# Europos Sąjungos C 334/2019

| | ISSN 1977-0960 |
| --- | --- |
| Europos Sąjungos
  oficialusis leidinys | C 334 |
| | |
| Leidimas lietuvių kalba | Informacija ir pranešimai | 62 metai2019m. spalio 4d. |

ISSN 1977-0960

Europos Sąjungos

oficialusis leidinys

C 334

Leidimas lietuvių kalba

Informacija ir pranešimai

62 metai2019m. spalio 4d.

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| Turinys | Puslapis |
| --- | --- |
| | IV   Pranešimai |
| | EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
| | Europos Komisija |
| 2019/C 334/01 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2019 m. liepos 1 d. iki 2019 m. rugpjūčio 31 d.  (Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį) | 1 |
| | EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
| 2019/C 334/02 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2019 m. liepos 1 d. iki 2019 m. rugpjūčio 31 d.(Sprendimai priimti pagal Direktyvos 2001/83/EB 34 straipsnį arba Direktyvos 2001/82/EB 38 straipsnį) | 17 |

Turinys

Puslapis

IV   Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

2019/C 334/01

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2019 m. liepos 1 d. iki 2019 m. rugpjūčio 31 d.  (Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį)

(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį)

1

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

2019/C 334/02

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2019 m. liepos 1 d. iki 2019 m. rugpjūčio 31 d.(Sprendimai priimti pagal Direktyvos 2001/83/EB 34 straipsnį arba Direktyvos 2001/82/EB 38 straipsnį)

(Sprendimai priimti pagal Direktyvos 2001/83/EB 34 straipsnį arba Direktyvos 2001/82/EB 38 straipsnį)

17

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| LT | |
| --- | --- |

LT

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IV Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

| 4.10.2019 | LT | Europos Sąjungos oficialusis leidinys | C 334/1 |
| --- | --- | --- | --- |

4.10.2019

LT

Europos Sąjungos oficialusis leidinys

C 334/1

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Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2019 m. liepos 1 d. iki 2019 m. rugpjūčio 31 d.

(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004
   (1) 13 straipsnį arba 38 straipsnį)

(2019/C 334/01)

| — | Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Priimta |
| --- | --- |

—

Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Priimta

| Sprendimo data | Vaisto pavadinimas | INN (Tarptautinis nepatentuotas pavadinimas) | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Farmacinė forma | ATC kodas (Anatominis terapinis cheminis kodas) | Pranešimo data |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2019 7 1 | Dovato | dolutegraviras / lamivudinas | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | ES/1/19/1370 | Plėvele dengta tabletė | J05AR25 | 2019 7 3 |
| 2019 7 1 | Xromi | hidroksikarbamidas | Nova Laboratories Ireland Limited
  3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland | ES/1/19/1366 | Geriamasis tirpalas | L01XX05 | 2019 7 3 |
| 2019 7 2 | Ultomiris | Ravulizumabas | Alexion Europe SAS
  103–105 Rue Anatole France, 92300 Levallois-Perret, France | ES/1/19/1371 | Koncentratas infuziniam tirpalui | L04AA | 2019 7 5 |
| 2019 7 25 | Cufence | trientino dihidrochloridas | Univar BV
  Schouwburgplein 30–34, 3012 CL Rotterdam, Nederland | ES/1/19/1365 | Kieta kapsulė | A16AX12 | 2019 7 29 |
| 2019 7 25 | LysaKare | argininas / lizinas | Advanced Accelerator Applications
  20 rue Diesel, 01630 Saint-Genis-Pouilly, France | ES/1/19/1381 | Infuzinis tirpalas | V03AF11 | 2019 7 29 |
| 2019 7 25 | Posaconazole Accord | pozakonazolas | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, Barcelona, 08039 Barcelona, España | ES/1/19/1379 | Skrandyje neiri tabletė | J02AC04 | 2019 7 30 |
| 2019 7 25 | Posaconazole AHCL | pozakonazolas | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | ES/1/19/1380 | Geriamoji suspensija | J02AC04 | 2019 7 29 |
| 2019 8 2 | Azacitidinas Celgene | azacitidinas | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | ES/1/19/1382 | Milteliai injekcinei suspensijai | L01BC07 | 2019 8 6 |
| 2019 8 23 | Giapreza | angiotenzino II acetatas | La Jolla Pharmaceutical II B.V.
  Herengracht 500, 1017 CB Amsterdam, Nederland | ES/1/19/1384 | Koncentratas infuziniam tirpalui | C01CX09 | 2019 8 27 |
| 2019 8 26 | Lacosamide UCB | Lakozamidas | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | ES/1/19/1383 | Infuzinis tirpalas Plėvele dengta tabletė Sirupas | N03AX18 | 2019 8 28 |

Sprendimo data

Vaisto pavadinimas

INN (Tarptautinis nepatentuotas pavadinimas)

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Farmacinė forma

ATC kodas (Anatominis terapinis cheminis kodas)

Pranešimo data

2019 7 1

Dovato

dolutegraviras / lamivudinas

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

ES/1/19/1370

Plėvele dengta tabletė

J05AR25

2019 7 3

2019 7 1

Xromi

hidroksikarbamidas

Nova Laboratories Ireland Limited

3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland

ES/1/19/1366

Geriamasis tirpalas

L01XX05

2019 7 3

2019 7 2

Ultomiris

Ravulizumabas

Alexion Europe SAS

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

ES/1/19/1371

Koncentratas infuziniam tirpalui

L04AA

2019 7 5

2019 7 25

Cufence

trientino dihidrochloridas

Univar BV

Schouwburgplein 30–34, 3012 CL Rotterdam, Nederland

ES/1/19/1365

Kieta kapsulė

A16AX12

2019 7 29

2019 7 25

LysaKare

argininas / lizinas

Advanced Accelerator Applications

20 rue Diesel, 01630 Saint-Genis-Pouilly, France

ES/1/19/1381

Infuzinis tirpalas

V03AF11

2019 7 29

2019 7 25

Posaconazole Accord

pozakonazolas

Accord Healthcare S.L.U.

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

ES/1/19/1379

Skrandyje neiri tabletė

J02AC04

2019 7 30

2019 7 25

Posaconazole AHCL

pozakonazolas

Accord Healthcare S.L.U.

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

ES/1/19/1380

Geriamoji suspensija

J02AC04

2019 7 29

2019 8 2

Azacitidinas Celgene

azacitidinas

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

ES/1/19/1382

Milteliai injekcinei suspensijai

L01BC07

2019 8 6

2019 8 23

Giapreza

angiotenzino II acetatas

La Jolla Pharmaceutical II B.V.

Herengracht 500, 1017 CB Amsterdam, Nederland

ES/1/19/1384

Koncentratas infuziniam tirpalui

C01CX09

2019 8 27

2019 8 26

Lacosamide UCB

Lakozamidas

UCB Pharma S.A.

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

ES/1/19/1383

Infuzinis tirpalas Plėvele dengta tabletė Sirupas

N03AX18

2019 8 28

| — | Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Atmesta |
| --- | --- |

—

Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Atmesta

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2019 7 11 | Cabazitaxel Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | — | 2019 7 15 |
| 2019 8 8 | Doxolipad | TLC Biopharmaceuticals B.V.
  J.H. Oortweg 19, 2333CH Leiden, Netherlands | — | 2019 8 12 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2019 7 11

Cabazitaxel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

—

2019 7 15

2019 8 8

Doxolipad

TLC Biopharmaceuticals B.V.

J.H. Oortweg 19, 2333CH Leiden, Netherlands

—

2019 8 12

| — | Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Priimta |
| --- | --- |

—

Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Priimta

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2019 7 1 | Benlysta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | ES/1/11/700 | 2019 7 3 |
| 2019 7 1 | Cetrotide | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | ES/1/99/100 | 2019 7 3 |
| 2019 7 1 | Comtan | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/98/081 | 2019 7 3 |
| 2019 7 1 | Eliquis | Bristol-Myers Squibb/Pfizer EEIG
  Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland | ES/1/11/691 | 2019 7 3 |
| 2019 7 1 | Eviplera | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | ES/1/11/737 | 2019 7 3 |
| 2019 7 1 | Exviera | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | ES/1/14/983 | 2019 7 3 |
| 2019 7 1 | Fiasp | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | ES/1/16/1160 | 2019 7 3 |
| 2019 7 1 | Instanyl | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | ES/1/09/531 | 2019 7 3 |
| 2019 7 1 | Mimpara | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | ES/1/04/292 | 2019 7 3 |
| 2019 7 1 | Ravicti | Immedica Pharma AB
  SE-113 29 Stockholm, Sverige | ES/1/15/1062 | 2019 7 3 |
| 2019 7 1 | Symtuza | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | ES/1/17/1225 | 2019 7 3 |
| 2019 7 1 | Xarelto | Bayer AG
  D-51368 Leverkusen, Deutschland | ES/1/08/472 | 2019 7 3 |
| 2019 7 4 | Dukoral | Valneva Sweden AB
  105 21 Stockholm, Sverige | ES/1/03/263 | 2019 7 8 |
| 2019 7 4 | IKERVIS | Santen Oy
  Niittyhaankatu 20, 33720 Tampere, Suomi | ES/1/15/990 | 2019 7 8 |
| 2019 7 4 | Kaletra | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | ES/1/01/172 | 2019 7 8 |
| 2019 7 4 | Nerlynx | Pierre Fabre Médicament
  45, place Abel Gance, 92100 Boulogne-Billancourt, France | ES/1/18/1311 | 2019 7 9 |
| 2019 7 4 | Orphacol | Laboratoires CTRS
  63 rue de l’Est, 92100 Boulogne-Billancourt, France | ES/1/13/870 | 2019 7 8 |
| 2019 7 4 | Prolia | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | ES/1/10/618 | 2019 7 8 |
| 2019 7 4 | Verkazia | Santen Oy
  Niittyhaankatu 20, 33720 Tampere, Suomi | ES/1/17/1219 | 2019 7 8 |
| 2019 7 4 | Zinforo | Pfizer Ireland Pharmaceuticals
  Operations Support Group, Ringaskiddy, County Cork, Ireland | ES/1/12/785 | 2019 7 8 |
| 2019 7 8 | Emtricitabine / Tenofovir disoproxil Krka d.d. | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | ES/1/17/1182 | 2019 7 10 |
| 2019 7 8 | Hefiya | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | ES/1/18/1287 | 2019 7 10 |
| 2019 7 8 | Pazenir | ratiopharm GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | ES/1/18/1317 | 2019 7 10 |
| 2019 7 8 | Tecentriq | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | ES/1/17/1220 | 2019 7 10 |
| 2019 7 8 | Tremfya | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | ES/1/17/1234 | 2019 7 10 |
| 2019 7 8 | Viekirax | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | ES/1/14/982 | 2019 7 10 |
| 2019 7 8 | Xultophy | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | ES/1/14/947 | 2019 7 10 |
| 2019 7 9 | Elocta | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | ES/1/15/1046 | 2019 7 11 |
| 2019 7 11 | Ammonaps | Immedica Pharma AB
  SE-113 29 Stockholm, Sverige | ES/1/99/120 | 2019 7 15 |
| 2019 7 11 | Defitelio | Gentium S.r.I.
  Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia | ES/1/13/878 | 2019 7 15 |
| 2019 7 11 | Gliolan | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | ES/1/07/413 | 2019 7 15 |
| 2019 7 11 | Halimatoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | ES/1/18/1288 | 2019 7 15 |
| 2019 7 11 | Tasigna | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/07/422 | 2019 7 15 |
| 2019 7 18 | Jentadueto | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | ES/1/12/780 | 2019 7 29 |
| 2019 7 18 | Myocet | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/00/141 | 2019 7 22 |
| 2019 7 18 | Norvir | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | ES/1/96/016 | 2019 7 22 |
| 2019 7 18 | Xadago | Zambon S.p.A.
  Via Lillo del Duca 10, 20091 Bresso (MI), Italia | ES/1/14/984 | 2019 7 22 |
| 2019 7 18 | Xyrem | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | ES/1/05/312 | 2019 7 22 |
| 2019 7 19 | Besponsa | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/17/1200 | 2019 7 23 |
| 2019 7 19 | Colobreathe | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/11/747 | 2019 7 23 |
| 2019 7 19 | Edistride | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/15/1052 | 2019 7 23 |
| 2019 7 19 | Exjade | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/06/356 | 2019 7 23 |
| 2019 7 19 | HyQvia | Baxalta Innovations GmbH
  Industriestraße 67, 1221 Wien, Österreich | ES/1/13/840 | 2019 7 23 |
| 2019 7 19 | Incruse Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | ES/1/14/922 | 2019 7 23 |
| 2019 7 19 | Lartruvo | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | ES/1/16/1143 | 2019 7 23 |
| 2019 7 19 | Truvada | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | ES/1/04/305 | 2019 7 23 |
| 2019 7 19 | Truxima | Celltrion Healthcare Hungary Kft.
  Váci út 1–3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | ES/1/16/1167 | 2019 7 23 |
| 2019 7 25 | Abasaglar | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | ES/1/14/944 | 2019 7 29 |
| 2019 7 25 | Abraxane | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | ES/1/07/428 | 2019 7 29 |
| 2019 7 25 | Anoro Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | ES/1/14/898 | 2019 7 29 |
| 2019 7 25 | Blitzima | Celltrion Healthcare Hungary Kft.
  Váci út 1–3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | ES/1/17/1205 | 2019 7 29 |
| 2019 7 25 | Corbilta | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | ES/1/13/859 | 2019 7 29 |
| 2019 7 25 | Deltyba | Otsuka Novel Products GmbH
  Erika-Mann-Straße 21, 80636 München, Deutschland | ES/1/13/875 | 2019 7 29 |
| 2019 7 25 | Edistride | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/15/1052 | 2019 7 29 |
| 2019 7 25 | Forxiga | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/12/795 | 2019 7 29 |
| 2019 7 25 | Gardasil 9 | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | ES/1/15/1007 | 2019 7 29 |
| 2019 7 25 | Genvoya | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | ES/1/15/1061 | 2019 7 29 |
| 2019 7 25 | Hepsera | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | ES/1/03/251 | 2019 7 29 |
| 2019 7 25 | Herceptin | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | ES/1/00/145 | 2019 7 29 |
| 2019 7 25 | KANJINTI | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | ES/1/18/1281 | 2019 7 29 |
| 2019 7 25 | Lixiana | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | ES/1/15/993 | 2019 7 29 |
| 2019 7 25 | Maviret | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | ES/1/17/1213 | 2019 7 29 |
| 2019 7 25 | NexoBrid | MediWound Germany GmbH
  Eisenstraße 5, 65428 Ruesselsheim, Deutschland | ES/1/12/803 | 2019 7 29 |
| 2019 7 25 | Ofev | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | ES/1/14/979 | 2019 7 29 |
| 2019 7 25 | Ontruzant | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | ES/1/17/1241 | 2019 7 29 |
| 2019 7 25 | Ritemvia | Celltrion Healthcare Hungary Kft.
  Váci út 1–3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | ES/1/17/1207 | 2019 7 29 |
| 2019 7 25 | Rolufta Ellipta | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | ES/1/17/1174 | 2019 7 29 |
| 2019 7 25 | Roteas | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | ES/1/16/1152 | 2019 7 29 |
| 2019 7 25 | Telmisartan Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/11/719 | 2019 7 29 |
| 2019 7 25 | Temozolomide SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, 2132 JH Hoofddorp, Nederland | ES/1/11/697 | 2019 7 29 |
| 2019 7 25 | Translarna | PTC Therapeutics International Limited
  5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland | ES/1/13/902 | 2019 7 29 |
| 2019 7 25 | Uptravi | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | ES/1/15/1083 | 2019 7 29 |
| 2019 7 25 | Visudyne | CHEPLAPHARM Arzneimittel GmbH
  Ziegelhof 24, 17489 Greifswald, Deutschland | ES/1/00/140 | 2019 7 29 |
| 2019 7 25 | Vizamyl | GE Healthcare AS
  Nycoveien 1, 0485, Oslo, Norge | ES/1/14/941 | 2019 7 29 |
| 2019 7 25 | Xigduo | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/13/900 | 2019 7 29 |
| 2019 7 25 | Zalmoxis | MolMed S.p.A.
  Via Olgettina 58, 20132 Milano, Italia | ES/1/16/1121 | 2019 7 29 |
| 2019 7 25 | Zinforo | Pfizer Ireland Pharmaceuticals
  Operations Support Group, Ringaskiddy, County Cork, Ireland | ES/1/12/785 | 2019 7 29 |
| 2019 7 25 | Zometa | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/01/176 | 2019 7 29 |
| 2019 7 31 | Aclasta | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/05/308 | 2019 8 2 |
| 2019 7 31 | Adenuric | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg | ES/1/08/447 | 2019 8 5 |
| 2019 7 31 | Adjupanrix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | ES/1/09/578 | 2019 8 2 |
| 2019 7 31 | Duloxetine Lilly | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | ES/1/14/972 | 2019 8 2 |
| 2019 7 31 | Fiasp | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | ES/1/16/1160 | 2019 8 2 |
| 2019 7 31 | Flebogamma DIF | Instituto Grifols, S.A.
  Can Guasch 2, Parets del Vallès, 08150 Barcelona, Espaňa | ES/1/07/404 | 2019 8 2 |
| 2019 7 31 | Forxiga | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/12/795 | 2019 8 2 |
| 2019 7 31 | Inovelon | Eisai GmbH
  Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland | ES/1/06/378 | 2019 8 2 |
| 2019 7 31 | Invirase | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | ES/1/96/026 | 2019 8 2 |
| 2019 7 31 | Ketoconazole HRA | Laboratoire HRA Pharma
  200 avenue de Paris, 92320 Chatillon, France | ES/1/14/965 | 2019 8 2 |
| 2019 7 31 | Nucala | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | ES/1/15/1043 | 2019 8 2 |
| 2019 7 31 | Rezolsta | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | ES/1/14/967 | 2019 8 2 |
| 2019 7 31 | Stalevo | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | ES/1/03/260 | 2019 8 2 |
| 2019 7 31 | Tadalafil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | ES/1/14/961 | 2019 8 2 |
| 2019 7 31 | Thalidomide Celgene | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | ES/1/08/443 | 2019 8 2 |
| 2019 7 31 | Trazimera | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/18/1295 | 2019 8 2 |
| 2019 7 31 | Vargatef | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | ES/1/14/954 | 2019 8 2 |
| 2019 7 31 | Vimpat | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | ES/1/08/470 | 2019 8 2 |
| 2019 7 31 | Xydalba | Allergan Pharmaceuticals International Limited
  Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland | ES/1/14/986 | 2019 8 2 |
| 2019 8 1 | Cyramza | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | ES/1/14/957 | 2019 8 5 |
| 2019 8 1 | Dupixent | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | ES/1/17/1229 | 2019 8 5 |
| 2019 8 1 | Ebymect | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/15/1051 | 2019 8 5 |
| 2019 8 1 | Faslodex | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/03/269 | 2019 8 5 |
| 2019 8 1 | Harvoni | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | ES/1/14/958 | 2019 8 6 |
| 2019 8 1 | Herzuma | Celltrion Healthcare Hungary Kft.
  Váci út 1–3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | ES/1/17/1257 | 2019 8 6 |
| 2019 8 1 | Hirobriz Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/09/594 | 2019 8 6 |
| 2019 8 1 | Laventair Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | ES/1/14/899 | 2019 8 6 |
| 2019 8 2 | Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | ES/1/17/1222 | 2019 8 6 |
| 2019 8 2 | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | ES/1/14/945 | 2019 8 6 |
| 2019 8 2 | JETREA | Oxurion NV
  Gaston Geenslaan 1, 3001 Leuven, België | ES/1/13/819 | 2019 8 6 |
| 2019 8 2 | Praxbind | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | ES/1/15/1056 | 2019 8 7 |
| 2019 8 8 | InductOs | Medtronic BioPharma B.V.
  Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland | ES/1/02/226 | 2019 8 12 |
| 2019 8 8 | Levodopa / Carbidopa / Entacapone Orion | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | ES/1/11/706 | 2019 8 12 |
| 2019 8 8 | Stivarga | Bayer AG
  D-51368 Leverkusen, Deutschland | ES/1/13/858 | 2019 8 12 |
| 2019 8 8 | Teysuno | Nordic Group B.V.
  Siriusdreef 22, 2132 WT Hoofddorp, Nederland | ES/1/11/669 | 2019 8 12 |
| 2019 8 9 | Jivi | Bayer AG
  D-51368 Leverkusen, Deutschland | ES/1/18/1324 | 2019 8 13 |
| 2019 8 9 | Travatan | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/01/199 | 2019 8 13 |
| 2019 8 9 | Truberzi | Allergan Pharmaceuticals International Limited
  Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland | ES/1/16/1126 | 2019 8 13 |
| 2019 8 9 | Victoza | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | ES/1/09/529 | 2019 8 13 |
| 2019 8 14 | Oslif Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/09/586 | 2019 8 19 |
| 2019 8 23 | Aimovig | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/18/1293 | 2019 8 27 |
| 2019 8 23 | Brimica Genuair | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/14/963 | 2019 8 27 |
| 2019 8 23 | Cinacalcet Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | ES/1/15/1054 | 2019 8 27 |
| 2019 8 23 | Cometriq | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | ES/1/13/890 | 2019 8 27 |
| 2019 8 23 | Duaklir Genuair | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/14/964 | 2019 8 27 |
| 2019 8 23 | Elmiron | bene-Arzneimittel GmbH
  Herterichstraße 1–3, 81479 München, Deutschland | ES/1/17/1189 | 2019 8 27 |
| 2019 8 23 | Empliciti | Bristol-Myers Squibb Pharma EEIG
  Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland | ES/1/16/1088 | 2019 8 27 |
| 2019 8 23 | Firdapse | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland | ES/1/09/601 | 2019 8 27 |
| 2019 8 23 | Flucelvax Tetra | Seqirus Netherlands B.V.
  Paasheuvelweg 28, 1105BJ Amsterdam, Netherlands | ES/1/18/1326 | 2019 8 27 |
| 2019 8 23 | Fluenz Tetra | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/13/887 | 2019 8 27 |
| 2019 8 23 | Nordimet | Nordic Group B.V.
  Siriusdreef 22, 2132 WT Hoofddorp, Nederland | ES/1/16/1124 | 2019 8 27 |
| 2019 8 23 | Otezla | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | ES/1/14/981 | 2019 8 27 |
| 2019 8 23 | Ovitrelle | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | ES/1/00/165 | 2019 8 27 |
| 2019 8 23 | Renagel | Genzyme Europe B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | ES/1/99/123 | 2019 8 27 |
| 2019 8 23 | Sevelamer carbonate Winthrop | Genzyme Europe B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | ES/1/14/952 | 2019 8 27 |
| 2019 8 23 | Sovaldi | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | ES/1/13/894 | 2019 8 27 |
| 2019 8 23 | Spinraza | Biogen Netherlands B.V.
  Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | ES/1/17/1188 | 2019 8 27 |
| 2019 8 23 | Trulicity | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | ES/1/14/956 | 2019 8 27 |
| 2019 8 23 | Zerbaxa | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | ES/1/15/1032 | 2019 8 27 |
| 2019 8 26 | Emadine | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/98/095 | 2019 8 28 |
| 2019 8 26 | Imraldi | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | ES/1/17/1216 | 2019 8 28 |
| 2019 8 26 | Jylamvo | Therakind (Europe) Limited
  3 Inn’s Quay, Dublin 7, D07 PW4F, Ireland | ES/1/17/1172 | 2019 8 28 |
| 2019 8 26 | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | ES/1/15/1024 | 2019 8 28 |
| 2019 8 26 | Levitra | Bayer AG
  D-51368 Leverkusen, Deutschland | ES/1/03/248 | 2019 8 28 |
| 2019 8 26 | Mycophenolate mofetil Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/07/439 | 2019 8 28 |
| 2019 8 26 | Nevanac | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/07/433 | 2019 8 28 |
| 2019 8 26 | Onbrez Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/09/593 | 2019 8 28 |
| 2019 8 26 | Prasugrel Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | ES/1/18/1273 | 2019 8 28 |
| 2019 8 26 | PREVYMIS | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | ES/1/17/1245 | 2019 8 28 |
| 2019 8 26 | Renvela | Genzyme Europe B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | ES/1/09/521 | 2019 8 28 |
| 2019 8 26 | Soliris | Alexion Europe SAS
  103–105 rue Anatole France, 92300 Levallois-Perret, France | ES/1/07/393 | 2019 8 28 |
| 2019 8 26 | TAGRISSO | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/16/1086 | 2019 8 28 |
| 2019 8 26 | Tasmar | MEDA AB
  Pipers väg 2A, 170 09 Solna, Sverige | ES/1/97/044 | 2019 8 28 |
| 2019 8 26 | Tecentriq | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | ES/1/17/1220 | 2019 8 28 |
| 2019 8 26 | Vargatef | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | ES/1/14/954 | 2019 8 28 |
| 2019 8 26 | Vivanza | Bayer AG
  D-51368 Leverkusen, Deutschland | ES/1/03/249 | 2019 8 28 |
| 2019 8 31 | Kisqali | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/17/1221 | 2019 8 2 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2019 7 1

Benlysta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ES/1/11/700

2019 7 3

2019 7 1

Cetrotide

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

ES/1/99/100

2019 7 3

2019 7 1

Comtan

Novartis Europharm Limited

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

ES/1/98/081

2019 7 3

2019 7 1

Eliquis

Bristol-Myers Squibb/Pfizer EEIG

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

ES/1/11/691

2019 7 3

2019 7 1

Eviplera

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

ES/1/11/737

2019 7 3

2019 7 1

Exviera

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

ES/1/14/983

2019 7 3

2019 7 1

Fiasp

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

ES/1/16/1160

2019 7 3

2019 7 1

Instanyl

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

ES/1/09/531

2019 7 3

2019 7 1

Mimpara

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

ES/1/04/292

2019 7 3

2019 7 1

Ravicti

Immedica Pharma AB

SE-113 29 Stockholm, Sverige

ES/1/15/1062

2019 7 3

2019 7 1

Symtuza

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

ES/1/17/1225

2019 7 3

2019 7 1

Xarelto

Bayer AG

D-51368 Leverkusen, Deutschland

ES/1/08/472

2019 7 3

2019 7 4

Dukoral

Valneva Sweden AB

105 21 Stockholm, Sverige

ES/1/03/263

2019 7 8

2019 7 4

IKERVIS

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

ES/1/15/990

2019 7 8

2019 7 4

Kaletra

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

ES/1/01/172

2019 7 8

2019 7 4

Nerlynx

Pierre Fabre Médicament

45, place Abel Gance, 92100 Boulogne-Billancourt, France

ES/1/18/1311

2019 7 9

2019 7 4

Orphacol

Laboratoires CTRS

63 rue de l’Est, 92100 Boulogne-Billancourt, France

ES/1/13/870

2019 7 8

2019 7 4

Prolia

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

ES/1/10/618

2019 7 8

2019 7 4

Verkazia

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

ES/1/17/1219

2019 7 8

2019 7 4

Zinforo

Pfizer Ireland Pharmaceuticals

Operations Support Group, Ringaskiddy, County Cork, Ireland

ES/1/12/785

2019 7 8

2019 7 8

Emtricitabine / Tenofovir disoproxil Krka d.d.

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

ES/1/17/1182

2019 7 10

2019 7 8

Hefiya

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

ES/1/18/1287

2019 7 10

2019 7 8

Pazenir

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

ES/1/18/1317

2019 7 10

2019 7 8

Tecentriq

Roche Registration GmbH

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

ES/1/17/1220

2019 7 10

2019 7 8

Tremfya

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

ES/1/17/1234

2019 7 10

2019 7 8

Viekirax

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

ES/1/14/982

2019 7 10

2019 7 8

Xultophy

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

ES/1/14/947

2019 7 10

2019 7 9

Elocta

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

ES/1/15/1046

2019 7 11

2019 7 11

Ammonaps

Immedica Pharma AB

SE-113 29 Stockholm, Sverige

ES/1/99/120

2019 7 15

2019 7 11

Defitelio

Gentium S.r.I.

Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia

ES/1/13/878

2019 7 15

2019 7 11

Gliolan

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

ES/1/07/413

2019 7 15

2019 7 11

Halimatoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

ES/1/18/1288

2019 7 15

2019 7 11

Tasigna

Novartis Europharm Limited

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

ES/1/07/422

2019 7 15

2019 7 18

Jentadueto

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

ES/1/12/780

2019 7 29

2019 7 18

Myocet

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/00/141

2019 7 22

2019 7 18

Norvir

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

ES/1/96/016

2019 7 22

2019 7 18

Xadago

Zambon S.p.A.

Via Lillo del Duca 10, 20091 Bresso (MI), Italia

ES/1/14/984

2019 7 22

2019 7 18

Xyrem

UCB Pharma S.A.

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

ES/1/05/312

2019 7 22

2019 7 19

Besponsa

Pfizer Europe MA EEIG

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

ES/1/17/1200

2019 7 23

2019 7 19

Colobreathe

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/11/747

2019 7 23

2019 7 19

Edistride

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/15/1052

2019 7 23

2019 7 19

Exjade

Novartis Europharm Limited

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

ES/1/06/356

2019 7 23

2019 7 19

HyQvia

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

ES/1/13/840

2019 7 23

2019 7 19

Incruse Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ES/1/14/922

2019 7 23

2019 7 19

Lartruvo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

ES/1/16/1143

2019 7 23

2019 7 19

Truvada

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

ES/1/04/305

2019 7 23

2019 7 19

Truxima

Celltrion Healthcare Hungary Kft.

Váci út 1–3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

ES/1/16/1167

2019 7 23

2019 7 25

Abasaglar

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

ES/1/14/944

2019 7 29

2019 7 25

Abraxane

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

ES/1/07/428

2019 7 29

2019 7 25

Anoro Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ES/1/14/898

2019 7 29

2019 7 25

Blitzima

Celltrion Healthcare Hungary Kft.

Váci út 1–3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

ES/1/17/1205

2019 7 29

2019 7 25

Corbilta

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

ES/1/13/859

2019 7 29

2019 7 25

Deltyba

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, 80636 München, Deutschland

ES/1/13/875

2019 7 29

2019 7 25

Edistride

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/15/1052

2019 7 29

2019 7 25

Forxiga

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/12/795

2019 7 29

2019 7 25

Gardasil 9

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

ES/1/15/1007

2019 7 29

2019 7 25

Genvoya

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

ES/1/15/1061

2019 7 29

2019 7 25

Hepsera

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

ES/1/03/251

2019 7 29

2019 7 25

Herceptin

Roche Registration GmbH

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

ES/1/00/145

2019 7 29

2019 7 25

KANJINTI

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

ES/1/18/1281

2019 7 29

2019 7 25

Lixiana

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

ES/1/15/993

2019 7 29

2019 7 25

Maviret

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

ES/1/17/1213

2019 7 29

2019 7 25

NexoBrid

MediWound Germany GmbH

Eisenstraße 5, 65428 Ruesselsheim, Deutschland

ES/1/12/803

2019 7 29

2019 7 25

Ofev

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

ES/1/14/979

2019 7 29

2019 7 25

Ontruzant

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

ES/1/17/1241

2019 7 29

2019 7 25

Ritemvia

Celltrion Healthcare Hungary Kft.

Váci út 1–3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

ES/1/17/1207

2019 7 29

2019 7 25

Rolufta Ellipta

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

ES/1/17/1174

2019 7 29

2019 7 25

Roteas

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

ES/1/16/1152

2019 7 29

2019 7 25

Telmisartan Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/11/719

2019 7 29

2019 7 25

Temozolomide SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

ES/1/11/697

2019 7 29

2019 7 25

Translarna

PTC Therapeutics International Limited

5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland

ES/1/13/902

2019 7 29

2019 7 25

Uptravi

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

ES/1/15/1083

2019 7 29

2019 7 25

Visudyne

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24, 17489 Greifswald, Deutschland

ES/1/00/140

2019 7 29

2019 7 25

Vizamyl

GE Healthcare AS

Nycoveien 1, 0485, Oslo, Norge

ES/1/14/941

2019 7 29

2019 7 25

Xigduo

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/13/900

2019 7 29

2019 7 25

Zalmoxis

MolMed S.p.A.

Via Olgettina 58, 20132 Milano, Italia

ES/1/16/1121

2019 7 29

2019 7 25

Zinforo

Pfizer Ireland Pharmaceuticals

Operations Support Group, Ringaskiddy, County Cork, Ireland

ES/1/12/785

2019 7 29

2019 7 25

Zometa

Novartis Europharm Limited

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

ES/1/01/176

2019 7 29

2019 7 31

Aclasta

Novartis Europharm Limited

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

ES/1/05/308

2019 8 2

2019 7 31

Adenuric

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg

ES/1/08/447

2019 8 5

2019 7 31

Adjupanrix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

ES/1/09/578

2019 8 2

2019 7 31

Duloxetine Lilly

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

ES/1/14/972

2019 8 2

2019 7 31

Fiasp

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

ES/1/16/1160

2019 8 2

2019 7 31

Flebogamma DIF

Instituto Grifols, S.A.

Can Guasch 2, Parets del Vallès, 08150 Barcelona, Espaňa

ES/1/07/404

2019 8 2

2019 7 31

Forxiga

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/12/795

2019 8 2

2019 7 31

Inovelon

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

ES/1/06/378

2019 8 2

2019 7 31

Invirase

Roche Registration GmbH

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

ES/1/96/026

2019 8 2

2019 7 31

Ketoconazole HRA

Laboratoire HRA Pharma

200 avenue de Paris, 92320 Chatillon, France

ES/1/14/965

2019 8 2

2019 7 31

Nucala

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

ES/1/15/1043

2019 8 2

2019 7 31

Rezolsta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

ES/1/14/967

2019 8 2

2019 7 31

Stalevo

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

ES/1/03/260

2019 8 2

2019 7 31

Tadalafil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

ES/1/14/961

2019 8 2

2019 7 31

Thalidomide Celgene

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

ES/1/08/443

2019 8 2

2019 7 31

Trazimera

Pfizer Europe MA EEIG

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

ES/1/18/1295

2019 8 2

2019 7 31

Vargatef

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

ES/1/14/954

2019 8 2

2019 7 31

Vimpat

UCB Pharma S.A.

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

ES/1/08/470

2019 8 2

2019 7 31

Xydalba

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland

ES/1/14/986

2019 8 2

2019 8 1

Cyramza

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

ES/1/14/957

2019 8 5

2019 8 1

Dupixent

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

ES/1/17/1229

2019 8 5

2019 8 1

Ebymect

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/15/1051

2019 8 5

2019 8 1

Faslodex

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/03/269

2019 8 5

2019 8 1

Harvoni

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

ES/1/14/958

2019 8 6

2019 8 1

Herzuma

Celltrion Healthcare Hungary Kft.

Váci út 1–3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

ES/1/17/1257

2019 8 6

2019 8 1

Hirobriz Breezhaler

Novartis Europharm Limited

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

ES/1/09/594

2019 8 6

2019 8 1

Laventair Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ES/1/14/899

2019 8 6

2019 8 2

Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

ES/1/17/1222

2019 8 6

2019 8 2

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

ES/1/14/945

2019 8 6

2019 8 2

JETREA

Oxurion NV

Gaston Geenslaan 1, 3001 Leuven, België

ES/1/13/819

2019 8 6

2019 8 2

Praxbind

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

ES/1/15/1056

2019 8 7

2019 8 8

InductOs

Medtronic BioPharma B.V.

Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland

ES/1/02/226

2019 8 12

2019 8 8

Levodopa / Carbidopa / Entacapone Orion

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

ES/1/11/706

2019 8 12

2019 8 8

Stivarga

Bayer AG

D-51368 Leverkusen, Deutschland

ES/1/13/858

2019 8 12

2019 8 8

Teysuno

Nordic Group B.V.

Siriusdreef 22, 2132 WT Hoofddorp, Nederland

ES/1/11/669

2019 8 12

2019 8 9

Jivi

Bayer AG

D-51368 Leverkusen, Deutschland

ES/1/18/1324

2019 8 13

2019 8 9

Travatan

Novartis Europharm Limited

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

ES/1/01/199

2019 8 13

2019 8 9

Truberzi

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland

ES/1/16/1126

2019 8 13

2019 8 9

Victoza

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

ES/1/09/529

2019 8 13

2019 8 14

Oslif Breezhaler

Novartis Europharm Limited

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

ES/1/09/586

2019 8 19

2019 8 23

Aimovig

Novartis Europharm Limited

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

ES/1/18/1293

2019 8 27

2019 8 23

Brimica Genuair

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/14/963

2019 8 27

2019 8 23

Cinacalcet Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

ES/1/15/1054

2019 8 27

2019 8 23

Cometriq

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

ES/1/13/890

2019 8 27

2019 8 23

Duaklir Genuair

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/14/964

2019 8 27

2019 8 23

Elmiron

bene-Arzneimittel GmbH

Herterichstraße 1–3, 81479 München, Deutschland

ES/1/17/1189

2019 8 27

2019 8 23

Empliciti

Bristol-Myers Squibb Pharma EEIG

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

ES/1/16/1088

2019 8 27

2019 8 23

Firdapse

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland

ES/1/09/601

2019 8 27

2019 8 23

Flucelvax Tetra

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105BJ Amsterdam, Netherlands

ES/1/18/1326

2019 8 27

2019 8 23

Fluenz Tetra

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/13/887

2019 8 27

2019 8 23

Nordimet

Nordic Group B.V.

Siriusdreef 22, 2132 WT Hoofddorp, Nederland

ES/1/16/1124

2019 8 27

2019 8 23

Otezla

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

ES/1/14/981

2019 8 27

2019 8 23

Ovitrelle

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

ES/1/00/165

2019 8 27

2019 8 23

Renagel

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

ES/1/99/123

2019 8 27

2019 8 23

Sevelamer carbonate Winthrop

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

ES/1/14/952

2019 8 27

2019 8 23

Sovaldi

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

ES/1/13/894

2019 8 27

2019 8 23

Spinraza

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

ES/1/17/1188

2019 8 27

2019 8 23

Trulicity

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

ES/1/14/956

2019 8 27

2019 8 23

Zerbaxa

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

ES/1/15/1032

2019 8 27

2019 8 26

Emadine

Novartis Europharm Limited

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

ES/1/98/095

2019 8 28

2019 8 26

Imraldi

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

ES/1/17/1216

2019 8 28

2019 8 26

Jylamvo

Therakind (Europe) Limited

3 Inn’s Quay, Dublin 7, D07 PW4F, Ireland

ES/1/17/1172

2019 8 28

2019 8 26

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

ES/1/15/1024

2019 8 28

2019 8 26

Levitra

Bayer AG

D-51368 Leverkusen, Deutschland

ES/1/03/248

2019 8 28

2019 8 26

Mycophenolate mofetil Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/07/439

2019 8 28

2019 8 26

Nevanac

Novartis Europharm Limited

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

ES/1/07/433

2019 8 28

2019 8 26

Onbrez Breezhaler

Novartis Europharm Limited

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

ES/1/09/593

2019 8 28

2019 8 26

Prasugrel Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

ES/1/18/1273

2019 8 28

2019 8 26

PREVYMIS

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

ES/1/17/1245

2019 8 28

2019 8 26

Renvela

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

ES/1/09/521

2019 8 28

2019 8 26

Soliris

Alexion Europe SAS

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

ES/1/07/393

2019 8 28

2019 8 26

TAGRISSO

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/16/1086

2019 8 28

2019 8 26

Tasmar

MEDA AB

Pipers väg 2A, 170 09 Solna, Sverige

ES/1/97/044

2019 8 28

2019 8 26

Tecentriq

Roche Registration GmbH

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

ES/1/17/1220

2019 8 28

2019 8 26

Vargatef

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

ES/1/14/954

2019 8 28

2019 8 26

Vivanza

Bayer AG

D-51368 Leverkusen, Deutschland

ES/1/03/249

2019 8 28

2019 8 31

Kisqali

Novartis Europharm Limited

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

ES/1/17/1221

2019 8 2

| — | Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis): Priimta |
| --- | --- |

—

Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis): Priimta

| Sprendimo data | Vaisto pavadinimas | INN (Tarptautinis nepatentuotas pavadinimas) | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Farmacinė forma | ATC kodas (Anatominis terapinis cheminis kodas) | Pranešimo data |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2019 7 19 | EVICTO | selamektino | VIRBAC
  1ère avenue – 2065m – LID, 06516 Carros, France | ES/2/19/242 | Užlašinamasis tirpalas | QP54AA05 | 2019 7 23 |
| 2019 7 29 | NASYM | Gyvas nusilpnintas galvijų respiracinis sincitinis virusas (BRSV), Lym-56 padermės | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | ES/2/19/241 | Liofilizatas ir skiediklis injekcinei suspensijai arba nosies purškalui ruošti | QI02AD04 | 2019 7 31 |

Sprendimo data

Vaisto pavadinimas

INN (Tarptautinis nepatentuotas pavadinimas)

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Farmacinė forma

ATC kodas (Anatominis terapinis cheminis kodas)

Pranešimo data

2019 7 19

EVICTO

selamektino

VIRBAC

1ère avenue – 2065m – LID, 06516 Carros, France

ES/2/19/242

Užlašinamasis tirpalas

QP54AA05

2019 7 23

2019 7 29

NASYM

Gyvas nusilpnintas galvijų respiracinis sincitinis virusas (BRSV), Lym-56 padermės

Laboratorios Hipra, S.A.

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

ES/2/19/241

Liofilizatas ir skiediklis injekcinei suspensijai arba nosies purškalui ruošti

QI02AD04

2019 7 31

| — | Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis): Priimta |
| --- | --- |

—

Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis): Priimta

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2019 7 1 | Osurnia | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | ES/2/14/170 | 2019 7 3 |
| 2019 7 4 | Bravecto Plus | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | ES/2/18/224 | 2019 7 9 |
| 2019 7 29 | Advocate | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | ES/2/03/039 | 2019 7 31 |
| 2019 8 9 | Vectormune ND | CEVA-Phylaxia Co. Ltd
  Szállás u. 5, 1107 Budapest, Magyarország | ES/2/15/188 | 2019 8 13 |
| 2019 8 19 | NexGard | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | ES/2/13/159 | 2019 8 21 |
| 2019 8 19 | NEXGARD SPECTRA | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | ES/2/14/177 | 2019 8 21 |
| 2019 8 29 | Bovilis Blue-8 | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | ES/2/17/218 | 2019 9 2 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2019 7 1

Osurnia

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

ES/2/14/170

2019 7 3

2019 7 4

Bravecto Plus

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

ES/2/18/224

2019 7 9

2019 7 29

Advocate

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

ES/2/03/039

2019 7 31

2019 8 9

Vectormune ND

CEVA-Phylaxia Co. Ltd

Szállás u. 5, 1107 Budapest, Magyarország

ES/2/15/188

2019 8 13

2019 8 19

NexGard

Merial

29 avenue Tony Garnier, 69007 Lyon, France

ES/2/13/159

2019 8 21

2019 8 19

NEXGARD SPECTRA

Merial

29 avenue Tony Garnier, 69007 Lyon, France

ES/2/14/177

2019 8 21

2019 8 29

Bovilis Blue-8

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

ES/2/17/218

2019 9 2

Norintieji susipažinti su nagrinėjamųjų vaistų vieša vertinimo ataskaita ir su ja susijusiais sprendimais, gali kreiptis į:

| European Medicines Agency |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| The Netherlands |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

The Netherlands

---

(1)  OL L 136, 2004 4 30, p. 1.

---

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

| 4.10.2019 | LT | Europos Sąjungos oficialusis leidinys | C 334/17 |
| --- | --- | --- | --- |

4.10.2019

LT

Europos Sąjungos oficialusis leidinys

C 334/17

---

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2019 m. liepos 1 d. iki 2019 m. rugpjūčio 31 d.

(Sprendimai priimti pagal Direktyvos 2001/83/EB
   (1) 34 straipsnį arba Direktyvos 2001/82/EB (2) 38 straipsnį)

(2019/C 334/02)

| — | Atsisakymas pakeisti nacionalinį rinkodaros leidimą |
| --- | --- |

—

Atsisakymas pakeisti nacionalinį rinkodaros leidimą

| Sprendimo data | Vaisto pavadinimas (-ai) | INN (Tarptautinis nepatentuotas pavadinimas) | Rinkodaros leidimo turėtojas (-ai) | Susijusi valstybė narė | Pranešimo data |
| --- | --- | --- | --- | --- | --- |
| 2019 7 4 | Basiron AC and associated names | benzoyl peroxide | Netaikoma | Netaikoma | 2019 7 5 |

Sprendimo data

Vaisto pavadinimas (-ai)

INN (Tarptautinis nepatentuotas pavadinimas)

Rinkodaros leidimo turėtojas (-ai)

Susijusi valstybė narė

Pranešimo data

2019 7 4

Basiron AC and associated names

benzoyl peroxide

Netaikoma

Netaikoma

2019 7 5

---

(1)  OL L 311, 2001 11 28, p. 67.

(2)  OL L 311, 2001 11 28, p. 1.

---