# Europos Sąjungos C 390/2018

| | ISSN 1977-0960 |
| --- | --- |
| Europos Sąjungos
  oficialusis leidinys | C 390 |
| | |
| Leidimas lietuvių kalba | Informacija ir pranešimai | 61 metai2018m. spalio 26d. |

ISSN 1977-0960

Europos Sąjungos

oficialusis leidinys

C 390

Leidimas lietuvių kalba

Informacija ir pranešimai

61 metai2018m. spalio 26d.

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| Turinys | Puslapis |
| --- | --- |
| | IV   Pranešimai |
| | EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
| | Europos Komisija |
| 2018/C 390/01 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2018 m. rugsėjo 1 d. iki 2018 m. rugsėjo 30 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį) | 1 |

Turinys

Puslapis

IV   Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

2018/C 390/01

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2018 m. rugsėjo 1 d. iki 2018 m. rugsėjo 30 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

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

LT

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IV Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

| 26.10.2018 | LT | Europos Sąjungos oficialusis leidinys | C 390/1 |
| --- | --- | --- | --- |

26.10.2018

LT

Europos Sąjungos oficialusis leidinys

C 390/1

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Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2018 m. rugsėjo 1 d. iki 2018 m. rugsėjo 30 d.

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

(2018/C 390/01)

| — | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2018 9 17 | Hulio | adalimumabum | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | ES/1/18/1319 | Injekcinis tirpalas | L04AB04 | 2018 9 19 |
| 2018 9 17 | Ilumetri | tildrakizumabas | Almirall, S.A.
  Ronda General Mitre, 151, 08022 Barcelona, España | ES/1/18/1323 | Injekcinis tirpalas | L04AC17 | 2018 9 19 |
| 2018 9 20 | Braftovi | enkorafenibas | Pierre Fabre Médicament
  45, place Abel Gance, 92100 Boulogne-Billancourt, France | ES/1/18/1314 | Kieta kapsulė | Pending | 2018 9 24 |
| 2018 9 20 | Deferiprone Lipomed | Deferipronas | Lipomed GmbH
  Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland | ES/1/18/1310 | Plėvele dengta tabletė | V03AC02 | 2018 9 24 |
| 2018 9 20 | Kigabeq | vigabatrinas | ORPHELIA Pharma SAS
  85 boulevard Saint-Michel, 75005 Paris, France | ES/1/18/1302 | Tirpinamoji tabletė | N03AG04 | 2018 9 24 |
| 2018 9 20 | Lenalidomide Accord | lenalidomidas | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | ES/1/18/1316 | Kieta kapsulė | L04AX04 | 2018 9 24 |
| 2018 9 20 | Mektovi | binimetinibas | Pierre Fabre Médicament
  45, place Abel Gance, 92100 Boulogne-Billancourt, France | ES/1/18/1315 | Plėvele dengta tabletė | L01XE41 | 2018 9 24 |
| 2018 9 20 | Slenyto | melatoninas | RAD Neurim Pharmaceuticals EEC Limited
  5th Floor, Thames Tower, Station Road, Reading, Berkshire RG1 1LX, United Kingdom | ES/1/18/1318 | Prailginto veikimo tabletės | N05CH01 | 2018 9 25 |
| 2018 9 20 | Xerava | eravaciklinas | Tetraphase Pharmaceuticals Ireland Limited
  10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland | ES/1/18/1312 | Milteliai koncentratui infuziniam tirpalui | J01AA13 | 2018 9 24 |
| 2018 9 21 | Imfinzi | durvalumabas | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/18/1322 | Koncentratas infuziniam tirpalui | L01XC | 2018 9 25 |
| 2018 9 21 | Pelgraz | pegfilgrastimas | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | ES/1/18/1313 | Injekcinis tirpalas užpildytame švirkšte | L03AA13 | 2018 9 25 |
| 2018 9 21 | Udenyca | pegfilgrastimas | ERA Consulting GmbH
  Lange Straße 70, 29664 Walsrode, Deutschland | ES/1/18/1303 | Injekcinis tirpalas | L03AA13 | 2018 9 25 |
| 2018 9 27 | Gefitinib Mylan | gefitinibo | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | ES/1/18/1321 | Plėvele dengta tabletė | L01XE02 | 2018 10 1 |
| 2018 9 27 | Verzenios | abemaciklibas | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | ES/1/18/1307 | Plėvele dengta tabletė | L01XE50 | 2018 10 1 |

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

2018 9 17

Hulio

adalimumabum

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

ES/1/18/1319

Injekcinis tirpalas

L04AB04

2018 9 19

2018 9 17

Ilumetri

tildrakizumabas

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

ES/1/18/1323

Injekcinis tirpalas

L04AC17

2018 9 19

2018 9 20

Braftovi

enkorafenibas

Pierre Fabre Médicament

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

ES/1/18/1314

Kieta kapsulė

Pending

2018 9 24

2018 9 20

Deferiprone Lipomed

Deferipronas

Lipomed GmbH

Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland

ES/1/18/1310

Plėvele dengta tabletė

V03AC02

2018 9 24

2018 9 20

Kigabeq

vigabatrinas

ORPHELIA Pharma SAS

85 boulevard Saint-Michel, 75005 Paris, France

ES/1/18/1302

Tirpinamoji tabletė

N03AG04

2018 9 24

2018 9 20

Lenalidomide Accord

lenalidomidas

Accord Healthcare Limited

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

ES/1/18/1316

Kieta kapsulė

L04AX04

2018 9 24

2018 9 20

Mektovi

binimetinibas

Pierre Fabre Médicament

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

ES/1/18/1315

Plėvele dengta tabletė

L01XE41

2018 9 24

2018 9 20

Slenyto

melatoninas

RAD Neurim Pharmaceuticals EEC Limited

5th Floor, Thames Tower, Station Road, Reading, Berkshire RG1 1LX, United Kingdom

ES/1/18/1318

Prailginto veikimo tabletės

N05CH01

2018 9 25

2018 9 20

Xerava

eravaciklinas

Tetraphase Pharmaceuticals Ireland Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

ES/1/18/1312

Milteliai koncentratui infuziniam tirpalui

J01AA13

2018 9 24

2018 9 21

Imfinzi

durvalumabas

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/18/1322

Koncentratas infuziniam tirpalui

L01XC

2018 9 25

2018 9 21

Pelgraz

pegfilgrastimas

Accord Healthcare Limited

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

ES/1/18/1313

Injekcinis tirpalas užpildytame švirkšte

L03AA13

2018 9 25

2018 9 21

Udenyca

pegfilgrastimas

ERA Consulting GmbH

Lange Straße 70, 29664 Walsrode, Deutschland

ES/1/18/1303

Injekcinis tirpalas

L03AA13

2018 9 25

2018 9 27

Gefitinib Mylan

gefitinibo

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

ES/1/18/1321

Plėvele dengta tabletė

L01XE02

2018 10 1

2018 9 27

Verzenios

abemaciklibas

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

ES/1/18/1307

Plėvele dengta tabletė

L01XE50

2018 10 1

| — | 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 |
| --- | --- | --- | --- | --- |
| 2018 9 4 | Invokana | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | ES/1/13/884 | 2018 9 6 |
| 2018 9 4 | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | ES/1/15/1024 | 2018 9 6 |
| 2018 9 4 | Olumiant | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | ES/1/16/1170 | 2018 9 7 |
| 2018 9 6 | Akynzeo | Helsinn Birex Pharmaceuticals Ltd
  Damastown, Mulhuddart, Dublin 15, Ireland | ES/1/15/1001 | 2018 9 10 |
| 2018 9 6 | Alkindi | Diurnal Europe B.V.
  Jachthavenweg 109 H, 1081 KM Amsterdam, Nederland | ES/1/17/1260 | 2018 9 10 |
| 2018 9 6 | Retacrit | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/07/431 | 2018 9 10 |
| 2018 9 6 | Silapo | STADA Arzneimittel AG
  Stadastraße 2–18, 61118 Bad Vilbel, Deutschland | ES/1/07/432 | 2018 9 10 |
| 2018 9 6 | Venclyxto | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | ES/1/16/1138 | 2018 9 10 |
| 2018 9 10 | ADCETRIS | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | ES/1/12/794 | 2018 9 12 |
| 2018 9 10 | Memantine Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | ES/1/13/827 | 2018 9 19 |
| 2018 9 10 | Pregabalinas Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | ES/1/15/997 | 2018 9 19 |
| 2018 9 12 | Tegsedi | Akcea Therapeutics UK Ltd.
  Office 32, 19–21 Crawford Street, London, W1H 1PJ, United Kingdom | ES/1/18/1296 | 2018 9 14 |
| 2018 9 17 | CRYSVITA | Kyowa Kirin Holdings B.V.
  Bloemlaan 2, 2132 NP Hoofddorp, Nederland | ES/1/17/1262 | 2018 9 19 |
| 2018 9 17 | Fortacin | Recordati Ireland Ltd
  Raheens East, Ringaskiddy Co. Cork, Ireland | ES/1/13/881 | 2018 9 19 |
| 2018 9 17 | Inhixa | Techdow Europe AB
  Kåbovägen 32, 75236 Uppsala, Sverige | ES/1/16/1132 | 2018 9 24 |
| 2018 9 17 | Kadcyla | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | ES/1/13/885 | 2018 9 19 |
| 2018 9 17 | Lartruvo | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | ES/1/16/1143 | 2018 9 19 |
| 2018 9 17 | Ninlaro | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | ES/1/16/1094 | 2018 9 19 |
| 2018 9 17 | Pregabalinas Mylan Pharma | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | ES/1/15/998 | 2018 9 19 |
| 2018 9 17 | Sovaldi | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | ES/1/13/894 | 2018 9 19 |
| 2018 9 17 | Stelara | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | ES/1/08/494 | 2018 9 19 |
| 2018 9 17 | Targretin | Eisai GmbH
  Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland | ES/1/01/178 | 2018 9 19 |
| 2018 9 20 | Atazanavir Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | ES/1/16/1091 | 2018 9 24 |
| 2018 9 20 | Blitzima | Celltrion Healthcare Hungary Kft.
  Váci út 1–3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | ES/1/17/1205 | 2018 9 24 |
| 2018 9 20 | Cinqaero | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/16/1125 | 2018 9 24 |
| 2018 9 20 | Cosentyx | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/14/980 | 2018 9 24 |
| 2018 9 20 | Cyramza | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | ES/1/14/957 | 2018 9 24 |
| 2018 9 20 | Diacomit | Biocodex
  7 avenue Gallieni, 94250 Gentilly, France | ES/1/06/367 | 2018 9 24 |
| 2018 9 20 | EndolucinBeta | ITG Isotope Technologies Garching GmbH
  Lichtenbergstraße 1, 85748 Garching, Deutschland | ES/1/16/1105 | 2018 9 24 |
| 2018 9 20 | Iclusig | Incyte Biosciences Distribution B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | ES/1/13/839 | 2018 9 24 |
| 2018 9 20 | INCRELEX | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | ES/1/07/402 | 2018 9 24 |
| 2018 9 20 | Kanuma | Alexion Europe SAS
  1–15 avenue Edouard Belin, 92500 Rueil-Malmaison, France | ES/1/15/1033 | 2018 9 24 |
| 2018 9 20 | Karvezide | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | ES/1/98/085 | 2018 9 24 |
| 2018 9 20 | Lumark | IDB Holland B.V.
  Weverstraat 17, 5111 PV Baarle-Nassau, Nederland | ES/1/15/1013 | 2018 9 24 |
| 2018 9 20 | Neofordex | Laboratoires CTRS
  63 rue de l’Est, 92100 Boulogne-Billancourt, France | ES/1/15/1053 | 2018 9 24 |
| 2018 9 20 | NeuroBloc | Sloan Pharma S.a.r.l.
  33 Rue de Puits Romain, 8070 Bertrange, Luxembourg | ES/1/00/166 | 2018 9 24 |
| 2018 9 20 | Nitisinone MDK | MendeliKABS Europe Limited
  The Light Box, 111 Power Rd, Unit G. 07, Chiswick, London, W4 5PY, United Kingdom | ES/1/17/1217 | 2018 9 24 |
| 2018 9 20 | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | ES/1/15/1014 | 2018 9 24 |
| 2018 9 20 | Ovitrelle | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | ES/1/00/165 | 2018 9 24 |
| 2018 9 20 | Rasilez | Noden Pharma DAC
  D’Olier Chambers, 16A D’Olier Street, Dublin 2, Ireland | ES/1/07/405 | 2018 9 24 |
| 2018 9 20 | Renvela | Genzyme Europe B.V.
  Gooimeer 10, 1411 DD Naarden, Nederland | ES/1/09/521 | 2018 9 24 |
| 2018 9 20 | Rixathon | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | ES/1/17/1185 | 2018 9 24 |
| 2018 9 20 | Ryzodeg | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | ES/1/12/806 | 2018 9 24 |
| 2018 9 20 | Sevelamer carbonate Zentiva | Genzyme Europe B.V.
  Gooimeer 10, 1411 DD Naarden, Nederland | ES/1/14/952 | 2018 9 24 |
| 2018 9 20 | Tecfidera | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | ES/1/13/837 | 2018 9 24 |
| 2018 9 20 | Topotecan Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/10/633 | 2018 9 24 |
| 2018 9 20 | Tresiba | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | ES/1/12/807 | 2018 9 24 |
| 2018 9 20 | Zoledronic acid Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/12/800 | 2018 9 24 |
| 2018 9 21 | Brilique | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/10/655 | 2018 9 25 |
| 2018 9 21 | Fycompa | Eisai GmbH
  Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland | ES/1/12/776 | 2018 9 25 |
| 2018 9 21 | Inovelon | Eisai GmbH
  Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland | ES/1/06/378 | 2018 9 25 |
| 2018 9 21 | Opsumit | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | ES/1/13/893 | 2018 9 25 |
| 2018 9 21 | Tivicay | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | ES/1/13/892 | 2018 9 25 |
| 2018 9 21 | Voriconazole Hikma | Hikma Farmacêutica (Portugal), S.A.
  Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705–906 Terrugem SNT, Portugal | ES/1/15/1004 | 2018 9 25 |
| 2018 9 21 | Zonegran | Eisai GmbH
  Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland | ES/1/04/307 | 2018 9 25 |
| 2018 9 27 | BeneFIX | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/97/047 | 2018 10 1 |
| 2018 9 27 | Ecalta | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/07/416 | 2018 10 1 |
| 2018 9 27 | Prevenar 13 | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/09/590 | 2018 10 1 |
| 2018 9 27 | Trumenba | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/17/1187 | 2018 10 1 |
| 2018 9 27 | Vimizim | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland | ES/1/14/914 | 2018 10 1 |
| 2018 9 28 | Celsentri | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | ES/1/07/418 | 2018 10 2 |
| 2018 9 28 | CoAprovel | Sanofi Clir SNC
  54 rue La Boétie, 75008 Paris, France | ES/1/98/086 | 2018 10 2 |
| 2018 9 28 | Docetaxel Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/09/611 | 2018 10 2 |
| 2018 9 28 | Dynastat | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/02/209 | 2018 10 2 |
| 2018 9 28 | HALAVEN | Eisai GmbH
  Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland | ES/1/11/678 | 2018 10 2 |
| 2018 9 28 | Imnovid | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | ES/1/13/850 | 2018 10 2 |
| 2018 9 28 | Imraldi | Samsung Bioepis UK Limited
  5th floor, Profile West, 950 Great West Road, Brentford, Middlesex TW8 9ES, United Kingdom | ES/1/17/1216 | 2018 10 2 |
| 2018 9 28 | IntronA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | ES/1/99/127 | 2018 10 2 |
| 2018 9 28 | Intuniv | Shire Pharmaceuticals Ireland Limited
  Block 2 & 3 Miesian Plaza, 50–58 Baggot Street Lower, Dublin 2, IRELAND | ES/1/15/1040 | 2018 10 2 |
| 2018 9 28 | Lamivudine Teva Pharma B.V. | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/09/596 | 2018 10 2 |
| 2018 9 28 | Metalyse | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | ES/1/00/169 | 2018 10 2 |
| 2018 9 28 | Nexium Control | Pfizer Healthcare Ireland
  9 Riverwalk National Digital Park, Citywest Business Campus, Dublin 24, D24 NT20, Ireland | ES/1/13/860 | 2018 10 2 |
| 2018 9 28 | NexoBrid | MediWound Germany GmbH
  Eisenstraße 5, 65428 Ruesselsheim, Deutschland | ES/1/12/803 | 2018 10 2 |
| 2018 9 28 | PegIntron | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | ES/1/00/131 | 2018 10 2 |
| 2018 9 28 | Pemetrexed Pfizer | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/17/1183 | 2018 10 2 |
| 2018 9 28 | Rebetol | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | ES/1/99/107 | 2018 10 2 |
| 2018 9 28 | Retacrit | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/07/431 | 2018 10 2 |
| 2018 9 28 | Ritemvia | Celltrion Healthcare Hungary Kft.
  Váci út 1–3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | ES/1/17/1207 | 2018 10 2 |
| 2018 9 28 | Telzir | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | ES/1/04/282 | 2018 10 2 |
| 2018 9 28 | Trizivir | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | ES/1/00/156 | 2018 10 2 |
| 2018 9 28 | Uptravi | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | ES/1/15/1083 | 2018 10 2 |
| 2018 9 28 | Vfend | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/02/212 | 2018 10 2 |
| 2018 9 28 | Vimizim | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland | ES/1/14/914 | 2018 10 2 |
| 2018 9 28 | ViraferonPeg | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | ES/1/00/132 | 2018 10 2 |
| 2018 9 28 | Xigduo | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/13/900 | 2018 10 2 |
| 2018 9 28 | Xofigo | Bayer AG
  D-51368 Leverkusen, Deutschland | ES/1/13/873 | 2018 10 2 |
| 2018 9 28 | Zavesca | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | ES/1/02/238 | 2018 10 2 |
| 2018 9 28 | Zoledronic acid Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76–78, 220 Hafnarfjörður, Íceland | ES/1/12/759 | 2018 10 2 |
| 2018 9 28 | Zoledronic acid Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | ES/1/12/786 | 2018 10 2 |
| 2018 9 28 | Zoledronic acid Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/12/771 | 2018 10 2 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2018 9 4

Invokana

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

ES/1/13/884

2018 9 6

2018 9 4

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

ES/1/15/1024

2018 9 6

2018 9 4

Olumiant

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

ES/1/16/1170

2018 9 7

2018 9 6

Akynzeo

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Ireland

ES/1/15/1001

2018 9 10

2018 9 6

Alkindi

Diurnal Europe B.V.

Jachthavenweg 109 H, 1081 KM Amsterdam, Nederland

ES/1/17/1260

2018 9 10

2018 9 6

Retacrit

Pfizer Europe MA EEIG

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

ES/1/07/431

2018 9 10

2018 9 6

Silapo

STADA Arzneimittel AG

Stadastraße 2–18, 61118 Bad Vilbel, Deutschland

ES/1/07/432

2018 9 10

2018 9 6

Venclyxto

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

ES/1/16/1138

2018 9 10

2018 9 10

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

ES/1/12/794

2018 9 12

2018 9 10

Memantine Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

ES/1/13/827

2018 9 19

2018 9 10

Pregabalinas Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

ES/1/15/997

2018 9 19

2018 9 12

Tegsedi

Akcea Therapeutics UK Ltd.

Office 32, 19–21 Crawford Street, London, W1H 1PJ, United Kingdom

ES/1/18/1296

2018 9 14

2018 9 17

CRYSVITA

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

ES/1/17/1262

2018 9 19

2018 9 17

Fortacin

Recordati Ireland Ltd

Raheens East, Ringaskiddy Co. Cork, Ireland

ES/1/13/881

2018 9 19

2018 9 17

Inhixa

Techdow Europe AB

Kåbovägen 32, 75236 Uppsala, Sverige

ES/1/16/1132

2018 9 24

2018 9 17

Kadcyla

Roche Registration GmbH

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

ES/1/13/885

2018 9 19

2018 9 17

Lartruvo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

ES/1/16/1143

2018 9 19

2018 9 17

Ninlaro

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

ES/1/16/1094

2018 9 19

2018 9 17

Pregabalinas Mylan Pharma

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

ES/1/15/998

2018 9 19

2018 9 17

Sovaldi

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

ES/1/13/894

2018 9 19

2018 9 17

Stelara

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

ES/1/08/494

2018 9 19

2018 9 17

Targretin

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

ES/1/01/178

2018 9 19

2018 9 20

Atazanavir Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

ES/1/16/1091

2018 9 24

2018 9 20

Blitzima

Celltrion Healthcare Hungary Kft.

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

ES/1/17/1205

2018 9 24

2018 9 20

Cinqaero

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/16/1125

2018 9 24

2018 9 20

Cosentyx

Novartis Europharm Limited

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

ES/1/14/980

2018 9 24

2018 9 20

Cyramza

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

ES/1/14/957

2018 9 24

2018 9 20

Diacomit

Biocodex

7 avenue Gallieni, 94250 Gentilly, France

ES/1/06/367

2018 9 24

2018 9 20

EndolucinBeta

ITG Isotope Technologies Garching GmbH

Lichtenbergstraße 1, 85748 Garching, Deutschland

ES/1/16/1105

2018 9 24

2018 9 20

Iclusig

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

ES/1/13/839

2018 9 24

2018 9 20

INCRELEX

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

ES/1/07/402

2018 9 24

2018 9 20

Kanuma

Alexion Europe SAS

1–15 avenue Edouard Belin, 92500 Rueil-Malmaison, France

ES/1/15/1033

2018 9 24

2018 9 20

Karvezide

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

ES/1/98/085

2018 9 24

2018 9 20

Lumark

IDB Holland B.V.

Weverstraat 17, 5111 PV Baarle-Nassau, Nederland

ES/1/15/1013

2018 9 24

2018 9 20

Neofordex

Laboratoires CTRS

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

ES/1/15/1053

2018 9 24

2018 9 20

NeuroBloc

Sloan Pharma S.a.r.l.

33 Rue de Puits Romain, 8070 Bertrange, Luxembourg

ES/1/00/166

2018 9 24

2018 9 20

Nitisinone MDK

MendeliKABS Europe Limited

The Light Box, 111 Power Rd, Unit G. 07, Chiswick, London, W4 5PY, United Kingdom

ES/1/17/1217

2018 9 24

2018 9 20

Opdivo

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

ES/1/15/1014

2018 9 24

2018 9 20

Ovitrelle

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

ES/1/00/165

2018 9 24

2018 9 20

Rasilez

Noden Pharma DAC

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

ES/1/07/405

2018 9 24

2018 9 20

Renvela

Genzyme Europe B.V.

Gooimeer 10, 1411 DD Naarden, Nederland

ES/1/09/521

2018 9 24

2018 9 20

Rixathon

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

ES/1/17/1185

2018 9 24

2018 9 20

Ryzodeg

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

ES/1/12/806

2018 9 24

2018 9 20

Sevelamer carbonate Zentiva

Genzyme Europe B.V.

Gooimeer 10, 1411 DD Naarden, Nederland

ES/1/14/952

2018 9 24

2018 9 20

Tecfidera

Biogen Idec Limited

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

ES/1/13/837

2018 9 24

2018 9 20

Topotecan Hospira

Pfizer Europe MA EEIG

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

ES/1/10/633

2018 9 24

2018 9 20

Tresiba

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

ES/1/12/807

2018 9 24

2018 9 20

Zoledronic acid Hospira

Pfizer Europe MA EEIG

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

ES/1/12/800

2018 9 24

2018 9 21

Brilique

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/10/655

2018 9 25

2018 9 21

Fycompa

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

ES/1/12/776

2018 9 25

2018 9 21

Inovelon

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

ES/1/06/378

2018 9 25

2018 9 21

Opsumit

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

ES/1/13/893

2018 9 25

2018 9 21

Tivicay

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

ES/1/13/892

2018 9 25

2018 9 21

Voriconazole Hikma

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705–906 Terrugem SNT, Portugal

ES/1/15/1004

2018 9 25

2018 9 21

Zonegran

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

ES/1/04/307

2018 9 25

2018 9 27

BeneFIX

Pfizer Europe MA EEIG

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

ES/1/97/047

2018 10 1

2018 9 27

Ecalta

Pfizer Europe MA EEIG

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

ES/1/07/416

2018 10 1

2018 9 27

Prevenar 13

Pfizer Europe MA EEIG

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

ES/1/09/590

2018 10 1

2018 9 27

Trumenba

Pfizer Europe MA EEIG

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

ES/1/17/1187

2018 10 1

2018 9 27

Vimizim

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland

ES/1/14/914

2018 10 1

2018 9 28

Celsentri

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

ES/1/07/418

2018 10 2

2018 9 28

CoAprovel

Sanofi Clir SNC

54 rue La Boétie, 75008 Paris, France

ES/1/98/086

2018 10 2

2018 9 28

Docetaxel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/09/611

2018 10 2

2018 9 28

Dynastat

Pfizer Europe MA EEIG

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

ES/1/02/209

2018 10 2

2018 9 28

HALAVEN

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

ES/1/11/678

2018 10 2

2018 9 28

Imnovid

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

ES/1/13/850

2018 10 2

2018 9 28

Imraldi

Samsung Bioepis UK Limited

5th floor, Profile West, 950 Great West Road, Brentford, Middlesex TW8 9ES, United Kingdom

ES/1/17/1216

2018 10 2

2018 9 28

IntronA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

ES/1/99/127

2018 10 2

2018 9 28

Intuniv

Shire Pharmaceuticals Ireland Limited

Block 2 & 3 Miesian Plaza, 50–58 Baggot Street Lower, Dublin 2, IRELAND

ES/1/15/1040

2018 10 2

2018 9 28

Lamivudine Teva Pharma B.V.

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/09/596

2018 10 2

2018 9 28

Metalyse

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

ES/1/00/169

2018 10 2

2018 9 28

Nexium Control

Pfizer Healthcare Ireland

9 Riverwalk National Digital Park, Citywest Business Campus, Dublin 24, D24 NT20, Ireland

ES/1/13/860

2018 10 2

2018 9 28

NexoBrid

MediWound Germany GmbH

Eisenstraße 5, 65428 Ruesselsheim, Deutschland

ES/1/12/803

2018 10 2

2018 9 28

PegIntron

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

ES/1/00/131

2018 10 2

2018 9 28

Pemetrexed Pfizer

Pfizer Europe MA EEIG

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

ES/1/17/1183

2018 10 2

2018 9 28

Rebetol

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

ES/1/99/107

2018 10 2

2018 9 28

Retacrit

Pfizer Europe MA EEIG

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

ES/1/07/431

2018 10 2

2018 9 28

Ritemvia

Celltrion Healthcare Hungary Kft.

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

ES/1/17/1207

2018 10 2

2018 9 28

Telzir

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

ES/1/04/282

2018 10 2

2018 9 28

Trizivir

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

ES/1/00/156

2018 10 2

2018 9 28

Uptravi

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

ES/1/15/1083

2018 10 2

2018 9 28

Vfend

Pfizer Europe MA EEIG

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

ES/1/02/212

2018 10 2

2018 9 28

Vimizim

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland

ES/1/14/914

2018 10 2

2018 9 28

ViraferonPeg

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

ES/1/00/132

2018 10 2

2018 9 28

Xigduo

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/13/900

2018 10 2

2018 9 28

Xofigo

Bayer AG

D-51368 Leverkusen, Deutschland

ES/1/13/873

2018 10 2

2018 9 28

Zavesca

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

ES/1/02/238

2018 10 2

2018 9 28

Zoledronic acid Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76–78, 220 Hafnarfjörður, Íceland

ES/1/12/759

2018 10 2

2018 9 28

Zoledronic acid Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

ES/1/12/786

2018 10 2

2018 9 28

Zoledronic acid Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/12/771

2018 10 2

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

—

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

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2018 9 27 | IONSYS | Incline Therapeutics Europe Ltd
  21 St Thomas Street, Bristol BS1 6JS, United Kingdom | ES/1/15/1050 | 2018 10 1 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2018 9 27

IONSYS

Incline Therapeutics Europe Ltd

21 St Thomas Street, Bristol BS1 6JS, United Kingdom

ES/1/15/1050

2018 10 1

| — | 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 |
| --- | --- | --- | --- | --- |
| 2018 9 24 | BROADLINE | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | ES/2/13/157 | 2018 9 26 |
| 2018 9 24 | Comfortis | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | ES/2/10/115 | 2018 9 26 |
| 2018 9 24 | FORTEKOR PLUS | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | ES/2/15/185 | 2018 9 26 |
| 2018 9 24 | Kexxtone | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | ES/2/12/145 | 2018 9 26 |
| 2018 9 24 | Sileo | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | ES/2/15/181 | 2018 9 26 |
| 2018 9 27 | Credelio | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | ES/2/17/206 | 2018 10 1 |
| 2018 9 27 | Ingelvac PCV FLEX | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | ES/2/17/208 | 2018 10 1 |
| 2018 9 27 | MS-H Vaccine | Pharmsure Veterinary Products Europe Ltd
  4 Ormond Quay Upper, DO7 PF53, Dublin, Ireland | ES/2/11/126 | 2018 10 1 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2018 9 24

BROADLINE

Merial

29 avenue Tony Garnier, 69007 Lyon, France

ES/2/13/157

2018 9 26

2018 9 24

Comfortis

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

ES/2/10/115

2018 9 26

2018 9 24

FORTEKOR PLUS

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

ES/2/15/185

2018 9 26

2018 9 24

Kexxtone

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

ES/2/12/145

2018 9 26

2018 9 24

Sileo

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

ES/2/15/181

2018 9 26

2018 9 27

Credelio

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

ES/2/17/206

2018 10 1

2018 9 27

Ingelvac PCV FLEX

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

ES/2/17/208

2018 10 1

2018 9 27

MS-H Vaccine

Pharmsure Veterinary Products Europe Ltd

4 Ormond Quay Upper, DO7 PF53, Dublin, Ireland

ES/2/11/126

2018 10 1

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

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

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