# Europos Sąjungos C 61/2017

| | ISSN 1977-0960 |
| --- | --- |
| Europos Sąjungos
  oficialusis leidinys | C 61 |
| | |
| Leidimas lietuvių kalba | Informacija ir pranešimai | 60 metai2017m. vasario 24d. |

ISSN 1977-0960

Europos Sąjungos

oficialusis leidinys

C 61

Leidimas lietuvių kalba

Informacija ir pranešimai

60 metai2017m. vasario 24d.

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| Pranešimo Nr. | Turinys | Puslapis |
| --- | --- | --- |
| | IV   Pranešimai |
| | EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
| | Europos Komisija |
| 2017/C 61/01 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2017 m. sausio 1 d. iki 2017 m. sausio 31 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį) | 1 |

Pranešimo Nr.

Turinys

Puslapis

IV   Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

2017/C 61/01

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2017 m. sausio 1 d. iki 2017 m. sausio 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

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| LT | |
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LT

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IV Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

| 24.2.2017 | LT | Europos Sąjungos oficialusis leidinys | C 61/1 |
| --- | --- | --- | --- |

24.2.2017

LT

Europos Sąjungos oficialusis leidinys

C 61/1

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Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2017 m. sausio 1 d. iki 2017 m. sausio 31 d.

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

(2017/C 061/01)

| — | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2017 1 4 | AFSTYLA | alfa lonoktokogs | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/16/1158 | Milteliai ir tirpiklis injekciniam tirpalui | B02BD02 | 2017 1 6 |
| 2017 1 4 | Darunavir Mylan | darunaviras | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/16/1140 | Plėvele dengta tabletė | J05AE10 | 2017 1 6 |
| 2017 1 4 | Lusduna | insulinas glarginas | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/16/1162 | Injekcinis tirpalas | A10AE04 | 2017 1 6 |
| 2017 1 4 | Terrosa | Teriparatida | Gedeon Richter Plc.
  Gyömrői út 19-21., H-1103 Budapest, Magyarország | EU/1/16/1159 | Injekcinis tirpalas | H05AA02 | 2017 1 6 |
| 2017 1 9 | Fiasp | Insulinas aspartas | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsværd, Danmark | EU/1/16/1160 | Injekcinis tirpalas | A10AB05 | 2017 1 11 |
| 2017 1 9 | Tadalafil Generics | tadalafilis | Mylan S.A.S.
  117 Allée des Parcs, 69800 Saint-Priest, France | EU/1/16/1153 | Plėvele dengta tabletė | G04BE08 | 2017 1 11 |
| 2017 1 9 | Vemlidy | tenofovir alafenamide | Gilead Sciences International Ltd.
  Cambridge, CB21 6GT, United Kingdom | EU/1/16/1154 | Plėvele dengta tabletė | J05AF13 | 2017 1 11 |
| 2017 1 11 | Movymia | Teriparatida | STADA Arzneimittel AG
  Stadastrasse 2-18, D-61118 Bad Vilbel, Deutschland | EU/1/16/1161 | Injekcinis tirpalas | H05AA02 | 2017 1 13 |
| 2017 1 11 | Suliqua | insulinum glarginum + lixisenatidum | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/16/1157 | Injekcinis tirpalas | A10AE54 | 2017 1 13 |
| 2017 1 18 | ZINPLAVA | bezlotoksumabas | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/16/1156 | Koncentratas infuziniam tirpalui | J06BB21 | 2017 1 20 |
| 2017 1 19 | Cystadrops | merkaptaminas | Orphan Europe SARL
  Immeuble „Le Wilson“, 70, Avenue du Général de Gaulle, 92800 Puteaux, France | EU/1/15/1049 | Akių lašai, tirpalas | S01XA21 | 2017 1 23 |

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

2017 1 4

AFSTYLA

alfa lonoktokogs

CSL Behring GmbH

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

EU/1/16/1158

Milteliai ir tirpiklis injekciniam tirpalui

B02BD02

2017 1 6

2017 1 4

Darunavir Mylan

darunaviras

Mylan S.A.S

117 allée des Parcs, F-69800 Saint Priest, France

EU/1/16/1140

Plėvele dengta tabletė

J05AE10

2017 1 6

2017 1 4

Lusduna

insulinas glarginas

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/16/1162

Injekcinis tirpalas

A10AE04

2017 1 6

2017 1 4

Terrosa

Teriparatida

Gedeon Richter Plc.

Gyömrői út 19-21., H-1103 Budapest, Magyarország

EU/1/16/1159

Injekcinis tirpalas

H05AA02

2017 1 6

2017 1 9

Fiasp

Insulinas aspartas

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsværd, Danmark

EU/1/16/1160

Injekcinis tirpalas

A10AB05

2017 1 11

2017 1 9

Tadalafil Generics

tadalafilis

Mylan S.A.S.

117 Allée des Parcs, 69800 Saint-Priest, France

EU/1/16/1153

Plėvele dengta tabletė

G04BE08

2017 1 11

2017 1 9

Vemlidy

tenofovir alafenamide

Gilead Sciences International Ltd.

Cambridge, CB21 6GT, United Kingdom

EU/1/16/1154

Plėvele dengta tabletė

J05AF13

2017 1 11

2017 1 11

Movymia

Teriparatida

STADA Arzneimittel AG

Stadastrasse 2-18, D-61118 Bad Vilbel, Deutschland

EU/1/16/1161

Injekcinis tirpalas

H05AA02

2017 1 13

2017 1 11

Suliqua

insulinum glarginum + lixisenatidum

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/16/1157

Injekcinis tirpalas

A10AE54

2017 1 13

2017 1 18

ZINPLAVA

bezlotoksumabas

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/16/1156

Koncentratas infuziniam tirpalui

J06BB21

2017 1 20

2017 1 19

Cystadrops

merkaptaminas

Orphan Europe SARL

Immeuble „Le Wilson“, 70, Avenue du Général de Gaulle, 92800 Puteaux, France

EU/1/15/1049

Akių lašai, tirpalas

S01XA21

2017 1 23

| — | 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 |
| --- | --- | --- | --- | --- |
| 2017 1 4 | Emadine | Alcon Laboratories (UK) Ltd
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/98/095 | 2017 1 6 |
| 2017 1 4 | Imatinib Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/845 | 2017 1 6 |
| 2017 1 4 | Incruse | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/922 | 2017 1 6 |
| 2017 1 4 | Kolbam | Retrophin Europe Limited
  Palmerstown House, Fenian Street, Dublin 2, Ireland | EU/1/13/895 | 2017 1 6 |
| 2017 1 4 | Vepacel | Nanotherapeutics Bohumil, s.r.o.
  Bohumil 138, 28163 Jevany, Česká republika | EU/1/12/752 | 2017 1 6 |
| 2017 1 4 | Zonegran | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/04/307 | 2017 1 6 |
| 2017 1 9 | Capecitabine Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/12/762 | 2017 1 11 |
| 2017 1 9 | Capecitabine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/761 | 2017 1 11 |
| 2017 1 9 | DaTSCAN | GE Healthcare Limited
  Little Chalfont, Bucks HP7 9NA, United Kingdom | EU/1/00/135 | 2017 1 11 |
| 2017 1 9 | Foclivia | Novartis Vaccines Influenza S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/09/577 | 2017 1 11 |
| 2017 1 9 | Naglazyme | BioMarin Europe Ltd.
  10 Bloomsbury Way, London WC1A 2SL, United Kingdom | EU/1/05/324 | 2017 1 13 |
| 2017 1 9 | Ofev | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/979 | 2017 1 11 |
| 2017 1 9 | Relistor | PharmaSwiss Česká republika s.r.o.
  Jankovcova 1569/2c 17000 Praha 7 Česká republika | EU/1/08/463 | 2017 1 11 |
| 2017 1 9 | Riluzole Zentiva | Aventis Pharma S.A.
  20 avenue Raymond Aron, F-92165 Antony CEDEX, France | EU/1/12/768 | 2017 1 11 |
| 2017 1 9 | SANCUSO | Kyowa Kirin Limited
  Galabank Business Park, Galashiels, TD1 1QH, United Kingdom | EU/1/12/766 | 2017 1 11 |
| 2017 1 9 | Translarna | PTC Therapeutics International Limited
  77 Sir John Rogerson’s Quay, Dublin 2, Ireland | EU/1/13/902 | 2017 1 11 |
| 2017 1 9 | Viagra | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/98/077 | 2017 1 11 |
| 2017 1 9 | Viramune | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/97/055 | 2017 1 11 |
| 2017 1 9 | Xultophy | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsværd, Danmark | EU/1/14/947 | 2017 1 11 |
| 2017 1 11 | Adenuric | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/08/447 | 2017 1 13 |
| 2017 1 11 | Brintellix | H. Lundbeck A/S
  Ottiliavej 9, DK-2500 Valby, Danmark | EU/1/13/891 | 2017 1 13 |
| 2017 1 11 | Bronchitol | Pharmaxis Pharmaceuticals Limited
  25 Moorgate, London, EC2R 6AY, United Kingdom. | EU/1/12/760 | 2017 1 13 |
| 2017 1 11 | Cometriq | Ipsen Pharma
  65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | EU/1/13/890 | 2017 1 13 |
| 2017 1 11 | Defitelio | Gentium S.r.l
  Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia | EU/1/13/878 | 2017 1 16 |
| 2017 1 11 | Entresto | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/1058 | 2017 1 13 |
| 2017 1 11 | Herceptin | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/00/145 | 2017 1 13 |
| 2017 1 11 | Imatinib Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/845 | 2017 1 13 |
| 2017 1 11 | Inovelon | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/06/378 | 2017 1 13 |
| 2017 1 11 | Invanz | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/02/216 | 2017 1 13 |
| 2017 1 11 | Ivemend | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/437 | 2017 1 13 |
| 2017 1 11 | Kuvan | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, Ireland | EU/1/08/481 | 2017 1 13 |
| 2017 1 11 | Pregabalinas Mylan | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/15/997 | 2017 1 13 |
| 2017 1 11 | Pregabalinas Mylan Pharma | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/15/998 | 2017 1 13 |
| 2017 1 11 | Ruconest | Pharming Group N.V.
  Darwinweg 24, NL-2333 CR Leiden, Nederland | EU/1/10/641 | 2017 1 13 |
| 2017 1 11 | Vimizim | BioMarin Europe Ltd.
  10 Bloomsbury Way, London WC1A 2SL, United Kingdom | EU/1/14/914 | 2017 1 13 |
| 2017 1 11 | Xadago | Zambon S.p.A.
  Via Lillo del Duca 10, 20 091 Bresso (MI), Italia | EU/1/14/984 | 2017 1 13 |
| 2017 1 19 | Jardiance | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/930 | 2017 1 23 |
| 2017 1 23 | Lymphoseek | Norgine B.V.
  Hogehilweg 7, 1101CA Amsterdam, Nederland | EU/1/14/955 | 2017 1 25 |
| 2017 1 23 | Remsima | Celltrion Healthcare Hungary Kft.
  Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország | EU/1/13/853 | 2017 1 25 |
| 2017 1 26 | Cinryze | Shire Services BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/688 | 2017 1 30 |
| 2017 1 26 | Iclusig | Incyte Biosciences UK Ltd
  Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom | EU/1/13/839 | 2017 1 30 |
| 2017 1 26 | NovoSeven | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsværd, Danmark | EU/1/96/006 | 2017 1 30 |
| 2017 1 26 | Orfadin | Swedish Orphan Biovitrum International AB
  SE-112 76 Stockholm, Sverige | EU/1/04/303 | 2017 1 30 |
| 2017 1 26 | Picato | LEO Laboratories Ltd.
  285 Cashel Road, Crumlin, Dublin 12, Ireland | EU/1/12/796 | 2017 1 30 |
| 2017 1 26 | Rezolsta | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/967 | 2017 1 30 |
| 2017 1 26 | Voriconazole Hikma | Hikma Farmacêutica (Portugal), S.A.
  Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal | EU/1/15/1004 | 2017 1 30 |
| 2017 1 27 | Ameluz | Biofrontera Bioscience GmbH
  Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland | EU/1/11/740 | 2017 1 31 |
| 2017 1 27 | Benepali | Samsung Bioepis UK Limited
  3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom | EU/1/15/1074 | 2017 1 31 |
| 2017 1 27 | Docetaxel Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/12/769 | 2017 1 31 |
| 2017 1 27 | Jentadueto | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/12/780 | 2017 1 31 |
| 2017 1 27 | KEYTRUDA | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/1024 | 2017 1 31 |
| 2017 1 27 | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 2017 1 31 |
| 2017 1 27 | Stivarga | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/13/858 | 2017 1 31 |
| 2017 1 27 | Trajenta | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/11/707 | 2017 1 31 |
| 2017 1 27 | Vaxelis | MCM Vaccine B.V.
  Robert Boyleweg 4, 2333 CG Leiden, Nederland | EU/1/15/1079 | 2017 1 31 |
| 2017 1 27 | Votubia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/710 | 2017 1 31 |
| 2017 1 27 | Xydalba | Allergan Pharmaceuticals International Limited
  Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland | EU/1/14/986 | 2017 1 31 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2017 1 4

Emadine

Alcon Laboratories (UK) Ltd

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

EU/1/98/095

2017 1 6

2017 1 4

Imatinib Accord

Accord Healthcare Limited

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

EU/1/13/845

2017 1 6

2017 1 4

Incruse

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/14/922

2017 1 6

2017 1 4

Kolbam

Retrophin Europe Limited

Palmerstown House, Fenian Street, Dublin 2, Ireland

EU/1/13/895

2017 1 6

2017 1 4

Vepacel

Nanotherapeutics Bohumil, s.r.o.

Bohumil 138, 28163 Jevany, Česká republika

EU/1/12/752

2017 1 6

2017 1 4

Zonegran

Eisai Limited

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

EU/1/04/307

2017 1 6

2017 1 9

Capecitabine Accord

Accord Healthcare Limited

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

EU/1/12/762

2017 1 11

2017 1 9

Capecitabine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/761

2017 1 11

2017 1 9

DaTSCAN

GE Healthcare Limited

Little Chalfont, Bucks HP7 9NA, United Kingdom

EU/1/00/135

2017 1 11

2017 1 9

Foclivia

Novartis Vaccines Influenza S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/09/577

2017 1 11

2017 1 9

Naglazyme

BioMarin Europe Ltd.

10 Bloomsbury Way, London WC1A 2SL, United Kingdom

EU/1/05/324

2017 1 13

2017 1 9

Ofev

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/14/979

2017 1 11

2017 1 9

Relistor

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c 17000 Praha 7 Česká republika

EU/1/08/463

2017 1 11

2017 1 9

Riluzole Zentiva

Aventis Pharma S.A.

20 avenue Raymond Aron, F-92165 Antony CEDEX, France

EU/1/12/768

2017 1 11

2017 1 9

SANCUSO

Kyowa Kirin Limited

Galabank Business Park, Galashiels, TD1 1QH, United Kingdom

EU/1/12/766

2017 1 11

2017 1 9

Translarna

PTC Therapeutics International Limited

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

EU/1/13/902

2017 1 11

2017 1 9

Viagra

Pfizer Limited

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

EU/1/98/077

2017 1 11

2017 1 9

Viramune

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/97/055

2017 1 11

2017 1 9

Xultophy

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsværd, Danmark

EU/1/14/947

2017 1 11

2017 1 11

Adenuric

Menarini International Operations Luxembourg S.A.

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

EU/1/08/447

2017 1 13

2017 1 11

Brintellix

H. Lundbeck A/S

Ottiliavej 9, DK-2500 Valby, Danmark

EU/1/13/891

2017 1 13

2017 1 11

Bronchitol

Pharmaxis Pharmaceuticals Limited

25 Moorgate, London, EC2R 6AY, United Kingdom.

EU/1/12/760

2017 1 13

2017 1 11

Cometriq

Ipsen Pharma

65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France

EU/1/13/890

2017 1 13

2017 1 11

Defitelio

Gentium S.r.l

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

EU/1/13/878

2017 1 16

2017 1 11

Entresto

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/1058

2017 1 13

2017 1 11

Herceptin

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/00/145

2017 1 13

2017 1 11

Imatinib Accord

Accord Healthcare Limited

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

EU/1/13/845

2017 1 13

2017 1 11

Inovelon

Eisai Limited

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

EU/1/06/378

2017 1 13

2017 1 11

Invanz

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/02/216

2017 1 13

2017 1 11

Ivemend

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/437

2017 1 13

2017 1 11

Kuvan

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, Ireland

EU/1/08/481

2017 1 13

2017 1 11

Pregabalinas Mylan

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/15/997

2017 1 13

2017 1 11

Pregabalinas Mylan Pharma

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/15/998

2017 1 13

2017 1 11

Ruconest

Pharming Group N.V.

Darwinweg 24, NL-2333 CR Leiden, Nederland

EU/1/10/641

2017 1 13

2017 1 11

Vimizim

BioMarin Europe Ltd.

10 Bloomsbury Way, London WC1A 2SL, United Kingdom

EU/1/14/914

2017 1 13

2017 1 11

Xadago

Zambon S.p.A.

Via Lillo del Duca 10, 20 091 Bresso (MI), Italia

EU/1/14/984

2017 1 13

2017 1 19

Jardiance

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/14/930

2017 1 23

2017 1 23

Lymphoseek

Norgine B.V.

Hogehilweg 7, 1101CA Amsterdam, Nederland

EU/1/14/955

2017 1 25

2017 1 23

Remsima

Celltrion Healthcare Hungary Kft.

Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország

EU/1/13/853

2017 1 25

2017 1 26

Cinryze

Shire Services BVBA

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

EU/1/11/688

2017 1 30

2017 1 26

Iclusig

Incyte Biosciences UK Ltd

Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom

EU/1/13/839

2017 1 30

2017 1 26

NovoSeven

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsværd, Danmark

EU/1/96/006

2017 1 30

2017 1 26

Orfadin

Swedish Orphan Biovitrum International AB

SE-112 76 Stockholm, Sverige

EU/1/04/303

2017 1 30

2017 1 26

Picato

LEO Laboratories Ltd.

285 Cashel Road, Crumlin, Dublin 12, Ireland

EU/1/12/796

2017 1 30

2017 1 26

Rezolsta

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/967

2017 1 30

2017 1 26

Voriconazole Hikma

Hikma Farmacêutica (Portugal), S.A.

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

EU/1/15/1004

2017 1 30

2017 1 27

Ameluz

Biofrontera Bioscience GmbH

Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland

EU/1/11/740

2017 1 31

2017 1 27

Benepali

Samsung Bioepis UK Limited

3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom

EU/1/15/1074

2017 1 31

2017 1 27

Docetaxel Accord

Accord Healthcare Limited

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

EU/1/12/769

2017 1 31

2017 1 27

Jentadueto

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/12/780

2017 1 31

2017 1 27

KEYTRUDA

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/15/1024

2017 1 31

2017 1 27

Opdivo

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

2017 1 31

2017 1 27

Stivarga

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/13/858

2017 1 31

2017 1 27

Trajenta

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/11/707

2017 1 31

2017 1 27

Vaxelis

MCM Vaccine B.V.

Robert Boyleweg 4, 2333 CG Leiden, Nederland

EU/1/15/1079

2017 1 31

2017 1 27

Votubia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/710

2017 1 31

2017 1 27

Xydalba

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland

EU/1/14/986

2017 1 31

| — | 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 |
| --- | --- | --- | --- | --- |
| 2017 1 9 | Vylaer Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/949 | 2017 1 11 |
| 2017 1 18 | Clopidogrel Acino | Acino AG
  Am Windfeld 35, 83714 D-Miesbach, Deutschland | EU/1/09/532 | 2017 1 20 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2017 1 9

Vylaer Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/949

2017 1 11

2017 1 18

Clopidogrel Acino

Acino AG

Am Windfeld 35, 83714 D-Miesbach, Deutschland

EU/1/09/532

2017 1 20

| — | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2017 1 9 | Coliprotec F4/F18 | Vakcina (gyvoji) nuo viduriavimo nujunkytiems paršeliams | Prevtec Microbia GmbH
  Geyerspergerstr 27, 80689 München, Deutschland | EU/2/16/202 | Liofilizatas geriamajai suspensijai | QI09AE03 | 2017 1 11 |

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

2017 1 9

Coliprotec F4/F18

Vakcina (gyvoji) nuo viduriavimo nujunkytiems paršeliams

Prevtec Microbia GmbH

Geyerspergerstr 27, 80689 München, Deutschland

EU/2/16/202

Liofilizatas geriamajai suspensijai

QI09AE03

2017 1 11

| — | 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 |
| --- | --- | --- | --- | --- |
| 2017 1 9 | Novaquin | Le Vet Beheer B.V.
  Wilgenweg 7, NL-3421 TV Oudewater, Nederland | EU/2/15/186 | 2017 1 11 |
| 2017 1 18 | Nobilis IB 4-91 | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/98/006 | 2017 1 20 |
| 2017 1 18 | Simparica | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/15/191 | 2017 1 20 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2017 1 9

Novaquin

Le Vet Beheer B.V.

Wilgenweg 7, NL-3421 TV Oudewater, Nederland

EU/2/15/186

2017 1 11

2017 1 18

Nobilis IB 4-91

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/98/006

2017 1 20

2017 1 18

Simparica

Zoetis Belgium S.A.

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

EU/2/15/191

2017 1 20

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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