# Iris Oifigiúil C 215/31 B

| | ISSN 1977-107X |
| --- | --- |
| Iris Oifigiúil
  an Aontais Eorpaigh | C 215 |
| | |
| An t-eagrán Gaeilge | Faisnéis agus Fógraí | 6531 Bealtaine 2022 |

ISSN 1977-107X

Iris Oifigiúil

an Aontais Eorpaigh

C 215

An t-eagrán Gaeilge

Faisnéis agus Fógraí

6531 Bealtaine 2022

---

| Clár | Leathanach |
| --- | --- |
| | IV   Fógraí |
| | FÓGRAÍ Ó INSTITIÚIDÍ, Ó CHOMHLACHTAÍ, Ó OIFIGÍ, AGUS Ó GHNÍOMHAIREACHTAÍ AN AONTAIS EORPAIGH |
| | An Coimisiún Eorpach |
| 2022/C 215/01 | Achoimre ar chinntí an Aontais Eorpaigh maidir le húdaruithe margaíochta i ndáil le táirgí íocshláinte ó 1 Aibreán 2022 go dtí 30 Aibreán 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 215/02 | Achoimre ar chinntí an Aontais Eorpaigh maidir le húdaruithe margaíochta i ndáil le táirgí íocshláinte ó 1 Aibreán 2022 go dtí 30 Aibreán 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) | 12 |

Clár

Leathanach

IV   Fógraí

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

An Coimisiún Eorpach

2022/C 215/01

Achoimre ar chinntí an Aontais Eorpaigh maidir le húdaruithe margaíochta i ndáil le táirgí íocshláinte ó 1 Aibreán 2022 go dtí 30 Aibreán 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 215/02

Achoimre ar chinntí an Aontais Eorpaigh maidir le húdaruithe margaíochta i ndáil le táirgí íocshláinte ó 1 Aibreán 2022 go dtí 30 Aibreán 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)

12

---

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

GA

---

IV Fógraí

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

An Coimisiún Eorpach

| 31.5.2022 | GA | Iris Oifigiúil an Aontais Eorpaigh | C 215/1 |
| --- | --- | --- | --- |

31.5.2022

GA

Iris Oifigiúil an Aontais Eorpaigh

C 215/1

---

Achoimre ar chinntí an Aontais Eorpaigh maidir le húdaruithe margaíochta i ndáil le táirgí íocshláinte ó 1 Aibreán 2022 go dtí 30 Aibreán 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 215/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.4.2022 | KIMMTRAK | tebentafusp | Immunocore Ireland Limited |
| Unit 1 Sky Business Centres, Unit 21 Block Port Tunnel Business Park, Clonshaugh, Dublin 17, Dublin, D17 FY82, 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

1.4.2022

KIMMTRAK

tebentafusp

Immunocore Ireland Limited

Unit 1 Sky Business Centres, Unit 21 Block Port Tunnel Business Park, Clonshaugh, Dublin 17, Dublin, D17 FY82, Ireland

EU/1/22/1630

Tiúchán do thuaslagán le haghaidh insilte

Pending

6.4.2022

4.4.2022

Breyanzi

lisocabtagene maraleucel

| 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/1/22/1631

Easrán le haghaidh insilte

Pending

5.4.2022

7.4.2022

Bosulif

Bosutinib

| 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/1/13/818

Piolla brataithe le scannán

L01XE14

8.4.2022

13.4.2022

Padcev

veadóitin eanfortúmaib

| Astellas Pharma Europe B.V. |
| --- |
| Sylviusweg 62, 2333 BE Leiden, Nederland |

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/21/1615

Púdar do thiúchán do thuaslagán le haghaidh insilte

L01FX13

19.4.2022

25.4.2022

Inpremzia

inslin dhaonna (rDNA)

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

Baxter Holding B.V.

Kobaltweg 49, 3542 CE Utrecht, Nederland

EU/1/22/1644

Tuaslagán le haghaidh insilte

A10AB01

27.4.2022

25.4.2022

Kapruvia

Difelikefalin

| 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/1/22/1643

Tuaslagán le haghaidh insteallta

V03AX04

27.4.2022

25.4.2022

PreHevbri

Vacsaín heipitíteas B (athchuingreach, neadaithe)

| VBI Vaccines B.V. |
| --- |
| Delflandlaan 1, Queen’s Tower Office Number 714, 1062 EA Amsterdam, Nederland |

VBI Vaccines B.V.

Delflandlaan 1, Queen’s Tower Office Number 714, 1062 EA Amsterdam, Nederland

EU/1/22/1641

Fuaidreán le haghaidh insteallta

J07BC01

27.4.2022

25.4.2022

Sitagliptin Accord

Sitagliptin

| 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/1/22/1633

Piolla brataithe le scannán

A10BH01

26.4.2022

25.4.2022

Truvelog Mix 30

aspairt insline

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

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/22/1639

Fuaidreán le haghaidh insteallta

A10AD05

26.4.2022

25.4.2022

Uplizna

inebilizumab

| Viela Bio B.V. |
| --- |
| Schiphol Boulevard 359, 1118 BJ Schiphol, Nederland |

Viela Bio B.V.

Schiphol Boulevard 359, 1118 BJ Schiphol, Nederland

EU/1/21/1602

Tiúchán do thuaslagán le haghaidh insilte

L04AA

29.4.2022

25. 4.2022

Vydura

rimegepant

| Biohaven Pharmaceutical Ireland DAC |
| --- |
| 6th Floor, South Bank House, Barrow Street, Dublin 4, D04 TR29, Ireland |

Biohaven Pharmaceutical Ireland DAC

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

EU/1/22/1645

Lyophilisate béil

N02CD

26.4.2022

29.4.2022

Orgovyx

relugolix

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

Myovant Sciences Ireland Limited

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

EU/1/22/1642

Piolla brataithe le scannán

L02BX04

4.5.2022

29.4.2022

QUVIVIQ

daridorexant

| Idorsia Pharmaceuticals Deutschland GmbH |
| --- |
| Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland |

Idorsia Pharmaceuticals Deutschland GmbH

Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland

EU/1/22/1638

Piolla brataithe le scannán

Pending

2.5.2022

—   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 |
| --- | --- | --- | --- | --- |
| 1.4.2022 | Aclasta | Novartis Europharm Limited |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Dáta an chinnidh

Ainm an táirge íocshláinte

Sealbhóir an údaraithe margaíochta

Uimhir na hiontrála sa Chlár Comhphobail

Dáta an fhógra

1.4.2022

Aclasta

Novartis Europharm Limited

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

EU/1/05/308

5. 4.2022

1.4.2022

Evista

| SUBSTIPHARM |
| --- |
| 24 rue Erlanger, 75016 Paris, France |

SUBSTIPHARM

24 rue Erlanger, 75016 Paris, France

EU/1/98/073

20.4.2022

1.4.2022

Kyprolis

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

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1060

5.4.2022

1.4.2022

Naglazyme

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

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork P43 R298, Ireland

EU/1/05/324

6.4.2022

1.4.2022

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

4.4.2022

1.4.2022

Replagal

| 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/1/01/189

5.4.2022

1.4.2022

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

12.4.2022

1. 4.2022

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

4.4.2022

1.4.2022

Ultomiris

| 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/1/19/1371

5.4.2022

1.4.2022

Verzenios

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/18/1307

4.4.2022

1.4.2022

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

4.4.2022

1.4.2022

Zostavax

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/06/341

4.4.2022

4.4.2022

Axura

| Merz Pharmaceuticals GmbH |
| --- |
| Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland |

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland

EU/1/02/218

6.4.2022

4.4.2022

Bemrist 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/1/20/1441

5.4.2022

4.4.2022

Capecitabine 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/1/12/762

5.4.2022

4.4.2022

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

6.4.2022

4.4.2022

Elaprase

| 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/1/06/365

19.4.2022

4.4.2022

Erelzi

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1195

5.4.2022

4.4.2022

HBVAXPRO

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/01/183

6.4.2022

4.4.2022

Incresync

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

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/13/842

6.4.2022

4.4.2022

Kisqali

| 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/1/17/1221

5.4.2022

4.4.2022

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

6.4.2022

4.4.2022

Memantine Merz

| Merz Pharmaceuticals GmbH |
| --- |
| Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland |

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland

EU/1/12/799

11.4.2022

4.4.2022

MenQuadfi

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

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

EU/1/20/1483

5.4.2022

4.4.2022

Ratiograstim

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

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/08/444

5.4.2022

4.4.2022

Reagila

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

Gedeon Richter Plc.

Gyömrői út 19-21, 1103 Budapest, Magyarország

EU/1/17/1209

7.4.2022

4.4.2022

Shingrix

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

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/18/1272

5.4.2022

4.4.2022

Tevagrastim

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

Teva GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/08/445

6.4.2022

4.4.2022

Vipdomet

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

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/13/843

6.4.2022

4.4.2022

Vipidia

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

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/13/844

6.4.2022

7.4.2022

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

7.4.2022

7.4.2022

Pifeltro

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1332

8.4.2022

12.4.2022

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

22.4.2022

13.4.2022

ADCETRIS

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

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/12/794

21.4.2022

13.4.2022

Aldara

| Meda AB |
| --- |
| Pipers väg 2A, 170 73 Solna, Sverige |

Meda AB

Pipers väg 2A, 170 73 Solna, Sverige

EU/1/98/080

21.4.2022

13.4.2022

Evkeeza

| Ultragenyx Germany GmbH |
| --- |
| Rahel-Hirsch-Str. 10, 10557 Berlin, Deutschland |

Ultragenyx Germany GmbH

Rahel-Hirsch-Str. 10, 10557 Berlin, Deutschland

EU/1/21/1551

20.4.2022

13.4.2022

Komboglyze

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/11/731

19.4.2022

13.4.2022

M-M-RVAXPRO

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/06/337

19.4.2022

13.4.2022

NeuroBloc

| Sloan Pharma S.a.r.l. |
| --- |
| 33 Rue de Puits Romain, 8070 Bertrange, Luxembourg |

Sloan Pharma S.a.r.l.

33 Rue de Puits Romain, 8070 Bertrange, Luxembourg

EU/1/00/166

21.4.2022

13.4.2022

Onglyza

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/09/545

19.4.2022

13.4.2022

ProQuad

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/05/323

19.4.2022

13.4.2022

Tremfya

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1234

19.4.2022

20.4.2022

Zolgensma

| Novartis Gene Therapies EU Limited |
| --- |
| Block B, The Crescent Building, Northwood, Santry, Dublin 9, D09 C6X8, Ireland |

Novartis Gene Therapies EU Limited

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

EU/1/20/1443

21.4.2022

25.4.2022

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

26.4.2022

25.4.2022

Byfavo

| PAION Netherlands B.V. |
| --- |
| Vogt 21, 6422 RK Heerlen, Nederland |

PAION Netherlands B.V.

Vogt 21, 6422 RK Heerlen, Nederland

EU/1/20/1505

27.4.2022

25.4.2022

Fampyra

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

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/11/699

28.4.2022

25.4.2022

Fycompa

| Eisai GmbH |
| --- |
| Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland |

Eisai GmbH

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

EU/1/12/776

26.4.2022

25.4.2022

Ilumetri

| Almirall, S.A. |
| --- |
| Ronda General Mitre, 151, 08022 Barcelona, España |

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/18/1323

2.5.2022

25.4.2022

Kevzara

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

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/17/1196

26.4.2022

25.4.2022

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

28.4.2022

25.4.2022

Koselugo

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1552

26.4.2022

25.4.2022

Kyntheum

| Leo Pharma A/S |
| --- |
| Industriparken 55, 2750 Ballerup, Danmark |

Leo Pharma A/S

Industriparken 55, 2750 Ballerup, Danmark

EU/1/16/1155

27.4.2022

25.4.2022

Lyumjev

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/20/1422

28.4.2022

25.4.2022

MAVENCLAD

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

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1212

26.4.2022

25.4.2022

Nerlynx

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

Pierre Fabre Médicament

Les Cauquillous, 81500 Lavaur, France

EU/1/18/1311

26.4.2022

25.4.2022

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

28.4.2022

25.4.2022

Sogroya

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/20/1501

27.4.2022

25.4.2022

Starlix

| 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/1/01/174

29.4.2022

25.4.2022

Tecentriq

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

Roche Registration GmbH

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

EU/1/17/1220

26.4.2022

25.4.2022

Trumenba

| 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/1/17/1187

26.4.2022

25.4.2022

Vazkepa

| Amarin Pharmaceuticals Ireland Limited |
| --- |
| 88 Harcourt Street, Dublin 2, D02DK18, Ireland |

Amarin Pharmaceuticals Ireland Limited

88 Harcourt Street, Dublin 2, D02DK18, Ireland

EU/1/20/1524

26.4.2022

25.4.2022

Xofluza

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

Roche Registration GmbH

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

EU/1/20/1500

26.4.2022

28.4.2022

Gardasil 9

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1007

29.4.2022

29.4.2022

Azacitidine 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/1/19/1413

2.5.2022

29.4.2022

CABOMETYX

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

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/16/1136

2.5.2022

29.4.2022

Ecansya

| 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/1/12/763

9.5.2022

29.4.2022

Gardasil

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/06/357

3.5.2022

29.4.2022

Gardasil 9

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1007

2.5.2022

29.4.2022

HyQvia

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

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/13/840

2.5.2022

29.4.2022

Imraldi

| 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/1/17/1216

4.5.2022

29.4.2022

Ixiaro

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

Valneva Austria GmbH

Campus Vienna Biocenter 3, 1030 Wien, Österreich

EU/1/08/501

2.5.2022

29.4.2022

Jakavi

| 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/1/12/773

3.5.2022

29.4.2022

Kalydeco

| 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/1/12/782

5.5.2022

29.4.2022

Mekinist

| 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/1/14/931

3.5.2022

29.4.2022

Nucala

| 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/1/15/1043

2.5.2022

29.4.2022

Ondexxya

| Alexion Europe S.A.S. |
| --- |
| 103 Rue Anatole France, 92300 Levallois Perret, France |

Alexion Europe S.A.S.

103 Rue Anatole France, 92300 Levallois Perret, France

EU/1/18/1345

4.5.2022

29.4.2022

Poteligeo

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

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/18/1335

3.5.2022

29.4.2022

Seebri 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/1/12/788

3.5.2022

29.4.2022

Spherox

| CO.DON AG |
| --- |
| Warthestraße 21, 14513 Teltow, Deutschland |

CO.DON AG

Warthestraße 21, 14513 Teltow, Deutschland

EU/1/17/1181

2.5.2022

29.4.2022

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

29.4.2022

29.4.2022

Tovanor 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/1/12/790

3.5.2022

29.4.2022

Trevicta

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/971

2.5.2022

29.4.2022

Vosevi

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/17/1223

3.5.2022

29.4.2022

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

29.4.2022

—   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 |
| --- | --- | --- | --- | --- |
| 13.4.2022 | Pramipexole Accord | Accord Healthcare S.L.U. |
| World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |

Dáta an chinnidh

Ainm an táirge íocshláinte

Sealbhóir an údaraithe margaíochta

Uimhir na hiontrála sa Chlár Comhphobail

Dáta an fhógra

13.4.2022

Pramipexole Accord

Accord Healthcare S.L.U.

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

EU/1/11/728

19.4.2022

25.4.2022

Docetaxel 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/1/07/384

26.4.2022

29.4.2022

Starlix

| 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/1/01/174

3.5.2022

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 19.4.2022 | Chanaxin | tulathromycin | Chanelle Pharmaceuticals Manufacturing Limited |
| Loughrea, Co. Galway, 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

19.4.2022

Chanaxin

tulathromycin

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/22/283

Tuaslagán le haghaidh insteallta

Pending

21.4.2022

19.4.2022

RenuTend

gaschealla mescenchymal forimeallacha allogeneic uile-ghineacha a dhíorthaítear ón fhuil

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/22/282

Fuaidreán le haghaidh insteallta

QM09AX90

22.4.2022

—   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 |
| --- | --- | --- | --- | --- |
| 4.4.2022 | LETIFEND | LETI Pharma, S.L.U. |
| C/Del Sol, 5, Poligono Industrial Norte, Tres Cantos, 28760 Madrid, España |

Dáta an chinnidh

Ainm an táirge íocshláinte

Sealbhóir an údaraithe margaíochta

Uimhir na hiontrála sa Chlár Comhphobail

Dáta an fhógra

4.4.2022

LETIFEND

LETI Pharma, S.L.U.

C/Del Sol, 5, Poligono Industrial Norte, Tres Cantos, 28760 Madrid, España

EU/2/16/195

6.4.2022

6.4.2022

CYTOPOINT

| 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/2/17/205

11.4.2022

6.4.2022

RESPIPORC FLUpan H1N1

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

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/17/209

7.4.2022

13.4.2022

Ingelvac CircoFLEX

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/07/079

20.4.2022

19.4.2022

SevoFlo

| 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/2/02/035

21.4.2022

26.4.2022

Credelio

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

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/17/206

28.4.2022

26.4.2022

CYTOPOINT

| 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/2/17/205

3.5.2022

26.4.2022

RESPIPORC FLUpan H1N1

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

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/17/209

2.5.2022

26.4.2022

Zulvac BTV

| 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/2/17/207

27.4.2022

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 |
| NETHERLANDS |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

---

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

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

---

| 31.5.2022 | GA | Iris Oifigiúil an Aontais Eorpaigh | C 215/12 |
| --- | --- | --- | --- |

31.5.2022

GA

Iris Oifigiúil an Aontais Eorpaigh

C 215/12

---

Achoimre ar chinntí an Aontais Eorpaigh maidir le húdaruithe margaíochta i ndáil le táirgí íocshláinte ó 1 Aibreán 2022 go dtí 30 Aibreán 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 ó Pharlaimint na hEorpa agus ón gComhairle (3)
  )

(2022/C 215/02)

—   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 |
| --- | --- | --- | --- | --- | --- |
| 1.4.2022 | Nasolam and associated names | midazolam | Féach an Iarscríbhinn | Féach an Iarscríbhinn | 4.4.2022 |

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

1.4.2022

Nasolam and associated names

midazolam

Féach an Iarscríbhinn

Féach an Iarscríbhinn

4.4.2022

---

(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 na dtáirgí leighis agus teacht i láthair

| Ballstát AE/LEE | Iarratasóir
  ainm na cuideachta, seoladh | (cumtha) Ainm | Láidreacht | Foirm chógaisíochta | Bealach Riartha | Ábhair
  (tiúchan) |
| --- | --- | --- | --- | --- | --- | --- |
| An Danmhairg | Tiofarma B.V. |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Ballstát AE/LEE

Iarratasóir

ainm na cuideachta, seoladh

(cumtha) Ainm

Láidreacht

Foirm chógaisíochta

Bealach Riartha

Ábhair

(tiúchan)

An Danmhairg

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 2,5  mg nasal spray, solution in single dose container (1)

2,5  mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

An Danmhairg

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 3,75  mg nasal spray, solution in single dose container (1)

3,75  mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

An Danmhairg

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 5 mg nasal spray, solution in single dose container (1)

5 mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

An Fhionlainn

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 2,5  mg nasal spray, solution in single dose container (1)

2,5  mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

An Fhionlainn

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 3,75  mg nasal spray, solution in single dose container

3,75  mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

An Fhionlainn

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 5 mg nasal spray, solution in single dose container

5 mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

An Ghearmáin

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 2,5  mg, Nasenspray, Lösung im Einzeldosisbehältnis

2,5  mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

An Ghearmáin

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 3,75  mg, Nasenspray, Lösung im Einzeldosisbehältnis

3,75  mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

An Ghearmáin

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 5 mg, Nasenspray, Lösung im Einzeldosisbehältnis

5 mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

Éire

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 2,5  mg nasal spray, solution in single dose container

2,5  mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

Éire

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 3,75  mg nasal spray, solution in single dose container

3,75  mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

Éire

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 5 mg nasal spray, solution in single dose container

5 mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

An Ísiltír

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 2,5  mg neusspray, oplossing in een verpakking voor éénmalig gebruik

2,5  mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

An Ísiltír

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 3,75  mg neusspray, oplossing in een verpakking voor éénmalig gebruik

3,75  mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

An Ísiltír

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 5 mg neusspray, oplossing in een verpakking voor éénmalig gebruik

5 mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

An Iorua

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASALAM 2,5  mg nasal spray, solution in single dose container (1)

2,5  mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

An Iorua

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASALAM 3,75  mg nasal spray, solution in single dose container (1)

3,75  mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

An Iorua

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASALAM 5 mg nasal spray, solution in single dose container (1)

5 mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

An tSualainn

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 2,5  mg nasal spray, solution in single dose container (1)

2,5  mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

An tSualainn

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 3,75  mg nasal spray, solution in single dose container (1)

3,75  mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

An tSualainn

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 5 mg nasal spray, solution in single dose container (1)

5 mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

An Ríocht Aontaithe (tuaisceart Éireann)

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 2,5  mg nasal spray, solution in single dose container (1)

2,5  mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

An Ríocht Aontaithe (tuaisceart Éireann)

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 3,75  mg nasal spray, solution in single dose container

3,75  mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

An Ríocht Aontaithe (tuaisceart Éireann)

| Tiofarma B.V. |
| --- |
| Benjamin Franklinstraat 9 |
| 3261 LW Oud-Beijerland |
| Netherlands |

Tiofarma B.V.

Benjamin Franklinstraat 9

3261 LW Oud-Beijerland

Netherlands

NASOLAM 5 mg nasal spray, solution in single dose container

5 mg

Sprae sróine, tuaslagán i gcoimeádán aon dáileoige

Úsáid sróine

50 mg/ml

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(1)  Ainm cumtha nár ghlac an tÚdarás Inniúil Náisiúnta leis, go dtí go ndéanfaidh an t-iarratasóir togra nua

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