# Iris Oifigiúil C 331/31 L

| | ISSN 1977-107X |
| --- | --- |
| Iris Oifigiúil
  an Aontais Eorpaigh | C 331 |
| | |
| An t-eagrán Gaeilge | Faisnéis agus Fógraí | 6531 Lúnasa 2022 |

ISSN 1977-107X

Iris Oifigiúil

an Aontais Eorpaigh

C 331

An t-eagrán Gaeilge

Faisnéis agus Fógraí

6531 Lúnasa 2022

---

| Clár | Leathanach |
| --- | --- |
| | IV   Fógraí |
| | FÓGRAÍ Ó INSTITIÚIDÍ, Ó CHOMHLACHTAÍ, Ó OIFIGÍ, AGUS Ó GHNÍOMHAIREACHTAÍ AN AONTAIS EORPAIGH |
| | An Coimisiún Eorpach |
| 2022/C 331/01 | Achoimre ar chinntí an Aontais Eorpaigh maidir le húdaruithe margaíochta i ndáil le táirgí íocshláinte ó 1 Iúil 2022 go dtí 31 Iúil 2022(Arna fhoilsiú de bhun Airteagal 13 nó Airteagal 38 de Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle nó Airteagal 5 de Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle) | 1 |
| 2022/C 331/02 | Achoimre ar chinntí an Aontais Eorpaigh maidir le húdaruithe margaíochta i ndáil le táirgí íocshláinte ón 1 Iúil 2022 go dtí an 31 Iúil 2022(Cinntí arna nglacadh de bhun Airteagal 34 de Threoir 2001/83/CE, Airteagal 38 de Threoir 2001/82/CE nó Airteagal 5 de Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle) | 13 |

Clár

Leathanach

IV   Fógraí

FÓGRAÍ Ó INSTITIÚIDÍ, Ó CHOMHLACHTAÍ, Ó OIFIGÍ, AGUS Ó GHNÍOMHAIREACHTAÍ AN AONTAIS EORPAIGH

An Coimisiún Eorpach

2022/C 331/01

Achoimre ar chinntí an Aontais Eorpaigh maidir le húdaruithe margaíochta i ndáil le táirgí íocshláinte ó 1 Iúil 2022 go dtí 31 Iúil 2022(Arna fhoilsiú de bhun Airteagal 13 nó Airteagal 38 de Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle nó Airteagal 5 de Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle)

(Arna fhoilsiú de bhun Airteagal 13 nó Airteagal 38 de Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle nó Airteagal 5 de Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle)

1

2022/C 331/02

Achoimre ar chinntí an Aontais Eorpaigh maidir le húdaruithe margaíochta i ndáil le táirgí íocshláinte ón 1 Iúil 2022 go dtí an 31 Iúil 2022(Cinntí arna nglacadh de bhun Airteagal 34 de Threoir 2001/83/CE, Airteagal 38 de Threoir 2001/82/CE nó Airteagal 5 de Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle)

(Cinntí arna nglacadh de bhun Airteagal 34 de Threoir 2001/83/CE, Airteagal 38 de Threoir 2001/82/CE nó Airteagal 5 de Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle)

13

---

| GA | |
| --- | --- |

GA

---

IV Fógraí

FÓGRAÍ Ó INSTITIÚIDÍ, Ó CHOMHLACHTAÍ, Ó OIFIGÍ, AGUS Ó GHNÍOMHAIREACHTAÍ AN AONTAIS EORPAIGH

An Coimisiún Eorpach

| 31.8.2022 | GA | Iris Oifigiúil an Aontais Eorpaigh | C 331/1 |
| --- | --- | --- | --- |

31.8.2022

GA

Iris Oifigiúil an Aontais Eorpaigh

C 331/1

---

Achoimre ar chinntí an Aontais Eorpaigh maidir le húdaruithe margaíochta i ndáil le táirgí íocshláinte ó 1 Iúil 2022 go dtí 31 Iúil 2022

(Arna fhoilsiú de bhun Airteagal 13 nó Airteagal 38 de Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle (1) nó Airteagal 5 de Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle (2))

(2022/C 331/01)

—   Údarú margaíochta a eisiúint (Airteagal 13 de Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle): Glactha

| Dáta an chinnidh | Ainm an táirge íocshláinte | ANI (an tAinm Neamhdhílseánaigh Idirnáisiúnta) | Sealbhóir an údaraithe margaíochta | Uimhir na hiontrála sa Chlár Comhphobail | Foirm chógaisíochta | An Cód CAT (an Cód Ceimiceach Teiripeach Anatamaíoch) | Dáta an fhógra |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.7.2022 | LIBTAYO | cemiplimab | Regeneron Ireland Designated Activity Company (DAC) |
| One Warrington Place, Dublin 2, D02 HH27 Ireland |

Dáta an chinnidh

Ainm an táirge íocshláinte

ANI (an tAinm Neamhdhílseánaigh Idirnáisiúnta)

Sealbhóir an údaraithe margaíochta

Uimhir na hiontrála sa Chlár Comhphobail

Foirm chógaisíochta

An Cód CAT (an Cód Ceimiceach Teiripeach Anatamaíoch)

Dáta an fhógra

1.7.2022

LIBTAYO

cemiplimab

Regeneron Ireland Designated Activity Company (DAC)

One Warrington Place, Dublin 2, D02 HH27 Ireland

EU/1/19/1376

Tiúchán do thuaslagán le haghaidh insilte

L01XC33

5.7.2022

15.7.2022

Cevenfacta

eptacog beta (activated)

| Laboratoire français du Fractionnement et des Biotechnologies |
| --- |
| Tour W, 102 Terrasse Boieldieu, 19ème Étage, 92800 Puteaux France |

Laboratoire français du Fractionnement et des Biotechnologies

Tour W, 102 Terrasse Boieldieu, 19ème Étage, 92800 Puteaux France

EU/1/22/1664

Púdar agus tuaslagóir do thuaslagán le haghaidh insteallta

B02BD08

22.7.2022

15.7.2022

Ertapenem SUN

ertapenem

| Sun Pharmaceutical Industries Europe B.V. |
| --- |
| Polarisavenue 87, 2132JH Hoofddorp, Nederland |

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87, 2132JH Hoofddorp, Nederland

EU/1/22/1656

Púdar do thiúchán do thuaslagán le haghaidh insilte

J01DH03

22.7.2022

15.7.2022

Ganirelix Gedeon Richter

ganirelix

| Gedeon Richter Plc. |
| --- |
| Gyömrői út 19-21, 1103 Budapest, Magyarország |

Gedeon Richter Plc.

Gyömrői út 19-21, 1103 Budapest, Magyarország

EU/1/22/1658

Tuaslagán le haghaidh insteallta

H01CC01

19.7.2022

15.7.2022

Kinpeygo

budesonide

| Calliditas Therapeutics AB |
| --- |
| Kungsbron 1, 11122 Stockholm, Sverige |

Calliditas Therapeutics AB

Kungsbron 1, 11122 Stockholm, Sverige

EU/1/22/1657

Modified-release capsule, hard

A07EA06

18.7.2022

15.7.2022

Sugammadex Fresenius Kabi

sugammadex

| 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/1/22/1663

Tuaslagán le haghaidh insteallta

V03AB35

18.7.2022

18.7.2022

NEXPOVIO

selinexor

| Karyopharm Europe GmbH |
| --- |
| Franziska-Bilek-Weg 9, 80339 München, Deutschland |

Karyopharm Europe GmbH

Franziska-Bilek-Weg 9, 80339 München, Deutschland

EU/1/21/1537

Piolla brataithe le scannán

L01XX66

19.7.2022

18.7.2022

Upstaza

eladocagene exuparvovec

| PTC Therapeutics International Limited |
| --- |
| 70 Sir John Rogerson's Quay, Dublin 2, Ireland |

PTC Therapeutics International Limited

70 Sir John Rogerson's Quay, Dublin 2, Ireland

EU/1/22/1653

Tuaslagán le haghaidh insilte

Pending

22.7.2022

18.7.2022

Zokinvy

lonafarnib

| EigerBio Europe Limited |
| --- |
| 1 Castlewood Avenue, Rathmines, Dublin 6, D06 H685, Ireland |

EigerBio Europe Limited

1 Castlewood Avenue, Rathmines, Dublin 6, D06 H685, Ireland

EU/1/22/1660

Capsúl, crua

A16AX20

19.7.2022

22.7.2022

Sitagliptin/Metformin hydrochloride Accord

sitagliptin/metformin hydrochloride

| 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/1/22/1661

Piolla brataithe le scannán

A10BD07

28.7.2022

—   Údarú margaíochta a mhodhnú (Airteagal 13 de Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle): Glactha

| Dáta an chinnidh | Ainm an táirge íocshláinte | Sealbhóir an údaraithe margaíochta | Uimhir na hiontrála sa Chlár Comhphobail | Dáta an fhógra |
| --- | --- | --- | --- | --- |
| 1.7.2022 | Armisarte | Actavis Group PTC ehf. |
| Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland |

Dáta an chinnidh

Ainm an táirge íocshláinte

Sealbhóir an údaraithe margaíochta

Uimhir na hiontrála sa Chlár Comhphobail

Dáta an fhógra

1.7.2022

Armisarte

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/15/1063

6.7.2022

1.7.2022

Entecavir 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/1/17/1211

4.7.2022

1.7.2022

Hetlioz

| Vanda Pharmaceuticals Netherlands B.V. |
| --- |
| Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland |

Vanda Pharmaceuticals Netherlands B.V.

Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland

EU/1/15/1008

8.8.2022

1.7.2022

Irbesartan / Hydrochlorothiazide Teva

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/583

4.7.2022

1.7.2022

Kinzalkomb

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

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/02/214

5.7.2022

1.7.2022

Levodopa/Carbidopa/Entacapone Orion

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

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/706

11.7.2022

1.7.2022

Neparvis

| 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/1/16/1103

7.7.2022

1.7.2022

Nuvaxovid

| Novavax CZ, a.s. |
| --- |
| Bohumil 138, 281 63 Jevany, Česká republika |

Novavax CZ, a.s.

Bohumil 138, 281 63 Jevany, Česká republika

EU/1/21/1618

1.7.2022

1.7.2022

Orladeyo

| Biocryst Ireland Limited |
| --- |
| Block 4, Harcourt Centre, Harcourt Road, Dublin 2, D02 HW77, Ireland |

Biocryst Ireland Limited

Block 4, Harcourt Centre, Harcourt Road, Dublin 2, D02 HW77, Ireland

EU/1/21/1544

5.7.2022

1.7.2022

Paxlovid

| 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/1/22/1625

1.7.2022

1.7.2022

Strensiq

| Alexion Europe SAS |
| --- |
| 103-105 rue Anatole France, 92300 Levallois-Perret, France |

Alexion Europe SAS

103-105 rue Anatole France, 92300 Levallois-Perret, France

EU/1/15/1015

4.7.2022

1.7.2022

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

19.7.2022

1.7.2022

Zirabev

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

Pfizer Europe MA EEIG

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

EU/1/18/1344

4.7.2022

4.7.2022

Prialt

| Esteve Pharmaceuticals GmbH |
| --- |
| Hohenzollerndamm 150-151, 14199 Berlin, Deutschland |

Esteve Pharmaceuticals GmbH

Hohenzollerndamm 150-151, 14199 Berlin, Deutschland

EU/1/04/302

7.7.2022

8.7.2022

Amsparity

| 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/1/19/1415

12.7.2022

8.7.2022

AUBAGIO

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

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/13/838

11.7.2022

8.7.2022

Azacitidine Betapharm

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95, 86156 Augsburg, Deutschland |

betapharm Arzneimittel GmbH

Kobelweg 95, 86156 Augsburg, Deutschland

EU/1/19/1416

12.7.2022

8.7.2022

Azacitidine 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/1/20/1426

12.7.2022

8.7.2022

Calquence

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/20/1479

11.7.2022

8.7.2022

Dexdor

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

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/718

11.7.2022

8.7.2022

EDURANT

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/11/736

12.7.2022

8.7.2022

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

13.7.2022

8.7.2022

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

12.7.2022

8.7.2022

Farydak

| Secura Bio Limited |
| --- |
| 32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland |

Secura Bio Limited

32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland

EU/1/15/1023

14.7.2022

8.7.2022

Fingolimod 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/1/20/1450

11.7.2022

8.7.2022

Fortacin

| Recordati Ireland Ltd |
| --- |
| Raheens East, Ringaskiddy Co. Cork, Ireland |

Recordati Ireland Ltd

Raheens East, Ringaskiddy Co. Cork, Ireland

EU/1/13/881

12.7.2022

8.7.2022

Giapreza

| PAION Deutschland GmbH |
| --- |
| Heussstraße 25, 52078 Aachen, Deutschland |

PAION Deutschland GmbH

Heussstraße 25, 52078 Aachen, Deutschland

EU/1/19/1384

13.7.2022

8.7.2022

Grasustek

| Juta Pharma GmbH |
| --- |
| Gutenbergstr. 13, 24941, Flensburg, Deutschland |

Juta Pharma GmbH

Gutenbergstr. 13, 24941, Flensburg, Deutschland

EU/1/19/1375

12.7.2022

8.7.2022

Herceptin

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

Roche Registration GmbH

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

EU/1/00/145

11.7.2022

8.7.2022

Iclusig

| Incyte Biosciences Distribution B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/13/839

15.7.2022

8.7.2022

INCRELEX

| Ipsen Pharma |
| --- |
| 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France |

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/07/402

12.7.2022

8.7.2022

Kadcyla

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

Roche Registration GmbH

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

EU/1/13/885

11.7.2022

8.7.2022

Keppra

| 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/1/00/146

12.7.2022

8.7.2022

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

11.7.2022

8.7.2022

Lutathera

| Advanced Accelerator Applications |
| --- |
| 20 rue Diesel, 01630 Saint-Genis-Pouilly, France |

Advanced Accelerator Applications

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

EU/1/17/1226

11.7.2022

8.7.2022

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

11.7.2022

8.7.2022

MicardisPlus

| 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/1/02/213

13.7.2022

8.7.2022

Minjuvi

| Incyte Biosciences Distribution B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/21/1570

11.7.2022

8.7.2022

Mvasi

| Amgen Technology (Ireland) UC |
| --- |
| Pottery Road, Dun Laoghaire, Co. Dublin, Ireland |

Amgen Technology (Ireland) UC

Pottery Road, Dun Laoghaire, Co. Dublin, Ireland

EU/1/17/1246

12.7.2022

8.7.2022

Orgovyx

| 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/1/22/1642

11.7.2022

8.7.2022

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

12.7.2022

8.7.2022

Pemetrexed Sandoz

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1037

12.7.2022

8.7.2022

Quinsair

| 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/1/14/973

13.7.2022

8.7.2022

Striascan

| CIS bio international |
| --- |
| RN 306 – Saclay, B.P. 32, F-91192 Gif-sur-Yvette Cedex, France |

CIS bio international

RN 306 – Saclay, B.P. 32, F-91192 Gif-sur-Yvette Cedex, France

EU/1/19/1372

11.7.2022

8.7.2022

Tepadina

| ADIENNE S.r.l.S.U. |
| --- |
| Via Galileo Galilei 19, 20867 Caponago (MB), Italia |

ADIENNE S.r.l.S.U.

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

EU/1/10/622

12.7.2022

8.7.2022

Thiotepa Riemser

| Esteve Pharmaceuticals GmbH |
| --- |
| Hohenzollerndamm 150-151, 14199 Berlin, Deutschland |

Esteve Pharmaceuticals GmbH

Hohenzollerndamm 150-151, 14199 Berlin, Deutschland

EU/1/21/1536

11.7.2022

8.7.2022

Tracleer

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/02/220

11.7.2022

8.7.2022

Vimpat

| 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/1/08/470

11.7.2022

8.7.2022

Votrient

| 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/1/10/628

11.7.2022

8.7.2022

Xeloda

| CHEPLAPHARM Arzneimittel GmbH |
| --- |
| Ziegelhof 24, 17489 Greifswald, Deutschland |

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24, 17489 Greifswald, Deutschland

EU/1/00/163

11.7.2022

8.7.2022

Xenleta

| Nabriva Therapeutics Ireland DAC |
| --- |
| Alexandra House, Office 225/227, The Sweepstakes Ballsbridge, Dublin 4, D04 C7H2, Ireland |

Nabriva Therapeutics Ireland DAC

Alexandra House, Office 225/227, The Sweepstakes Ballsbridge, Dublin 4, D04 C7H2, Ireland

EU/1/20/1457

13.7.2022

8.7.2022

Yondelis

| Pharma Mar S.A. |
| --- |
| Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España |

Pharma Mar S.A.

Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España

EU/1/07/417

12.7.2022

11.7.2022

Enhertu

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

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/20/1508

13.7.2022

15.7.2022

Alecensa

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

Roche Registration GmbH

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

EU/1/16/1169

19.7.2022

15.7.2022

AYVAKYT

| Blueprint Medicines (Netherlands) B.V. |
| --- |
| Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland |

Blueprint Medicines (Netherlands) B.V.

Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland

EU/1/20/1473

18.7.2022

15.7.2022

Edistride

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1052

19.7.2022

15.7.2022

Elebrato Ellipta

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

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/17/1237

19.7.2022

15.7.2022

Emgality

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/18/1330

19.7.2022

15.7.2022

Forxiga

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/795

19.7.2022

15.7.2022

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

10.8.2022

15.7.2022

Galvus

| 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/1/07/414

18.7.2022

15.7.2022

Idefirix

| Hansa Biopharma AB |
| --- |
| P.O. Box 785, 220 07 Lund, Sverige |

Hansa Biopharma AB

P.O. Box 785, 220 07 Lund, Sverige

EU/1/20/1471

19.7.2022

15.7.2022

Jalra

| 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/1/08/485

18.7.2022

15.7.2022

Nitisinone MDK

| MendeliKABS Europe Limited |
| --- |
| Unit 3D, North Point House, North Point Business Park, New Mallow Road 9, Cork, T23 AT2P, Ireland |

MendeliKABS Europe Limited

Unit 3D, North Point House, North Point Business Park, New Mallow Road 9, Cork, T23 AT2P, Ireland

EU/1/17/1217

19.7.2022

15.7.2022

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

20.7.2022

15.7.2022

Posaconazole AHCL

| 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/1/19/1380

3.8.2022

15.7.2022

Raxone

| Santhera Pharmaceuticals (Deutschland) GmbH |
| --- |
| Marie-Curie Straße 8, 79539 Lörrach, Deutschland |

Santhera Pharmaceuticals (Deutschland) GmbH

Marie-Curie Straße 8, 79539 Lörrach, Deutschland

EU/1/15/1020

2.8.2022

15.7.2022

Remsima

| 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/1/13/853

18.7.2022

15.7.2022

Trelegy 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/1/17/1236

19.7.2022

15.7.2022

Tremfya

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1234

19.7.2022

15.7.2022

Xiliarx

| 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/1/08/486

18.7.2022

18.7.2022

Accofil

| 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/1/14/946

8.8.2022

18.7.2022

Bortezomib 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/1/19/1397

20.7.2022

18.7.2022

Cyramza

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/957

22.7.2022

18.7.2022

Darunavir Krka d.d.

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

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1248

20.7.2022

18.7.2022

Irbesartan 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/1/06/376

19.7.2022

18.7.2022

Lenalidomide 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/1/20/1519

22.7.2022

18.7.2022

Mayzent

| 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/1/19/1414

19.7.2022

18.7.2022

Suboxone

| Indivior Europe Limited |
| --- |
| 27 Windsor Place, Dublin 2, D02 DK44, Ireland |

Indivior Europe Limited

27 Windsor Place, Dublin 2, D02 DK44, Ireland

EU/1/06/359

22.7.2022

18.7.2022

Zejula

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

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/17/1235

20.7.2022

19.7.2022

Veklury

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/20/1459

19.7.2022

22.7.2022

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

28.7.2022

22.7.2022

Imvanex

| Bavarian Nordic A/S |
| --- |
| Philip Heymans Allé 3, DK-2900 Hellerup, Danmark |

Bavarian Nordic A/S

Philip Heymans Allé 3, DK-2900 Hellerup, Danmark

EU/1/13/855

25.7.2022

22.7.2022

Kirsty

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

Mylan IRE Healthcare Limited

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

EU/1/20/1506

26.7.2022

22.7.2022

Lonquex

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/13/856

2.8.2022

22.7.2022

Miglustat Dipharma

| Dipharma B.V. |
| --- |
| Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland |

Dipharma B.V.

Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland

EU/1/18/1346

26.7.2022

22.7.2022

Onureg

| 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/1/21/1556

27.7.2022

22.7.2022

Rinvoq

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/19/1404

25.7.2022

22.7.2022

Ryeqo

| Gedeon Richter Plc. |
| --- |
| Gyömrői út 19-21, 1103 Budapest, Magyarország |

Gedeon Richter Plc.

Gyömrői út 19-21, 1103 Budapest, Magyarország

EU/1/21/1565

27.7.2022

22.7.2022

Xevudy

| 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/1/21/1562

22.7.2022

22.7.2022

Zavesca

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/02/238

26.7.2022

25.7.2022

Braftovi

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

Pierre Fabre Médicament

Les Cauquillous, 81500 Lavaur, France

EU/1/18/1314

26.7.2022

25.7.2022

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

28.7.2022

25.7.2022

Cyramza

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/957

27.7.2022

25.7.2022

Zerbaxa

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1032

26.7.2022

27.7.2022

BroPair Spiromax

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/21/1534

2.8.2022

27.7.2022

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

29.7.2022

27.7.2022

Fluenz Tetra

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/887

28.7.2022

27.7.2022

Phesgo

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

Roche Registration GmbH

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

EU/1/20/1497

29.7.2022

27.7.2022

Rinvoq

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/19/1404

28.7.2022

27.7.2022

Seffalair Spiromax

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/21/1533

2.8.2022

27.7.2022

Zubsolv

| 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/1/17/1233

8.8.2022

28.7.2022

COVID-19 Vaccine (inactivated, adjuvanted) Valneva

| Valneva Austria GmbH |
| --- |
| Campus Vienna Biocenter 3, 1030 Wien, Österreich |

Valneva Austria GmbH

Campus Vienna Biocenter 3, 1030 Wien, Österreich

EU/1/21/1624

29.7.2022

—   Údarú margaíochta a tharraingt siar (Airteagal 13 de Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle)

| Dáta an chinnidh | Ainm an táirge íocshláinte | Sealbhóir an údaraithe margaíochta | Uimhir na hiontrála sa Chlár Comhphobail | Dáta an fhógra |
| --- | --- | --- | --- | --- |
| 1.7.2022 | Thymanax | Servier (Ireland) Industries Limited |
| Gorey Road, Arklow, Co. Wicklow, Ireland |

Dáta an chinnidh

Ainm an táirge íocshláinte

Sealbhóir an údaraithe margaíochta

Uimhir na hiontrála sa Chlár Comhphobail

Dáta an fhógra

1.7.2022

Thymanax

Servier (Ireland) Industries Limited

Gorey Road, Arklow, Co. Wicklow, Ireland

EU/1/08/498

5.7.2022

—   Údarú margaíochta a eisiúint (Airteagal 38 de Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle; Airteagal 5 de Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle): Glactha

| Dáta an chinnidh | Ainm an táirge íocshláinte | ANI (an tAinm Neamhdhílseánaigh Idirnáisiúnta) | Sealbhóir an údaraithe margaíochta | Uimhir na hiontrála sa Chlár Comhphobail | Foirm chógaisíochta | An Cód CAT (an Cód Ceimiceach Teiripeach Anatamaíoch) | Dáta an fhógra |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 27.7.2022 | Cortaderm | Hydrocortisone aceponate | Alfasan Nederland B.V. |
| Kuipersweg 9, 3449 JA Woerden, Nederland |

Dáta an chinnidh

Ainm an táirge íocshláinte

ANI (an tAinm Neamhdhílseánaigh Idirnáisiúnta)

Sealbhóir an údaraithe margaíochta

Uimhir na hiontrála sa Chlár Comhphobail

Foirm chógaisíochta

An Cód CAT (an Cód Ceimiceach Teiripeach Anatamaíoch)

Dáta an fhógra

27.7.2022

Cortaderm

Hydrocortisone aceponate

Alfasan Nederland B.V.

Kuipersweg 9, 3449 JA Woerden, Nederland

EU/2/22/287

Cutaneous spray, solution

QD07AC16

29.7.2022

27.7.2022

Evanovo

Vacsaín beo Coccidiosis do sicíní

| 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/2/22/284

Suspension and solvent for suspension for injection

Pending

28.7.2022

—   Údarú margaíochta a mhodhnú (Airteagal 38 de Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle; Airteagal 5 de Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle): Glactha

| Dáta an chinnidh | Ainm an táirge íocshláinte | Sealbhóir an údaraithe margaíochta | Uimhir na hiontrála sa Chlár Comhphobail | Dáta an fhógra |
| --- | --- | --- | --- | --- |
| 4.7.2022 | BTVPUR | Boehringer Ingelheim Vetmedica GmbH |
| 55216 Ingelheim am Rhein, Deutschland |

Dáta an chinnidh

Ainm an táirge íocshláinte

Sealbhóir an údaraithe margaíochta

Uimhir na hiontrála sa Chlár Comhphobail

Dáta an fhógra

4.7.2022

BTVPUR

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/10/113

5.7.2022

4.7.2022

Tulinovet

| V.M.D.n.v. |
| --- |
| Hoge Mauw 900, 2370 Arendonk, Belgïe |

V.M.D.n.v.

Hoge Mauw 900, 2370 Arendonk, Belgïe

EU/2/20/257

5.7.2022

11.7.2022

Coliprotec F4/F18

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

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/16/202

12.7.2022

11.7.2022

HorStem

| EquiCord S.L |
| --- |
| 103-D Loeches, Polígono. Industrial Ventorro del Cano, Alcorcón, 28925 Madrid, España. |

EquiCord S.L

103-D Loeches, Polígono. Industrial Ventorro del Cano, Alcorcón, 28925 Madrid, España.

EU/2/18/226

12.7.2022

11.7.2022

Loxicom

| Norbrook Laboratories (Ireland) Limited |
| --- |
| Rossmore Industrial Estate, Monaghan, Ireland |

Norbrook Laboratories (Ireland) Limited

Rossmore Industrial Estate, Monaghan, Ireland

EU/2/08/090

14.7.2022

11.7.2022

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

13.7.2022

11.7.2022

VEPURED

| 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/2/17/214

14.7.2022

15.7.2022

Bravecto

| 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/2/13/158

19.7.2022

15.7.2022

Cerenia

| 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/2/06/062

19.7.2022

15.7.2022

GUMBOHATCH

| 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/2/19/245

19.7.2022

15.7.2022

Nobivac L4

| 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/2/12/143

19.7.2022

15.7.2022

Suprelorin

| 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/2/07/072

19.7.2022

15.7.2022

Suvaxyn PRRS MLV

| 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/2/17/215

22.7.2022

22.7.2022

Comfortis

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

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/10/115

27.7.2022

22.7.2022

FRONTPRO

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/19/240

25.7.2022

22.7.2022

GALLIPRANT

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

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/17/221

27.7.2022

22.7.2022

Onsior

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

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/08/089

27.7.2022

22.7.2022

Vectra Felis

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

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/14/165

26.7.2022

22.7.2022

VEPURED

| 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/2/17/214

27.7.2022

27.7.2022

Circovac

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

CEVA-Phylaxia Co. Ltd

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/07/075

29.7.2022

27.7.2022

Loxicom

| Norbrook Laboratories (Ireland) Limited |
| --- |
| Rossmore Industrial Estate, Monaghan, Ireland |

Norbrook Laboratories (Ireland) Limited

Rossmore Industrial Estate, Monaghan, Ireland

EU/2/08/090

29.7.2022

27.7.2022

Nobilis IB 4-91

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

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/98/006

29.7.2022

—   Údarú margaíochta a tharraingt siar (Airteagal 38 de Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle; Airteagal 5 de Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle)

| Dáta an chinnidh | Ainm an táirge íocshláinte | Sealbhóir an údaraithe margaíochta | Uimhir na hiontrála sa Chlár Comhphobail | Dáta an fhógra |
| --- | --- | --- | --- | --- |
| 22.7.2022 | Bovilis BTV8 | Intervet International B.V. |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Dáta an chinnidh

Ainm an táirge íocshláinte

Sealbhóir an údaraithe margaíochta

Uimhir na hiontrála sa Chlár Comhphobail

Dáta an fhógra

22.7.2022

Bovilis BTV8

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/10/106

9.8.2022

Aon duine ar mian leis féachaint ar an tuarascáil mheasúnaithe phoiblí maidir leis na táirgí íocshláinte atá i gceist agus na cinntí a bhaineann léi, iarrtar orthu teagmháil a dhéanamh le:

| European Medicines Agency |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| AN ÍSILTÍR |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

AN ÍSILTÍR

---

(1)  IO L 136, 30.4.2004, lch. 1.

(2)  IO L 4, 7.1.2019, lch. 43.

---

| 31.8.2022 | GA | Iris Oifigiúil an Aontais Eorpaigh | C 331/13 |
| --- | --- | --- | --- |

31.8.2022

GA

Iris Oifigiúil an Aontais Eorpaigh

C 331/13

---

Achoimre ar chinntí an Aontais Eorpaigh maidir le húdaruithe margaíochta i ndáil le táirgí íocshláinte ón 1 Iúil 2022 go dtí an 31 Iúil 2022

(Cinntí arna nglacadh de bhun Airteagal 34 de Threoir 2001/83/CE (1), Airteagal 38 de Threoir 2001/82/CE (2) nó Airteagal 5 de Rialachán (AE) 2019/6 (3) ó Pharlaimint na hEorpa agus ón gComhairle)

(2022/C 331/02)

—   Údarú margaíochta náisiúnta a eisiúint, a choinneáil nó a mhodhnú

| Dáta an chinnidh | Ainm nó ainmneacha an táirge íocshláinte | ANI (an tAinm Neamhdhílseánaigh Idirnáisiúnta) | Sealbhóir nó sealbhóirí an údaraithe margaíochta | An Ballstát lena mbaineann | Dáta an fhógra |
| --- | --- | --- | --- | --- | --- |
| 18.7.2022 | Daruph and Anafezyn and associated names | dasatinib (anhydrous) | Féach an Iarscríbhinn | Féach an Iarscríbhinn | 19.7.2022 |

Dáta an chinnidh

Ainm nó ainmneacha an táirge íocshláinte

ANI (an tAinm Neamhdhílseánaigh Idirnáisiúnta)

Sealbhóir nó sealbhóirí an údaraithe margaíochta

An Ballstát lena mbaineann

Dáta an fhógra

18.7.2022

Daruph and Anafezyn and associated names

dasatinib (anhydrous)

Féach an Iarscríbhinn

Féach an Iarscríbhinn

19.7.2022

---

(1)  IO L 311, 28.11.2001, lch. 67.

(2)  IO L 311, 28.11.2001, lch. 1.

(3)  IO L 4, 7.1.2019, lch. 43.

---

IARSCRÍBHINN

Liosta táirgí íocshláinte agus cur i láthair

| Ballstát AE/LEE | Ainm cuideachta an iarratasóra
  Seoladh | Ainm (cumtha) | Neart | Foirm Chógaisíochta | Bealach riartha |
| --- | --- | --- | --- | --- | --- |
| An Fhrainc | Zentiva, k.s. |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Ballstát AE/LEE

Ainm cuideachta an iarratasóra

Seoladh

Ainm (cumtha)

Neart

Foirm Chógaisíochta

Bealach riartha

An Fhrainc

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn 16 mg, comprimé pelliculé (1)

16 mg

táibléad sceobhrataithe

úsáid bhéil

An Fhrainc

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn 40 mg, comprimé pelliculé1

40 mg

táibléad sceobhrataithe

úsáid bhéil

An Fhrainc

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn 55 mg, comprimé pelliculé1

55 mg

táibléad sceobhrataithe

úsáid bhéil

An Fhrainc

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn 63 mg, comprimé pelliculé1

63 mg

táibléad sceobhrataithe

úsáid bhéil

An Fhrainc

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn 79 mg, comprimé pelliculé1

79 mg

táibléad sceobhrataithe

úsáid bhéil

An Fhrainc

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn 111 mg, comprimé pelliculé1

111 mg

táibléad sceobhrataithe

úsáid bhéil

An Ghearmáin

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn 16 mg Filmtabletten

16 mg

táibléad sceobhrataithe

úsáid bhéil

An Ghearmáin

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 16 mg Filmtabletten

16 mg

táibléad sceobhrataithe

úsáid bhéil

An Ghearmáin

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn 40 mg Filmtabletten

40 mg

táibléad sceobhrataithe

úsáid bhéil

An Ghearmáin

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 40 mg Filmtabletten

40 mg

táibléad sceobhrataithe

úsáid bhéil

An Ghearmáin

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn 55 mg Filmtabletten

55 mg

táibléad sceobhrataithe

úsáid bhéil

An Ghearmáin

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 55 mg Filmtabletten

55 mg

táibléad sceobhrataithe

úsáid bhéil

An Ghearmáin

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn 63 mg Filmtabletten

63 mg

táibléad sceobhrataithe

úsáid bhéil

An Ghearmáin

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 63 mg Filmtabletten

63 mg

táibléad sceobhrataithe

úsáid bhéil

An Ghearmáin

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn 79 mg Filmtabletten

79 mg

táibléad sceobhrataithe

úsáid bhéil

An Ghearmáin

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 79 mg Filmtabletten

79 mg

táibléad sceobhrataithe

úsáid bhéil

An Ghearmáin

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn 111 mg Filmtabletten

111 mg

táibléad sceobhrataithe

úsáid bhéil

An Ghearmáin

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 111 mg Filmtabletten

111 mg

táibléad sceobhrataithe

úsáid bhéil

An Ungáir

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 16 mg filmtabletta

16 mg

táibléad sceobhrataithe

úsáid bhéil

An Ungáir

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 40 mg filmtabletta

40 mg

táibléad sceobhrataithe

úsáid bhéil

An Ungáir

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 55 mg filmtabletta

55 mg

táibléad sceobhrataithe

úsáid bhéil

An Ungáir

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 63 mg filmtabletta

63 mg

táibléad sceobhrataithe

úsáid bhéil

An Ungáir

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 79 mg filmtabletta

79 mg

táibléad sceobhrataithe

úsáid bhéil

An Ungáir

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 111 mg filmtabletta

111 mg

táibléad sceobhrataithe

úsáid bhéil

Éire

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn 16 mg film-coated tablets

16 mg

táibléad sceobhrataithe

úsáid bhéil

Éire

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn 40 mg film-coated tablets

40 mg

táibléad sceobhrataithe

úsáid bhéil

Éire

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn 55 mg film-coated tablets

55 mg

táibléad sceobhrataithe

úsáid bhéil

Éire

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn 63 mg film-coated tablets

63 mg

táibléad sceobhrataithe

úsáid bhéil

Éire

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn 79 mg film-coated tablets

79 mg

táibléad sceobhrataithe

úsáid bhéil

Éire

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn 111 mg film-coated tablets

111 mg

táibléad sceobhrataithe

úsáid bhéil

An Iodáil

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph

16 mg

táibléad sceobhrataithe

úsáid bhéil

An Iodáil

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph

40 mg

táibléad sceobhrataithe

úsáid bhéil

An Iodáil

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph

55 mg

táibléad sceobhrataithe

úsáid bhéil

An Iodáil

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph

63 mg

táibléad sceobhrataithe

úsáid bhéil

An Iodáil

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph

79 mg

táibléad sceobhrataithe

úsáid bhéil

An Iodáil

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph

111 mg

táibléad sceobhrataithe

úsáid bhéil

An Pholainn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph

16 mg

táibléad sceobhrataithe

úsáid bhéil

An Pholainn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph

40 mg

táibléad sceobhrataithe

úsáid bhéil

An Pholainn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph

55 mg

táibléad sceobhrataithe

úsáid bhéil

An Pholainn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph

63 mg

táibléad sceobhrataithe

úsáid bhéil

An Pholainn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph

79 mg

táibléad sceobhrataithe

úsáid bhéil

An Pholainn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph

111 mg

táibléad sceobhrataithe

úsáid bhéil

An Phortaingéil

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn

16 mg

táibléad sceobhrataithe

úsáid bhéil

An Phortaingéil

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn

40 mg

táibléad sceobhrataithe

úsáid bhéil

An Phortaingéil

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn

55 mg

táibléad sceobhrataithe

úsáid bhéil

An Phortaingéil

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn

63 mg

táibléad sceobhrataithe

úsáid bhéil

An Phortaingéil

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn

79 mg

táibléad sceobhrataithe

úsáid bhéil

An Phortaingéil

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn

111 mg

táibléad sceobhrataithe

úsáid bhéil

An Rómáin

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 16 mg comprimate filmate

16 mg

táibléad sceobhrataithe

úsáid bhéil

An Rómáin

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 40 mg comprimate filmate

40 mg

táibléad sceobhrataithe

úsáid bhéil

An Rómáin

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 55 mg comprimate filmate

55 mg

táibléad sceobhrataithe

úsáid bhéil

An Rómáin

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 63 mg comprimate filmate

63 mg

táibléad sceobhrataithe

úsáid bhéil

An Rómáin

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 79 mg comprimate filmate

79 mg

táibléad sceobhrataithe

úsáid bhéil

An Rómáin

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 111 mg comprimate filmate

111 mg

táibléad sceobhrataithe

úsáid bhéil

Poblacht na Slóvaice

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 16 mg

16 mg

táibléad sceobhrataithe

úsáid bhéil

Poblacht na Slóvaice

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 40 mg

40 mg

táibléad sceobhrataithe

úsáid bhéil

Poblacht na Slóvaice

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 55 mg

55 mg

táibléad sceobhrataithe

úsáid bhéil

Poblacht na Slóvaice

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 63 mg

63 mg

táibléad sceobhrataithe

úsáid bhéil

Poblacht na Slóvaice

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 79 mg

79 mg

táibléad sceobhrataithe

úsáid bhéil

Poblacht na Slóvaice

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 111 mg

111 mg

táibléad sceobhrataithe

úsáid bhéil

An tSualainn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn

16 mg

táibléad sceobhrataithe

úsáid bhéil

An tSualainn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph

16 mg

táibléad sceobhrataithe

úsáid bhéil

An tSualainn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn

40 mg

táibléad sceobhrataithe

úsáid bhéil

An tSualainn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph

40 mg

táibléad sceobhrataithe

úsáid bhéil

An tSualainn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn

55 mg

táibléad sceobhrataithe

úsáid bhéil

An tSualainn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph

55 mg

táibléad sceobhrataithe

úsáid bhéil

An tSualainn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn

63 mg

táibléad sceobhrataithe

úsáid bhéil

An tSualainn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph

63 mg

táibléad sceobhrataithe

úsáid bhéil

An tSualainn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn

79 mg

táibléad sceobhrataithe

úsáid bhéil

An tSualainn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph

79 mg

táibléad sceobhrataithe

úsáid bhéil

An tSualainn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn

111 mg

táibléad sceobhrataithe

úsáid bhéil

An tSualainn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph

111 mg

táibléad sceobhrataithe

úsáid bhéil

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(1)  Níor ghlac an tÚdarás Inniúil Náisiúnta leis an ainm cumtha, ag feitheamh le moladh nua ón iarratasóir.

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