# Europos Sąjungos C 116/2016

| | ISSN 1977-0960 |
| --- | --- |
| Europos Sąjungos
  oficialusis leidinys | C 116 |
| | |
| Leidimas lietuvių kalba | Informacija ir pranešimai | 59 tomas2016m. balandžio 1d. |

ISSN 1977-0960

Europos Sąjungos

oficialusis leidinys

C 116

Leidimas lietuvių kalba

Informacija ir pranešimai

59 tomas2016m. balandžio 1d.

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| Pranešimo Nr. | Turinys | Puslapis |
| --- | --- | --- |
| | IV   Pranešimai |
| | EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
| | Europos Komisija |
| 2016/C 116/01 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2016 m. vasario 1 d. iki 2016 m. vasario 29 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

2016/C 116/01

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2016 m. vasario 1 d. iki 2016 m. vasario 29 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

| 1.4.2016 | LT | Europos Sąjungos oficialusis leidinys | C 116/1 |
| --- | --- | --- | --- |

1.4.2016

LT

Europos Sąjungos oficialusis leidinys

C 116/1

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Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2016 m. vasario 1 d. iki 2016 m. vasario 29 d.

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

(2016/C 116/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2016 2 2 | TAGRISSO | osimertinibas | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | ES/1/16/1086 | Plėvele dengta tabletė | L01XE35 | 2016 2 4 |
| 2016 2 11 | Caspofungin Accord | kaspofunginas | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | ES/1/15/1081 | Milteliai koncentratui infuziniam tirpalui | J02AX04 | 2016 2 15 |
| 2016 2 15 | Portrazza | Necitumumabas | Eli Lilly Nederland B.V.
  Grootslag 1–5, NL-3991 RA Houten, Nederland | ES/1/15/1084 | Koncentratas infuziniam tirpalui | L01XC22 | 2016 2 18 |
| 2016 2 15 | Vaxelis | Vakcina nuo difterijos, stabligės, kokliušo (neląstelinė, komponentinė), hepatito B (rDNR), nuo poliomielito (inaktyvuota) ir nuo b tipo Haemophilus, konjuguota, (adsorbuota). | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | ES/1/15/1079 | Injekcinė suspensija | J07CA09 | 2016 2 17 |
| 2016 2 18 | Feraccru | geležies maltolas | Iron Therapeutics (UK) Ltd
  Gateshead Quays, NE8 3DF, United Kingdom | ES/1/15/1075 | Kieta kapsulė | B03AB10 | 2016 2 22 |
| 2016 2 18 | Iblias | oktokogas alfa | Bayer Pharma AG
  D-13342 Berlin, Deutschland | ES/1/15/1077 | Milteliai ir tirpiklis injekciniam tirpalui | B02BD02 | 2016 2 22 |
| 2016 2 18 | Kovaltry | oktokogas alfa | Bayer Pharma AG
  D-13342 Berlin, Deutschland | ES/1/15/1076 | Milteliai ir tirpiklis injekciniam tirpalui | B02BD02 | 2016 2 22 |
| 2016 2 18 | Zurampic | Lesinuradas | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | ES/1/15/1080 | Plėvele dengta tabletė | M04AB05 | 2016 2 22 |

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

2016 2 2

TAGRISSO

osimertinibas

AstraZeneca AB

SE-151 85 Södertälje, Sverige

ES/1/16/1086

Plėvele dengta tabletė

L01XE35

2016 2 4

2016 2 11

Caspofungin Accord

kaspofunginas

Accord Healthcare Limited

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

ES/1/15/1081

Milteliai koncentratui infuziniam tirpalui

J02AX04

2016 2 15

2016 2 15

Portrazza

Necitumumabas

Eli Lilly Nederland B.V.

Grootslag 1–5, NL-3991 RA Houten, Nederland

ES/1/15/1084

Koncentratas infuziniam tirpalui

L01XC22

2016 2 18

2016 2 15

Vaxelis

Vakcina nuo difterijos, stabligės, kokliušo (neląstelinė, komponentinė), hepatito B (rDNR), nuo poliomielito (inaktyvuota) ir nuo b tipo Haemophilus, konjuguota, (adsorbuota).

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

ES/1/15/1079

Injekcinė suspensija

J07CA09

2016 2 17

2016 2 18

Feraccru

geležies maltolas

Iron Therapeutics (UK) Ltd

Gateshead Quays, NE8 3DF, United Kingdom

ES/1/15/1075

Kieta kapsulė

B03AB10

2016 2 22

2016 2 18

Iblias

oktokogas alfa

Bayer Pharma AG

D-13342 Berlin, Deutschland

ES/1/15/1077

Milteliai ir tirpiklis injekciniam tirpalui

B02BD02

2016 2 22

2016 2 18

Kovaltry

oktokogas alfa

Bayer Pharma AG

D-13342 Berlin, Deutschland

ES/1/15/1076

Milteliai ir tirpiklis injekciniam tirpalui

B02BD02

2016 2 22

2016 2 18

Zurampic

Lesinuradas

AstraZeneca AB

SE-151 85 Södertälje, Sverige

ES/1/15/1080

Plėvele dengta tabletė

M04AB05

2016 2 22

—   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 |
| --- | --- | --- | --- | --- |
| 2016 2 8 | Hepsera | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | ES/1/03/251 | 2016 2 10 |
| 2016 2 8 | Irbesartan Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/09/576 | 2016 2 10 |
| 2016 2 8 | Iscover | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | ES/1/98/070 | 2016 2 10 |
| 2016 2 8 | Metiltioninio chloridas Proveblue | Provepharm S.A.S.
  22 Rue Marc Donadille, 13013 Marseille, France | ES/1/11/682 | 2016 2 10 |
| 2016 2 8 | Plavix | Sanofi Clir SNC
  54 rue La Boétie, F-75008 Paris, France | ES/1/98/069 | 2016 2 10 |
| 2016 2 8 | Zoledronic acid Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | ES/1/13/834 | 2016 2 10 |
| 2016 2 11 | Sevelamer carbonate Zentiva | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | ES/1/14/952 | 2016 2 15 |
| 2016 2 11 | Simbrinza | Alcon Laboratories (UK) Ltd
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | ES/1/14/933 | 2016 2 15 |
| 2016 2 11 | Sutent | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | ES/1/06/347 | 2016 2 15 |
| 2016 2 11 | Truvada | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | ES/1/04/305 | 2016 2 15 |
| 2016 2 11 | Vitekta | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | ES/1/13/883 | 2016 2 15 |
| 2016 2 11 | Xigduo | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | ES/1/13/900 | 2016 2 15 |
| 2016 2 11 | Zoledronic acid Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/12/771 | 2016 2 15 |
| 2016 2 11 | Zostavax | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | ES/1/06/341 | 2016 2 15 |
| 2016 2 11 | Zydelig | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | ES/1/14/938 | 2016 2 15 |
| 2016 2 15 | Latuda | Sunovion Pharmaceuticals Europe Ltd
  First Floor, Southside, 97–105 Victoria Street, London SW1E 6QT, United Kingdom | ES/1/14/913 | 2016 2 17 |
| 2016 2 15 | Rivastigmine Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegur 76–78, 220 Hafnarfjörður, Ísland | ES/1/11/693 | 2016 2 17 |
| 2016 2 18 | Aldara | MEDA AB
  Pipers väg 2A, SE-170 73 Solna, Sverige | ES/1/98/080 | 2016 2 22 |
| 2016 2 18 | Benlysta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ES/1/11/700 | 2016 2 22 |
| 2016 2 18 | Biopoin | Teva GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | ES/1/09/565 | 2016 2 22 |
| 2016 2 18 | Brilique | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | ES/1/10/655 | 2016 2 22 |
| 2016 2 18 | BYDUREON | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | ES/1/11/696 | 2016 2 22 |
| 2016 2 18 | Hizentra | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | ES/1/11/687 | 2016 2 22 |
| 2016 2 18 | Lamivudine Teva Pharma B.V. | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/09/596 | 2016 2 22 |
| 2016 2 18 | Lojuxta | Aegerion Pharmaceuticals Limited
  Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom | ES/1/13/851 | 2016 2 22 |
| 2016 2 18 | Metiltioninio chloridas Proveblue | Provepharm S.A.S.
  22 Rue Marc Donadille, 13013 Marseille, France | ES/1/11/682 | 2016 2 22 |
| 2016 2 18 | Mycophenolate mofetil Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/07/439 | 2016 2 22 |
| 2016 2 18 | Myfenax | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/07/438 | 2016 2 22 |
| 2016 2 18 | NULOJIX | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | ES/1/11/694 | 2016 2 22 |
| 2016 2 18 | TOBI Podhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/10/652 | 2016 2 22 |
| 2016 2 18 | Trajenta | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | ES/1/11/707 | 2016 2 22 |
| 2016 2 18 | Victrelis | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/11/704 | 2016 2 22 |
| 2016 2 22 | Azilect | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/04/304 | 2016 2 24 |
| 2016 2 22 | Constella | Allergan Pharmaceuticals International Ltd.
  Clonshaugh Business & Technology Park Coolock Dublin D17 E400, Ireland | ES/1/12/801 | 2016 2 24 |
| 2016 2 22 | Eporatio | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | ES/1/09/573 | 2016 2 24 |
| 2016 2 22 | Fasturtec | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | ES/1/00/170 | 2016 2 24 |
| 2016 2 22 | Herceptin | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | ES/1/00/145 | 2016 2 24 |
| 2016 2 22 | Ketoconazole HRA | Laboratoire HRA Pharma
  15 rue Béranger, F-75003 Paris, France | ES/1/14/965 | 2016 2 24 |
| 2016 2 22 | Scintimun | CIS bio international
  Boîte postale 32, F-91192 Gif-sur-Yvette, France | ES/1/09/602 | 2016 2 24 |
| 2016 2 22 | Tygacil | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | ES/1/06/336 | 2016 2 24 |
| 2016 2 22 | Vizarsin | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | ES/1/09/551 | 2016 2 24 |
| 2016 2 22 | Zoledronic acid Mylan | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | ES/1/12/786 | 2016 2 24 |
| 2016 2 24 | Afinitor | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/09/538 | 2016 2 26 |
| 2016 2 24 | Brintellix | H. Lundbeck A/S
  Ottiliavej 9, DK-2500 Valby, Danmark | ES/1/13/891 | 2016 2 26 |
| 2016 2 24 | Firdapse | BioMarin Europe Ltd.
  10 Bloomsbury Way, London WC1A 2SL, United Kingdom | ES/1/09/601 | 2016 2 26 |
| 2016 2 24 | Odomzo | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/15/1030 | 2016 2 26 |
| 2016 2 24 | Peyona | Chiesi Farmaceutici S.P.A.
  Via Palermo 26/A, 43122 Parma, Italia | ES/1/09/528 | 2016 2 26 |
| 2016 2 24 | Ravicti | Horizon Pharma Ireland Limited
  Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland | ES/1/15/1062 | 2016 3 3 |
| 2016 2 24 | Silodyx | Recordati Ireland Ltd
  Raheens East, Ringaskiddy Co. Cork, Ireland | ES/1/09/607 | 2016 2 26 |
| 2016 2 24 | Stribild | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | ES/1/13/830 | 2016 2 26 |
| 2016 2 24 | Vylaer Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | ES/1/14/949 | 2016 2 26 |
| 2016 2 24 | Xultophy | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | ES/1/14/947 | 2016 2 26 |
| 2016 2 25 | Cerdelga | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | ES/1/14/974 | 2016 3 1 |
| 2016 2 26 | Bridion | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/08/466 | 2016 3 1 |
| 2016 2 26 | Clopidogrel/Acetylsalicylic acid Zentiva (ex DuoCover) | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | ES/1/10/623 | 2016 3 1 |
| 2016 2 26 | Jentadueto | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | ES/1/12/780 | 2016 3 1 |
| 2016 2 26 | PREZISTA | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | ES/1/06/380 | 2016 3 1 |
| 2016 2 26 | Urorec | Recordati Ireland Ltd
  Raheens East, Ringaskiddy Co. Cork, Ireland | ES/1/09/608 | 2016 3 1 |
| 2016 2 26 | Vibativ | Clinigen Healthcare Limited
  Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom | ES/1/11/705 | 2016 3 2 |
| 2016 2 26 | Viread | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | ES/1/01/200 | 2016 3 1 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2016 2 8

Hepsera

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

ES/1/03/251

2016 2 10

2016 2 8

Irbesartan Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/09/576

2016 2 10

2016 2 8

Iscover

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

ES/1/98/070

2016 2 10

2016 2 8

Metiltioninio chloridas Proveblue

Provepharm S.A.S.

22 Rue Marc Donadille, 13013 Marseille, France

ES/1/11/682

2016 2 10

2016 2 8

Plavix

Sanofi Clir SNC

54 rue La Boétie, F-75008 Paris, France

ES/1/98/069

2016 2 10

2016 2 8

Zoledronic acid Accord

Accord Healthcare Limited

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

ES/1/13/834

2016 2 10

2016 2 11

Sevelamer carbonate Zentiva

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

ES/1/14/952

2016 2 15

2016 2 11

Simbrinza

Alcon Laboratories (UK) Ltd

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

ES/1/14/933

2016 2 15

2016 2 11

Sutent

Pfizer Limited

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

ES/1/06/347

2016 2 15

2016 2 11

Truvada

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

ES/1/04/305

2016 2 15

2016 2 11

Vitekta

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

ES/1/13/883

2016 2 15

2016 2 11

Xigduo

AstraZeneca AB

SE-151 85 Södertälje, Sverige

ES/1/13/900

2016 2 15

2016 2 11

Zoledronic acid Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/12/771

2016 2 15

2016 2 11

Zostavax

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

ES/1/06/341

2016 2 15

2016 2 11

Zydelig

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

ES/1/14/938

2016 2 15

2016 2 15

Latuda

Sunovion Pharmaceuticals Europe Ltd

First Floor, Southside, 97–105 Victoria Street, London SW1E 6QT, United Kingdom

ES/1/14/913

2016 2 17

2016 2 15

Rivastigmine Actavis

Actavis Group PTC ehf.

Reykjavíkurvegur 76–78, 220 Hafnarfjörður, Ísland

ES/1/11/693

2016 2 17

2016 2 18

Aldara

MEDA AB

Pipers väg 2A, SE-170 73 Solna, Sverige

ES/1/98/080

2016 2 22

2016 2 18

Benlysta

Glaxo Group Ltd

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

ES/1/11/700

2016 2 22

2016 2 18

Biopoin

Teva GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

ES/1/09/565

2016 2 22

2016 2 18

Brilique

AstraZeneca AB

SE-151 85 Södertälje, Sverige

ES/1/10/655

2016 2 22

2016 2 18

BYDUREON

AstraZeneca AB

SE-151 85 Södertälje, Sverige

ES/1/11/696

2016 2 22

2016 2 18

Hizentra

CSL Behring GmbH

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

ES/1/11/687

2016 2 22

2016 2 18

Lamivudine Teva Pharma B.V.

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/09/596

2016 2 22

2016 2 18

Lojuxta

Aegerion Pharmaceuticals Limited

Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom

ES/1/13/851

2016 2 22

2016 2 18

Metiltioninio chloridas Proveblue

Provepharm S.A.S.

22 Rue Marc Donadille, 13013 Marseille, France

ES/1/11/682

2016 2 22

2016 2 18

Mycophenolate mofetil Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/07/439

2016 2 22

2016 2 18

Myfenax

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/07/438

2016 2 22

2016 2 18

NULOJIX

Bristol-Myers Squibb Pharma EEIG

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

ES/1/11/694

2016 2 22

2016 2 18

TOBI Podhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/10/652

2016 2 22

2016 2 18

Trajenta

Boehringer Ingelheim International GmbH

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

ES/1/11/707

2016 2 22

2016 2 18

Victrelis

Merck Sharp & Dohme Limited

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

ES/1/11/704

2016 2 22

2016 2 22

Azilect

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/04/304

2016 2 24

2016 2 22

Constella

Allergan Pharmaceuticals International Ltd.

Clonshaugh Business & Technology Park Coolock Dublin D17 E400, Ireland

ES/1/12/801

2016 2 24

2016 2 22

Eporatio

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

ES/1/09/573

2016 2 24

2016 2 22

Fasturtec

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

ES/1/00/170

2016 2 24

2016 2 22

Herceptin

Roche Registration Limited

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

ES/1/00/145

2016 2 24

2016 2 22

Ketoconazole HRA

Laboratoire HRA Pharma

15 rue Béranger, F-75003 Paris, France

ES/1/14/965

2016 2 24

2016 2 22

Scintimun

CIS bio international

Boîte postale 32, F-91192 Gif-sur-Yvette, France

ES/1/09/602

2016 2 24

2016 2 22

Tygacil

Pfizer Limited

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

ES/1/06/336

2016 2 24

2016 2 22

Vizarsin

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

ES/1/09/551

2016 2 24

2016 2 22

Zoledronic acid Mylan

Mylan S.A.S

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

ES/1/12/786

2016 2 24

2016 2 24

Afinitor

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/09/538

2016 2 26

2016 2 24

Brintellix

H. Lundbeck A/S

Ottiliavej 9, DK-2500 Valby, Danmark

ES/1/13/891

2016 2 26

2016 2 24

Firdapse

BioMarin Europe Ltd.

10 Bloomsbury Way, London WC1A 2SL, United Kingdom

ES/1/09/601

2016 2 26

2016 2 24

Odomzo

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/15/1030

2016 2 26

2016 2 24

Peyona

Chiesi Farmaceutici S.P.A.

Via Palermo 26/A, 43122 Parma, Italia

ES/1/09/528

2016 2 26

2016 2 24

Ravicti

Horizon Pharma Ireland Limited

Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland

ES/1/15/1062

2016 3 3

2016 2 24

Silodyx

Recordati Ireland Ltd

Raheens East, Ringaskiddy Co. Cork, Ireland

ES/1/09/607

2016 2 26

2016 2 24

Stribild

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

ES/1/13/830

2016 2 26

2016 2 24

Vylaer Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

ES/1/14/949

2016 2 26

2016 2 24

Xultophy

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

ES/1/14/947

2016 2 26

2016 2 25

Cerdelga

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

ES/1/14/974

2016 3 1

2016 2 26

Bridion

Merck Sharp & Dohme Limited

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

ES/1/08/466

2016 3 1

2016 2 26

Clopidogrel/Acetylsalicylic acid Zentiva (ex DuoCover)

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

ES/1/10/623

2016 3 1

2016 2 26

Jentadueto

Boehringer Ingelheim International GmbH

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

ES/1/12/780

2016 3 1

2016 2 26

PREZISTA

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

ES/1/06/380

2016 3 1

2016 2 26

Urorec

Recordati Ireland Ltd

Raheens East, Ringaskiddy Co. Cork, Ireland

ES/1/09/608

2016 3 1

2016 2 26

Vibativ

Clinigen Healthcare Limited

Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom

ES/1/11/705

2016 3 2

2016 2 26

Viread

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

ES/1/01/200

2016 3 1

—   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 |
| --- | --- | --- | --- | --- |
| 2016 2 24 | Kepivance | Swedish Orphan Biovitrum AB (publ)
  SE-112 76 Stockholm, Sverige | ES/1/05/314 | 2016 2 29 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2016 2 24

Kepivance

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm, Sverige

ES/1/05/314

2016 2 29

—   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 |
| --- | --- | --- | --- | --- |
| 2016 2 10 | Zactran | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | ES/2/08/082 | 2016 2 12 |
| 2016 2 25 | Activyl Tick Plus | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | ES/2/11/137 | 2016 2 29 |
| 2016 2 25 | Vectra 3D | CEVA SANTE ANIMALE
  10 avenue de la Ballastière, F-33500 Libourne, France | ES/2/13/156 | 2016 2 29 |
| 2016 2 25 | Vectra Felis | CEVA SANTE ANIMALE
  10 avenue de la Ballastière, F-33500 Libourne, France | ES/2/14/165 | 2016 2 29 |
| 2016 2 26 | Econor | Elanco Europe Ltd.
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | ES/2/98/010 | 2016 3 1 |
| 2016 2 26 | Trifexis | Eli Lilly and Company Ltd, Elanco Animal Health
  Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | ES/2/13/155 | 2016 3 1 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2016 2 10

Zactran

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

ES/2/08/082

2016 2 12

2016 2 25

Activyl Tick Plus

Intervet International B.V.

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

ES/2/11/137

2016 2 29

2016 2 25

Vectra 3D

CEVA SANTE ANIMALE

10 avenue de la Ballastière, F-33500 Libourne, France

ES/2/13/156

2016 2 29

2016 2 25

Vectra Felis

CEVA SANTE ANIMALE

10 avenue de la Ballastière, F-33500 Libourne, France

ES/2/14/165

2016 2 29

2016 2 26

Econor

Elanco Europe Ltd.

Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

ES/2/98/010

2016 3 1

2016 2 26

Trifexis

Eli Lilly and Company Ltd, Elanco Animal Health

Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

ES/2/13/155

2016 3 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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