# Europos Sąjungos C 229/2016

| | ISSN 1977-0960 |
| --- | --- |
| Europos Sąjungos
  oficialusis leidinys | C 229 |
| | |
| Leidimas lietuvių kalba | Informacija ir pranešimai | 59 tomas2016m. birželio 24d. |

ISSN 1977-0960

Europos Sąjungos

oficialusis leidinys

C 229

Leidimas lietuvių kalba

Informacija ir pranešimai

59 tomas2016m. birželio 24d.

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| Pranešimo Nr. | Turinys | Puslapis |
| --- | --- | --- |
| | IV   Pranešimai |
| | EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
| | Europos Komisija |
| 2016/C 229/01 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2016 m. gegužės 1 d. iki 2016 m. gegužės 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

2016/C 229/01

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2016 m. gegužės 1 d. iki 2016 m. gegužės 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 | |
| --- | --- |

LT

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IV Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

| 24.6.2016 | LT | Europos Sąjungos oficialusis leidinys | C 229/1 |
| --- | --- | --- | --- |

24.6.2016

LT

Europos Sąjungos oficialusis leidinys

C 229/1

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Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2016 m. gegužės 1 d. iki 2016 m. gegužės 31 d.

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

(2016/C 229/01)

—   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 5 11 | Empliciti | elotuzumabas | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/16/1088 | Milteliai koncentratui infuziniam tirpalui | L01XC23 | 2016 5 13 |
| 2016 5 11 | IDELVION | albutrepenonakogas alfa | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/16/1095 | Milteliai ir tirpiklis injekciniam tirpalui | B02BD04 | 2016 5 13 |
| 2016 5 12 | ALPROLIX | eftrenonakogo alfa (eftrenonacogum alfa) | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/16/1098 | Milteliai ir tirpiklis injekciniam tirpalui | B02BD04 | 2016 5 13 |
| 2016 5 12 | Uptravi | seleksipagas | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/15/1083 | Plėvele dengta tabletė | B01AC27 | 2016 5 19 |
| 2016 5 20 | Darzalex | Daratumumabas | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/16/1101 | Koncentratas infuziniam tirpalui | L01XC24 | 2016 5 24 |
| 2016 5 20 | Pandeminė vakcina nuo gripo H5N1 MedImmune | Pandeminė vakcina nuo gripo (H5N1) (gyvoji susilpninta, į nosį) | MedImmune, LLC
  Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland | EU/1/16/1089 | Nosies purškalas, suspensija | J07BB03 | 2016 5 24 |
| 2016 5 26 | Galafold | Migalastatas | Amicus Therapeutics UK Ltd
  Phoenix House, Oxford Road, Tatling End, Gerrards Cross, Buckinghamshire SL9 7AP, United Kingdom | EU/1/15/1082 | Kieta kapsulė | Pending | 2016 5 31 |
| 2016 5 26 | Neparvis | sakubitrilas/valsartanas | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/16/1103 | Plėvele dengta tabletė | C09DX04 | 2016 5 30 |
| 2016 5 26 | Palonosetron Accord | palonosetronas | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/16/1104 | Injekcinis tirpalas | A04AA05 | 2016 5 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

2016 5 11

Empliciti

elotuzumabas

Bristol-Myers Squibb Pharma EEIG

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

EU/1/16/1088

Milteliai koncentratui infuziniam tirpalui

L01XC23

2016 5 13

2016 5 11

IDELVION

albutrepenonakogas alfa

CSL Behring GmbH

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

EU/1/16/1095

Milteliai ir tirpiklis injekciniam tirpalui

B02BD04

2016 5 13

2016 5 12

ALPROLIX

eftrenonakogo alfa (eftrenonacogum alfa)

Biogen Idec Limited

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

EU/1/16/1098

Milteliai ir tirpiklis injekciniam tirpalui

B02BD04

2016 5 13

2016 5 12

Uptravi

seleksipagas

Actelion Registration Ltd

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

EU/1/15/1083

Plėvele dengta tabletė

B01AC27

2016 5 19

2016 5 20

Darzalex

Daratumumabas

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/16/1101

Koncentratas infuziniam tirpalui

L01XC24

2016 5 24

2016 5 20

Pandeminė vakcina nuo gripo H5N1 MedImmune

Pandeminė vakcina nuo gripo (H5N1) (gyvoji susilpninta, į nosį)

MedImmune, LLC

Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland

EU/1/16/1089

Nosies purškalas, suspensija

J07BB03

2016 5 24

2016 5 26

Galafold

Migalastatas

Amicus Therapeutics UK Ltd

Phoenix House, Oxford Road, Tatling End, Gerrards Cross, Buckinghamshire SL9 7AP, United Kingdom

EU/1/15/1082

Kieta kapsulė

Pending

2016 5 31

2016 5 26

Neparvis

sakubitrilas/valsartanas

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/16/1103

Plėvele dengta tabletė

C09DX04

2016 5 30

2016 5 26

Palonosetron Accord

palonosetronas

Accord Healthcare Limited

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

EU/1/16/1104

Injekcinis tirpalas

A04AA05

2016 5 31

—   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 5 2 | Bortezomib Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1019 | 2016 5 4 |
| 2016 5 2 | Combivir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/98/058 | 2016 5 4 |
| 2016 5 2 | Ebilfumin | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland | EU/1/14/915 | 2016 5 4 |
| 2016 5 2 | ellaOne | Laboratoire HRA Pharma
  15 rue Béranger, F-75003 Paris, France | EU/1/09/522 | 2016 5 4 |
| 2016 5 2 | HALAVEN | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | EU/1/11/678 | 2016 5 4 |
| 2016 5 2 | Harvoni | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/958 | 2016 5 4 |
| 2016 5 2 | Ixiaro | Valneva Austria GmbH
  Campus Vienna Biocenter 3, A-1030 Wien, Österreich | EU/1/08/501 | 2016 5 4 |
| 2016 5 2 | Lyxumia | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/12/811 | 2016 5 4 |
| 2016 5 2 | Norvir | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/96/016 | 2016 5 4 |
| 2016 5 2 | Quadramet | CIS bio international
  Boite Postale 32, F-91192 Gif-sur-Yvette, France | EU/1/97/057 | 2016 5 4 |
| 2016 5 2 | Synflorix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/09/508 | 2016 5 4 |
| 2016 5 2 | Tafinlar | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/865 | 2016 5 4 |
| 2016 5 11 | Desloratadine Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland | EU/1/11/745 | 2016 5 13 |
| 2016 5 11 | Humalog | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/96/007 | 2016 5 13 |
| 2016 5 11 | Humira | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/03/256 | 2016 5 13 |
| 2016 5 11 | Imatinib Medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/13/876 | 2016 5 13 |
| 2016 5 11 | Inlyta | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/777 | 2016 5 13 |
| 2016 5 11 | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 2016 5 13 |
| 2016 5 11 | Plenadren | ViroPharma SPRL-BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/715 | 2016 5 13 |
| 2016 5 11 | Zerit | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/96/009 | 2016 5 13 |
| 2016 5 12 | Brimica Genuair | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/14/963 | 2016 5 16 |
| 2016 5 12 | Clopidogrel Mylan | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/09/559 | 2016 5 17 |
| 2016 5 12 | Desloratadine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/732 | 2016 5 17 |
| 2016 5 12 | Docetaxel Winthrop | Aventis Pharma S.A.
  20 avenue Raymond Aron, F-92165 Antony CEDEX, France | EU/1/07/384 | 2016 5 17 |
| 2016 5 12 | Enurev Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/789 | 2016 5 16 |
| 2016 5 12 | Glybera | uniQure biopharma B.V.
  Meibergdreef 61, NL-1105 BA Amsterdam, Nederland | EU/1/12/791 | 2016 5 17 |
| 2016 5 12 | Integrilin | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/99/109 | 2016 5 16 |
| 2016 5 12 | NovoEight | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/13/888 | 2016 5 17 |
| 2016 5 12 | Seebri Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/788 | 2016 5 16 |
| 2016 5 12 | Tepadina | ADIENNE S.r.l.
  Via Galileo Galilei 19, 20867 Caponago (MB), Italia | EU/1/10/622 | 2016 5 16 |
| 2016 5 12 | Tovanor Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/790 | 2016 5 16 |
| 2016 5 13 | Hexacima | Sanofi Pasteur SA
  2 avenue Pont Pasteur, F-69007 Lyon, France | EU/1/13/828 | 2016 5 24 |
| 2016 5 17 | Capecitabine SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | EU/1/13/831 | 2016 5 19 |
| 2016 5 17 | Champix | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/360 | 2016 5 19 |
| 2016 5 17 | Epivir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/96/015 | 2016 5 19 |
| 2016 5 17 | Imatinib Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/808 | 2016 5 19 |
| 2016 5 17 | Wilzin | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | EU/1/04/286 | 2016 5 19 |
| 2016 5 20 | Ceprotin | Baxter AG
  Industriestrasse 67, A-1221 Wien, Österreich | EU/1/01/190 | 2016 5 24 |
| 2016 5 20 | Clopidogrel Krka d.d. | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/562 | 2016 5 24 |
| 2016 5 20 | Gazyvaro | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/14/937 | 2016 5 24 |
| 2016 5 20 | Hexyon | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/13/829 | 2016 5 24 |
| 2016 5 26 | Actos | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/00/150 | 2016 5 30 |
| 2016 5 26 | Afinitor | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/538 | 2016 5 30 |
| 2016 5 26 | Buccolam | Shire Services BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/709 | 2016 5 30 |
| 2016 5 26 | Capecitabine medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/12/802 | 2016 5 30 |
| 2016 5 26 | Cayston | Gilead Sciences International Limited
  Granta Park, Abington, Cambridge CB21 6GT, United Kingdom | EU/1/09/543 | 2016 5 31 |
| 2016 5 26 | Cinryze | Shire Services BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/688 | 2016 5 30 |
| 2016 5 26 | Clopidogrel/Acetylsalicylic acid Teva | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/942 | 2016 5 30 |
| 2016 5 26 | Clopidogrel HCS | HCS bvba
  H. Kennisstraat 53, B-2650 Edegem, België | EU/1/10/651 | 2016 5 30 |
| 2016 5 26 | Clopidogrel Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/540 | 2016 5 30 |
| 2016 5 26 | Competact | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/06/354 | 2016 5 30 |
| 2016 5 26 | Conbriza | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/09/511 | 2016 5 31 |
| 2016 5 26 | Constella | Allergan Pharmaceuticals International Ltd.
  Clonshaugh Business and Technology Park Coolock Dublin D17 E400, Ireland | EU/1/12/801 | 2016 5 30 |
| 2016 5 26 | DepoCyte | Pacira Limited
  Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom | EU/1/01/187 | 2016 5 28 |
| 2016 5 26 | Dexdor | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/11/718 | 2016 5 30 |
| 2016 5 26 | Duaklir Genuair | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/14/964 | 2016 5 30 |
| 2016 5 26 | Ferriprox | Apotex Europe B.V.
  Darwinweg 20, NL- 2333 CR Leiden, Nederland | EU/1/99/108 | 2016 5 30 |
| 2016 5 26 | Firazyr | Shire Orphan Therapies GmbH
  Friedrichstraße 149, D-10117 Berlin, Deutschland | EU/1/08/461 | 2016 5 30 |
| 2016 5 26 | Glubrava | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/07/421 | 2016 5 30 |
| 2016 5 26 | Glustin | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/00/151 | 2016 5 30 |
| 2016 5 26 | HyQvia | Baxalta Innovations GmbH
  Industriestrasse 67, A-1221 Wien, Österreich | EU/1/13/840 | 2016 5 30 |
| 2016 5 26 | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/945 | 2016 5 30 |
| 2016 5 26 | Imnovid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/13/850 | 2016 5 31 |
| 2016 5 26 | Levodopa/Carbidopa/Entacapone Orion | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/11/706 | 2016 5 30 |
| 2016 5 26 | Liprolog | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/01/195 | 2016 5 30 |
| 2016 5 26 | Mabthera | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/98/067 | 2016 5 31 |
| 2016 5 26 | Neulasta | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/02/227 | 2016 5 30 |
| 2016 5 26 | Nexium Control | Pfizer Consumer Healthcare Limited
  Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/13/860 | 2016 5 31 |
| 2016 5 26 | Rixubis | Baxalta Innovations GmbH
  Industriestrasse 67, A-1221 Wien, Österreich | EU/1/14/970 | 2016 5 30 |
| 2016 5 26 | Strimvelis | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/16/1097 | 2016 5 30 |
| 2016 5 26 | Tandemact | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/06/366 | 2016 5 30 |
| 2016 5 26 | Taxotere | Aventis Pharma S.A.
  20 avenue Raymond Aron, F-92165 Antony CEDEX, France | EU/1/95/002 | 2016 5 30 |
| 2016 5 26 | Trevicta | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/971 | 2016 5 30 |
| 2016 5 26 | Vibativ | Clinigen Healthcare Limited
  Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom | EU/1/11/705 | 2016 5 28 |
| 2016 5 26 | Victoza | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/09/529 | 2016 5 30 |
| 2016 5 26 | XALKORI | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/793 | 2016 5 31 |
| 2016 5 26 | Ytracis | CIS bio international
  Boite Postale 32, F-91192 Gif-sur-Yvette, France | EU/1/03/250 | 2016 5 30 |
| 2016 5 26 | Zytiga | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/11/714 | 2016 5 30 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2016 5 2

Bortezomib Accord

Accord Healthcare Limited

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

EU/1/15/1019

2016 5 4

2016 5 2

Combivir

ViiV Healthcare UK Limited

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

EU/1/98/058

2016 5 4

2016 5 2

Ebilfumin

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland

EU/1/14/915

2016 5 4

2016 5 2

ellaOne

Laboratoire HRA Pharma

15 rue Béranger, F-75003 Paris, France

EU/1/09/522

2016 5 4

2016 5 2

HALAVEN

Eisai Europe Limited

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

EU/1/11/678

2016 5 4

2016 5 2

Harvoni

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/958

2016 5 4

2016 5 2

Ixiaro

Valneva Austria GmbH

Campus Vienna Biocenter 3, A-1030 Wien, Österreich

EU/1/08/501

2016 5 4

2016 5 2

Lyxumia

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/12/811

2016 5 4

2016 5 2

Norvir

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/96/016

2016 5 4

2016 5 2

Quadramet

CIS bio international

Boite Postale 32, F-91192 Gif-sur-Yvette, France

EU/1/97/057

2016 5 4

2016 5 2

Synflorix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/09/508

2016 5 4

2016 5 2

Tafinlar

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/865

2016 5 4

2016 5 11

Desloratadine Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland

EU/1/11/745

2016 5 13

2016 5 11

Humalog

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/96/007

2016 5 13

2016 5 11

Humira

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/03/256

2016 5 13

2016 5 11

Imatinib Medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/13/876

2016 5 13

2016 5 11

Inlyta

Pfizer Limited

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

EU/1/12/777

2016 5 13

2016 5 11

Opdivo

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

2016 5 13

2016 5 11

Plenadren

ViroPharma SPRL-BVBA

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

EU/1/11/715

2016 5 13

2016 5 11

Zerit

Bristol-Myers Squibb Pharma EEIG

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

EU/1/96/009

2016 5 13

2016 5 12

Brimica Genuair

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/14/963

2016 5 16

2016 5 12

Clopidogrel Mylan

Mylan S.A.S

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

EU/1/09/559

2016 5 17

2016 5 12

Desloratadine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/732

2016 5 17

2016 5 12

Docetaxel Winthrop

Aventis Pharma S.A.

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

EU/1/07/384

2016 5 17

2016 5 12

Enurev Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/789

2016 5 16

2016 5 12

Glybera

uniQure biopharma B.V.

Meibergdreef 61, NL-1105 BA Amsterdam, Nederland

EU/1/12/791

2016 5 17

2016 5 12

Integrilin

Glaxo Group Ltd

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

EU/1/99/109

2016 5 16

2016 5 12

NovoEight

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/13/888

2016 5 17

2016 5 12

Seebri Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/788

2016 5 16

2016 5 12

Tepadina

ADIENNE S.r.l.

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

EU/1/10/622

2016 5 16

2016 5 12

Tovanor Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/790

2016 5 16

2016 5 13

Hexacima

Sanofi Pasteur SA

2 avenue Pont Pasteur, F-69007 Lyon, France

EU/1/13/828

2016 5 24

2016 5 17

Capecitabine SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland

EU/1/13/831

2016 5 19

2016 5 17

Champix

Pfizer Limited

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

EU/1/06/360

2016 5 19

2016 5 17

Epivir

ViiV Healthcare UK Limited

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

EU/1/96/015

2016 5 19

2016 5 17

Imatinib Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/808

2016 5 19

2016 5 17

Wilzin

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France

EU/1/04/286

2016 5 19

2016 5 20

Ceprotin

Baxter AG

Industriestrasse 67, A-1221 Wien, Österreich

EU/1/01/190

2016 5 24

2016 5 20

Clopidogrel Krka d.d.

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/562

2016 5 24

2016 5 20

Gazyvaro

Roche Registration Limited

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

EU/1/14/937

2016 5 24

2016 5 20

Hexyon

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/13/829

2016 5 24

2016 5 26

Actos

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/00/150

2016 5 30

2016 5 26

Afinitor

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/538

2016 5 30

2016 5 26

Buccolam

Shire Services BVBA

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

EU/1/11/709

2016 5 30

2016 5 26

Capecitabine medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/12/802

2016 5 30

2016 5 26

Cayston

Gilead Sciences International Limited

Granta Park, Abington, Cambridge CB21 6GT, United Kingdom

EU/1/09/543

2016 5 31

2016 5 26

Cinryze

Shire Services BVBA

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

EU/1/11/688

2016 5 30

2016 5 26

Clopidogrel/Acetylsalicylic acid Teva

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/942

2016 5 30

2016 5 26

Clopidogrel HCS

HCS bvba

H. Kennisstraat 53, B-2650 Edegem, België

EU/1/10/651

2016 5 30

2016 5 26

Clopidogrel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/540

2016 5 30

2016 5 26

Competact

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/06/354

2016 5 30

2016 5 26

Conbriza

Pfizer Limited

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

EU/1/09/511

2016 5 31

2016 5 26

Constella

Allergan Pharmaceuticals International Ltd.

Clonshaugh Business and Technology Park Coolock Dublin D17 E400, Ireland

EU/1/12/801

2016 5 30

2016 5 26

DepoCyte

Pacira Limited

Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom

EU/1/01/187

2016 5 28

2016 5 26

Dexdor

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/11/718

2016 5 30

2016 5 26

Duaklir Genuair

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/14/964

2016 5 30

2016 5 26

Ferriprox

Apotex Europe B.V.

Darwinweg 20, NL- 2333 CR Leiden, Nederland

EU/1/99/108

2016 5 30

2016 5 26

Firazyr

Shire Orphan Therapies GmbH

Friedrichstraße 149, D-10117 Berlin, Deutschland

EU/1/08/461

2016 5 30

2016 5 26

Glubrava

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/07/421

2016 5 30

2016 5 26

Glustin

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/00/151

2016 5 30

2016 5 26

HyQvia

Baxalta Innovations GmbH

Industriestrasse 67, A-1221 Wien, Österreich

EU/1/13/840

2016 5 30

2016 5 26

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/945

2016 5 30

2016 5 26

Imnovid

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/13/850

2016 5 31

2016 5 26

Levodopa/Carbidopa/Entacapone Orion

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/11/706

2016 5 30

2016 5 26

Liprolog

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/01/195

2016 5 30

2016 5 26

Mabthera

Roche Registration Limited

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

EU/1/98/067

2016 5 31

2016 5 26

Neulasta

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/02/227

2016 5 30

2016 5 26

Nexium Control

Pfizer Consumer Healthcare Limited

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

EU/1/13/860

2016 5 31

2016 5 26

Rixubis

Baxalta Innovations GmbH

Industriestrasse 67, A-1221 Wien, Österreich

EU/1/14/970

2016 5 30

2016 5 26

Strimvelis

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/16/1097

2016 5 30

2016 5 26

Tandemact

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/06/366

2016 5 30

2016 5 26

Taxotere

Aventis Pharma S.A.

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

EU/1/95/002

2016 5 30

2016 5 26

Trevicta

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/971

2016 5 30

2016 5 26

Vibativ

Clinigen Healthcare Limited

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

EU/1/11/705

2016 5 28

2016 5 26

Victoza

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/09/529

2016 5 30

2016 5 26

XALKORI

Pfizer Limited

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

EU/1/12/793

2016 5 31

2016 5 26

Ytracis

CIS bio international

Boite Postale 32, F-91192 Gif-sur-Yvette, France

EU/1/03/250

2016 5 30

2016 5 26

Zytiga

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/714

2016 5 30

—   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 5 3 | Suvaxyn PCV | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/099 | 2016 5 20 |
| 2016 5 17 | Apoquel | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/13/154 | 2016 5 19 |
| 2016 5 17 | Bravecto | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/13/158 | 2016 5 19 |
| 2016 5 17 | MS-H Vaccine | Pharmsure International Ltd
  Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom | EU/2/11/126 | 2016 5 19 |
| 2016 5 17 | Proteq West Nile | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/11/129 | 2016 5 19 |
| 2016 5 26 | Aivlosin | ECO Animal Health Ltd
  78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom | EU/2/04/044 | 2016 5 31 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2016 5 3

Suvaxyn PCV

Zoetis Belgium S.A.

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

EU/2/09/099

2016 5 20

2016 5 17

Apoquel

Zoetis Belgium S.A.

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

EU/2/13/154

2016 5 19

2016 5 17

Bravecto

Intervet International B.V.

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

EU/2/13/158

2016 5 19

2016 5 17

MS-H Vaccine

Pharmsure International Ltd

Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom

EU/2/11/126

2016 5 19

2016 5 17

Proteq West Nile

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/11/129

2016 5 19

2016 5 26

Aivlosin

ECO Animal Health Ltd

78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom

EU/2/04/044

2016 5 31

—   Rinkodaros leidimo atšaukimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis)

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2016 5 26 | RevitaCAM | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/12/138 | 2016 5 30 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2016 5 26

RevitaCAM

Zoetis Belgium S.A.

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

EU/2/12/138

2016 5 30

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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