# Europos Sąjungos C 96/2022

| | ISSN 1977-0960 |
| --- | --- |
| Europos Sąjungos
  oficialusis leidinys | C 96 |
| | |
| Leidimas lietuvių kalba | Informacija ir pranešimai | 65 metai2022m. vasario 28d. |

ISSN 1977-0960

Europos Sąjungos

oficialusis leidinys

C 96

Leidimas lietuvių kalba

Informacija ir pranešimai

65 metai2022m. vasario 28d.

---

| Turinys | Puslapis |
| --- | --- |
| | IV   Pranešimai |
| | EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
| | Europos Komisija |
| 2022/C 96/01 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2021 m. sausio 1 d. iki 2021 m. gruodžio 31 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį) | 1 |
| 2022/C 96/02 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2022 m. sausio 1 d. iki 2022 m. sausio 31 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį) | 6 |

Turinys

Puslapis

IV   Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

2022/C 96/01

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2021 m. sausio 1 d. iki 2021 m. gruodžio 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

2022/C 96/02

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2022 m. sausio 1 d. iki 2022 m. sausio 31 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį)

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

6

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| LT | |
| --- | --- |

LT

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IV Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

| 2022 2 28 | LT | Europos Sąjungos oficialusis leidinys | C 96/1 |
| --- | --- | --- | --- |

2022 2 28

LT

Europos Sąjungos oficialusis leidinys

C 96/1

---

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2021 m. sausio 1 d. iki 2021 m. gruodžio 31 d.

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

(2022/C 96/01)

—   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 1 14 | Emselex | zr pharma& GmbH |
| Hietzinger Hauptstrasse 37, 1130 Wien, Österreich |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2021 1 14

Emselex

zr pharma& GmbH

Hietzinger Hauptstrasse 37, 1130 Wien, Österreich

EU/1/04/294

2021 9 2

2021 1 22

Vizamyl

| GE Healthcare AS |
| --- |
| Nycoveien 1, 0485, Oslo, Norge |

GE Healthcare AS

Nycoveien 1, 0485, Oslo, Norge

EU/1/14/941

2021 2 1

2021 5 25

Januvia

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/383

2022 1 18

2021 7 5

Helicobacter Test INFAI

| INFAI GmbH |
| --- |
| Riehler Straße 36, 50668 Köln, Deutschland |

INFAI GmbH

Riehler Straße 36, 50668 Köln, Deutschland

EU/1/97/045

2021 7 29

2021 7 9

Vihuma

| Octapharma AB |
| --- |
| Lars Forssells gata 23, 112 75 Stockholm, Sverige |

Octapharma AB

Lars Forssells gata 23, 112 75 Stockholm, Sverige

EU/1/16/1168

2021 7 29

2021 7 16

Atazanavir Mylan

| Mylan Pharmaceuticals Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland |

Mylan Pharmaceuticals Limited

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

EU/1/16/1091

2021 8 31

2021 7 16

Bondronat

| Atnahs Pharma Netherlands B.V. |
| --- |
| Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Danmark |

Atnahs Pharma Netherlands B.V.

Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Danmark

EU/1/96/012

2021 8 18

2021 7 16

Glyxambi

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

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/16/1146

2021 7 20

2021 7 16

Mysildecard

| Viatris Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland |

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/16/1134

2021 9 8

2021 7 23

Fluad Tetra

| Seqirus Netherlands B.V. |
| --- |
| Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland |

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland

EU/1/20/1433

2021 8 26

2021 7 23

Flucelvax Tetra

| Seqirus Netherlands B.V. |
| --- |
| Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland |

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland

EU/1/18/1326

2021 8 26

2021 7 23

Galafold

| Amicus Therapeutics Europe Limited |
| --- |
| Block 1 Blanchardstown Corporate Park, Ballycoolen Road, Blanchardstown, Dublin, D15 AKK1, Ireland |

Amicus Therapeutics Europe Limited

Block 1 Blanchardstown Corporate Park, Ballycoolen Road, Blanchardstown, Dublin, D15 AKK1, Ireland

EU/1/15/1082

2021 7 28

2021 7 23

Sildenafil Actavis

| Actavis Group PTC ehf. |
| --- |
| Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland |

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/09/595

2021 8 16

2021 7 23

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

EU/1/17/1178

2021 7 27

2021 7 28

Leflunomide ratiopharm

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3, 89079 Ulm, Deutschland |

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/10/654

2021 9 1

2021 8 12

Lenalidomide Mylan

| Mylan Ireland Limited |
| --- |
| Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland |

Mylan Ireland Limited

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

EU/1/20/1490

2021 9 23

2021 8 18

Hemlibra

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

Roche Registration GmbH

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

EU/1/18/1271

2021 10 18

2021 8 18

Palynziq

| BioMarin International Limited |
| --- |
| Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland |

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland

EU/1/19/1362

2021 10 8

2021 8 20

OBIZUR

| Baxalta Innovations GmbH |
| --- |
| Industriestraße 67, 1221 Wien, Österreich |

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/15/1035

2021 9 16

2021 9 15

Velmetia

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/456

2021 9 17

2021 9 16

Luminity

| Lantheus EU Limited |
| --- |
| Rocktwist House, Block 1, Western Business Park, Shannon, Co. Clare, V14 FW97, Ireland |

Lantheus EU Limited

Rocktwist House, Block 1, Western Business Park, Shannon, Co. Clare, V14 FW97, Ireland

EU/1/06/361

2021 10 19

2021 9 29

Abilify

| Otsuka Pharmaceutical Netherlands B.V. |
| --- |
| Herikerbergweg 292, 1101 CT, Amsterdam, Nederland |

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

EU/1/04/276

2021 12 9

2021 9 29

Cegfila

| Mundipharma Corporation (Ireland) Limited |
| --- |
| Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland |

Mundipharma Corporation (Ireland) Limited

Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland

EU/1/19/1409

2021 10 13

2021 9 29

Colobreathe

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/747

2021 10 4

2021 9 29

elmiron

| bene-Arzneimittel GmbH |
| --- |
| Herterichstraße 1-3, 81479 München, Deutschland |

bene-Arzneimittel GmbH

Herterichstraße 1-3, 81479 München, Deutschland

EU/1/17/1189

2021 10 5

2021 9 29

Praxbind

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

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/15/1056

2021 10 5

2021 9 29

VPRIV

| Takeda Pharmaceuticals International AG Ireland Branch |
| --- |
| Block 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland |

Takeda Pharmaceuticals International AG Ireland Branch

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

EU/1/10/646

2021 9 30

2021 9 29

Zoledrono rūgštis medac

| medac Gesellschaft für klinische Spezialpräparate mbH |
| --- |
| Theaterstraße 6, 22880 Wedel, Deutschland |

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/12/779

2021 10 15

2021 10 11

Ibandronic acid Sandoz

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/11/685

2021 11 8

2021 10 19

Natpar

| Takeda Pharmaceuticals International AG Ireland Branch |
| --- |
| Block 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland |

Takeda Pharmaceuticals International AG Ireland Branch

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

EU/1/15/1078

2021 10 20

2021 10 19

Rivastigmine HEXAL

| Hexal AG |
| --- |
| Industriestraße 25, 83607 Holzkirchen, Deutschland |

Hexal AG

Industriestraße 25, 83607 Holzkirchen, Deutschland

EU/1/09/589

2021 11 26

2021 10 22

Gencebok

| Gennisium Pharma |
| --- |
| Swen Parc de Vitrolles, Chemin de la Bastide Blanche, 13127 Vitrolles, France |

Gennisium Pharma

Swen Parc de Vitrolles, Chemin de la Bastide Blanche, 13127 Vitrolles, France

EU/1/20/1465

2021 11 9

2021 10 22

Topotecan Hospira

| 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

EU/1/10/633

2021 10 25

2021 11 15

Atazanavir Krka

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

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/19/1353

2021 12 3

2021 11 15

Pregabalin Pfizer

| Upjohn EESV |
| --- |
| Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland |

Upjohn EESV

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

EU/1/14/916

2021 12 14

2021 11 15

Revatio

| Upjohn EESV |
| --- |
| Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland |

Upjohn EESV

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

EU/1/05/318

2021 12 22

2021 11 15

Ulunar Breezhaler

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

Novartis Europharm Limited

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

EU/1/14/917

2021 11 17

2021 11 18

Ocaliva

| Intercept Pharma International Limited |
| --- |
| Ormond Building, 31 – 36 Ormond Quay Upper, Dublin 7, Ireland |

Intercept Pharma International Limited

Ormond Building, 31 – 36 Ormond Quay Upper, Dublin 7, Ireland

EU/1/16/1139

2021 12 1

2021 11 22

Jylamvo

| Therakind (Europe) Limited |
| --- |
| Paramount Court, Corrig Road, Sandyford Business Park, Dublin 18, D18 R9C7, Ireland |

Therakind (Europe) Limited

Paramount Court, Corrig Road, Sandyford Business Park, Dublin 18, D18 R9C7, Ireland

EU/1/17/1172

2021 12 22

2021 11 26

Glustin

| Takeda Pharma A/S |
| --- |
| Delta Park 45, 2665 Vallensbæk Strand, Danmark |

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbæk Strand, Danmark

EU/1/00/151

2021 12 9

2021 11 26

Lixiana

| Daiichi Sankyo Europe GmbH |
| --- |
| Zielstattstraße 48, 81379 München, Deutschland |

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/15/993

2021 12 3

2021 12 9

Imnovid

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

Bristol Myers Squibb Pharma EEIG

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

EU/1/13/850

2022 1 7

2021 12 9

Relistor

| Bausch Health Ireland Limited |
| --- |
| 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland |

Bausch Health Ireland Limited

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

EU/1/08/463

2021 12 14

2021 12 13

AJOVY

| Teva GmbH |
| --- |
| Graf-Arco-Straße 3, 89079 Ulm, Deutschland |

Teva GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/19/1358

2021 12 15

2021 12 13

Micardis

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

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/98/090

2022 1 14

2021 12 13

Onbrez Breezhaler

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

Novartis Europharm Limited

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

EU/1/09/593

2022 1 14

2021 12 16

PREVYMIS

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/17/1245

2022 1 17

2021 12 20

Trazimera

| 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

EU/1/18/1295

2021 12 22

—   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 29 | Glustin | Takeda Pharma A/S |
| Delta Park 45, 2665 Vallensbæk Strand, Danmark |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2021 11 29

Glustin

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbæk Strand, Danmark

EU/1/00/151

2021 12 9

—   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 3 26 | Purevax RCPCh FeLV | Boehringer Ingelheim Vetmedica GmbH |
| D-55216 Ingelheim am Rhein, Deutschland |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2021 3 26

Purevax RCPCh FeLV

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/047

2021 3 30

2021 7 13

Coxevac

| Ceva Santé Animale |
| --- |
| 10 avenue de La Ballastière, 33500 Libourne, France |

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/10/110

2021 8 5

2021 7 30

Meloxoral

| Dechra Regulatory B.V. |
| --- |
| Handelsweg 25, 5531 AE Bladel, Nederland |

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/10/111

2021 8 16

2021 7 30

Prevomax

| Dechra Regulatory B.V. |
| --- |
| Handelsweg 25, 5531 AE Bladel, Nederland |

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/17/211

2021 8 16

2021 8 16

Suvaxyn CSF Marker

| 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

EU/2/14/179

2021 9 7

2021 8 18

Poulvac E. coli

| 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

EU/2/12/140

2021 10 18

2021 10 25

Felisecto Plus

| 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

EU/2/19/238

2021 11 24

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

---

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

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| 2022 2 28 | LT | Europos Sąjungos oficialusis leidinys | C 96/6 |
| --- | --- | --- | --- |

2022 2 28

LT

Europos Sąjungos oficialusis leidinys

C 96/6

---

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2022 m. sausio 1 d. iki 2022 m. sausio 31 d.

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

(2022/C 96/02)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2022 1 6 | Lumykras | sotorasibas | Amgen Europe B.V. |
| Minervum 7061, 4817 ZK Breda, Nederland |

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

2022 1 6

Lumykras

sotorasibas

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/21/1603

Plėvele dengta tabletė

L01XX73

2022 1 7

2022 1 6

Riltrava Aerosphere

formoterolio fumaratas dihidratas / glikopironis / budezonidas

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1604

Suslėgtoji įkvepiamoji suspensija

R03AL11

2022 1 7

2022 1 6

Tecovirimat SIGA

tekovirimatas

| SIGA Technologies Netherlands B.V. |
| --- |
| Prinsenhil 29, Breda 4825 AX, Nederland |

SIGA Technologies Netherlands B.V.

Prinsenhil 29, Breda 4825 AX, Nederland

EU/1/21/1600

Kieta kapsulė

J05AX24

2022 1 7

2022 1 6

Wegovy

Semagliutido

| Novo Nordisk A/S |
| --- |
| Novo Allé, 2880 Bagsværd, Danmark |

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/21/1608

Injekcinis tirpalas

A10BJ06

2022 1 7

2022 1 11

Lonapegsomatropin Ascendis Pharma

Lonapegsomatropinas

| Ascendis Pharma Endocrinology Division A/S |
| --- |
| Tuborg Boulevard 12, 2900 Hellerup, Danmark |

Ascendis Pharma Endocrinology Division A/S

Tuborg Boulevard 12, 2900 Hellerup, Danmark

EU/1/21/1607

Milteliai ir tirpiklis injekciniam tirpalui

Pending

2022 1 17

2022 1 11

Tavneos

avakopanas

| Vifor Fresenius Medical Care Renal Pharma France |
| --- |
| 100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France |

Vifor Fresenius Medical Care Renal Pharma France

100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France

EU/1/21/1605

Kieta kapsulė

Pending

2022 1 19

2022 1 11

Voraxaze

gliukarpidazė

| SERB SAS |
| --- |
| 40 Avenue George V, 75008 Paris, France |

SERB SAS

40 Avenue George V, 75008 Paris, France

EU/1/21/1586

Milteliai injekciniam tirpalui

V03AF09

2022 1 13

2022 1 24

Vyepti

eptinezumabas

| H. Lundbeck A/S |
| --- |
| Ottiliavej 9, 2500 Valby, Danmark |

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/21/1599

Koncentratas infuziniam tirpalui

N02CD05

2022 1 25

—   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 |
| --- | --- | --- | --- | --- |
| 2022 1 6 | Nouryant | Kyowa Kirin Holdings B.V. |
| Bloemlaan 2, 2132 NP Hoofddorp, Nederland |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2022 1 6

Nouryant

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

—

2022 1 11

—   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 |
| --- | --- | --- | --- | --- |
| 2022 1 3 | COVID-19 Vaccine Janssen | Janssen-Cilag International NV |
| Turnhoutseweg 30, 2340 Beerse, België |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2022 1 3

COVID-19 Vaccine Janssen

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

2022 1 4

2022 1 6

ADYNOVI

| Baxalta Innovations GmbH |
| --- |
| Industriestraße 67, 1221 Wien, Österreich |

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/17/1247

2022 1 7

2022 1 6

Arsenic trioxide Mylan

| Mylan Ireland Limited |
| --- |
| Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland |

Mylan Ireland Limited

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

EU/1/20/1427

2022 1 7

2022 1 6

Bavencio

| Merck Europe B.V. |
| --- |
| Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland |

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1214

2022 1 10

2022 1 6

Braftovi

| Pierre Fabre Médicament |
| --- |
| Les Cauquillous, 81500 Lavaur, France |

Pierre Fabre Médicament

Les Cauquillous, 81500 Lavaur, France

EU/1/18/1314

2022 1 10

2022 1 6

CRYSVITA

| Kyowa Kirin Holdings B.V. |
| --- |
| Bloemlaan 2, 2132 NP Hoofddorp, Nederland |

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/17/1262

2022 1 12

2022 1 6

Darzalex

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/16/1101

2022 1 7

2022 1 6

Dupixent

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/17/1229

2022 1 7

2022 1 6

Elocta

| Swedish Orphan Biovitrum AB (publ) |
| --- |
| 112 76 Stockholm, Sverige |

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/15/1046

2022 1 10

2022 1 6

Emtricitabine /Tenofovir disoproxil 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

EU/1/17/1182

2022 1 12

2022 1 6

Ferriprox

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A, 43122 Parma, Italia |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/99/108

2022 2 3

2022 1 6

Inhixa

| Techdow Pharma Netherlands B.V. |
| --- |
| Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland |

Techdow Pharma Netherlands B.V.

Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland

EU/1/16/1132

2022 1 18

2022 1 6

Metalyse

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

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/00/169

2022 1 11

2022 1 6

Noxafil

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/05/320

2022 1 10

2022 1 6

Nuwiq

| Octapharma AB |
| --- |
| Lars Forssells gata 23, 112 75 Stockholm, Sverige |

Octapharma AB

Lars Forssells gata 23, 112 75 Stockholm, Sverige

EU/1/14/936

2022 1 10

2022 1 6

Qarziba

| EUSA Pharma (Netherlands) B.V. |
| --- |
| Beechavenue 54, 1119PW Schiphol-Rijk, Nederland |

EUSA Pharma (Netherlands) B.V.

Beechavenue 54, 1119PW Schiphol-Rijk, Nederland

EU/1/17/1191

2022 1 12

2022 1 6

Sirturo

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/901

2022 1 7

2022 1 6

Tecfidera

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

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/13/837

2022 1 7

2022 1 6

Trydonis

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A, 43122 Parma, Italia |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/18/1274

2022 1 7

2022 1 6

Vfend

| 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

EU/1/02/212

2022 1 7

2022 1 6

Zytiga

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/11/714

2022 1 7

2022 1 7

Epclusa

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1116

2022 1 10

2022 1 7

Kaftrio

| Vertex Pharmaceuticals (Ireland) Limited |
| --- |
| 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland |

Vertex Pharmaceuticals (Ireland) Limited

28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland

EU/1/20/1468

2022 1 10

2022 1 7

Kalydeco

| Vertex Pharmaceuticals (Ireland) Limited |
| --- |
| 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland |

Vertex Pharmaceuticals (Ireland) Limited

28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland

EU/1/12/782

2022 1 10

2022 1 7

Ledaga

| Helsinn Birex Pharmaceuticals Ltd. |
| --- |
| Damastown, Mulhuddart, Dublin 15, Ireland |

Helsinn Birex Pharmaceuticals Ltd.

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/16/1171

2022 1 10

2022 1 7

LIBTAYO

| Regeneron Ireland Designated Activity Company (DAC) |
| --- |
| One Warrington Place, Dublin 2, D02 HH27 Ireland |

Regeneron Ireland Designated Activity Company (DAC)

One Warrington Place, Dublin 2, D02 HH27 Ireland

EU/1/19/1376

2022 1 11

2022 1 7

Rolufta 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

EU/1/17/1174

2022 1 11

2022 1 7

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

EU/1/11/698

2022 1 13

2022 1 11

Caprelsa

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

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/11/749

2022 1 13

2022 1 11

elmiron

| bene-Arzneimittel GmbH |
| --- |
| Herterichstraße 1-3, 81479 München, Deutschland |

bene-Arzneimittel GmbH

Herterichstraße 1-3, 81479 München, Deutschland

EU/1/17/1189

2022 1 12

2022 1 11

Ozempic

| Novo Nordisk A/S |
| --- |
| Novo Allé, 2880 Bagsværd, Danmark |

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/17/1251

2022 1 12

2022 1 11

Yargesa

| Piramal Critical Care B.V. |
| --- |
| Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland |

Piramal Critical Care B.V.

Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland

EU/1/17/1176

2022 1 13

2022 1 12

Multaq

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/09/591

2022 1 13

2022 1 12

Ocaliva

| Intercept Pharma International Limited |
| --- |
| Ormond Building, 31 – 36 Ormond Quay Upper, Dublin 7, Ireland |

Intercept Pharma International Limited

Ormond Building, 31 – 36 Ormond Quay Upper, Dublin 7, Ireland

EU/1/16/1139

2022 1 13

2022 1 14

COVID-19 Vaccine Janssen

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

2022 1 14

2022 1 14

Lonquex

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/13/856

2022 1 18

2022 1 14

Vaxzevria

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1529

2022 1 14

2022 1 20

Abecma

| 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

EU/1/21/1539

2022 1 21

2022 1 20

Cosentyx

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

Novartis Europharm Limited

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

EU/1/14/980

2022 1 24

2022 1 20

Inhixa

| Techdow Pharma Netherlands B.V. |
| --- |
| Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland |

Techdow Pharma Netherlands B.V.

Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland

EU/1/16/1132

2022 1 21

2022 1 20

Lumigan

| Allergan Pharmaceuticals Ireland |
| --- |
| Castlebar Road, Westport, County Mayo, Ireland |

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

EU/1/02/205

2022 1 25

2022 1 20

Plenadren

| Takeda Pharmaceuticals International AG Ireland Branch |
| --- |
| Block 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland |

Takeda Pharmaceuticals International AG Ireland Branch

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

EU/1/11/715

2022 1 24

2022 1 20

Pradaxa

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

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/08/442

2022 1 24

2022 1 20

Yescarta

| Kite Pharma EU B.V. |
| --- |
| Tufsteen 1, 2132 NT Hoofddorp, Nederland |

Kite Pharma EU B.V.

Tufsteen 1, 2132 NT Hoofddorp, Nederland

EU/1/18/1299

2022 1 21

2022 1 24

Bridion

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/466

2022 1 25

2022 1 24

Cinryze

| Shire Services BVBA |
| --- |
| rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België |

Shire Services BVBA

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

EU/1/11/688

2022 1 25

2022 1 24

Circadin

| RAD Neurim Pharmaceuticals EEC SARL |
| --- |
| 4 rue de Marivaux, 75002 Paris, France |

RAD Neurim Pharmaceuticals EEC SARL

4 rue de Marivaux, 75002 Paris, France

EU/1/07/392

2022 1 26

2022 1 24

Comirnaty

| BioNTech Manufacturing GmbH |
| --- |
| An der Goldgrube 12, 55131 Mainz, Deutschland |

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

2022 1 24

2022 1 24

Exjade

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

Novartis Europharm Limited

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

EU/1/06/356

2022 1 25

2022 1 24

Fotivda

| EUSA Pharma (Netherlands) B.V. |
| --- |
| Beechavenue 54, 1119PW Schiphol-Rijk, Nederland |

EUSA Pharma (Netherlands) B.V.

Beechavenue 54, 1119PW Schiphol-Rijk, Nederland

EU/1/17/1215

2022 1 28

2022 1 24

Javlor

| PIERRE FABRE MEDICAMENT |
| --- |
| Les Cauquillous, 81500 Lavaur, France |

PIERRE FABRE MEDICAMENT

Les Cauquillous, 81500 Lavaur, France

EU/1/09/550

2022 1 25

2022 1 24

KEYTRUDA

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

2022 1 25

2022 1 24

Kymriah

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

Novartis Europharm Limited

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

EU/1/18/1297

2022 1 25

2022 1 24

Lokelma

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1173

2022 1 25

2022 1 24

NUCEIVA

| Evolus Pharma B.V. |
| --- |
| Apollolaan 151, 1077 AR Amsterdam, Nederland |

Evolus Pharma B.V.

Apollolaan 151, 1077 AR Amsterdam, Nederland

EU/1/19/1364

2022 2 7

2022 1 24

Oslif Breezhaler

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

Novartis Europharm Limited

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

EU/1/09/586

2022 1 25

2022 1 24

Pregabalin Sandoz GmbH

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1012

2022 1 25

2022 1 24

Tecartus

| Kite Pharma EU B.V. |
| --- |
| Tufsteen 1, 2132 NT Hoofddorp, Nederland |

Kite Pharma EU B.V.

Tufsteen 1, 2132 NT Hoofddorp, Nederland

EU/1/20/1492

2022 1 25

2022 1 24

Teysuno

| Nordic Group B.V. |
| --- |
| Siriusdreef 41, 2132 WT Hoofddorp, Nederland |

Nordic Group B.V.

Siriusdreef 41, 2132 WT Hoofddorp, Nederland

EU/1/11/669

2022 1 26

2022 1 24

Ultibro Breezhaler

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

Novartis Europharm Limited

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

EU/1/13/862

2022 1 25

2022 1 24

Vizarsin

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

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/551

2022 1 26

2022 1 24

Zynquista

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

Guidehouse Germany GmbH

Albrechtstrasse 10c, 10117 Berlin, Deutschland

EU/1/19/1363

2022 1 29

2022 1 25

Actraphane

| Novo Nordisk A/S |
| --- |
| Novo Allé, 2880 Bagsværd, Danmark |

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/02/229

2022 1 31

2022 1 25

Actrapid

| Novo Nordisk A/S |
| --- |
| Novo Allé, 2880 Bagsværd, Danmark |

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/02/230

2022 1 26

2022 1 25

Fasenra

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1252

2022 1 27

2022 1 25

Lantus

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/134

2022 1 26

2022 1 25

Prolia

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

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/10/618

2022 1 27

2022 1 25

Sixmo

| L. Molteni & C. dei F.lli Alitti Soc.Es.S.p.A |
| --- |
| Strada Statale 67, 50018 Scandicci (Firenze), Italia |

L. Molteni & C. dei F.lli Alitti Soc.Es.S.p.A

Strada Statale 67, 50018 Scandicci (Firenze), Italia

EU/1/19/1369

2022 1 27

2022 1 27

Arsenic trioxide medac

| medac Gesellschaft für klinische Spezialpräparate mbH |
| --- |
| Theaterstraße 6, 22880 Wedel, Deutschland |

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/20/1475

2022 1 31

2022 1 27

Desloratadine ratiopharm

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3, 89079 Ulm, Deutschland |

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/11/746

2022 1 30

2022 1 27

Gilenya

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

Novartis Europharm Limited

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

EU/1/11/677

2022 1 28

2022 1 27

Libmeldy

| Orchard Therapeutics (Netherlands) B.V. |
| --- |
| Prins Bernhardplein 200, 1097 JB, Noord-Holland, Amsterdam, Nederland |

Orchard Therapeutics (Netherlands) B.V.

Prins Bernhardplein 200, 1097 JB, Noord-Holland, Amsterdam, Nederland

EU/1/20/1493

2022 1 31

2022 1 27

Lorviqua

| 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

EU/1/19/1355

2022 1 28

2022 1 27

Pemetrexed Accord

| 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

EU/1/15/1071

2022 1 28

2022 1 27

Staquis

| 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

EU/1/19/1421

2022 1 28

2022 1 27

Telmisartan Teva Pharma

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/719

2022 1 28

2022 1 27

Zinforo

| Pfizer Ireland Pharmaceuticals |
| --- |
| Operations Support Group, Ringaskiddy, County Cork, Ireland |

Pfizer Ireland Pharmaceuticals

Operations Support Group, Ringaskiddy, County Cork, Ireland

EU/1/12/785

2022 1 28

2022 1 27

Zonegran

| Amdipharm Limited |
| --- |
| 3 Burlington Road, Dublin 4, D04 RD68, IRELAND |

Amdipharm Limited

3 Burlington Road, Dublin 4, D04 RD68, IRELAND

EU/1/04/307

2022 1 28

2022 1 31

Avastin

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

Roche Registration GmbH

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

EU/1/04/300

2022 2 1

2022 1 31

Benepali

| Samsung Bioepis NL B.V. |
| --- |
| Olof Palmestraat 10, 2616 LR Delft, Nederland |

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/15/1074

2022 2 4

2022 1 31

Besremi

| AOP Orphan Pharmaceuticals GmbH, |
| --- |
| Leopold-Ungar-Platz 2, 1190 Wien, Österreich |

AOP Orphan Pharmaceuticals GmbH,

Leopold-Ungar-Platz 2, 1190 Wien, Österreich

EU/1/18/1352

2022 2 2

2022 1 31

Entyvio

| Takeda Pharma A/S |
| --- |
| Delta Park 45, 2665 Vallensbæk Strand, Danmark |

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbæk Strand, Danmark

EU/1/14/923

2022 2 2

2022 1 31

Ervebo

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/19/1392

2022 2 2

2022 1 31

Fareston

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

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/96/004

2022 2 1

2022 1 31

Juluca

| ViiV Healthcare B.V. |
| --- |
| Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands |

ViiV Healthcare B.V.

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

EU/1/18/1282

2022 2 1

2022 1 31

Luveris

| Merck Europe B.V. |
| --- |
| Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland |

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/00/155

2022 2 2

2022 1 31

Mulpleo

| Shionogi B.V. |
| --- |
| Kingsfordweg 151, 1043 GR Amsterdam, Nederland |

Shionogi B.V.

Kingsfordweg 151, 1043 GR Amsterdam, Nederland

EU/1/18/1348

2022 2 1

2022 1 31

Pemetrexed Hospira

| 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

EU/1/15/1057

2022 2 1

2022 1 31

Rhokiinsa

| Santen Oy |
| --- |
| Niittyhaankatu 20, 33720 Tampere, Suomi |

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

EU/1/19/1400

2022 2 2

2022 1 31

Spinraza

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

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/17/1188

2022 2 1

2022 1 31

Tivicay

| ViiV Healthcare BV |
| --- |
| Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland |

ViiV Healthcare BV

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

EU/1/13/892

2022 2 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 |
| --- | --- | --- | --- | --- |
| 2022 1 31 | Staquis | Pfizer Europe MA EEIG |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2022 1 31

Staquis

Pfizer Europe MA EEIG

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

EU/1/19/1421

2022 2 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2022 1 11 | CircoMax | Kiaulių cirkoviruso vakcina (inaktyvinta, rekombinantinė) | Zoetis Belgium S.A. |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

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

2022 1 11

CircoMax

Kiaulių cirkoviruso vakcina (inaktyvinta, rekombinantinė)

Zoetis Belgium S.A.

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

EU/2/21/281

Injekcinė emulsija

QI09AA07

2022 1 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 |
| --- | --- | --- | --- | --- |
| 2022 1 4 | Meloxidolor | Le Vet Beheer B.V. |
| Wilgenweg 7, 3421 TV Oudewater, Nederland |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2022 1 4

Meloxidolor

Le Vet Beheer B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/13/148

2022 1 11

2022 1 4

Sileo

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

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/15/181

2022 1 5

2022 1 4

VarroMed

| BeeVital GmbH |
| --- |
| Wiesenbergstrasse 19,A- 5164, Seeham, Österreich |

BeeVital GmbH

Wiesenbergstrasse 19,A- 5164, Seeham, Österreich

EU/2/16/203

2022 1 17

2022 1 11

Innovax-ILT

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

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/15/182

2022 1 13

2022 1 11

Vectormune FP ILT + AE

| Ceva-Phylaxia Co. Ltd. |
| --- |
| Szállás u. 5, 1107 Budapest, Magyarország |

Ceva-Phylaxia Co. Ltd.

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/20/250

2022 1 17

2022 1 20

Improvac

| 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

EU/2/09/095

2022 1 21

2022 1 24

Suvaxyn Aujeszky 783 + O/W

| 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

EU/2/98/009

2022 1 25

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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