 Iserlohn, Deutschland | EU/1/07/412 | 4.9.2018. |
| 31.8.2018. | Bavencio | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/17/1214 | 4.9.2018. |
| 31.8.2018. | Binocrit | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/07/410 | 4.9.2018. |
| 31.8.2018. | Darzalex | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/16/1101 | 4.9.2018. |
| 31.8.2018. | Efavirenz/Emtricitabine/Tenofovir disoproxil Krka | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/17/1263 | 4.9.2018. |
| 31.8.2018. | Epoetin alfa Hexal | Hexal AG
  Industriestraße 25, 83607 Holzkirchen, Deutschland | EU/1/07/411 | 4.9.2018. |
| 31.8.2018. | Spinraza | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/17/1188 | 4.9.2018. |
| 31.8.2018. | TAGRISSO | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/16/1086 | 4.9.2018. |
| 31.8.2018. | Viekirax | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/14/982 | 4.9.2018. |
| 31.8.2018. | XALKORI | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/12/793 | 4.9.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

2.8.2018.

Avonex

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/97/033

6.8.2018.

2.8.2018.

Bosulif

Pfizer Europe MA EEIG

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

EU/1/13/818

6.8.2018.

2.8.2018.

Cetrotide

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/99/100

6.8.2018.

2.8.2018.

Conbriza

Pfizer Europe MA EEIG

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

EU/1/09/511

6.8.2018.

2.8.2018.

Dexdor

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/718

6.8.2018.

2.8.2018.

DUAVIVE

Pfizer Europe MA EEIG

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

EU/1/14/960

6.8.2018.

2.8.2018.

Fampyra

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/11/699

6.8.2018.

2.8.2018.

Insulin lispro Sanofi

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Pariz, France

EU/1/17/1203

6.8.2018.

2.8.2018.

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

6.8.2018.

2.8.2018.

Kyntheum

Leo Pharma A/S

Industriparken 55, 2750 Ballerup, Danmark

EU/1/16/1155

6.8.2018.

2.8.2018.

Onglyza

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/09/545

6.8.2018.

2.8.2018.

Otezla

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/14/981

6.8.2018.

2.8.2018.

Rapamune

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/01/171

6.8.2018.

2.8.2018.

ReFacto AF

Pfizer Europe MA EEIG

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

EU/1/99/103

6.8.2018.

2.8.2018.

Siklos

Addmedica

37 rue de Caumartin, 75009 Pariz, France

EU/1/07/397

6.8.2018.

2.8.2018.

Temomedac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/09/605

6.8.2018.

2.8.2018.

Tepadina

ADIENNE S.r.l.

Via Galileo Galilei 19, 20867 Caponago (MB), Italia

EU/1/10/622

6.8.2018.

2.8.2018.

Tysabri

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/06/346

6.8.2018.

2.8.2018.

Zoledronic acid Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/13/834

6.8.2018.

3.8.2018.

Accofil

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/14/946

7.8.2018.

3.8.2018.

Brimica Genuair

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/963

7.8.2018.

3.8.2018.

Crixivan

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/96/024

7.8.2018.

3.8.2018.

Duaklir Genuair

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/964

7.8.2018.

3.8.2018.

Duloxetine Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/1010

7.8.2018.

3.8.2018.

Inlyta

Pfizer Europe MA EEIG

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

EU/1/12/777

7.8.2018.

3.8.2018.

Inovelon

Eisai Limited

European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom

EU/1/06/378

7.8.2018.

3.8.2018.

Memantin Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/13/880

7.8.2018.

3.8.2018.

Numient

Amneal Pharma Europe Ltd

70 Sir John Rogerson’s Quay, Dublin 2, Ireland

EU/1/15/1044

7.8.2018.

3.8.2018.

Ribavirin Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/10/634

7.8.2018.

3.8.2018.

Tadalafil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/14/961

7.8.2018.

3.8.2018.

Vyndaqel

Pfizer Europe MA EEIG

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

EU/1/11/717

7.8.2018.

6.8.2018.

GONAL-f

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/95/001

8.8.2018.

8.8.2018.

Bortezomib Hospira

Pfizer Europe MA EEIG

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

EU/1/16/1114

10.8.2018.

8.8.2018.

Brinavess

Correvio

15 rue du Bicentenaire, 92800 Puteaux, France

EU/1/10/645

10.8.2018.

8.8.2018.

CANCIDAS

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/01/196

10.8.2018.

8.8.2018.

Cubicin

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/05/328

10.8.2018.

8.8.2018.

Januvia

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/383

10.8.2018.

8.8.2018.

Lymphoseek

Norgine B.V.

Hogehilweg 7, 1101 CA Amsterdam, Nederland

EU/1/14/955

10.8.2018.

8.8.2018.

Sivextro

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/991

10.8.2018.

8.8.2018.

Tesavel

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/435

10.8.2018.

8.8.2018.

Thalidomide Celgene

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/08/443

10.8.2018.

8.8.2018.

Torisel

Pfizer Europe MA EEIG

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

EU/1/07/424

10.8.2018.

13.8.2018.

Ivabradine Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/16/1144

15.8.2018.

13.8.2018.

Komboglyze

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/11/731

15.8.2018.

13.8.2018.

Orbactiv

Rempex London Ltd

115L Milton Park, Abingdon, Oxfordshire, OX14 4SA, United Kingdom

EU/1/15/989

15.8.2018.

13.8.2018.

Xyrem

UCB Pharma S.A.

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

EU/1/05/312

15.8.2018.

20.8.2018.

Cholib

Mylan IRE Healthcare Ltd

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

EU/1/13/866

22.8.2018.

20.8.2018.

Lenvima

Eisai Europe Limited

European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom

EU/1/15/1002

22.8.2018.

20.8.2018.

Luveris

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/00/155

22.8.2018.

20.8.2018.

Pergoveris

Merck Europe B.V.

Gustav Mahlerplein 102, lto Toren, 1082 MA Amsterdam, Nederland

EU/1/07/396

22.8.2018.

20.8.2018.

Xelevia

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/382

22.8.2018.

23.8.2018.

Abilify

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

EU/1/04/276

28.8.2018.

23.8.2018.

Aranesp

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/01/185

27.8.2018.

23.8.2018.

Arixtra

Aspen Pharma Trading Limited

3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

EU/1/02/206

27.8.2018.

23.8.2018.

Beromun

BELPHARMA s.a.

2, Rue Albert 1er, L-1117, Luxembourg, Luxembourg

EU/1/99/097

27.8.2018.

23.8.2018.

Biktarvy

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/18/1289

27.8.2018.

23.8.2018.

Blincyto

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1047

27.8.2018.

23.8.2018.

CABOMETYX

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/16/1136

27.8.2018.

23.8.2018.

Entyvio

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/14/923

27.8.2018.

23.8.2018.

Evicel

Omrix Biopharmaceuticals N.V.

Leonardo Da Vincilaan 15, 1831 Diegem, België

EU/1/08/473

27.8.2018.

23.8.2018.

Firazyr

Shire Pharmaceuticals Ireland Limited

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

EU/1/08/461

27.8.2018.

23.8.2018.

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/945

27.8.2018.

23.8.2018.

Intelence

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/08/468

27.8.2018.

23.8.2018.

Kalydeco

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/12/782

28.8.2018.

23.8.2018.

Lemtrada

Sanofi Belgium

Leonardo Da Vincilaan 19, B-1831 Diegem, België

EU/1/13/869

28.8.2018.

23.8.2018.

LIFMIOR

Pfizer Europe MA EEIG

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

EU/1/16/1165

28.8.2018.

23.8.2018.

Nivestim

Pfizer Europe MA EEIG

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

EU/1/10/631

27.8.2018.

23.8.2018.

Opsumit

Actelion Registration Ltd

Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/13/893

27.8.2018.

23.8.2018.

Orkambi

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/15/1059

28.8.2018.

23.8.2018.

Parsabiv

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1142

27.8.2018.

23.8.2018.

Pixuvri

CTI Life Sciences Ltd

Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom

EU/1/12/764

28.8.2018.

23.8.2018.

Ristaben

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/10/621

28.8.2018.

23.8.2018.

RoActemra

Roche Registration GmbH

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

EU/1/08/492

27.8.2018.

23.8.2018.

Somavert

Pfizer Europe MA EEIG

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

EU/1/02/240

27.8.2018.

23.8.2018.

Sovaldi

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/894

27.8.2018.

23.8.2018.

Steglujan

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1266

27.8.2018.

23.8.2018.

Strimvelis

Orchard Therapeutics (Netherlands) B.V.

Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland

EU/1/16/1097

27.8.2018.

23.8.2018.

Temodal

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/98/096

28.8.2018.

23.8.2018.

Venclyxto

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/16/1138

27.8.2018.

23.8.2018.

Xagrid

Shire Pharmaceuticals Ireland Limited

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

EU/1/04/295

25.8.2018.

23.8.2018.

Xarelto

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/08/472

27.8.2018.

27.8.2018.

ABILIFY MAINTENA

Otsuka Pharmaceutical Europe Ltd

Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

EU/1/13/882

29.8.2018.

27.8.2018.

BYDUREON

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/11/696

29.8.2018.

27.8.2018.

Cinryze

Shire Services BVBA

rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België

EU/1/11/688

29.8.2018.

27.8.2018.

Coagadex

Bio Products Laboratory Ltd

Dagger Lane, Elstree, Hertfordshire WD6 3BX, United Kingdom

EU/1/16/1087

29.8.2018.

27.8.2018.

Cometriq

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/13/890

29.8.2018.

27.8.2018.

Filgrastim Hexal

Hexal AG

Industriestraße 25, 83607 Holzkirchen, Deutschland

EU/1/08/496

29.8.2018.

27.8.2018.

Fulvestrant Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/17/1253

29.8.2018.

27.8.2018.

Lojuxta

Amryt Pharmaceuticals DAC

90 Harcourt Street, Dublin 2, Ireland

EU/1/13/851

29.8.2018.

27.8.2018.

Mekinist

Novartis Europharm Limited

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

EU/1/14/931

29.8.2018.

27.8.2018.

Nucala

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/15/1043

29.8.2018.

27.8.2018.

Rasilez HCT

Noden Pharma DAC

D’Olier Chambers, 16 A D’Olier Street, Dublin 2, Ireland

EU/1/08/491

29.8.2018.

27.8.2018.

Tafinlar

Novartis Europharm Limited

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

EU/1/13/865

29.8.2018.

27.8.2018.

Varuby

TESARO U.K. Limited

55 Baker Street, London W1U 7EU, United Kingdom

EU/1/17/1180

29.8.2018.

27.8.2018.

Victoza

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/09/529

29.8.2018.

27.8.2018.

Vokanamet

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/918

29.8.2018.

27.8.2018.

Xarelto

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/08/472

29.8.2018.

27.8.2018.

Zarzio

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/08/495

29.8.2018.

28.8.2018.

Fluenz Tetra

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/887

30.8.2018.

28.8.2018.

Steglatro

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1267

30.8.2018.

31.8.2018.

Abseamed

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37, 58638 Iserlohn, Deutschland

EU/1/07/412

4.9.2018.

31.8.2018.

Bavencio

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1214

4.9.2018.

31.8.2018.

Binocrit

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/07/410

4.9.2018.

31.8.2018.

Darzalex

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/16/1101

4.9.2018.

31.8.2018.

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1263

4.9.2018.

31.8.2018.

Epoetin alfa Hexal

Hexal AG

Industriestraße 25, 83607 Holzkirchen, Deutschland

EU/1/07/411

4.9.2018.

31.8.2018.

Spinraza

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/17/1188

4.9.2018.

31.8.2018.

TAGRISSO

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1086

4.9.2018.

31.8.2018.

Viekirax

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/982

4.9.2018.

31.8.2018.

XALKORI

Pfizer Europe MA EEIG

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

EU/1/12/793

4.9.2018.

| — | Povlačenje odobrenja za stavljanje u promet (članak 13. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) |
| --- | --- |

—

Povlačenje odobrenja za stavljanje u promet (članak 13. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 3.8.2018. | Intanza | Sanofi Pasteur Europe
  2 avenue Pont Pasteur, 69007 Lyon, France | EU/1/08/505 | 7.8.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

3.8.2018.

Intanza

Sanofi Pasteur Europe

2 avenue Pont Pasteur, 69007 Lyon, France

EU/1/08/505

7.8.2018.

| — | Izdavanje odobrenja za stavljanje u promet (članak 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno |
| --- | --- |

—

Izdavanje odobrenja za stavljanje u promet (članak 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | INN (medunarodni nezašticeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 27.8.2018. | Cortacare | Hidrokortizon aceponat | Ecuphar NV
  Legeweg 157-i, 8020 Oostkamp, België | EU/2/18/230 | Sprej za kožu, otopina | QD07AC16 | 29.8.2018. |

Datum odluke

Naziv lijeka

INN (medunarodni nezašticeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

27.8.2018.

Cortacare

Hidrokortizon aceponat

Ecuphar NV

Legeweg 157-i, 8020 Oostkamp, België

EU/2/18/230

Sprej za kožu, otopina

QD07AC16

29.8.2018.

| — | Izmjena odobrenja za stavljanje u promet (članak 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno |
| --- | --- |

—

Izmjena odobrenja za stavljanje u promet (članak 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 3.8.2018. | Cerenia | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/06/062 | 7.8.2018. |
| 3.8.2018. | LETIFEND | Laboratorios LETI, S.L.unipersonal
  C/Del Sol 5, Polígono Industrial Norte, Tres Cantos, 28760 Madrid, España | EU/2/16/195 | 7.8.2018. |
| 3.8.2018. | Novem | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/04/042 | 7.8.2018. |
| 3.8.2018. | Onsior | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/08/089 | 7.8.2018. |
| 9.8.2018. | Leucofeligen FeLV/RCP | Virbac
  1ère Avenue – 2065 m – L.I.D., 06516 Carros Cedex, France | EU/2/09/097 | 14.8.2018. |
| 9.8.2018. | Nobivac LeuFel | Virbac
  1ère Avenue – 2065 m – L.I.D., 06516 Carros Cedex, France | EU/2/17/217 | 14.8.2018. |
| 20.8.2018. | BTVPUR | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/10/113 | 22.8.2018. |
| 20.8.2018. | CLYNAV | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/16/197 | 22.8.2018. |
| 20.8.2018. | Leucogen | Virbac
  1ère Avenue – 2065 m – L.I.D., 06516 Carros Cedex, France | EU/2/09/096 | 22.8.2018. |
| 27.8.2018. | Prac-Tic | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/06/066 | 29.8.2018. |
| 27.8.2018. | Vectra 3D | Ceva Santé Animale
  10 avenue de la Ballastière, 33500 Libourne, France | EU/2/13/156 | 29.8.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

3.8.2018.

Cerenia

Zoetis Belgium S.A.

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

EU/2/06/062

7.8.2018.

3.8.2018.

LETIFEND

Laboratorios LETI, S.L.unipersonal

C/Del Sol 5, Polígono Industrial Norte, Tres Cantos, 28760 Madrid, España

EU/2/16/195

7.8.2018.

3.8.2018.

Novem

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/042

7.8.2018.

3.8.2018.

Onsior

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/08/089

7.8.2018.

9.8.2018.

Leucofeligen FeLV/RCP

Virbac

1ère Avenue – 2065 m – L.I.D., 06516 Carros Cedex, France

EU/2/09/097

14.8.2018.

9.8.2018.

Nobivac LeuFel

Virbac

1ère Avenue – 2065 m – L.I.D., 06516 Carros Cedex, France

EU/2/17/217

14.8.2018.

20.8.2018.

BTVPUR

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/10/113

22.8.2018.

20.8.2018.

CLYNAV

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/16/197

22.8.2018.

20.8.2018.

Leucogen

Virbac

1ère Avenue – 2065 m – L.I.D., 06516 Carros Cedex, France

EU/2/09/096

22.8.2018.

27.8.2018.

Prac-Tic

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/06/066

29.8.2018.

27.8.2018.

Vectra 3D

Ceva Santé Animale

10 avenue de la Ballastière, 33500 Libourne, France

EU/2/13/156

29.8.2018.

| — | Povlačenje odobrenja za stavljanje u promet (članak 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) |
| --- | --- |

—

Povlačenje odobrenja za stavljanje u promet (članak 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 20.8.2018. | Gripovac 3 | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/09/102 | 22.8.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

20.8.2018.

Gripovac 3

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/09/102

22.8.2018.

Zainteresirane osobe koje žele na uvid dobiti javno izvješće o procjeni predmetnih lijekova i odluka koje se na njih odnose trebale bi se obratiti:

| European Medicines Agency |
| --- |
| 30 Churchill Place |
| Canary Wharf |
| London E14 5EU |
| United Kingdom |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

(1)  SL L 136, 30.4.2004., str. 1.

---

| 28.9.2018 | HR | Službeni list Europske unije | C 349/14 |
| --- | --- | --- | --- |

28.9.2018

HR

Službeni list Europske unije

C 349/14

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. kolovoza 2018. do 31. kolovoza 2018.

(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ (1) ili člankom 38. Direktive 2001/82/EZ (2))

(2018/C 349/02)

| — | Izdavanje, zadržavanje ili izmjena nacionalnog odobrenja za stavljanje u promet |
| --- | --- |

—

Izdavanje, zadržavanje ili izmjena nacionalnog odobrenja za stavljanje u promet

| Datum odluke | Naziv(i) lijeka | INN (međunarodni nezaštićeni naziv lijeka) | Nositelj(i) odobrenja za stavljanje u promet | Država članica na koju se odnosi | Datum obavijesti |
| --- | --- | --- | --- | --- | --- |
| 2.8.2018. | Scandonest and associated names | mepivacaine | Vidjeti Prilog | Vidjeti Prilog | 3.8.2018. |

Datum odluke

Naziv(i) lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj(i) odobrenja za stavljanje u promet

Država članica na koju se odnosi

Datum obavijesti

2.8.2018.

Scandonest and associated names

mepivacaine

Vidjeti Prilog

Vidjeti Prilog

3.8.2018.

---

(1)  SL L 311, 28.11.2001., str. 67.

(2)  SL L 311, 28.11.2001., str. 1.

---

PRILOG

Popis lijekova i farmaceutskih oblika

| Država članica EU/EGP | Nositelj odobrenja | Zaštićeno ime | Jačina | Farmaceutski oblik | Put primjene | Sadržaj
  (koncentracija) |
| --- | --- | --- | --- | --- | --- | --- |
| Austrija | Septodont GmbH
  Felix-Wankel-Str. 9
  53859 Niederkassel-Mondorf
  Germany | SCANDONEST 3 % OHNE VASOKONSTRIKTOR – ZYLINDERAMPULLEN | 3 % | Otopina za injekciju | Dentalno | 30 mg/ml |
| Belgija | Septodont NV-SA
  87 Avenue de la Constitution
  B-1083 Bruxelles
  Belgium | SCANDONEST 3 % SANS VASOCONSTRICTEUR | 3 % | Otopina za injekciju | Dentalno | 30 mg/ml |
| Bugarska | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST 30 MG/ML | 30 mg/ml | Otopina za injekciju | Dentalno | 30 mg/ml |
| Hrvatska | Apolonia d.o.o.
  Dubrova 308
  52220 Labin
  Croatia | SCANDONEST 30 mg/ml otopina za injekciju | 30 mg/ml | Otopina za injekciju | Dentalno
  Perineuralno
  Submukozno | 30 mg/ml |
| Danska | Spécialités Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST | 30 mg/ml | Otopina za injekciju | Dentalno
  Perineuralno
  Submukozno | 30 mg/ml |
| Estonija | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST | 30 mg/ml | Otopina za injekciju u ulošku | Dentalno
  Perineuralno
  Submukozno | 30 mg/ml |
| Finska | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST | 30 mg/ml | Otopina za injekciju | Dentalno | 30 mg/ml |
| Francuska | Laboratoires Septodont
  58, rue du Pont de Créteil
  94107 Saint-Maur-des-Fossés Cedex
  France | SCANDONEST 30 MG/ML, SOLUTION INJECTABLE À USAGE DENTAIRE | 30 mg/ml | Otopina za injekciju | Dentalno
  Perineuralno
  Submukozno | 30 mg/ml |
| Njemačka | Septodont GmbH
  Felix-Wankel-Str. 9
  53859 Niederkassel-Mondorf
  Germany | SCANDONEST 3 % OHNE VASOKONSTRIKTOR | 3 % | Otopina za injekciju | Dentalno
  Perineuralno | 30 mg/ml |
| Grčka | John Tsaprazis SA
  157 Michalakopoulou Str.
  11527, Athens
  Greece | SCANDONEST 3 % | 3 % | Otopina za injekciju | Parodontno | 30 mg/ml |
| Mađarska | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST 30 MG/ML | 30 mg/ml | Otopina za injekciju | Dentalno
  Perineuralno
  Submukozno | 30 mg/ml |
| Irska | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST 3 % W/V SOLUTION FOR INJECTION | 3 % | Otopina za injekciju | Dentalno | 30 mg/ml |
| Italija | Laboratoires Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST | 3 % without vasoconstrictor | Otopina za injekciju | Dentalno | 30 mg/ml |
| Latvija | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST 30 MG/ML ŠĶĪDUMS INJEKCIJĀM KĀRTRIDŽĀ | 30 mg/ml | Otopina za injekciju u ulošku | Perineuralno
  Submukozno | 30 mg/ml |
| Litva | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST 30 MG/ML, injekcinis tirpalas užtaise | 30 mg/ml | Otopina za injekciju u ulošku | Infiltracijom
  Perineuralno | 30 mg/ml |
| Luksemburg | Septodont NV-SA
  Grondwetlaan
  87 Avenue de la Constitution
  B-1083 Brussel
  Belgium | SCANDONEST 3 % SANS VASOCONSTRICTEUR | 3 % | Otopina za injekciju | Dentalno | 30 mg/ml |
| Malta | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST 30 MG/ML | 30 mg/ml | Otopina za injekciju | Dentalno
  Perineuralno
  Submukozno
  Infiltracijom | 30 mg/ml |
| Nizozemska | Septodont NV-SA
  Grondwetlaan
  87 Avenue de la Constitution
  B-1083 Brussel
  Belgium | SCANDONEST 3 % ZONDER VASOCONSTRICTOR | 3 % | Otopina za injekciju | Perineuralno | 30 mg/ml |
| Norveška | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST PLAIN 30 MG/ML | 30 mg/ml | Otopina za injekciju | Dentalno | 30 mg/ml |
| Poljska | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST 30 mg/ml | 30 mg/ml | Otopina za injekciju | Infiltracijom
  Perineuralno | 30 mg/ml |
| Portugal | Septodont, S.A.S.
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST | 30 mg/ml | Otopina za injekciju | Za desni | 30 mg/ml |
| Rumunjska | Laboratoires Septodont
  58, rue du Pont de Créteil
  94107 Saint-Maur-des-Fossés Cedex
  France | SCANDONEST 3 % PLAIN, SOLUŢIE INJECTABILĂ | 3 % | Otopina za injekciju | Dentalno | 30 mg/ml |
| Slovačka | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST 3 % | 3 % | Otopina za injekciju | Dentalno
  Perineuralno
  Submukozno | 30 mg/ml |
| Slovenija | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDICAINE 30 MG/ML RAZTOPINA ZA INJICIRANJE | 30 mg/ml | Otopina za injekciju | Dentalno | 30 mg/ml |
| Španjolska | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | SCANDONEST 30 mg/ml SOLUCIÓN INYECTABLE | 30 mg/ml | Otopina za injekciju | Perineuralno
  Infiltracijom | 30 mg/ml |
| Švedska | Septodont
  58, rue du Pont de Créteil
  94100 Saint-Maur-des-Fossés
  France | Scandonest | 30 mg/ml | Otopina za injekciju | Dentalno | 30 mg/ml |
| Ujedinjeno Kraljevstvo | Septodont Ltd
  Unit R & S
  Orchard Business Centre
  St Barnabas Close
  Allington Maidstone
  Kent ME16 OJZ
  England | SCANDONEST 3 % PLAIN
  BIOCAINE 3 % PLAIN | 3 % | Otopina za injekciju | Dentalno
  Perineuralno
  Submukozno | 30 mg/ml |

Država članica EU/EGP

Nositelj odobrenja

Zaštićeno ime

Jačina

Farmaceutski oblik

Put primjene

Sadržaj

(koncentracija)

Austrija

Septodont GmbH

Felix-Wankel-Str. 9

53859 Niederkassel-Mondorf

Germany

SCANDONEST 3 % OHNE VASOKONSTRIKTOR – ZYLINDERAMPULLEN

3 %

Otopina za injekciju

Dentalno

30 mg/ml

Belgija

Septodont NV-SA

87 Avenue de la Constitution

B-1083 Bruxelles

Belgium

SCANDONEST 3 % SANS VASOCONSTRICTEUR

3 %

Otopina za injekciju

Dentalno

30 mg/ml

Bugarska

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST 30 MG/ML

30 mg/ml

Otopina za injekciju

Dentalno

30 mg/ml

Hrvatska

Apolonia d.o.o.

Dubrova 308

52220 Labin

Croatia

SCANDONEST 30 mg/ml otopina za injekciju

30 mg/ml

Otopina za injekciju

Dentalno

Perineuralno

Submukozno

30 mg/ml

Danska

Spécialités Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST

30 mg/ml

Otopina za injekciju

Dentalno

Perineuralno

Submukozno

30 mg/ml

Estonija

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST

30 mg/ml

Otopina za injekciju u ulošku

Dentalno

Perineuralno

Submukozno

30 mg/ml

Finska

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST

30 mg/ml

Otopina za injekciju

Dentalno

30 mg/ml

Francuska

Laboratoires Septodont

58, rue du Pont de Créteil

94107 Saint-Maur-des-Fossés Cedex

France

SCANDONEST 30 MG/ML, SOLUTION INJECTABLE À USAGE DENTAIRE

30 mg/ml

Otopina za injekciju

Dentalno

Perineuralno

Submukozno

30 mg/ml

Njemačka

Septodont GmbH

Felix-Wankel-Str. 9

53859 Niederkassel-Mondorf

Germany

SCANDONEST 3 % OHNE VASOKONSTRIKTOR

3 %

Otopina za injekciju

Dentalno

Perineuralno

30 mg/ml

Grčka

John Tsaprazis SA

157 Michalakopoulou Str.

11527, Athens

Greece

SCANDONEST 3 %

3 %

Otopina za injekciju

Parodontno

30 mg/ml

Mađarska

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST 30 MG/ML

30 mg/ml

Otopina za injekciju

Dentalno

Perineuralno

Submukozno

30 mg/ml

Irska

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST 3 % W/V SOLUTION FOR INJECTION

3 %

Otopina za injekciju

Dentalno

30 mg/ml

Italija

Laboratoires Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST

3 % without vasoconstrictor

Otopina za injekciju

Dentalno

30 mg/ml

Latvija

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST 30 MG/ML ŠĶĪDUMS INJEKCIJĀM KĀRTRIDŽĀ

30 mg/ml

Otopina za injekciju u ulošku

Perineuralno

Submukozno

30 mg/ml

Litva

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST 30 MG/ML, injekcinis tirpalas užtaise

30 mg/ml

Otopina za injekciju u ulošku

Infiltracijom

Perineuralno

30 mg/ml

Luksemburg

Septodont NV-SA

Grondwetlaan

87 Avenue de la Constitution

B-1083 Brussel

Belgium

SCANDONEST 3 % SANS VASOCONSTRICTEUR

3 %

Otopina za injekciju

Dentalno

30 mg/ml

Malta

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST 30 MG/ML

30 mg/ml

Otopina za injekciju

Dentalno

Perineuralno

Submukozno

Infiltracijom

30 mg/ml

Nizozemska

Septodont NV-SA

Grondwetlaan

87 Avenue de la Constitution

B-1083 Brussel

Belgium

SCANDONEST 3 % ZONDER VASOCONSTRICTOR

3 %

Otopina za injekciju

Perineuralno

30 mg/ml

Norveška

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST PLAIN 30 MG/ML

30 mg/ml

Otopina za injekciju

Dentalno

30 mg/ml

Poljska

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST 30 mg/ml

30 mg/ml

Otopina za injekciju

Infiltracijom

Perineuralno

30 mg/ml

Portugal

Septodont, S.A.S.

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST

30 mg/ml

Otopina za injekciju

Za desni

30 mg/ml

Rumunjska

Laboratoires Septodont

58, rue du Pont de Créteil

94107 Saint-Maur-des-Fossés Cedex

France

SCANDONEST 3 % PLAIN, SOLUŢIE INJECTABILĂ

3 %

Otopina za injekciju

Dentalno

30 mg/ml

Slovačka

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST 3 %

3 %

Otopina za injekciju

Dentalno

Perineuralno

Submukozno

30 mg/ml

Slovenija

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDICAINE 30 MG/ML RAZTOPINA ZA INJICIRANJE

30 mg/ml

Otopina za injekciju

Dentalno

30 mg/ml

Španjolska

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

SCANDONEST 30 mg/ml SOLUCIÓN INYECTABLE

30 mg/ml

Otopina za injekciju

Perineuralno

Infiltracijom

30 mg/ml

Švedska

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Scandonest

30 mg/ml

Otopina za injekciju

Dentalno

30 mg/ml

Ujedinjeno Kraljevstvo

Septodont Ltd

Unit R & S

Orchard Business Centre

St Barnabas Close

Allington Maidstone

Kent ME16 OJZ

England

SCANDONEST 3 % PLAIN

BIOCAINE 3 % PLAIN

3 %

Otopina za injekciju

Dentalno

Perineuralno

Submukozno

30 mg/ml

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