ISSN 1977-0960

Europos Sąjungos

oficialusis leidinys

C 527
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Leidimas lietuvių kalba

Informacija ir pranešimai

64 metai
2021m. gruodžio 29d.

Turinys

Puslapis

 

IV   Pranešimai

 

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

 

Europos Komisija

2021/C 527/01

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2021 m. lapkričio 1 d. iki 2021 m. lapkričio 30 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį)

1

LT

 

IV Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

2021 12 29   

LT

Europos Sąjungos oficialusis leidinys

C 527/1

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2021 m. lapkričio 1 d. iki 2021 m. lapkričio 30 d.

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

(2021/C 527/01)

—   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

2021 11 12

Libmyris

adalimumabas (adalimumabum)

STADA Arzneimittel AG

Stadastraße 2–18, 61118 Bad Vilbel, Deutschland

EU/1/21/1590

Injekcinis tirpalas

L04AB04

2021 11 16

2021 11 12

Rivaroxaban Mylan

rivaroksabanas

Mylan Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

EU/1/21/1588

Tabletės

B01AF01

2021 12 3

2021 11 15

Hukyndra

adalimumabas (adalimumabum)

STADA Arzneimittel AG

Stadastraße 2–18, 61118 Bad Vilbel, Deutschland

EU/1/21/1589

Injekcinis tirpalas

L04AB04

2021 11 16

2021 11 15

Sugammadex Mylan

sugamadeksas

Mylan Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

EU/1/21/1583

Injekcinis tirpalas

V03AB35

2021 12 3

2021 11 15

Vumerity

diroksimelio fumaratas

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/21/1585

Skrandyje neirios kapsulės, kietos

L04AX09

2021 11 16

2021 11 18

GAVRETO

pralsetinibum

Roche Registration GmbH

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

EU/1/21/1555

Kieta kapsulė

L01EX23

2021 11 22

2021 11 18

QINLOCK

ripretinibas

Deciphera Pharmaceuticals (Netherlands) B.V.

Atrium Building Floor 4th, Strawinskylaan 3051, Amsterdam, Noord-Holland, 1077 ZX, Nederland

EU/1/21/1569

Tabletės

L01EX19

2021 11 24

2021 11 22

Artesunate Amivas

artesunatas

Amivas Ireland Limited

Durands Court 7, Parnell Street, Waterford, Ireland

EU/1/21/1582

Milteliai ir tirpiklis injekciniam tirpalui

P01BE03

2021 11 24

2021 11 22

Brukinsa

zanubrutinibas

BeiGene Ireland Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Co. Dublin, Ireland

EU/1/21/1576

Kieta kapsulė

L01EL03

2021 11 23

2021 11 22

Trodelvy

sacituzumabas govitekanas

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/21/1592

Milteliai koncentratui infuziniam tirpalui

L01FX17

2021 11 23

—   Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Atmesta

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2021 11 15

Raylumis

Pfizer Europe MA EEIG

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

—

2021 11 17

—   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

2021 11 3

Besponsa

Pfizer Europe MA EEIG

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

EU/1/17/1200

2021 11 4

2021 11 3

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

2021 11 3

2021 11 3

Extavia

Novartis Europharm Limited

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

EU/1/08/454

2021 11 8

2021 11 3

Fulvestrant Mylan

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/17/1253

2021 11 4

2021 11 3

Lamzede

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/17/1258

2021 11 5

2021 11 3

Pregabalinas Mylan

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/15/997

2021 11 4

2021 11 3

Pregabalinas Mylan Pharma

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/998

2021 11 5

2021 11 3

Spikevax

MODERNA BIOTECH SPAIN, S.L.

Calle Monte Esquinza 30, 28010 Madrid, España

EU/1/20/1507

2021 11 4

2021 11 9

Clopidogrel Viatris

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/09/568

2021 11 30

2021 11 9

Enyglid

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/580

2021 12 1

2021 11 9

Luxturna

Novartis Europharm Limited

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

EU/1/18/1331

2021 11 10

2021 11 9

Sutent

Pfizer Europe MA EEIG

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

EU/1/06/347

2021 11 10

2021 11 9

Talmanco

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/16/1153

2021 12 1

2021 11 9

Tegsedi

Akcea Therapeutics Ireland Ltd

Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland

EU/1/18/1296

2021 11 30

2021 11 9

Vaxzevria

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1529

2021 11 10

2021 11 11

Spikevax

MODERNA BIOTECH SPAIN, S.L.

Calle Monte Esquinza 30, 28010 Madrid, España

EU/1/20/1507

2021 11 12

2021 11 12

Akynzeo

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/15/1001

2021 11 19

2021 11 12

Atriance

Novartis Europharm Limited

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

EU/1/07/403

2021 11 15

2021 11 12

Atripla

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/07/430

2021 11 15

2021 11 12

Daptomycin Hospira

Pfizer Europe MA EEIG

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

EU/1/17/1175

2021 11 16

2021 11 12

Dzuveo

Laboratoire Aguettant

1 Rue Alexander Fleming, 69007 Lyon, France

EU/1/18/1284

2021 11 16

2021 11 12

Edistride

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1052

2021 11 15

2021 11 12

Enhertu

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/20/1508

2021 12 2

2021 11 12

Evoltra

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/06/334

2021 11 16

2021 11 12

Iasibon

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/10/659

2021 11 16

2021 11 12

Jyseleca

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/20/1480

2021 11 15

2021 11 12

Lacosamide Accord

Accord Healthcare S.L.U.

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

EU/1/17/1230

2021 11 15

2021 11 12

Lyrica

Upjohn EESV

Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland

EU/1/04/279

2021 12 3

2021 11 12

Ninlaro

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbæk Strand, Danmark

EU/1/16/1094

2021 12 1

2021 11 12

Nucala

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/15/1043

2021 11 15

2021 11 12

Olanzapinas Mylan

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/08/475

2021 11 15

2021 11 12

Olumiant

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1170

2021 11 16

2021 11 12

Sevelamer carbonate Winthrop

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/14/952

2021 12 7

2021 11 12

SomaKit TOC

Advanced Accelerator Applications

20 rue Diesel, 01630 Saint-Genis-Pouilly, France

EU/1/16/1141

2021 11 16

2021 11 12

Steglujan

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1266

2021 11 15

2021 11 12

Stelara

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/08/494

2021 11 15

2021 11 12

Suliqua

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/16/1157

2021 11 15

2021 11 12

Tadalafil Lilly

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/17/1177

2021 11 15

2021 11 12

Tivicay

ViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

EU/1/13/892

2021 11 17

2021 11 12

Viagra

Upjohn EESV

Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland

EU/1/98/077

2021 12 3

2021 11 12

Xermelo

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/17/1224

2021 12 8

2021 11 15

Aldurazyme

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/03/253

2021 12 7

2021 11 15

Brilique

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/10/655

2021 11 17

2021 11 15

Clopidogrel Taw Pharma

Taw Pharma (Ireland) Limited

104 Lower Baggot Street, Dublin 2, Ireland

EU/1/09/559

2021 11 25

2021 11 15

Dovato

ViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

EU/1/19/1370

2021 11 17

2021 11 15

Emtricitabine/Tenofovir disoproxil Mylan

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/16/1133

2021 11 16

2021 11 15

Fasturtec

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/00/170

2021 11 16

2021 11 15

Forxiga

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/795

2021 11 17

2021 11 15

Gardasil

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/357

2021 11 17

2021 11 15

Hizentra

CSL Behring GmbH

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

EU/1/11/687

2021 11 18

2021 11 15

Hulio

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/18/1319

2021 11 17

2021 11 15

Invokana

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/884

2021 11 16

2021 11 15

Jorveza

Dr Falk Pharma GmbH

Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland

EU/1/17/1254

2021 11 16

2021 11 15

Kevzara

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/17/1196

2021 11 16

2021 11 15

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

2021 11 20

2021 11 15

Myalepta

Amryt Pharmaceuticals DAC

45 Mespil Road, Dublin 4, Ireland

EU/1/18/1276

2021 11 18

2021 11 15

Praluent

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/15/1031

2021 11 16

2021 11 15

Remicade

Janssen Biologics B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/99/116

2021 11 19

2021 11 15

Rilutek

Sanofi Mature IP

54 rue La Boétie, 75008, Paris, France

EU/1/96/010

2021 11 18

2021 11 15

Sirturo

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/901

2021 11 16

2021 11 15

Skyrizi

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/19/1361

2021 11 16

2021 11 15

Thyrogen

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/99/122

2021 11 17

2021 11 15

Triumeq

ViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

EU/1/14/940

2021 11 17

2021 11 15

Truxima

Celltrion Healthcare Hungary Kft.

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

EU/1/16/1167

2021 11 16

2021 11 15

Xeljanz

Pfizer Europe MA EEIG

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

EU/1/17/1178

2021 11 17

2021 11 15

Yellox

Bausch Health Ireland Limited

3013 Lake DRIVE, Citywest Business Campus, Dublin 24, D24PPT3, Ireland

EU/1/11/692

2021 12 2

2021 11 15

Zercepac

Accord Healthcare S.L.U.

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

EU/1/20/1456

2021 11 16

2021 11 15

Zercepac

Accord Healthcare S.L.U.

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

EU/1/20/1456

2021 11 16

2021 11 15

Zoledronic acid Mylan

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/12/786

2021 11 16

2021 11 15

Zonisamide Mylan

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/16/1093

2021 11 16

2021 11 18

Abecma

Bristol-Myers Squibb Pharma EEIG

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

EU/1/21/1539

2021 11 21

2021 11 18

Aripiprazole Mylan Pharma

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/15/1005

2021 11 19

2021 11 18

Axumin

Blue Earth Diagnostics Ireland Ltd

6th Floor, 2 Grand Canal Square, Dublin 2, Ιreland

EU/1/17/1186

2021 11 23

2021 11 18

Aybintio

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/20/1454

2021 11 22

2021 11 18

Beovu

Novartis Europharm Limited

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

EU/1/19/1417

2021 11 26

2021 11 18

Champix

Pfizer Europe MA EEIG

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

EU/1/06/360

2021 11 19

2021 11 18

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

2021 11 18

2021 11 18

Marixino

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/13/820

2021 11 22

2021 11 18

Ogivri

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/18/1341

2021 11 22

2021 11 18

Opatanol

Novartis Europharm Limited

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

EU/1/02/217

2021 11 19

2021 11 18

Pemetrexed Krka

KRKA, d.d.

Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/18/1283

2021 11 22

2021 11 18

Prometax

Novartis Europharm Limited

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

EU/1/98/092

2021 11 19

2021 11 18

Ritonavir Mylan

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/17/1242

2021 11 19

2021 11 18

Steglujan

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1266

2021 11 20

2021 11 18

Tecartus

Kite Pharma ES B.V.

Tufsteen 1, 2132 NT Hoofddorp, Nederland

EU/1/20/1492

2021 11 19

2021 11 18

Xagrid

Shire Pharmaceuticals Ireland Limited

Block 2 & 3 Miesian Plaza, 50–58 Baggot Street Lower, D02 Y754 Dublin 2, Ireland

EU/1/04/295

2021 11 19

2021 11 18

Xoterna Breezhaler

Novartis Europharm Limited

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

EU/1/13/863

2021 11 19

2021 11 18

Zeffix

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/99/114

2021 11 19

2021 11 18

Zeposia

Bristol-Myers Squibb Pharma EEIG

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

EU/1/20/1442

2021 11 21

2021 11 19

Aripiprazole Mylan Pharma

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/15/1005

2021 11 22

2021 11 22

Briviact

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/15/1073

2021 12 1

2021 11 22

BYANNLI

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1453

2021 11 23

2021 11 22

Foclivia

Seqirus S.r.l.,

Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italia

EU/1/09/577

2021 11 23

2021 11 22

Lacosamide Accord

Accord Healthcare S.L.U.

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

EU/1/17/1230

2021 11 23

2021 11 22

Pregabalin Zentiva k.s

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/16/1166

2021 11 23

2021 11 22

Saxenda

Novo Nordisk A/S

Novo Allé, 2880 Bagsvæaerd, Danmark

EU/1/15/992

2021 11 23

2021 11 22

Suliqua

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/16/1157

2021 11 23

2021 11 22

Talmanco

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/16/1153

2021 11 23

2021 11 22

TOBI Podhaler

Mylan IRE Healthcare Ltd

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

EU/1/10/652

2021 11 23

2021 11 22

Zypadhera

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/08/479

2021 11 23

2021 11 23

Vaxzevria

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1529

2021 11 23

2021 11 26

Clopidogrel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/540

2021 11 30

2021 11 26

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

2021 11 26

2021 11 26

Corbilta

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/13/859

2021 11 30

2021 11 26

Kisplyx

Eisai GmbH

Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland

EU/1/16/1128

2021 11 29

2021 11 26

Lenvima

Eisai GmbH

Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland

EU/1/15/1002

2021 11 29

2021 11 26

Lyxumia

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/12/811

2021 11 29

2021 11 26

NeoRecormon

Roche Registration GmbH

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

EU/1/97/031

2021 12 1

2021 11 26

Pritor

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/98/089

2021 11 30

2021 11 26

Relvar Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/13/886

2021 11 29

2021 11 26

Repatha

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1016

2021 11 29

2021 11 26

Replagal

Shire Human Genetic Therapies AB

Lindhagensgatan 120, 112 51, Stockholm, Sverige

EU/1/01/189

2021 12 6

2021 11 26

Rivaroxaban Accord

Accord Healthcare S.L.U.

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

EU/1/20/1488

2021 10 24

2021 11 26

Rivaroxaban Accord

Accord Healthcare S.L.U.

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

EU/1/20/1488

2021 11 30

2021 11 26

Uptravi

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/15/1083

2021 12 29

2021 11 29

Carmustine Obvius

Obvius Investment B.V.

De Cuserstraat 93, 1081 CN Amsterdam, Nederland

EU/1/18/1278

2021 12 1

2021 11 29

Hirobriz Breezhaler

Novartis Europharm Limited

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

EU/1/09/594

2021 11 30

2021 11 29

IntronA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/99/127

2021 12 1

2021 11 29

Simulect

Novartis Europharm Limited

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

EU/1/98/084

2021 11 30

—   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

2021 11 3

Pregabalinas Mylan Pharma

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/998

2021 11 5

2021 11 15

Atripla

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/07/430

2021 11 16

2021 11 18

Skysona

bluebird bio (Netherlands) B.V.

Stadsplateau 7, WTC Utrecht, 3521 AZ Utrecht, Nederland

EU/1/21/1563

2021 11 19

2021 11 30

IntronA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/99/127

2021 12 1

—   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

2021 11 11

Felpreva

tigolaneras/emodepsidas/prazikvantelis

Vetoquinol S.A.

Magny-Vernois, 70200 Lure, France

EU/2/21/277

Užlašinamasis tirpalas

QP52AA51

2021 11 12

—   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

2021 11 3

Chanhold

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/19/236

2021 11 5

2021 11 3

Equilis Prequenza

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/05/056

2021 11 5

2021 11 3

Equilis Prequenza Te

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/05/057

2021 11 5

2021 11 3

Kexxtone

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/12/145

2021 11 4

2021 11 11

Cepedex

CP Pharma Handelsgesellschaft mbH

Ostlandring 13, 31303 Burgdorf, Deutschland

EU/2/16/200

2021 11 25

2021 11 11

Coliprotec F4/F18

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/16/202

2021 11 15

2021 11 12

Aivlosin

ECO Animal Health Europe Limited

6th Floor, South Bank House, Barrow Street, Dublin 4, D04 TR29, Ireland

EU/2/04/044

2021 11 16

2021 11 12

Simparica Trio

Zoetis Belgium S.A.

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

EU/2/19/243

2021 11 16

2021 11 26

PREVEXXION RN

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/20/254

2021 12 3

2021 11 29

NexGard Combo

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/20/267

2021 11 30

—   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

2021 11 15

Coliprotec F4

Prevtec Microbia GmbH

Geyerspergerstr 27, 80689 München, Deutschland

EU/2/14/180

2021 12 7

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

(1)  OL L 136, 2004 4 30, p. 1.