# Europos Sąjungos C 350/2023

| | ISSN 1977-0960 |
| --- | --- |
| Europos Sąjungos
  oficialusis leidinys | C 350 |
| | |
| Leidimas lietuvių kalba | Informacija ir pranešimai | 66 metai2023m. rugsėjo 29d. |

ISSN 1977-0960

Europos Sąjungos

oficialusis leidinys

C 350

Leidimas lietuvių kalba

Informacija ir pranešimai

66 metai2023m. rugsėjo 29d.

---

| Turinys | Puslapis |
| --- | --- |
| | IV   Pranešimai |
| | EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
| | Europos Komisija |
| 2023/C 350/01 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2023 m. rugpjūčio 1 d. iki 2023 m. rugpjūčio 31 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį arba Europos Parlamento ir Tarybos reglamento (ES) 2019/6 5 straipsnį) | 1 |

Turinys

Puslapis

IV   Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

2023/C 350/01

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2023 m. rugpjūčio 1 d. iki 2023 m. rugpjūčio 31 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį arba Europos Parlamento ir Tarybos reglamento (ES) 2019/6 5 straipsnį)

(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį arba Europos Parlamento ir Tarybos reglamento (ES) 2019/6 5 straipsnį)

1

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

LT

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IV Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

| 2023 9 29 | LT | Europos Sąjungos oficialusis leidinys | C 350/1 |
| --- | --- | --- | --- |

2023 9 29

LT

Europos Sąjungos oficialusis leidinys

C 350/1

---

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2023 m. rugpjūčio 1 d. iki 2023 m. rugpjūčio 31 d.

(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 (1) 13 straipsnį arba 38 straipsnį arba Europos Parlamento ir Tarybos reglamento (ES) 2019/6 5 straipsnį (2))

(2023/C 350/01)

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

Rinkodaros leidimo suteikimas

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2023 8 11 | AQUIPTA | atogepantas | AbbVie Deutschland GmbH & Co. KG |
| Knollstrasse, 67061 Ludwigshafen, Deutschland |

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

2023 8 11

AQUIPTA

atogepantas

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/23/1750

Tabletės

N02CD07

2023 8 14

2023 8 21

TALVEY

talkvetamabas

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/23/1748

Injekcinis tirpalas

L01FX

2023 8 22

2023 8 23

Abrysvo

Respiracinio sincitinio viruso vakcina (dvivalentė, rekombinanantinė)

| 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/1/23/1752

Milteliai ir tirpiklis injekciniam tirpalui

J07BX05

2023 8 24

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

Rinkodaros leidimo pakeitimas

Priimta

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2023 8 3 | Eladynos | Theramex Ireland Limited |
| 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2023 8 3

Eladynos

Theramex Ireland Limited

3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

EU/1/22/1706

2023 8 4

2023 8 3

Hulio

| Biosimilar Collaborations Ireland Limited |
| --- |
| Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland |

Biosimilar Collaborations Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland

EU/1/18/1319

2023 8 4

2023 8 3

Palforzia

| Aimmune Therapeutics Ireland Limited |
| --- |
| Block B, The Crescent Building, Northwood Crescent Northwood, Dublin 9, D09 C6X8 Ireland |

Aimmune Therapeutics Ireland Limited

Block B, The Crescent Building, Northwood Crescent Northwood, Dublin 9, D09 C6X8 Ireland

EU/1/20/1495

2023 8 8

2023 8 4

Actelsar HCT

| Actavis Group PTC ehf. |
| --- |
| Dalshraun 1, 220 Hafnarfjörður, Íceland |

Actavis Group PTC ehf.

Dalshraun 1, 220 Hafnarfjörður, Íceland

EU/1/13/817

2023 8 7

2023 8 4

Clopidogrel Viatris

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

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/09/568

2023 8 8

2023 8 4

Hetlioz

| Vanda Pharmaceuticals Netherlands B.V. |
| --- |
| Basisweg 10, 1043 AP Amsterdam, Nederland |

Vanda Pharmaceuticals Netherlands B.V.

Basisweg 10, 1043 AP Amsterdam, Nederland

EU/1/15/1008

2023 8 9

2023 8 4

IMJUDO

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/22/1713

2023 8 7

2023 8 4

Lacosamide 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

a

EU/1/17/1230

2023 8 7

2023 8 4

Ogivri

| Biosimilar Collaborations Ireland Limited |
| --- |
| Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland |

Biosimilar Collaborations Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland

EU/1/18/1341

2023 8 8

2023 8 4

Pemetrexed Pfizer

| 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

2023 8 7

2023 8 4

Refixia

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/17/1193

2023 8 8

2023 8 4

RotaTeq

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/06/348

2023 8 8

2023 8 4

Rukobia

| 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/1/20/1518

2023 8 8

2023 8 4

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

EU/1/16/1127

2023 8 8

2023 8 4

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

2023 8 7

2023 8 4

Viramune

| 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/1/97/055

2023 8 8

2023 8 4

Ziagen

| 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/1/99/112

2023 8 7

2023 8 8

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

2023 8 9

2023 8 9

Lenalidomide 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

a

EU/1/18/1316

2023 8 11

2023 8 9

Namuscla

| Lupin Europe GmbH |
| --- |
| Hanauer Landstraße 139-143, 60314 Frankfurt am Main, Deutschland |

Lupin Europe GmbH

Hanauer Landstraße 139-143, 60314 Frankfurt am Main, Deutschland

EU/1/18/1325

2023 8 11

2023 8 9

Pemetrexed Fresenius Kabi

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland

EU/1/16/1115

2023 8 14

2023 8 9

Roteas

| Berlin-Chemie AG |
| --- |
| Glienicker Weg 125, 12489 Berlin, Deutschland |

Berlin-Chemie AG

Glienicker Weg 125, 12489 Berlin, Deutschland

EU/1/16/1152

2023 8 10

2023 8 11

Armisarte

| Actavis Group PTC ehf. |
| --- |
| Dalshraun 1, 220 Hafnarfjörður, Íceland |

Actavis Group PTC ehf.

Dalshraun 1, 220 Hafnarfjörður, Íceland

EU/1/15/1063

2023 8 14

2023 8 11

Dengvaxia

| Sanofi Pasteur |
| --- |
| 14 Espace Henry Vallée, 69007 Lyon, France |

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

EU/1/18/1338

2023 8 30

2023 8 11

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

2023 8 14

2023 8 11

Invirase

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

Roche Registration GmbH

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

EU/1/96/026

2023 8 14

2023 8 11

Rivaroxaban Viatris

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

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/21/1588

2023 8 14

2023 8 11

Spikevax

| MODERNA BIOTECH SPAIN, S.L. |
| --- |
| Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España |

MODERNA BIOTECH SPAIN, S.L.

Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España

EU/1/20/1507

2023 8 21

2023 8 11

TAKHZYRO

| Takeda Pharmaceuticals International AG Ireland Branch |
| --- |
| Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland |

Takeda Pharmaceuticals International AG Ireland Branch

Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland

EU/1/18/1340

2023 8 18

2023 8 11

Venclyxto

| AbbVie Deutschland GmbH & Co. KG |
| --- |
| Knollstrasse, 67061 Ludwigshafen, Deutschland |

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/16/1138

2023 8 14

2023 8 16

Calquence

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/20/1479

2023 8 17

2023 8 16

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

2023 8 17

2023 8 16

Evrysdi

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

Roche Registration GmbH

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

EU/1/21/1531

2023 8 17

2023 8 16

EVUSHELD

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/22/1651

2023 8 17

2023 8 16

Foclivia

| Seqirus S.r.l. |
| --- |
| Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italia |

Seqirus S.r.l.

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

EU/1/09/577

2023 8 17

2023 8 16

Mabthera

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

Roche Registration GmbH

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

EU/1/98/067

2023 8 17

2023 8 16

Ovaleap

| Theramex Ireland Limited |
| --- |
| 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland |

Theramex Ireland Limited

3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

EU/1/13/871

2023 8 17

2023 8 16

Retsevmo

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/20/1527

2023 8 17

2023 8 16

Riximyo

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1184

2023 8 17

2023 8 16

TECVAYLI

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/22/1675

2023 8 17

2023 8 16

Truxima

| Celltrion Healthcare Hungary Kft. |
| --- |
| Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország |

Celltrion Healthcare Hungary Kft.

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

EU/1/16/1167

2023 8 22

2023 8 16

VITRAKVI

| Bayer AG |
| --- |
| D-51368 Leverkusen, Deutschland |

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/19/1385

2023 8 17

2023 8 21

Duloxetine 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

EU/1/15/1028

2023 8 22

2023 8 21

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

EU/1/15/1014

2023 8 24

2023 8 21

Signifor

| Recordati Rare Diseases |
| --- |
| Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France |

Recordati Rare Diseases

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

EU/1/12/753

2023 8 23

2023 8 23

Blitzima

| Celltrion Healthcare Hungary Kft. |
| --- |
| Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország |

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1205

2023 8 25

2023 8 23

Celdoxome pegylated liposomal

| YES Pharmaceutical Development Services GmbH |
| --- |
| Basler Strasse 7, 61352 Bad Homburg, Deutschland |

YES Pharmaceutical Development Services GmbH

Basler Strasse 7, 61352 Bad Homburg, Deutschland

EU/1/22/1666

2023 9 6

2023 8 23

Cholib

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

Viatris Healthcare Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/13/866

2023 8 24

2023 8 23

Efmody

| Diurnal Europe B.V. |
| --- |
| Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland |

Diurnal Europe B.V.

Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland

EU/1/21/1549

2023 8 29

2023 8 23

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

2023 8 28

2023 8 23

Mounjaro

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/22/1685

2023 8 25

2023 8 23

Neuraceq

| Life Radiopharma Berlin GmbH |
| --- |
| Max-Planck-Straße 4, 12489 Berlin, Deutschland |

Life Radiopharma Berlin GmbH

Max-Planck-Straße 4, 12489 Berlin, Deutschland

EU/1/13/906

2023 8 24

2023 8 23

PecFent

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

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/10/644

2023 9 4

2023 8 23

Rixathon

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1185

2023 8 24

2023 8 23

Ruxience

| 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/1/20/1431

2023 8 24

2023 8 23

Symkevi

| Vertex Pharmaceuticals (Ireland) Limited |
| --- |
| Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland |

Vertex Pharmaceuticals (Ireland) Limited

Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland

EU/1/18/1306

2023 8 24

2023 8 23

Tadalafil Lilly

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/17/1177

2023 8 25

2023 8 23

Vargatef

| 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/1/14/954

2023 8 28

2023 8 23

ZOLSKETIL pegylated liposomal

| 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

a

EU/1/22/1629

2023 8 24

2023 8 25

Caelyx pegylated liposomal

| Baxter Holding B.V. |
| --- |
| Kobaltweg 49, 3542 CE Utrecht, Nederland |

Baxter Holding B.V.

Kobaltweg 49, 3542 CE Utrecht, Nederland

EU/1/96/011

2023 8 29

2023 8 25

Cialis

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/02/237

2023 8 28

2023 8 25

Erleada

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/18/1342

2023 8 28

2023 8 25

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

EU/1/11/716

2023 8 28

2023 8 25

Fintepla

| UCB Pharma S.A. |
| --- |
| Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |

UCB Pharma S.A.

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

EU/1/20/1491

2023 8 29

2023 8 25

Reyataz

| 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/1/03/267

2023 9 1

2023 8 25

Semglee

| Biosimilar Collaborations Ireland Limited |
| --- |
| Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland |

Biosimilar Collaborations Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland

EU/1/18/1270

2023 8 28

2023 8 29

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

2023 8 30

2023 8 29

Spikevax

| MODERNA BIOTECH SPAIN, S.L. |
| --- |
| Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España |

MODERNA BIOTECH SPAIN, S.L.

Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España

EU/1/20/1507

2023 8 30

2023 8 30

Abevmy

| Biosimilar Collaborations Ireland Limited |
| --- |
| Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland |

Biosimilar Collaborations Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland

EU/1/20/1515

2023 9 4

2023 8 30

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

2023 9 1

2023 8 30

Hulio

| Biosimilar Collaborations Ireland Limited |
| --- |
| Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland |

Biosimilar Collaborations Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland

EU/1/18/1319

2023 9 4

2023 8 30

Kirsty

| Biosimilar Collaborations Ireland Limited |
| --- |
| Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland |

Biosimilar Collaborations Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland

EU/1/20/1506

2023 9 4

2023 8 30

Myclausen

| Passauer Pharma GmbH |
| --- |
| Eiderstedter Weg 3, 14129 Berlin, Deutschland |

Passauer Pharma GmbH

Eiderstedter Weg 3, 14129 Berlin, Deutschland

EU/1/10/647

2023 9 4

2023 8 30

Nepexto

| Biosimilar Collaborations Ireland Limited |
| --- |
| Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland |

Biosimilar Collaborations Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland

EU/1/20/1436

2023 9 4

2023 8 30

Ogivri

| Biosimilar Collaborations Ireland Limited |
| --- |
| Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland |

Biosimilar Collaborations Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland

EU/1/18/1341

2023 9 4

2023 8 30

Renvela

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

Sanofi B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/09/521

2023 8 31

2023 8 30

Synjardy

| 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/1/15/1003

2023 9 1

2023 8 31

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

2023 9 1

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

Rinkodaros leidimo atšaukimas

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2023 8 16 | Invirase | Roche Registration GmbH |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2023 8 16

Invirase

Roche Registration GmbH

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

EU/1/96/026

2023 8 17

2023 8 30

Imatinib Koanaa

| Koanaa Healthcare GmbH |
| --- |
| Fehrgasse 7, 2401 Fischamend, Österreich |

Koanaa Healthcare GmbH

Fehrgasse 7, 2401 Fischamend, Österreich

EU/1/21/1568

2023 9 4

2023 8 30

JETREA

| Inceptua AB |
| --- |
| Gustavslundsv. 143, 16751 Bromma, Sverige |

Inceptua AB

Gustavslundsv. 143, 16751 Bromma, Sverige

EU/1/13/819

2023 8 31

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

Rinkodaros leidimo sustabdymas

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2023 8 3 | Adakveo | Novartis Europharm Limited |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2023 8 3

Adakveo

Novartis Europharm Limited

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

EU/1/20/1476

2023 8 4

—   Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis; Europos Parlamento ir Tarybos reglamento (ES) 2019/6 5 straipsnis): Priimta

Rinkodaros leidimo pakeitimas

Priimta

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2023 8 4 | CYTOPOINT | Zoetis Belgium |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2023 8 4

CYTOPOINT

Zoetis Belgium

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

EU/2/17/205

2023 8 7

2023 8 4

MHYOSPHERE PCV ID

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

Laboratorios Hipra, S.A.

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

EU/2/20/259

2023 8 21

2023 8 4

NASYM

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

Laboratorios Hipra, S.A.

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

EU/2/19/241

2023 9 1

2023 8 8

Easotic

| VIRBAC |
| --- |
| 1ère avenue 2065 m LID, 06516 Carros, France |

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/08/085

2023 8 10

2023 8 8

Versican Plus DHPPi

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

Zoetis Belgium

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

EU/2/14/169

2023 8 29

2023 8 8

Versican Plus DHPPi/L4

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

Zoetis Belgium

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

EU/2/14/164

2023 8 29

2023 8 11

Felpreva

| Vetoquinol S.A. |
| --- |
| Magny-Vernois, 70200 Lure, France |

Vetoquinol S.A.

Magny-Vernois, 70200 Lure, France

EU/2/21/277

2023 8 21

2023 8 11

SevoFlo

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

Zoetis Belgium

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

EU/2/02/035

2023 8 14

2023 8 24

Apoquel

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

Zoetis Belgium

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

EU/2/13/154

2023 8 25

2023 8 24

Cimalgex

| Vétoquinol SA |
| --- |
| Magny-Vernois, 70200 Lure, France |

Vétoquinol SA

Magny-Vernois, 70200 Lure, France

EU/2/10/119

2023 8 25

2023 8 24

CircoMax Myco

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

Zoetis Belgium

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

EU/2/20/264

2023 8 25

2023 8 24

Dexdomitor

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

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/02/033

2023 8 25

2023 8 24

NexGard Combo

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/20/267

2023 8 25

2023 8 24

Panacur AquaSol

| 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/2/11/135

2023 8 25

2023 8 24

RenuTend

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/22/282

2023 8 25

2023 8 24

Ypozane

| VIRBAC S.A. |
| --- |
| 1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France |

VIRBAC S.A.

1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France

EU/2/06/068

2023 8 25

2023 8 24

Zactran

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/08/082

2023 8 25

2023 8 24

Zuprevo

| 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/2/11/124

2023 8 29

2023 8 25

Bonqat

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

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/21/273

2023 8 28

2023 8 25

Palladia

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

Zoetis Belgium

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

EU/2/09/100

2023 9 1

2023 8 30

Porcilis PCV

| 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/2/08/091

2023 8 31

2023 8 30

Tessie

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

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/21/276

2023 8 31

—   Rinkodaros leidimo atšaukimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis; Europos Parlamento ir Tarybos reglamento (ES) 2019/6 5 straipsnis)

Rinkodaros leidimo atšaukimas

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2023 8 24 | Nobivac Myxo-RHD | Intervet International B.V. |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2023 8 24

Nobivac Myxo-RHD

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/11/132

2023 8 28

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.

1

(2)  
  OL L 4, 2019 1 7, p. 43.

2

---