# Official Journal C 334/2019

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 334 |
| | |
| English edition | Information and Notices | Volume 624 October 2019 |

ISSN 1977-091X

Official Journal

of the European Union

C 334

English edition

Information and Notices

Volume 624 October 2019

---

| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2019/C 334/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2019 to 31 August 2019  (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| 2019/C 334/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2019 to 31 August 2019  (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 17 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2019/C 334/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2019 to 31 August 2019  (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

1

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

2019/C 334/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2019 to 31 August 2019  (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

17

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| EN | |
| --- | --- |

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 4.10.2019 | EN | Official Journal of the European Union | C 334/1 |
| --- | --- | --- | --- |

4.10.2019

EN

Official Journal of the European Union

C 334/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2019 to 31 August 2019

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
   (1))

(2019/C 334/01)

| — | Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.7.2019 | Dovato | dolutegravir/lamivudine | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/19/1370 | Film-coated tablet | J05AR25 | 3.7.2019 |
| 1.7.2019 | Xromi | hydroxycarbamide | Nova Laboratories Ireland Limited
  3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland | EU/1/19/1366 | Oral solution | L01XX05 | 3.7.2019 |
| 2.7.2019 | Ultomiris | Ravulizumab | Alexion Europe SAS
  103-105 Rue Anatole France, 92300 Levallois-Perret, France | EU/1/19/1371 | Concentrate for solution for infusion | L04AA | 5.7.2019 |
| 25.7.2019 | Cufence | trientine dihydrochloride | Univar BV
  Schouwburgplein 30-34, 3012 CL Rotterdam, Nederland | EU/1/19/1365 | Capsule, hard | A16AX12 | 29.7.2019 |
| 25.7.2019 | LysaKare | arginine/lysine | Advanced Accelerator Applications
  20 rue Diesel, 01630 Saint-Genis-Pouilly, France | EU/1/19/1381 | Solution for infusion | V03AF11 | 29.7.2019 |
| 25.7.2019 | Posaconazole Accord | posaconazole | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, Barcelona, 08039 Barcelona, España | EU/1/19/1379 | Gastro-resistant tablet | J02AC04 | 30.7.2019 |
| 25.7.2019 | Posaconazole AHCL | posaconazole | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/19/1380 | Oral suspension | J02AC04 | 29.7.2019 |
| 2.8.2019 | Azacitidine Celgene | azacitidine | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/19/1382 | Powder for suspension for injection | L01BC07 | 6.8.2019 |
| 23.8.2019 | Giapreza | angiotensin II acetate | La Jolla Pharmaceutical II B.V.
  Herengracht 500, 1017 CB Amsterdam, Nederland | EU/1/19/1384 | Concentrate for solution for infusion | C01CX09 | 27.8.2019 |
| 26.8.2019 | Lacosamide UCB | lacosamide | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/19/1383 | Film-coated tablet Solution for infusion Syrup | N03AX18 | 28.8.2019 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

1.7.2019

Dovato

dolutegravir/lamivudine

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/19/1370

Film-coated tablet

J05AR25

3.7.2019

1.7.2019

Xromi

hydroxycarbamide

Nova Laboratories Ireland Limited

3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland

EU/1/19/1366

Oral solution

L01XX05

3.7.2019

2.7.2019

Ultomiris

Ravulizumab

Alexion Europe SAS

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

EU/1/19/1371

Concentrate for solution for infusion

L04AA

5.7.2019

25.7.2019

Cufence

trientine dihydrochloride

Univar BV

Schouwburgplein 30-34, 3012 CL Rotterdam, Nederland

EU/1/19/1365

Capsule, hard

A16AX12

29.7.2019

25.7.2019

LysaKare

arginine/lysine

Advanced Accelerator Applications

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

EU/1/19/1381

Solution for infusion

V03AF11

29.7.2019

25.7.2019

Posaconazole Accord

posaconazole

Accord Healthcare S.L.U.

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

EU/1/19/1379

Gastro-resistant tablet

J02AC04

30.7.2019

25.7.2019

Posaconazole AHCL

posaconazole

Accord Healthcare S.L.U.

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

EU/1/19/1380

Oral suspension

J02AC04

29.7.2019

2.8.2019

Azacitidine Celgene

azacitidine

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/19/1382

Powder for suspension for injection

L01BC07

6.8.2019

23.8.2019

Giapreza

angiotensin II acetate

La Jolla Pharmaceutical II B.V.

Herengracht 500, 1017 CB Amsterdam, Nederland

EU/1/19/1384

Concentrate for solution for infusion

C01CX09

27.8.2019

26.8.2019

Lacosamide UCB

lacosamide

UCB Pharma S.A.

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

EU/1/19/1383

Film-coated tablet Solution for infusion Syrup

N03AX18

28.8.2019

| — | Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected |
| --- | --- |

—

Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 11.7.2019 | Cabazitaxel Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | — | 15.7.2019 |
| 8.8.2019 | Doxolipad | TLC Biopharmaceuticals B.V.
  J.H. Oortweg 19, 2333CH Leiden, Netherlands | — | 12.8.2019 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

11.7.2019

Cabazitaxel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

—

15.7.2019

8.8.2019

Doxolipad

TLC Biopharmaceuticals B.V.

J.H. Oortweg 19, 2333CH Leiden, Netherlands

—

12.8.2019

| — | Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 1.7.2019 | Benlysta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/11/700 | 3.7.2019 |
| 1.7.2019 | Cetrotide | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/99/100 | 3.7.2019 |
| 1.7.2019 | Comtan | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/98/081 | 3.7.2019 |
| 1.7.2019 | Eliquis | Bristol-Myers Squibb/Pfizer EEIG
  Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland | EU/1/11/691 | 3.7.2019 |
| 1.7.2019 | Eviplera | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/11/737 | 3.7.2019 |
| 1.7.2019 | Exviera | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/14/983 | 3.7.2019 |
| 1.7.2019 | Fiasp | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/16/1160 | 3.7.2019 |
| 1.7.2019 | Instanyl | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/09/531 | 3.7.2019 |
| 1.7.2019 | Mimpara | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/04/292 | 3.7.2019 |
| 1.7.2019 | Ravicti | Immedica Pharma AB
  SE-113 29 Stockholm, Sverige | EU/1/15/1062 | 3.7.2019 |
| 1.7.2019 | Symtuza | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/17/1225 | 3.7.2019 |
| 1.7.2019 | Xarelto | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/08/472 | 3.7.2019 |
| 4.7.2019 | Dukoral | Valneva Sweden AB
  105 21 Stockholm, Sverige | EU/1/03/263 | 8.7.2019 |
| 4.7.2019 | IKERVIS | Santen Oy
  Niittyhaankatu 20, 33720 Tampere, Suomi | EU/1/15/990 | 8.7.2019 |
| 4.7.2019 | Kaletra | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/01/172 | 8.7.2019 |
| 4.7.2019 | Nerlynx | Pierre Fabre Médicament
  45, place Abel Gance, 92100 Boulogne-Billancourt, France | EU/1/18/1311 | 9.7.2019 |
| 4.7.2019 | Orphacol | Laboratoires CTRS
  63 rue de l’Est, 92100 Boulogne-Billancourt, France | EU/1/13/870 | 8.7.2019 |
| 4.7.2019 | Prolia | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/10/618 | 8.7.2019 |
| 4.7.2019 | Verkazia | Santen Oy
  Niittyhaankatu 20, 33720 Tampere, Suomi | EU/1/17/1219 | 8.7.2019 |
| 4.7.2019 | Zinforo | Pfizer Ireland Pharmaceuticals
  Operations Support Group, Ringaskiddy, County Cork, Ireland | EU/1/12/785 | 8.7.2019 |
| 8.7.2019 | Emtricitabine/Tenofovir disoproxil Krka d.d. | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/17/1182 | 10.7.2019 |
| 8.7.2019 | Hefiya | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1287 | 10.7.2019 |
| 8.7.2019 | Pazenir | ratiopharm GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | EU/1/18/1317 | 10.7.2019 |
| 8.7.2019 | Tecentriq | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/17/1220 | 10.7.2019 |
| 8.7.2019 | Tremfya | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/17/1234 | 10.7.2019 |
| 8.7.2019 | Viekirax | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/14/982 | 10.7.2019 |
| 8.7.2019 | Xultophy | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/14/947 | 10.7.2019 |
| 9.7.2019 | Elocta | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | EU/1/15/1046 | 11.7.2019 |
| 11.7.2019 | Ammonaps | Immedica Pharma AB
  SE-113 29 Stockholm, Sverige | EU/1/99/120 | 15.7.2019 |
| 11.7.2019 | Defitelio | Gentium S.r.I.
  Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia | EU/1/13/878 | 15.7.2019 |
| 11.7.2019 | Gliolan | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/07/413 | 15.7.2019 |
| 11.7.2019 | Halimatoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1288 | 15.7.2019 |
| 11.7.2019 | Tasigna | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/07/422 | 15.7.2019 |
| 18.7.2019 | Jentadueto | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/12/780 | 29.7.2019 |
| 18.7.2019 | Myocet | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/00/141 | 22.7.2019 |
| 18.7.2019 | Norvir | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/96/016 | 22.7.2019 |
| 18.7.2019 | Xadago | Zambon S.p.A.
  Via Lillo del Duca 10, 20091 Bresso (MI), Italia | EU/1/14/984 | 22.7.2019 |
| 18.7.2019 | Xyrem | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/05/312 | 22.7.2019 |
| 19.7.2019 | Besponsa | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/17/1200 | 23.7.2019 |
| 19.7.2019 | Colobreathe | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/747 | 23.7.2019 |
| 19.7.2019 | Edistride | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/15/1052 | 23.7.2019 |
| 19.7.2019 | Exjade | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/356 | 23.7.2019 |
| 19.7.2019 | HyQvia | Baxalta Innovations GmbH
  Industriestraße 67, 1221 Wien, Österreich | EU/1/13/840 | 23.7.2019 |
| 19.7.2019 | Incruse Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/922 | 23.7.2019 |
| 19.7.2019 | Lartruvo | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/16/1143 | 23.7.2019 |
| 19.7.2019 | Truvada | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/04/305 | 23.7.2019 |
| 19.7.2019 | Truxima | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/16/1167 | 23.7.2019 |
| 25.7.2019 | Abasaglar | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/944 | 29.7.2019 |
| 25.7.2019 | Abraxane | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/07/428 | 29.7.2019 |
| 25.7.2019 | Anoro Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/898 | 29.7.2019 |
| 25.7.2019 | Blitzima | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/17/1205 | 29.7.2019 |
| 25.7.2019 | Corbilta | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/13/859 | 29.7.2019 |
| 25.7.2019 | Deltyba | Otsuka Novel Products GmbH
  Erika-Mann-Straße 21, 80636 München, Deutschland | EU/1/13/875 | 29.7.2019 |
| 25.7.2019 | Edistride | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/15/1052 | 29.7.2019 |
| 25.7.2019 | Forxiga | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/12/795 | 29.7.2019 |
| 25.7.2019 | Gardasil 9 | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/15/1007 | 29.7.2019 |
| 25.7.2019 | Genvoya | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/15/1061 | 29.7.2019 |
| 25.7.2019 | Hepsera | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/03/251 | 29.7.2019 |
| 25.7.2019 | Herceptin | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/00/145 | 29.7.2019 |
| 25.7.2019 | KANJINTI | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/18/1281 | 29.7.2019 |
| 25.7.2019 | Lixiana | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/15/993 | 29.7.2019 |
| 25.7.2019 | Maviret | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/17/1213 | 29.7.2019 |
| 25.7.2019 | NexoBrid | MediWound Germany GmbH
  Eisenstraße 5, 65428 Ruesselsheim, Deutschland | EU/1/12/803 | 29.7.2019 |
| 25.7.2019 | Ofev | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/979 | 29.7.2019 |
| 25.7.2019 | Ontruzant | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | EU/1/17/1241 | 29.7.2019 |
| 25.7.2019 | Ritemvia | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/17/1207 | 29.7.2019 |
| 25.7.2019 | Rolufta Ellipta | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/17/1174 | 29.7.2019 |
| 25.7.2019 | Roteas | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/16/1152 | 29.7.2019 |
| 25.7.2019 | Telmisartan Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/719 | 29.7.2019 |
| 25.7.2019 | Temozolomide SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, 2132 JH Hoofddorp, Nederland | EU/1/11/697 | 29.7.2019 |
| 25.7.2019 | Translarna | PTC Therapeutics International Limited
  5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland | EU/1/13/902 | 29.7.2019 |
| 25.7.2019 | Uptravi | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/15/1083 | 29.7.2019 |
| 25.7.2019 | Visudyne | CHEPLAPHARM Arzneimittel GmbH
  Ziegelhof 24, 17489 Greifswald, Deutschland | EU/1/00/140 | 29.7.2019 |
| 25.7.2019 | Vizamyl | GE Healthcare AS
  Nycoveien 1, 0485, Oslo, Norge | EU/1/14/941 | 29.7.2019 |
| 25.7.2019 | Xigduo | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/13/900 | 29.7.2019 |
| 25.7.2019 | Zalmoxis | MolMed S.p.A.
  Via Olgettina 58, 20132 Milano, Italia | EU/1/16/1121 | 29.7.2019 |
| 25.7.2019 | Zinforo | Pfizer Ireland Pharmaceuticals
  Operations Support Group, Ringaskiddy, County Cork, Ireland | EU/1/12/785 | 29.7.2019 |
| 25.7.2019 | Zometa | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/01/176 | 29.7.2019 |
| 31.7.2019 | Aclasta | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/05/308 | 2.8.2019 |
| 31.7.2019 | Adenuric | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/08/447 | 5.8.2019 |
| 31.7.2019 | Adjupanrix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/09/578 | 2.8.2019 |
| 31.7.2019 | Duloxetine Lilly | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/972 | 2.8.2019 |
| 31.7.2019 | Fiasp | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/16/1160 | 2.8.2019 |
| 31.7.2019 | Flebogamma DIF | Instituto Grifols, S.A.
  Can Guasch 2, Parets del Vallès, 08150 Barcelona, Espaňa | EU/1/07/404 | 2.8.2019 |
| 31.7.2019 | Forxiga | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/12/795 | 2.8.2019 |
| 31.7.2019 | Inovelon | Eisai GmbH
  Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland | EU/1/06/378 | 2.8.2019 |
| 31.7.2019 | Invirase | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/96/026 | 2.8.2019 |
| 31.7.2019 | Ketoconazole HRA | Laboratoire HRA Pharma
  200 avenue de Paris, 92320 Chatillon, France | EU/1/14/965 | 2.8.2019 |
| 31.7.2019 | Nucala | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/15/1043 | 2.8.2019 |
| 31.7.2019 | Rezolsta | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/967 | 2.8.2019 |
| 31.7.2019 | Stalevo | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/03/260 | 2.8.2019 |
| 31.7.2019 | Tadalafil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/14/961 | 2.8.2019 |
| 31.7.2019 | Thalidomide Celgene | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/08/443 | 2.8.2019 |
| 31.7.2019 | Trazimera | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/18/1295 | 2.8.2019 |
| 31.7.2019 | Vargatef | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/954 | 2.8.2019 |
| 31.7.2019 | Vimpat | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/08/470 | 2.8.2019 |
| 31.7.2019 | Xydalba | Allergan Pharmaceuticals International Limited
  Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland | EU/1/14/986 | 2.8.2019 |
| 1.8.2019 | Cyramza | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/957 | 5.8.2019 |
| 1.8.2019 | Dupixent | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/17/1229 | 5.8.2019 |
| 1.8.2019 | Ebymect | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/15/1051 | 5.8.2019 |
| 1.8.2019 | Faslodex | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/03/269 | 5.8.2019 |
| 1.8.2019 | Harvoni | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/14/958 | 6.8.2019 |
| 1.8.2019 | Herzuma | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/17/1257 | 6.8.2019 |
| 1.8.2019 | Hirobriz Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/594 | 6.8.2019 |
| 1.8.2019 | Laventair Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/899 | 6.8.2019 |
| 2.8.2019 | Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/17/1222 | 6.8.2019 |
| 2.8.2019 | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/945 | 6.8.2019 |
| 2.8.2019 | JETREA | Oxurion NV
  Gaston Geenslaan 1, 3001 Leuven, België | EU/1/13/819 | 6.8.2019 |
| 2.8.2019 | Praxbind | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/15/1056 | 7.8.2019 |
| 8.8.2019 | InductOs | Medtronic BioPharma B.V.
  Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland | EU/1/02/226 | 12.8.2019 |
| 8.8.2019 | Levodopa/Carbidopa/Entacapone Orion | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/11/706 | 12.8.2019 |
| 8.8.2019 | Stivarga | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/858 | 12.8.2019 |
| 8.8.2019 | Teysuno | Nordic Group B.V.
  Siriusdreef 22, 2132 WT Hoofddorp, Nederland | EU/1/11/669 | 12.8.2019 |
| 9.8.2019 | Jivi | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/18/1324 | 13.8.2019 |
| 9.8.2019 | Travatan | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/01/199 | 13.8.2019 |
| 9.8.2019 | Truberzi | Allergan Pharmaceuticals International Limited
  Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland | EU/1/16/1126 | 13.8.2019 |
| 9.8.2019 | Victoza | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/09/529 | 13.8.2019 |
| 14.8.2019 | Oslif Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/586 | 19.8.2019 |
| 23.8.2019 | Aimovig | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/18/1293 | 27.8.2019 |
| 23.8.2019 | Brimica Genuair | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/14/963 | 27.8.2019 |
| 23.8.2019 | Cinacalcet Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/15/1054 | 27.8.2019 |
| 23.8.2019 | Cometriq | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/13/890 | 27.8.2019 |
| 23.8.2019 | Duaklir Genuair | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/14/964 | 27.8.2019 |
| 23.8.2019 | Elmiron | bene-Arzneimittel GmbH
  Herterichstraße 1-3, 81479 München, Deutschland | EU/1/17/1189 | 27.8.2019 |
| 23.8.2019 | Empliciti | Bristol-Myers Squibb Pharma EEIG
  Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland | EU/1/16/1088 | 27.8.2019 |
| 23.8.2019 | Firdapse | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland | EU/1/09/601 | 27.8.2019 |
| 23.8.2019 | Flucelvax Tetra | Seqirus Netherlands B.V.
  Paasheuvelweg 28, 1105BJ Amsterdam, Netherlands | EU/1/18/1326 | 27.8.2019 |
| 23.8.2019 | Fluenz Tetra | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/13/887 | 27.8.2019 |
| 23.8.2019 | Nordimet | Nordic Group B.V.
  Siriusdreef 22, 2132 WT Hoofddorp, Nederland | EU/1/16/1124 | 27.8.2019 |
| 23.8.2019 | Otezla | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/14/981 | 27.8.2019 |
| 23.8.2019 | Ovitrelle | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/00/165 | 27.8.2019 |
| 23.8.2019 | Renagel | Genzyme Europe B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | EU/1/99/123 | 27.8.2019 |
| 23.8.2019 | Sevelamer carbonate Winthrop | Genzyme Europe B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | EU/1/14/952 | 27.8.2019 |
| 23.8.2019 | Sovaldi | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/894 | 27.8.2019 |
| 23.8.2019 | Spinraza | Biogen Netherlands B.V.
  Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | EU/1/17/1188 | 27.8.2019 |
| 23.8.2019 | Trulicity | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/956 | 27.8.2019 |
| 23.8.2019 | Zerbaxa | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1032 | 27.8.2019 |
| 26.8.2019 | Emadine | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/98/095 | 28.8.2019 |
| 26.8.2019 | Imraldi | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | EU/1/17/1216 | 28.8.2019 |
| 26.8.2019 | Jylamvo | Therakind (Europe) Limited
  3 Inn’s Quay, Dublin 7, D07 PW4F, Ireland | EU/1/17/1172 | 28.8.2019 |
| 26.8.2019 | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 28.8.2019 |
| 26.8.2019 | Levitra | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/03/248 | 28.8.2019 |
| 26.8.2019 | Mycophenolate mofetil Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/07/439 | 28.8.2019 |
| 26.8.2019 | Nevanac | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/07/433 | 28.8.2019 |
| 26.8.2019 | Onbrez Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/593 | 28.8.2019 |
| 26.8.2019 | Prasugrel Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/18/1273 | 28.8.2019 |
| 26.8.2019 | PREVYMIS | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/17/1245 | 28.8.2019 |
| 26.8.2019 | Renvela | Genzyme Europe B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | EU/1/09/521 | 28.8.2019 |
| 26.8.2019 | Soliris | Alexion Europe SAS
  103-105 rue Anatole France, 92300 Levallois-Perret, France | EU/1/07/393 | 28.8.2019 |
| 26.8.2019 | TAGRISSO | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/16/1086 | 28.8.2019 |
| 26.8.2019 | Tasmar | Meda AB
  Pipers väg 2A, 170 09 Solna, Sverige | EU/1/97/044 | 28.8.2019 |
| 26.8.2019 | Tecentriq | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/17/1220 | 28.8.2019 |
| 26.8.2019 | Vargatef | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/954 | 28.8.2019 |
| 26.8.2019 | Vivanza | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/03/249 | 28.8.2019 |
| 31.8.2019 | Kisqali | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/17/1221 | 2.8.2019 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

1.7.2019

Benlysta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/11/700

3.7.2019

1.7.2019

Cetrotide

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/99/100

3.7.2019

1.7.2019

Comtan

Novartis Europharm Limited

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

EU/1/98/081

3.7.2019

1.7.2019

Eliquis

Bristol-Myers Squibb/Pfizer EEIG

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

EU/1/11/691

3.7.2019

1.7.2019

Eviplera

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/11/737

3.7.2019

1.7.2019

Exviera

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/983

3.7.2019

1.7.2019

Fiasp

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/16/1160

3.7.2019

1.7.2019

Instanyl

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/09/531

3.7.2019

1.7.2019

Mimpara

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/04/292

3.7.2019

1.7.2019

Ravicti

Immedica Pharma AB

SE-113 29 Stockholm, Sverige

EU/1/15/1062

3.7.2019

1.7.2019

Symtuza

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1225

3.7.2019

1.7.2019

Xarelto

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/08/472

3.7.2019

4.7.2019

Dukoral

Valneva Sweden AB

105 21 Stockholm, Sverige

EU/1/03/263

8.7.2019

4.7.2019

IKERVIS

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

EU/1/15/990

8.7.2019

4.7.2019

Kaletra

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/01/172

8.7.2019

4.7.2019

Nerlynx

Pierre Fabre Médicament

45, place Abel Gance, 92100 Boulogne-Billancourt, France

EU/1/18/1311

9.7.2019

4.7.2019

Orphacol

Laboratoires CTRS

63 rue de l’Est, 92100 Boulogne-Billancourt, France

EU/1/13/870

8.7.2019

4.7.2019

Prolia

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/10/618

8.7.2019

4.7.2019

Verkazia

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

EU/1/17/1219

8.7.2019

4.7.2019

Zinforo

Pfizer Ireland Pharmaceuticals

Operations Support Group, Ringaskiddy, County Cork, Ireland

EU/1/12/785

8.7.2019

8.7.2019

Emtricitabine/Tenofovir disoproxil Krka d.d.

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1182

10.7.2019

8.7.2019

Hefiya

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1287

10.7.2019

8.7.2019

Pazenir

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/18/1317

10.7.2019

8.7.2019

Tecentriq

Roche Registration GmbH

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

EU/1/17/1220

10.7.2019

8.7.2019

Tremfya

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1234

10.7.2019

8.7.2019

Viekirax

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/982

10.7.2019

8.7.2019

Xultophy

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/14/947

10.7.2019

9.7.2019

Elocta

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/15/1046

11.7.2019

11.7.2019

Ammonaps

Immedica Pharma AB

SE-113 29 Stockholm, Sverige

EU/1/99/120

15.7.2019

11.7.2019

Defitelio

Gentium S.r.I.

Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia

EU/1/13/878

15.7.2019

11.7.2019

Gliolan

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/07/413

15.7.2019

11.7.2019

Halimatoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1288

15.7.2019

11.7.2019

Tasigna

Novartis Europharm Limited

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

EU/1/07/422

15.7.2019

18.7.2019

Jentadueto

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/12/780

29.7.2019

18.7.2019

Myocet

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/00/141

22.7.2019

18.7.2019

Norvir

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/96/016

22.7.2019

18.7.2019

Xadago

Zambon S.p.A.

Via Lillo del Duca 10, 20091 Bresso (MI), Italia

EU/1/14/984

22.7.2019

18.7.2019

Xyrem

UCB Pharma S.A.

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

EU/1/05/312

22.7.2019

19.7.2019

Besponsa

Pfizer Europe MA EEIG

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

EU/1/17/1200

23.7.2019

19.7.2019

Colobreathe

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/747

23.7.2019

19.7.2019

Edistride

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1052

23.7.2019

19.7.2019

Exjade

Novartis Europharm Limited

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

EU/1/06/356

23.7.2019

19.7.2019

HyQvia

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/13/840

23.7.2019

19.7.2019

Incruse Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/922

23.7.2019

19.7.2019

Lartruvo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1143

23.7.2019

19.7.2019

Truvada

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/04/305

23.7.2019

19.7.2019

Truxima

Celltrion Healthcare Hungary Kft.

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

EU/1/16/1167

23.7.2019

25.7.2019

Abasaglar

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/944

29.7.2019

25.7.2019

Abraxane

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/07/428

29.7.2019

25.7.2019

Anoro Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/898

29.7.2019

25.7.2019

Blitzima

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1205

29.7.2019

25.7.2019

Corbilta

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/13/859

29.7.2019

25.7.2019

Deltyba

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, 80636 München, Deutschland

EU/1/13/875

29.7.2019

25.7.2019

Edistride

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1052

29.7.2019

25.7.2019

Forxiga

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/795

29.7.2019

25.7.2019

Gardasil 9

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/15/1007

29.7.2019

25.7.2019

Genvoya

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/15/1061

29.7.2019

25.7.2019

Hepsera

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/03/251

29.7.2019

25.7.2019

Herceptin

Roche Registration GmbH

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

EU/1/00/145

29.7.2019

25.7.2019

KANJINTI

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/18/1281

29.7.2019

25.7.2019

Lixiana

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/15/993

29.7.2019

25.7.2019

Maviret

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/17/1213

29.7.2019

25.7.2019

NexoBrid

MediWound Germany GmbH

Eisenstraße 5, 65428 Ruesselsheim, Deutschland

EU/1/12/803

29.7.2019

25.7.2019

Ofev

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/979

29.7.2019

25.7.2019

Ontruzant

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/17/1241

29.7.2019

25.7.2019

Ritemvia

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1207

29.7.2019

25.7.2019

Rolufta Ellipta

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/17/1174

29.7.2019

25.7.2019

Roteas

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/16/1152

29.7.2019

25.7.2019

Telmisartan Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/719

29.7.2019

25.7.2019

Temozolomide SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/11/697

29.7.2019

25.7.2019

Translarna

PTC Therapeutics International Limited

5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland

EU/1/13/902

29.7.2019

25.7.2019

Uptravi

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/15/1083

29.7.2019

25.7.2019

Visudyne

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24, 17489 Greifswald, Deutschland

EU/1/00/140

29.7.2019

25.7.2019

Vizamyl

GE Healthcare AS

Nycoveien 1, 0485, Oslo, Norge

EU/1/14/941

29.7.2019

25.7.2019

Xigduo

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/900

29.7.2019

25.7.2019

Zalmoxis

MolMed S.p.A.

Via Olgettina 58, 20132 Milano, Italia

EU/1/16/1121

29.7.2019

25.7.2019

Zinforo

Pfizer Ireland Pharmaceuticals

Operations Support Group, Ringaskiddy, County Cork, Ireland

EU/1/12/785

29.7.2019

25.7.2019

Zometa

Novartis Europharm Limited

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

EU/1/01/176

29.7.2019

31.7.2019

Aclasta

Novartis Europharm Limited

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

EU/1/05/308

2.8.2019

31.7.2019

Adenuric

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg

EU/1/08/447

5.8.2019

31.7.2019

Adjupanrix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/09/578

2.8.2019

31.7.2019

Duloxetine Lilly

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/972

2.8.2019

31.7.2019

Fiasp

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/16/1160

2.8.2019

31.7.2019

Flebogamma DIF

Instituto Grifols, S.A.

Can Guasch 2, Parets del Vallès, 08150 Barcelona, Espaňa

EU/1/07/404

2.8.2019

31.7.2019

Forxiga

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/795

2.8.2019

31.7.2019

Inovelon

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

EU/1/06/378

2.8.2019

31.7.2019

Invirase

Roche Registration GmbH

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

EU/1/96/026

2.8.2019

31.7.2019

Ketoconazole HRA

Laboratoire HRA Pharma

200 avenue de Paris, 92320 Chatillon, France

EU/1/14/965

2.8.2019

31.7.2019

Nucala

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/15/1043

2.8.2019

31.7.2019

Rezolsta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/967

2.8.2019

31.7.2019

Stalevo

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/03/260

2.8.2019

31.7.2019

Tadalafil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/14/961

2.8.2019

31.7.2019

Thalidomide Celgene

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/08/443

2.8.2019

31.7.2019

Trazimera

Pfizer Europe MA EEIG

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

EU/1/18/1295

2.8.2019

31.7.2019

Vargatef

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/954

2.8.2019

31.7.2019

Vimpat

UCB Pharma S.A.

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

EU/1/08/470

2.8.2019

31.7.2019

Xydalba

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland

EU/1/14/986

2.8.2019

1.8.2019

Cyramza

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/957

5.8.2019

1.8.2019

Dupixent

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/17/1229

5.8.2019

1.8.2019

Ebymect

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1051

5.8.2019

1.8.2019

Faslodex

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/03/269

5.8.2019

1.8.2019

Harvoni

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/14/958

6.8.2019

1.8.2019

Herzuma

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1257

6.8.2019

1.8.2019

Hirobriz Breezhaler

Novartis Europharm Limited

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

EU/1/09/594

6.8.2019

1.8.2019

Laventair Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/899

6.8.2019

2.8.2019

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/17/1222

6.8.2019

2.8.2019

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/945

6.8.2019

2.8.2019

JETREA

Oxurion NV

Gaston Geenslaan 1, 3001 Leuven, België

EU/1/13/819

6.8.2019

2.8.2019

Praxbind

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/15/1056

7.8.2019

8.8.2019

InductOs

Medtronic BioPharma B.V.

Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland

EU/1/02/226

12.8.2019

8.8.2019

Levodopa/Carbidopa/Entacapone Orion

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/706

12.8.2019

8.8.2019

Stivarga

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/858

12.8.2019

8.8.2019

Teysuno

Nordic Group B.V.

Siriusdreef 22, 2132 WT Hoofddorp, Nederland

EU/1/11/669

12.8.2019

9.8.2019

Jivi

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/18/1324

13.8.2019

9.8.2019

Travatan

Novartis Europharm Limited

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

EU/1/01/199

13.8.2019

9.8.2019

Truberzi

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland

EU/1/16/1126

13.8.2019

9.8.2019

Victoza

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/09/529

13.8.2019

14.8.2019

Oslif Breezhaler

Novartis Europharm Limited

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

EU/1/09/586

19.8.2019

23.8.2019

Aimovig

Novartis Europharm Limited

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

EU/1/18/1293

27.8.2019

23.8.2019

Brimica Genuair

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/963

27.8.2019

23.8.2019

Cinacalcet Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/1054

27.8.2019

23.8.2019

Cometriq

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/13/890

27.8.2019

23.8.2019

Duaklir Genuair

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/964

27.8.2019

23.8.2019

Elmiron

bene-Arzneimittel GmbH

Herterichstraße 1-3, 81479 München, Deutschland

EU/1/17/1189

27.8.2019

23.8.2019

Empliciti

Bristol-Myers Squibb Pharma EEIG

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

EU/1/16/1088

27.8.2019

23.8.2019

Firdapse

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland

EU/1/09/601

27.8.2019

23.8.2019

Flucelvax Tetra

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105BJ Amsterdam, Netherlands

EU/1/18/1326

27.8.2019

23.8.2019

Fluenz Tetra

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/887

27.8.2019

23.8.2019

Nordimet

Nordic Group B.V.

Siriusdreef 22, 2132 WT Hoofddorp, Nederland

EU/1/16/1124

27.8.2019

23.8.2019

Otezla

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/14/981

27.8.2019

23.8.2019

Ovitrelle

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/00/165

27.8.2019

23.8.2019

Renagel

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/99/123

27.8.2019

23.8.2019

Sevelamer carbonate Winthrop

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/14/952

27.8.2019

23.8.2019

Sovaldi

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/894

27.8.2019

23.8.2019

Spinraza

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/17/1188

27.8.2019

23.8.2019

Trulicity

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/956

27.8.2019

23.8.2019

Zerbaxa

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1032

27.8.2019

26.8.2019

Emadine

Novartis Europharm Limited

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

EU/1/98/095

28.8.2019

26.8.2019

Imraldi

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/17/1216

28.8.2019

26.8.2019

Jylamvo

Therakind (Europe) Limited

3 Inn’s Quay, Dublin 7, D07 PW4F, Ireland

EU/1/17/1172

28.8.2019

26.8.2019

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

28.8.2019

26.8.2019

Levitra

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/03/248

28.8.2019

26.8.2019

Mycophenolate mofetil Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/439

28.8.2019

26.8.2019

Nevanac

Novartis Europharm Limited

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

EU/1/07/433

28.8.2019

26.8.2019

Onbrez Breezhaler

Novartis Europharm Limited

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

EU/1/09/593

28.8.2019

26.8.2019

Prasugrel Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/18/1273

28.8.2019

26.8.2019

PREVYMIS

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/17/1245

28.8.2019

26.8.2019

Renvela

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/09/521

28.8.2019

26.8.2019

Soliris

Alexion Europe SAS

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

EU/1/07/393

28.8.2019

26.8.2019

TAGRISSO

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1086

28.8.2019

26.8.2019

Tasmar

Meda AB

Pipers väg 2A, 170 09 Solna, Sverige

EU/1/97/044

28.8.2019

26.8.2019

Tecentriq

Roche Registration GmbH

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

EU/1/17/1220

28.8.2019

26.8.2019

Vargatef

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/954

28.8.2019

26.8.2019

Vivanza

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/03/249

28.8.2019

31.8.2019

Kisqali

Novartis Europharm Limited

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

EU/1/17/1221

2.8.2019

| — | Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 19.7.2019 | EVICTO | selamectin | VIRBAC
  1ère avenue – 2065m – LID, 06516 Carros, France | EU/2/19/242 | Spot-on solution | QP54AA05 | 23.7.2019 |
| 29.7.2019 | NASYM | Live attenuated bovine respiratory syncytial virus (BRSV), strain Lym-56 | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/19/241 | Lyophilisate and solvent for suspension for injection or nasal spray | QI02AD04 | 31.7.2019 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

19.7.2019

EVICTO

selamectin

VIRBAC

1ère avenue – 2065m – LID, 06516 Carros, France

EU/2/19/242

Spot-on solution

QP54AA05

23.7.2019

29.7.2019

NASYM

Live attenuated bovine respiratory syncytial virus (BRSV), strain Lym-56

Laboratorios Hipra, S.A.

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

EU/2/19/241

Lyophilisate and solvent for suspension for injection or nasal spray

QI02AD04

31.7.2019

| — | Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 1.7.2019 | Osurnia | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/14/170 | 3.7.2019 |
| 4.7.2019 | Bravecto Plus | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/18/224 | 9.7.2019 |
| 29.7.2019 | Advocate | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/03/039 | 31.7.2019 |
| 9.8.2019 | Vectormune ND | CEVA-Phylaxia Co. Ltd
  Szállás u. 5, 1107 Budapest, Magyarország | EU/2/15/188 | 13.8.2019 |
| 19.8.2019 | NexGard | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/13/159 | 21.8.2019 |
| 19.8.2019 | NEXGARD SPECTRA | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/14/177 | 21.8.2019 |
| 29.8.2019 | Bovilis Blue-8 | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/17/218 | 2.9.2019 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

1.7.2019

Osurnia

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/14/170

3.7.2019

4.7.2019

Bravecto Plus

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/18/224

9.7.2019

29.7.2019

Advocate

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/03/039

31.7.2019

9.8.2019

Vectormune ND

CEVA-Phylaxia Co. Ltd

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/15/188

13.8.2019

19.8.2019

NexGard

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/13/159

21.8.2019

19.8.2019

NEXGARD SPECTRA

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/14/177

21.8.2019

29.8.2019

Bovilis Blue-8

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/17/218

2.9.2019

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| European Medicines Agency |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| The Netherlands |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

The Netherlands

---

(1)  OJ L 136, 30.4.2004, p. 1.

---

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

| 4.10.2019 | EN | Official Journal of the European Union | C 334/17 |
| --- | --- | --- | --- |

4.10.2019

EN

Official Journal of the European Union

C 334/17

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2019 to 31 August 2019

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
   (1) or Article 38 of Directive 2001/82/EC (2))

(2019/C 334/02)

| — | Refusal of modification of a national marketing authorisation |
| --- | --- |

—

Refusal of modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 4.7.2019 | Basiron AC and associated names | benzoyl peroxide | Not applicable | Not applicable | 5.7.2019 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

4.7.2019

Basiron AC and associated names

benzoyl peroxide

Not applicable

Not applicable

5.7.2019

---

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

---