# Europos Sąjungos C 66/2020

| | ISSN 1977-0960 |
| --- | --- |
| Europos Sąjungos
  oficialusis leidinys | C 66 |
| | |
| Leidimas lietuvių kalba | Informacija ir pranešimai | 63 metai2020m. vasario 28d. |

ISSN 1977-0960

Europos Sąjungos

oficialusis leidinys

C 66

Leidimas lietuvių kalba

Informacija ir pranešimai

63 metai2020m. vasario 28d.

---

| Turinys | Puslapis |
| --- | --- |
| | IV   Pranešimai |
| | EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
| | Europos Komisija |
| 2020/C 66/01 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2020 m. sausio 1 d. iki 2020 m. sausio 31 d. (Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/200413 straipsnį arba 38 straipsnį) | 1 |

Turinys

Puslapis

IV   Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

2020/C 66/01

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2020 m. sausio 1 d. iki 2020 m. sausio 31 d. (Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/200413 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

| 28.2.2020 | LT | Europos Sąjungos oficialusis leidinys | C 66/1 |
| --- | --- | --- | --- |

28.2.2020

LT

Europos Sąjungos oficialusis leidinys

C 66/1

---

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2020 m. sausio 1 d. iki 2020 m. sausio 31 d.

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

(2020/C 66/01)

| — | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.1.2020 | Clopidogrel/Acetylsalicylic acid Mylan | Clopidogrel/Acetylsalicylic acid | Mylan S.A.S. |
| 117 allée des Parcs, 69800 Saint Priest, |
| France |

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

9.1.2020

Clopidogrel/Acetylsalicylic acid Mylan

Clopidogrel/Acetylsalicylic acid

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest,

France

ES/1/19/1395

Plėvele dengta tabletė

B01AC30

2020 1 13

9.1.2020

Deferasirox Accord

deferasiroksum

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, |
| España |

Accord Healthcare S.L.U.

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

España

ES/1/19/1412

Plėvele dengta tabletė

V03AC03

2020 1 13

9.1.2020

Isturisa

osilodrostatas

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, |
| Ireland |

Novartis Europharm Limited

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

Ireland

ES/1/19/1407

Plėvele dengta tabletė

H02CA02

2020 1 13

9.1.2020

TAVLESSE

fostamatinibas

| Rigel Pharmaceuticals B.V. |
| --- |
| Avenue Ceramique 223, 6621 KX Maastricht, |
| Nederland |

Rigel Pharmaceuticals B.V.

Avenue Ceramique 223, 6621 KX Maastricht,

Nederland

ES/1/19/1405

Plėvele dengta tabletė

B02BX09

2020 1 13

13.1.2020

Mayzent

siponimodas

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, |
| Ireland |

Novartis Europharm Limited

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

Ireland

ES/1/19/1414

Plėvele dengta tabletė

L04AA42

2020 1 15

16.1.2020

Polivy

polatuzumabo vedotinas

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, |
| Deutschland |

Roche Registration GmbH

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

Deutschland

ES/1/19/1388

Milteliai koncentratui infuziniam tirpalui

L01XC37

2020 1 20

16.1.2020

Sunosi

solriamfetolas

| Jazz Pharmaceuticals Ireland Ltd |
| --- |
| 5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, |
| Ireland |

Jazz Pharmaceuticals Ireland Ltd

5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7,

Ireland

ES/1/19/1408

Plėvele dengta tabletė

N06BA14

2020 1 20

| — | 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 |
| --- | --- | --- | --- | --- |
| 2020 1 9 | Akynzeo | Helsinn Birex Pharmaceuticals Ltd |
| Damastown, Mulhuddart, Dublin 15, |
| Ireland |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2020 1 9

Akynzeo

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15,

Ireland

ES/1/15/1001

2020 1 13

2020 1 9

Clopidogrel ratiopharm GmbH

| Archie Samuel s.r.o. |
| --- |
| Slunná 16, 61700 Brno, |
| Česká republika |

Archie Samuel s.r.o.

Slunná 16, 61700 Brno,

Česká republika

ES/1/09/541

2020 1 13

2020 1 9

Cymbalta

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, |
| Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht,

Nederland

ES/1/04/296

2020 1 13

2020 1 9

Elebrato Ellipta

| GlaxoSmithKline Trading Services Limited |
| --- |
| Riverwalk 12, Citywest Business Campus, Dublin 24, |
| Ireland |

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24,

Ireland

ES/1/17/1237

2020 1 13

2020 1 9

Kigabeq

| ORPHELIA Pharma SAS |
| --- |
| 85 boulevard Saint-Michel, 75005 Paris, |
| France |

ORPHELIA Pharma SAS

85 boulevard Saint-Michel, 75005 Paris,

France

ES/1/18/1302

2020 1 13

2020 1 9

Sirturo

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, |
| België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse,

België

ES/1/13/901

2020 1 13

2020 1 9

Sivextro

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem,

Nederland

ES/1/15/991

2020 1 13

2020 1 9

Taxotere

| Sanofi Mature IP |
| --- |
| 54 Rue de la Boetie, 75008, Paris, |
| FRANCE |

Sanofi Mature IP

54 Rue de la Boetie, 75008, Paris,

FRANCE

ES/1/95/002

2020 1 13

2020 1 9

Tecfidera

| Biogen Netherlands B.V. |
| --- |
| Prins Mauritslaan 13, 1171 LP Badhoevedorp, |
| Nederland |

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp,

Nederland

ES/1/13/837

2020 1 13

2020 1 13

Abasaglar

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, |
| Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht,

Nederland

ES/1/14/944

2020 1 15

2020 1 13

Caprelsa

| Genzyme Europe B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, |
| Nederland |

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam,

Nederland

ES/1/11/749

2020 1 15

2020 1 13

Darunavir Krka d.d.

| Krka d. d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, |
| Slovenija |

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto,

Slovenija

ES/1/17/1248

2020 1 15

2020 1 13

Dexdor

| Orion Corporation |
| --- |
| Orionintie 1, 02200 Espoo, |
| Suomi |

Orion Corporation

Orionintie 1, 02200 Espoo,

Suomi

ES/1/11/718

2020 1 15

2020 1 13

Hizentra

| CSL Behring GmbH |
| --- |
| Emil-von-Behring-Straße 76, 35041 Marburg, |
| Deutschland |

CSL Behring GmbH

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

Deutschland

ES/1/11/687

2020 1 15

2020 1 13

Infanrix hexa

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l’Institut 89, 1330 Rixensart, |
| Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart,

Belgique

ES/1/00/152

2020 1 15

2020 1 13

Invokana

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, |
| België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse,

België

ES/1/13/884

2020 1 15

2020 1 13

Orbactiv

| Menarini International Operations Luxembourg S.A. |
| --- |
| 1 avenue de la Gare, 1611 Luxembourg, |
| Grand-Duché de Luxembourg |

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg,

Grand-Duché de Luxembourg

ES/1/15/989

2020 1 15

2020 1 13

Tenofovir disoproxil Mylan

| Mylan S.A.S. |
| --- |
| 117 allée des Parcs, 69800 Saint Priest, |
| France |

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest,

France

ES/1/16/1129

2020 1 15

2020 1 13

Tenofovir disoproxil Zentiva

| Zentiva, k.s. |
| --- |
| U Kabelovny 130, 102 37 Praha 10, |
| Česká republika |

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10,

Česká republika

ES/1/16/1127

2020 1 15

2020 1 13

Vaxelis

| MCM Vaccine B.V. |
| --- |
| Robert Boyleweg 4, 2333 CG Leiden, |
| Nederland |

MCM Vaccine B.V.

Robert Boyleweg 4, 2333 CG Leiden,

Nederland

ES/1/15/1079

2020 1 16

2020 1 13

Yescarta

| Kite Pharma ES B.V. |
| --- |
| Science Park 408, 1098 XH Amsterdam, |
| Nederland |

Kite Pharma ES B.V.

Science Park 408, 1098 XH Amsterdam,

Nederland

ES/1/18/1299

2020 1 15

2020 1 13

Zepatier

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem,

Nederland

ES/1/16/1119

2020 1 15

2020 1 16

Gardasil 9

| MSD VACCINS |
| --- |
| 162 avenue Jean Jaurès, 69007 Lyon, |
| France |

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon,

France

ES/1/15/1007

2020 1 20

2020 1 16

Humalog

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, |
| Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht,

Nederland

ES/1/96/007

2020 1 20

2020 1 16

Lantus

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, |
| Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

ES/1/00/134

2020 1 20

2020 1 16

Lemtrada

| Sanofi Belgium |
| --- |
| Leonardo Da Vincilaan 19, B-1831 Diegem, |
| België |

Sanofi Belgium

Leonardo Da Vincilaan 19, B-1831 Diegem,

België

ES/1/13/869

2020 1 20

2020 1 16

Liprolog

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, |
| Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht,

Nederland

ES/1/01/195

2020 1 20

2020 1 16

Mysimba

| Orexigen Therapeutics Ireland Limited |
| --- |
| 2nd Floor, Palmerston House, Fenian Street, Dublin 2, |
| Ireland |

Orexigen Therapeutics Ireland Limited

2nd Floor, Palmerston House, Fenian Street, Dublin 2,

Ireland

ES/1/14/988

2020 1 20

16.1.2020

Prolia

| Amgen Europe B.V. |
| --- |
| Minervum 7061, 4817 ZK Breda, |
| Nederland |

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda,

Nederland

ES/1/10/618

2020 1 20

16.1.2020

Semglee

| Mylan S.A.S. |
| --- |
| 117 allée des Parcs, 69800 Saint Priest, |
| France |

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest,

France

ES/1/18/1270

2020 1 20

16.1.2020

Toujeo

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, |
| Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

ES/1/00/133

2020 1 20

16.1.2020

Viread

| Gilead Sciences Ireland UC |
| --- |
| Carrigtohill, County Cork, T45 DP77, |
| Ireland |

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77,

Ireland

ES/1/01/200

2020 1 20

2020 1 16

Zirabev

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, |
| België |

Pfizer Europe MA EEIG

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

België

ES/1/18/1344

2020 1 20

2020 1 17

Verzenios

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, |
| Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht,

Nederland

ES/1/18/1307

2020 1 21

2020 1 20

Darzalex

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, |
| België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse,

België

ES/1/16/1101

2020 1 22

2020 1 20

Eurartesim

| Alfasigma S.p.A. |
| --- |
| Via Ragazzi del ’99, n.5, 40133 Bologna, |
| Italia |

Alfasigma S.p.A.

Via Ragazzi del ’99, n.5, 40133 Bologna,

Italia

ES/1/11/716

2020 1 22

2020 1 20

Fertavid

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem,

Nederland

ES/1/09/510

2020 1 22

2020 1 20

OPDIVO

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, |
| Ireland |

Bristol-Myers Squibb Pharma EEIG

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

Ireland

ES/1/15/1014

2020 1 22

2020 1 20

Stelara

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, |
| België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse,

België

ES/1/08/494

2020 1 22

2020 1 20

Yervoy

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, |
| Ireland |

Bristol-Myers Squibb Pharma EEIG

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

Ireland

ES/1/11/698

2020 1 22

2020 1 23

Bydureon

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, |
| Sverige |

AstraZeneca AB

151 85 Södertälje,

Sverige

ES/1/11/696

2020 1 27

2020 1 23

Cyramza

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, |
| Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht,

Nederland

ES/1/14/957

2020 1 27

2020 1 23

Hemlibra

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, |
| Deutschland |

Roche Registration GmbH

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

Deutschland

ES/1/18/1271

2020 1 28

2020 1 23

Ketoconazole HRA

| HRA Pharma Rare Diseases |
| --- |
| 200 avenue de Paris, 92320 Chatillon, |
| France |

HRA Pharma Rare Diseases

200 avenue de Paris, 92320 Chatillon,

France

ES/1/14/965

2020 1 27

2020 1 23

Menveo

| GSK Vaccines S.r.l. |
| --- |
| Via Fiorentina 1, 53100 Siena, |
| Italia |

GSK Vaccines S.r.l.

Via Fiorentina 1, 53100 Siena,

Italia

ES/1/10/614

2020 1 27

2020 1 23

Sirturo

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, |
| België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse,

België

ES/1/13/901

2020 1 27

2020 1 23

Xeristar

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, |
| Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht,

Nederland

ES/1/04/297

2020 1 27

2020 1 23

Zynquista

| Navigant Germany GmbH |
| --- |
| Albrechtstrasse 10c, 10117 Berlin, |
| Deutschland |

Navigant Germany GmbH

Albrechtstrasse 10c, 10117 Berlin,

Deutschland

ES/1/19/1363

2020 1 27

2020 1 27

Delstrigo

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem,

Nederland

ES/1/18/1333

2020 1 29

2020 1 27

Erleada

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, |
| België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse,

België

ES/1/18/1342

2020 1 29

2020 1 27

Rubraca

| Clovis Oncology Ireland Limited |
| --- |
| Regus Dublin Airport, Skybridge House - Dublin Airport, Swords, Co. Dublin, K67 P6K2, |
| Ireland |

Clovis Oncology Ireland Limited

Regus Dublin Airport, Skybridge House - Dublin Airport, Swords, Co. Dublin, K67 P6K2,

Ireland

ES/1/17/1250

2020 1 29

2020 1 31

Otezla

| Amgen Europe B.V. |
| --- |
| Minervum 7061, 4817 ZK Breda, |
| Nederland |

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda,

Nederland

ES/1/14/981

2020 2 4

2020 1 31

Panretin

| Eisai GmbH |
| --- |
| Lyoner Straße 36, 60528 Frankfurt am Main, |
| Deutschland |

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main,

Deutschland

ES/1/00/149

2020 2 4

2020 1 31

Xeljanz

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, |
| België |

Pfizer Europe MA EEIG

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

België

ES/1/17/1178

2020 2 4

2020 1 31

Zejula

| GlaxoSmithKline (Ireland) Limited |
| --- |
| 12 Riverwalk, Citywest Business Campus, Dublin 24, |
| Ireland |

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24,

Ireland

ES/1/17/1235

2020 2 4

| — | 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 |
| --- | --- | --- | --- | --- |
| 2020 1 13 | Clopidogrel ratiopharm GmbH | Archie Samuel s.r.o. |
| Slunná 16, 61700 Brno, |
| Česká republika |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2020 1 13

Clopidogrel ratiopharm GmbH

Archie Samuel s.r.o.

Slunná 16, 61700 Brno,

Česká republika

ES/1/09/541

2020 1 15

2020 1 23

Fertavid

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem,

Nederland

ES/1/09/510

2020 1 27

2020 1 23

Varuby

| TESARO Bio Netherlands B.V. |
| --- |
| Joop Geeskinkweg 901, 1114AB Amsterdam-Duisvendrecht, |
| Nederland |

TESARO Bio Netherlands B.V.

Joop Geeskinkweg 901, 1114AB Amsterdam-Duisvendrecht,

Nederland

ES/1/17/1180

2020 1 27

| — | Rinkodaros leidimo sustabdymas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 20 straipsnis) |
| --- | --- |

—

Rinkodaros leidimo sustabdymas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 20 straipsnis)

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 20201 17 | Picato | LEO Laboratories Ltd |
| 285 Cashel Road, Crumlin, Dublin 12, |
| Ireland |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

20201 17

Picato

LEO Laboratories Ltd

285 Cashel Road, Crumlin, Dublin 12,

Ireland

ES/1/12/796

2020 1 21

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

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

| Sprendimo data | Vaisto pavadinimas | INN (Tarptautinis nepatentuotaspavadinimas) | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Farmacinė forma | ATC kodas (Anatominis terapinis cheminis kodas) | Pranešimo data |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2020 1 15 | Stelfonta | tigilanolo tiglatas | QBiotics Netherlands B.V. |
| Prinses Margrietplantsoen 33, 2595 AM Den Haag, |
| Nederland |

Sprendimo data

Vaisto pavadinimas

INN (Tarptautinis nepatentuotaspavadinimas)

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Farmacinė forma

ATC kodas (Anatominis terapinis cheminis kodas)

Pranešimo data

2020 1 15

Stelfonta

tigilanolo tiglatas

QBiotics Netherlands B.V.

Prinses Margrietplantsoen 33, 2595 AM Den Haag,

Nederland

ES/2/19/248

Injekcinis tirpalas

QL01XX91

2020 1 17

2020 1 28

Aservo EquiHaler

ciklezonido

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein,

Deutschland

ES/2/19/249

Įkvepiamasis tirpalas

QR03BA08

2020 1 30

| — | 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 |
| --- | --- | --- | --- | --- |
| 2020 1 15 | BTVPUR | Boehringer Ingelheim Vetmedica GmbH |
| Binger Straße 173, 55216 Ingelheim am Rhein, |
| Deutschland |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2020 1 15

BTVPUR

Boehringer Ingelheim Vetmedica GmbH

Binger Straße 173, 55216 Ingelheim am Rhein,

Deutschland

ES/2/10/113

2020 1 17

2020 1 15

Coliprotec F4

| Prevtec Microbia GmbH |
| --- |
| Geyerspergerstr 27, 80689 München, |
| Deutschland |

Prevtec Microbia GmbH

Geyerspergerstr 27, 80689 München,

Deutschland

ES/2/14/180

2020 1 17

2020 1 15

Nobilis IB 4–91

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, 5831 AN Boxmeer, |
| Nederland |

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer,

Nederland

ES/2/98/006

2020 1 17

2020 1 15

Pirsue

| Zoetis Belgium S.A. |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, |
| Belgique |

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve,

Belgique

ES/2/00/027

2020 1 17

2020 1 15

ProteqFlu

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein,

Deutschland

ES/2/03/037

2020 1 17

2020 1 15

ProteqFlu-Te

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein,

Deutschland

ES/2/03/038

2020 1 17

2020 1 15

Proteq West Nile

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Straße 173, 55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim Vetmedica GmbH

Binger Straße 173, 55216 Ingelheim am Rhein,

Deutschland

ES/2/11/129

2020 1 17

2020 1 15

Purevax Rabies

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Straße 173, 55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim Vetmedica GmbH

Binger Straße 173, 55216 Ingelheim am Rhein,

Deutschland

ES/2/10/117

2020 1 17

2020 1 15

Semintra

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein,

Deutschland

ES/2/12/146

2020 1 17

2020 1 15

Zulvac SBV

| Zoetis Belgium S.A. |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, |
| Belgique |

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve,

Belgique

ES/2/14/178

2020 1 17

2020 1 20

Onsior

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4, 27472 Cuxhaven, |
| Deutschland |

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven,

Deutschland

ES/2/08/089

2020 1 22

2020 1 27

ERAVAC

| Laboratorios Hipra, S.A. |
| --- |
| Avda. La Selva, 135, 17170 Amer (Girona), |
| España |

Laboratorios Hipra, S.A.

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

España

ES/2/16/199

2020 1 29

2020 1 27

Kexxtone

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4, 27472 Cuxhaven, |
| Deutschland |

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven,

Deutschland

ES/2/12/145

2020 1 29

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

| European Medicines Agency |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| NETHERLANDS |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

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

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