# C_2018229EN.01000101.xml

| 29.6.2018 | EN | Official Journal of the European Union | C 229/1 |
| --- | --- | --- | --- |

29.6.2018

EN

Official Journal of the European Union

C 229/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2018 to 31 May 2018

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

1

(2018/C 229/01)

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

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

Issuing of a marketing authorization

Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 16.5.2018 | Juluca | dolutegravir/rilpivirine | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/18/1282 | Film-coated tablet | J05AR21 | 18.5.2018 |
| 16.5.2018 | KANJINTI | trastuzumab | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/18/1281 | Powder for concentrate for solution for infusion | L01XC03 | 18.5.2018 |
| 16.5.2018 | Prasugrel Mylan | prasugrel | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/18/1273 | Film-coated tablet | B01AC22 | 18.5.2018 |
| 18.5.2018 | Zessly | infliximab | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1280 | Powder for concentrate and diluent for solution for infusion | L04AB02 | 23.5.2018 |
| 22.5.2018 | Pemetrexed Krka | pemetrexed | KRKA, d.d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/18/1283 | Powder for concentrate for solution for infusion | L01BA04 | 24.5.2018 |
| 24.5.2018 | AMGLIDIA | glibenclamide | AMMTeK
  15 rue Béranger, 75003 Paris, France | EU/1/18/1279 | Oral suspension | A10BB01 | 28.5.2018 |
| 24.5.2018 | Rubraca | rucaparib | Clovis Oncology UK Limited
  Sheraton House, Castle Park, Castle Hill, Cambridge CB3 0AX, United Kingdom | EU/1/17/1250 | Film-coated tablet | L01XX55 | 29.5.2018 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

16.5.2018

Juluca

dolutegravir/rilpivirine

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/18/1282

Film-coated tablet

J05AR21

18.5.2018

16.5.2018

KANJINTI

trastuzumab

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/18/1281

Powder for concentrate for solution for infusion

L01XC03

18.5.2018

16.5.2018

Prasugrel Mylan

prasugrel

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/18/1273

Film-coated tablet

B01AC22

18.5.2018

18.5.2018

Zessly

infliximab

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1280

Powder for concentrate and diluent for solution for infusion

L04AB02

23.5.2018

22.5.2018

Pemetrexed Krka

pemetrexed

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/18/1283

Powder for concentrate for solution for infusion

L01BA04

24.5.2018

24.5.2018

AMGLIDIA

glibenclamide

AMMTeK

15 rue Béranger, 75003 Paris, France

EU/1/18/1279

Oral suspension

A10BB01

28.5.2018

24.5.2018

Rubraca

rucaparib

Clovis Oncology UK Limited

Sheraton House, Castle Park, Castle Hill, Cambridge CB3 0AX, United Kingdom

EU/1/17/1250

Film-coated tablet

L01XX55

29.5.2018

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

—

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

Modification of a marketing authorization

Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 8.5.2018 | Afinitor | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/538 | 15.5.2018 |
| 8.5.2018 | Aflunov | Seqirus S.r.l.
  Via Fiorentina 1, Siena, Italia | EU/1/10/658 | 15.5.2018 |
| 8.5.2018 | Alofisel | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/17/1261 | 16.5.2018 |
| 8.5.2018 | Busulfan Fresenius Kabi | Fresenius Kabi Deutschland GmbH
  Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland | EU/1/14/951 | 16.5.2018 |
| 8.5.2018 | CABOMETYX | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/16/1136 | 15.5.2018 |
| 8.5.2018 | Docetaxel Kabi | Fresenius Kabi Deutschland GmbH
  Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland | EU/1/12/770 | 16.5.2018 |
| 8.5.2018 | Effentora | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/08/441 | 15.5.2018 |
| 8.5.2018 | Elonva | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/09/609 | 16.5.2018 |
| 8.5.2018 | Flixabi | Samsung Bioepis UK Limited
  5th floor, Profile West, 950 Great West Road, Brentford, Middlesex TW8 9ES, United Kingdom | EU/1/16/1106 | 15.5.2018 |
| 8.5.2018 | Inflectra | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom | EU/1/13/854 | 16.5.2018 |
| 8.5.2018 | Instanyl | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/09/531 | 15.5.2018 |
| 8.5.2018 | Invanz | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/02/216 | 15.5.2018 |
| 8.5.2018 | Izba | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/13/905 | 15.5.2018 |
| 8.5.2018 | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 15.5.2018 |
| 8.5.2018 | LIFMIOR | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/16/1165 | 15.5.2018 |
| 8.5.2018 | Lonquex | UAB ‘Sicor Biotech’
  Molėtų pl. 5, 08409 Vilnius, Lietuva | EU/1/13/856 | 15.5.2018 |
| 8.5.2018 | Lynparza | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/14/959 | 15.5.2018 |
| 8.5.2018 | Odomzo | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, 2132 JH Hoofddorp, Nederland | EU/1/15/1030 | 15.5.2018 |
| 8.5.2018 | Orphacol | Laboratoires CTRS
  63 rue de l’Est, 92100 Boulogne-Billancourt, France | EU/1/13/870 | 15.5.2018 |
| 8.5.2018 | Oslif Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/586 | 15.5.2018 |
| 8.5.2018 | PecFent | Kyowa Kirin Services Ltd
  Galabank Business Park, Galashiels, TD1 1QH, United Kingdom | EU/1/10/644 | 15.5.2018 |
| 8.5.2018 | Pemetrexed Fresenius Kabi | Fresenius Kabi Oncology Plc.
  Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom | EU/1/16/1115 | 15.5.2018 |
| 8.5.2018 | Pemetrexed Hospira | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom | EU/1/15/1057 | 15.5.2018 |
| 8.5.2018 | Pramipexole Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/11/728 | 15.5.2018 |
| 8.5.2018 | Prometax | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/98/092 | 15.5.2018 |
| 8.5.2018 | Rekovelle | Ferring Pharmaceuticals A/S
  Kay Fiskers Plads 11, 2300 Copenhagen S, Danmark | EU/1/16/1150 | 15.5.2018 |
| 8.5.2018 | Repatha | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1016 | 15.5.2018 |
| 8.5.2018 | Riluzole Zentiva | Zentiva k.s.
  U kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/12/768 | 15.5.2018 |
| 8.5.2018 | Starlix | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/01/174 | 15.5.2018 |
| 8.5.2018 | Synagis | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/99/117 | 15.5.2018 |
| 8.5.2018 | Tafinlar | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/865 | 15.5.2018 |
| 8.5.2018 | Tivicay | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/13/892 | 16.5.2018 |
| 8.5.2018 | Travatan | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/01/199 | 15.5.2018 |
| 8.5.2018 | Ulunar Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/917 | 15.5.2018 |
| 8.5.2018 | Votrient | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/10/628 | 15.5.2018 |
| 8.5.2018 | Zerbaxa | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/1032 | 15.5.2018 |
| 16.5.2018 | Giotrif | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/13/879 | 18.5.2018 |
| 16.5.2018 | Januvia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/383 | 18.5.2018 |
| 16.5.2018 | Nordimet | Nordic Group B.V.
  Siriusdreef 22, 2132 WT Hoofddorp, Nederland | EU/1/16/1124 | 18.5.2018 |
| 16.5.2018 | Odefsey | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/16/1112 | 18.5.2018 |
| 16.5.2018 | Ovaleap | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/13/871 | 18.5.2018 |
| 22.5.2018 | Bosulif | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/13/818 | 24.5.2018 |
| 22.5.2018 | Efficib | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/457 | 24.5.2018 |
| 22.5.2018 | Jakavi | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/12/773 | 25.5.2018 |
| 22.5.2018 | Janumet | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/455 | 24.5.2018 |
| 22.5.2018 | Jylamvo | Therakind Ltd
  314 Regents Park Road, London N3 2JX, United Kingdom | EU/1/17/1172 | 24.5.2018 |
| 22.5.2018 | Osseor | Les Laboratoires Servier
  50 rue Carnot, 92284 Suresnes Cedex, France | EU/1/04/287 | 24.5.2018 |
| 22.5.2018 | Pedea | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France | EU/1/04/284 | 24.5.2018 |
| 22.5.2018 | Protelos | Les Laboratoires Servier
  50 rue Carnot, 92284 Suresnes Cedex, France | EU/1/04/288 | 24.5.2018 |
| 22.5.2018 | Ristaben | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/621 | 24.5.2018 |
| 22.5.2018 | Ristfor | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/620 | 24.5.2018 |
| 22.5.2018 | Stivarga | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/858 | 24.5.2018 |
| 22.5.2018 | Stribild | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/830 | 24.5.2018 |
| 22.5.2018 | Tesavel | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/435 | 24.5.2018 |
| 22.5.2018 | Tybost | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/872 | 24.5.2018 |
| 22.5.2018 | Tyverb | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/07/440 | 24.5.2018 |
| 22.5.2018 | Ultibro Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/862 | 24.5.2018 |
| 22.5.2018 | Velmetia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/456 | 24.5.2018 |
| 22.5.2018 | Xarelto | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/08/472 | 24.5.2018 |
| 22.5.2018 | Xelevia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/382 | 24.5.2018 |
| 22.5.2018 | Xoterna Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/863 | 24.5.2018 |
| 23.5.2018 | Kaletra | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/01/172 | 25.5.2018 |
| 24.5.2018 | Atazanavir Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/16/1091 | 28.5.2018 |
| 24.5.2018 | Cayston | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/09/543 | 28.5.2018 |
| 24.5.2018 | Darunavir Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/16/1140 | 28.5.2018 |
| 24.5.2018 | Emend | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/03/262 | 29.5.2018 |
| 24.5.2018 | Norvir | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/96/016 | 29.5.2018 |
| 24.5.2018 | Procysbi | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/13/861 | 28.5.2018 |
| 24.5.2018 | Vipdomet | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/13/843 | 28.5.2018 |
| 24.5.2018 | Vipidia | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/13/844 | 28.5.2018 |
| 25.5.2018 | Armisarte | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/15/1063 | 28.5.2018 |
| 25.5.2018 | Incresync | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/13/842 | 28.5.2018 |
| 28.5.2018 | Atosiban SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, 2132 JH Hoofddorp, Nederland | EU/1/13/852 | 30.5.2018 |
| 28.5.2018 | AUBAGIO | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/13/838 | 30.5.2018 |
| 28.5.2018 | Bortezomib Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1019 | 30.5.2018 |
| 28.5.2018 | Descovy | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/16/1099 | 30.5.2018 |
| 28.5.2018 | Epclusa | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/16/1116 | 30.5.2018 |
| 28.5.2018 | Eviplera | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/11/737 | 30.5.2018 |
| 28.5.2018 | Hepsera | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/03/251 | 30.5.2018 |
| 28.5.2018 | Ledaga | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/16/1171 | 30.5.2018 |
| 28.5.2018 | Lixiana | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/15/993 | 30.5.2018 |
| 28.5.2018 | Plavix | Sanofi Clir SNC
  54 rue La Boétie, 75008 Paris, France | EU/1/98/069 | 30.5.2018 |
| 28.5.2018 | Senshio | Shionogi Limited
  33 Kingsway, London WC2B 6UF, United Kingdom | EU/1/14/978 | 30.5.2018 |
| 28.5.2018 | Tecfidera | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/13/837 | 30.5.2018 |
| 28.5.2018 | Temodal | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/98/096 | 30.5.2018 |
| 28.5.2018 | Vemlidy | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/16/1154 | 30.5.2018 |
| 28.5.2018 | Vokanamet | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/918 | 30.5.2018 |
| 31.5.2018 | Alecensa | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/16/1169 | 4.6.2018 |
| 31.5.2018 | Champix | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/360 | 4.6.2018 |
| 31.5.2018 | Chenodeoxycholic acid Leadiant | Leadiant GmbH
  Liebherrstraße 22, 80538 München, Deutschland | EU/1/16/1110 | 4.6.2018 |
| 31.5.2018 | DuoTrav | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/338 | 5.6.2018 |
| 31.5.2018 | Eliquis | Bristol-Myers Squibb/Pfizer EEIG
  Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | EU/1/11/691 | 4.6.2018 |
| 31.5.2018 | Exviera | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/14/983 | 4.6.2018 |
| 31.5.2018 | Perjeta | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/13/813 | 4.6.2018 |
| 31.5.2018 | Sprycel | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/06/363 | 4.6.2018 |
| 31.5.2018 | Tadalafil Lilly | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/17/1177 | 4.6.2018 |
| 31.5.2018 | Twynsta | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/10/648 | 4.6.2018 |
| 31.5.2018 | Venclyxto | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/16/1138 | 4.6.2018 |
| 31.5.2018 | Votubia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/710 | 4.6.2018 |
| 31.5.2018 | Yervoy | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/11/698 | 4.6.2018 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

8.5.2018

Afinitor

Novartis Europharm Limited

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

EU/1/09/538

15.5.2018

8.5.2018

Aflunov

Seqirus S.r.l.

Via Fiorentina 1, Siena, Italia

EU/1/10/658

15.5.2018

8.5.2018

Alofisel

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/17/1261

16.5.2018

8.5.2018

Busulfan Fresenius Kabi

Fresenius Kabi Deutschland GmbH

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

EU/1/14/951

16.5.2018

8.5.2018

CABOMETYX

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/16/1136

15.5.2018

8.5.2018

Docetaxel Kabi

Fresenius Kabi Deutschland GmbH

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

EU/1/12/770

16.5.2018

8.5.2018

Effentora

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/08/441

15.5.2018

8.5.2018

Elonva

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/09/609

16.5.2018

8.5.2018

Flixabi

Samsung Bioepis UK Limited

5th floor, Profile West, 950 Great West Road, Brentford, Middlesex TW8 9ES, United Kingdom

EU/1/16/1106

15.5.2018

8.5.2018

Inflectra

Hospira UK Limited

Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom

EU/1/13/854

16.5.2018

8.5.2018

Instanyl

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/09/531

15.5.2018

8.5.2018

Invanz

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/02/216

15.5.2018

8.5.2018

Izba

Novartis Europharm Limited

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

EU/1/13/905

15.5.2018

8.5.2018

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

15.5.2018

8.5.2018

LIFMIOR

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/16/1165

15.5.2018

8.5.2018

Lonquex

UAB ‘Sicor Biotech’

Molėtų pl. 5, 08409 Vilnius, Lietuva

EU/1/13/856

15.5.2018

8.5.2018

Lynparza

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/959

15.5.2018

8.5.2018

Odomzo

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/15/1030

15.5.2018

8.5.2018

Orphacol

Laboratoires CTRS

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

EU/1/13/870

15.5.2018

8.5.2018

Oslif Breezhaler

Novartis Europharm Limited

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

EU/1/09/586

15.5.2018

8.5.2018

PecFent

Kyowa Kirin Services Ltd

Galabank Business Park, Galashiels, TD1 1QH, United Kingdom

EU/1/10/644

15.5.2018

8.5.2018

Pemetrexed Fresenius Kabi

Fresenius Kabi Oncology Plc.

Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom

EU/1/16/1115

15.5.2018

8.5.2018

Pemetrexed Hospira

Hospira UK Limited

Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom

EU/1/15/1057

15.5.2018

8.5.2018

Pramipexole Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/11/728

15.5.2018

8.5.2018

Prometax

Novartis Europharm Limited

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

EU/1/98/092

15.5.2018

8.5.2018

Rekovelle

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11, 2300 Copenhagen S, Danmark

EU/1/16/1150

15.5.2018

8.5.2018

Repatha

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1016

15.5.2018

8.5.2018

Riluzole Zentiva

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/12/768

15.5.2018

8.5.2018

Starlix

Novartis Europharm Limited

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

EU/1/01/174

15.5.2018

8.5.2018

Synagis

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/99/117

15.5.2018

8.5.2018

Tafinlar

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/865

15.5.2018

8.5.2018

Tivicay

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/13/892

16.5.2018

8.5.2018

Travatan

Novartis Europharm Limited

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

EU/1/01/199

15.5.2018

8.5.2018

Ulunar Breezhaler

Novartis Europharm Limited

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

EU/1/14/917

15.5.2018

8.5.2018

Votrient

Novartis Europharm Limited

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

EU/1/10/628

15.5.2018

8.5.2018

Zerbaxa

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/15/1032

15.5.2018

16.5.2018

Giotrif

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/13/879

18.5.2018

16.5.2018

Januvia

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/383

18.5.2018

16.5.2018

Nordimet

Nordic Group B.V.

Siriusdreef 22, 2132 WT Hoofddorp, Nederland

EU/1/16/1124

18.5.2018

16.5.2018

Odefsey

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1112

18.5.2018

16.5.2018

Ovaleap

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/13/871

18.5.2018

22.5.2018

Bosulif

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/13/818

24.5.2018

22.5.2018

Efficib

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/457

24.5.2018

22.5.2018

Jakavi

Novartis Europharm Limited

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

EU/1/12/773

25.5.2018

22.5.2018

Janumet

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/455

24.5.2018

22.5.2018

Jylamvo

Therakind Ltd

314 Regents Park Road, London N3 2JX, United Kingdom

EU/1/17/1172

24.5.2018

22.5.2018

Osseor

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/04/287

24.5.2018

22.5.2018

Pedea

Orphan Europe S.A.R.L.

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

EU/1/04/284

24.5.2018

22.5.2018

Protelos

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/04/288

24.5.2018

22.5.2018

Ristaben

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/10/621

24.5.2018

22.5.2018

Ristfor

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/10/620

24.5.2018

22.5.2018

Stivarga

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/858

24.5.2018

22.5.2018

Stribild

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/830

24.5.2018

22.5.2018

Tesavel

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/435

24.5.2018

22.5.2018

Tybost

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/872

24.5.2018

22.5.2018

Tyverb

Novartis Europharm Limited

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

EU/1/07/440

24.5.2018

22.5.2018

Ultibro Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/862

24.5.2018

22.5.2018

Velmetia

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/456

24.5.2018

22.5.2018

Xarelto

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/08/472

24.5.2018

22.5.2018

Xelevia

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/382

24.5.2018

22.5.2018

Xoterna Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/863

24.5.2018

23.5.2018

Kaletra

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/01/172

25.5.2018

24.5.2018

Atazanavir Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1091

28.5.2018

24.5.2018

Cayston

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/09/543

28.5.2018

24.5.2018

Darunavir Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1140

28.5.2018

24.5.2018

Emend

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/03/262

29.5.2018

24.5.2018

Norvir

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/96/016

29.5.2018

24.5.2018

Procysbi

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/13/861

28.5.2018

24.5.2018

Vipdomet

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/13/843

28.5.2018

24.5.2018

Vipidia

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/13/844

28.5.2018

25.5.2018

Armisarte

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/15/1063

28.5.2018

25.5.2018

Incresync

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/13/842

28.5.2018

28.5.2018

Atosiban SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/13/852

30.5.2018

28.5.2018

AUBAGIO

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/13/838

30.5.2018

28.5.2018

Bortezomib Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/15/1019

30.5.2018

28.5.2018

Descovy

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1099

30.5.2018

28.5.2018

Epclusa

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1116

30.5.2018

28.5.2018

Eviplera

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/11/737

30.5.2018

28.5.2018

Hepsera

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/03/251

30.5.2018

28.5.2018

Ledaga

Actelion Registration Ltd

Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/16/1171

30.5.2018

28.5.2018

Lixiana

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/15/993

30.5.2018

28.5.2018

Plavix

Sanofi Clir SNC

54 rue La Boétie, 75008 Paris, France

EU/1/98/069

30.5.2018

28.5.2018

Senshio

Shionogi Limited

33 Kingsway, London WC2B 6UF, United Kingdom

EU/1/14/978

30.5.2018

28.5.2018

Tecfidera

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/13/837

30.5.2018

28.5.2018

Temodal

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/98/096

30.5.2018

28.5.2018

Vemlidy

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1154

30.5.2018

28.5.2018

Vokanamet

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/918

30.5.2018

31.5.2018

Alecensa

Roche Registration GmbH

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

EU/1/16/1169

4.6.2018

31.5.2018

Champix

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/06/360

4.6.2018

31.5.2018

Chenodeoxycholic acid Leadiant

Leadiant GmbH

Liebherrstraße 22, 80538 München, Deutschland

EU/1/16/1110

4.6.2018

31.5.2018

DuoTrav

Novartis Europharm Limited

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

EU/1/06/338

5.6.2018

31.5.2018

Eliquis

Bristol-Myers Squibb/Pfizer EEIG

Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/11/691

4.6.2018

31.5.2018

Exviera

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/983

4.6.2018

31.5.2018

Perjeta

Roche Registration GmbH

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

EU/1/13/813

4.6.2018

31.5.2018

Sprycel

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/06/363

4.6.2018

31.5.2018

Tadalafil Lilly

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/17/1177

4.6.2018

31.5.2018

Twynsta

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/10/648

4.6.2018

31.5.2018

Venclyxto

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/16/1138

4.6.2018

31.5.2018

Votubia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/710

4.6.2018

31.5.2018

Yervoy

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/11/698

4.6.2018

| — | Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
| --- | --- |

—

Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

Withdrawal of a marketing authorization

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 8.5.2018 | Imatinib Teva B.V. | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/17/1243 | 15.5.2018 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

8.5.2018

Imatinib Teva B.V.

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/17/1243

15.5.2018

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

—

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

Issuing of a marketing authorization

Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 8.5.2018 | Bravecto Plus | fluralaner/moxidectin | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/18/224 | Spot-on solution | QP54AB52 | 16.5.2018 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

8.5.2018

Bravecto Plus

fluralaner/moxidectin

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/18/224

Spot-on solution

QP54AB52

16.5.2018

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

—

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

Modification of a marketing authorization

Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 8.5.2018 | Fevaxyn Pentofel | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/96/002 | 15.5.2018 |
| 8.5.2018 | Semintra | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/12/146 | 16.5.2018 |
| 8.5.2018 | Suvaxyn Aujeszky 783 + O/W | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/98/009 | 16.5.2018 |
| 25.5.2018 | GALLIPRANT | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/17/221 | 29.5.2018 |
| 25.5.2018 | Osurnia | Elanco Europe Ltd
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/14/170 | 29.5.2018 |
| 25.5.2018 | Profender | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/05/054 | 29.5.2018 |
| 25.5.2018 | Sevohale | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | EU/2/16/196 | 30.5.2018 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

8.5.2018

Fevaxyn Pentofel

Zoetis Belgium S.A.

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

EU/2/96/002

15.5.2018

8.5.2018

Semintra

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/12/146

16.5.2018

8.5.2018

Suvaxyn Aujeszky 783 + O/W

Zoetis Belgium S.A.

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

EU/2/98/009

16.5.2018

25.5.2018

GALLIPRANT

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/17/221

29.5.2018

25.5.2018

Osurnia

Elanco Europe Ltd

Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

EU/2/14/170

29.5.2018

25.5.2018

Profender

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/05/054

29.5.2018

25.5.2018

Sevohale

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/16/196

30.5.2018

| — | Withdrawal of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
| --- | --- |

—

Withdrawal of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

Withdrawal of a marketing authorization

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 8.5.2018 | BTVPUR AlSap 1 | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/10/112 | 16.5.2018 |
| 8.5.2018 | BTVPUR AlSap 8 | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/09/094 | 16.5.2018 |
| 25.5.2018 | Meloxivet | Eli Lilly and Company Limited
  Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | EU/2/07/077 | 29.5.2018 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

8.5.2018

BTVPUR AlSap 1

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/10/112

16.5.2018

8.5.2018

BTVPUR AlSap 8

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/09/094

16.5.2018

25.5.2018

Meloxivet

Eli Lilly and Company Limited

Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom

EU/2/07/077

29.5.2018

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 |
| --- |
| 30 Churchill Place |
| Canary Wharf |
| London E14 5EU |
| United Kingdom |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

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

1

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