Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2020 to 30 April 2020 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2020-05-29
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2020181EN.01000101.xml










29.5.2020   


EN


Official Journal of the European Union


C 181/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2020 to 30 April 2020
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2020/C 181/01)
—   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




1.4.2020


Arsenic trioxide Mylan


arsenic trioxide


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


EU/1/20/1427


Concentrate and solvent for solution for infusion


L01XX27


2.4.2020




1.4.2020


Nilemdo


bempedoic acid


FGK Representative Service GmbH
Heimeranstraße 35, 80339 München, Deutschland


EU/1/20/1425


Film-coated tablet


C10AX15


2.4.2020




1.4.2020


Ruxience


rituximab


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


EU/1/20/1431


Concentrate for solution for infusion


L01XC02


6.4.2020




1.4.2020


Vaxchora


Cholera vaccine (recombinant, live, oral)


Emergent Netherlands B.V.
Strawinskylaan 411, 1077 XX Amsterdam, Nederland


EU/1/20/1423


Effervescent powder and powder for oral suspension.


J07AE02


15.4.2020




3.4.2020


Budesonide/Formoterol Teva Pharma B.V.


budesonide/formoterol fumarate dihydrate


Teva Pharma B.V.
Swensweg 5, 2031GA Haarlem, Nederland


EU/1/19/1403


Inhalation powder


R03AK07


7.4.2020




3.4.2020


Cinacalcet Accordpharma


cinacalcet


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


EU/1/20/1429


Film-coated tablet


H05BX01


7.4.2020




3.4.2020


Rybelsus


semaglutide


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


EU/1/20/1430


Tablet


A10BJ06


7.4.2020




3.4.2020


Trepulmix


treprostinil sodium


SciPharm Sàrl
7, Fausermillen, 6689 Mertert, Luxembourg


EU/1/19/1419


Solution for infusion


B01AC21


7.4.2020




17.4.2020


Tigecycline Accord


tigecycline


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


EU/1/19/1394


Powder for solution for infusion


J01AA12


20.4.2020




23.4.2020


Fetcroja


cefiderocol


Shionogi B.V.
Kingsfordweg 151, 1043 GR Amsterdam, Nederland


EU/1/20/1434


Powder for concentrate for solution for infusion


J01DI04


24.4.2020




—   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




1.4.2020


Advate


Takeda Manufacturing Austria AG
Industriestraße 67, 1221 Wien, Österreich


EU/1/03/271


9.4.2020




1.4.2020


Alunbrig


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/18/1264


2.4.2020




1.4.2020


Defitelio


Gentium S.r.I.
Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia


EU/1/13/878


6.4.2020




1.4.2020


Dovato


ViiV Healthcare BV
Huis ter Heideweg 62, 3705 LZ Zeist, Nederland


EU/1/19/1370


7.4.2020




1.4.2020


Dynastat


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


EU/1/02/209


8.4.2020




1.4.2020


Intrarosa


Endoceutics S.A.
Rue Belliard 40, 1040 Brussels, Belgium


EU/1/17/1255


3.4.2020




1.4.2020


Isturisa


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


EU/1/19/1407


2.4.2020




1.4.2020


Juluca


ViiV Healthcare BV
Huis ter Heideweg 62, 3705 LZ Zeist, Nederland


EU/1/18/1282


7.4.2020




1.4.2020


Lonsurf


Les Laboratoires Servier
50 rue Carnot, 92284 Suresnes Cedex, France


EU/1/16/1096


2.4.2020




1.4.2020


Lutathera


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


EU/1/17/1226


6.4.2020




1.4.2020


Mirvaso


Galderma International
Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France


EU/1/13/904


6.4.2020




1.4.2020


Mvasi


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


EU/1/17/1246


3.4.2020




1.4.2020


Odefsey


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


EU/1/16/1112


2.4.2020




1.4.2020


Ondexxya


Portola Netherlands B.V.
Prins Bernhardplein 200, 1097 JB, Amsterdam, Netherlands


EU/1/18/1345


10.4.2020




1.4.2020


RoActemra


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


EU/1/08/492


2.4.2020




1.4.2020


Synjardy


Boehringer Ingelheim International GmbH
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland


EU/1/15/1003


3.4.2020




1.4.2020


TAVLESSE


Instituto Grifols, S.A.
Can Guasc, 2, Parets del Vallès, 08150 Barcelona, Espaňa


EU/1/19/1405


3.4.2020




1.4.2020


Trecondi


medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstraße 6, 22880 Wedel, Deutschland


EU/1/18/1351


2.4.2020




1.4.2020


Triumeq


ViiV Healthcare BV
Huis ter Heideweg 62, 3705 LZ Zeist, Nederland


EU/1/14/940


7.4.2020




1.4.2020


Vemlidy


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


EU/1/16/1154


2.4.2020




1.4.2020


Zoledronic acid Mylan


Mylan S.A.S.
117 allée des Parcs, 69800 Saint Priest, France


EU/1/12/786


3.4.2020




3.4.2020


AFSTYLA


CSL Behring GmbH
Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland


EU/1/16/1158


7.4.2020




3.4.2020


Alecensa


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


EU/1/16/1169


6.4.2020




3.4.2020


Avastin


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


EU/1/04/300


6.4.2020




3.4.2020


Bortezomib Accord


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


EU/1/15/1019


6.4.2020




3.4.2020


Elmiron


bene-Arzneimittel GmbH
Herterichstraße 1-3, 81479 München, Deutschland


EU/1/17/1189


20.4.2020




3.4.2020


Glivec


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/01/198


8.4.2020




3.4.2020


Jinarc


Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland


EU/1/15/1000


7.4.2020




3.4.2020


Lorviqua


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


EU/1/19/1355


8.4.2020




3.4.2020


Naglazyme


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


EU/1/05/324


6.4.2020




3.4.2020


NULOJIX


Bristol-Myers Squibb Pharma EEIG
Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland


EU/1/11/694


6.4.2020




3.4.2020


Pregabalin Mylan


Mylan S.A.S.
117 allée des Parcs, 69800 Saint Priest, France


EU/1/15/997


7.4.2020




3.4.2020


Pregabalin Mylan Pharma


Mylan S.A.S.
117 allée des Parcs, 69800 Saint Priest, France


EU/1/15/998


7.4.2020




8.4.2020


Insuman


Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main, Deutschland


EU/1/97/030


23.4.2020




8.4.2020


Otezla


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


EU/1/14/981


14.4.2020




8.4.2020


Pifeltro


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


EU/1/18/1332


23.4.2020




8.4.2020


Pregabalin Accord


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


EU/1/15/1027


14.4.2020




8.4.2020


Tamiflu


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


EU/1/02/222


14.4.2020




8.4.2020


Tivicay


ViiV Healthcare BV
Huis ter Heideweg 62, 3705 LZ Zeist, Nederland


EU/1/13/892


14.4.2020




8.4.2020


Venclyxto


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


EU/1/16/1138


15.4.2020




8.4.2020


Vidaza


Celgene Europe B.V.
Winthontlaan 6 N, 3526 KV Utrecht, Nederland


EU/1/08/488


14.4.2020




8.4.2020


Xaluprine


Nova Laboratories Ireland Limited
3rd Floor, Ulysses House, Foley Street, Dublin 1, Ireland


EU/1/11/727


14.4.2020




14.4.2020


Repatha


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


EU/1/15/1016


16.4.2020




17.4.2020


Cystagon


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


EU/1/97/039


23.4.2020




17.4.2020


Ofev


Boehringer Ingelheim International GmbH
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland


EU/1/14/979


20.4.2020




17.4.2020


Rubraca


Clovis Oncology Ireland Limited
Regus Dublin Airport, Skybridge House — Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland


EU/1/17/1250


20.4.2020




17.4.2020


Zerbaxa


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


EU/1/15/1032


23.4.2020




23.4.2020


Bevespi Aerosphere


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/18/1339


5.5.2020




23.4.2020


Bridion


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


EU/1/08/466


24.4.2020




23.4.2020


Carbaglu


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


EU/1/02/246


5.5.2020




23.4.2020


Cresemba


Basilea Pharmaceutica Deutschland GmbH
Marie-Curie-Strasse 8, 79539 Loerrach, Baden-Wuerttemberg, Deutschland


EU/1/15/1036


24.4.2020




23.4.2020


Cystadane


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


EU/1/06/379


24.4.2020




23.4.2020


Deltyba


Otsuka Novel Products GmbH
Erika-Mann-Straße 21, 80636 München, Deutschland


EU/1/13/875


27.4.2020




23.4.2020


Descovy


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


EU/1/16/1099


24.4.2020




23.4.2020


Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva


Zentiva, k.s.
U Kabelovny 130, 102 37 Praha 10, Česká republika


EU/1/17/1210


24.4.2020




23.4.2020


Kanuma


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


EU/1/15/1033


24.4.2020




23.4.2020


Lumark


IDB Holland B.V.
Weverstraat 17, 5111 PV Baarle-Nassau, Nederland


EU/1/15/1013


30.4.2020




23.4.2020


Onivyde pegylated liposomal


Les Laboratoires Servier
50 rue Carnot, 92284 Suresnes Cedex, France


EU/1/16/1130


5.5.2020




23.4.2020


OPDIVO


Bristol-Myers Squibb Pharma EEIG
Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland


EU/1/15/1014


24.4.2020




23.4.2020


Pedea


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


EU/1/04/284


24.4.2020




23.4.2020


Respreeza


CSL Behring GmbH
Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland


EU/1/15/1006


27.4.2020




23.4.2020


Sustiva


Bristol-Myers Squibb Pharma EEIG
Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland


EU/1/99/110


24.4.2020




23.4.2020


Tysabri


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


EU/1/06/346


24.4.2020




23.4.2020


Ultibro Breezhaler


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/13/862


24.4.2020




23.4.2020


Zytiga


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


EU/1/11/714


24.4.2020




28.4.2020


Abilify


Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland


EU/1/04/276


29.4.2020




28.4.2020


ABILIFY MAINTENA


Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland


EU/1/13/882


30.4.2020




28.4.2020


Aripiprazole Sandoz


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/15/1029


6.5.2020




28.4.2020


Bexsero


GlaxoSmithKline Vaccines S.r.l.
Via Fiorentina, 1, 53100 Siena, Italia


EU/1/12/812


29.4.2020




28.4.2020


Cayston


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


EU/1/09/543


29.4.2020




28.4.2020


Cosentyx


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/14/980


30.4.2020




28.4.2020


Docetaxel Teva


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


EU/1/09/611


29.4.2020




28.4.2020


Entyvio


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/14/923


7.5.2020




28.4.2020


Farydak


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


EU/1/15/1023


30.4.2020




28.4.2020


Fycompa


Eisai GmbH
Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland


EU/1/12/776


1.5.2020




28.4.2020


Humira


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


EU/1/03/256


29.4.2020




28.4.2020


Intelence


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


EU/1/08/468


29.4.2020




28.4.2020


Kevzara


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


EU/1/17/1196


30.4.2020




28.4.2020


Kineret


Swedish Orphan Biovitrum AB (publ)
112 76 Stockholm, Sverige


EU/1/02/203


30.4.2020




28.4.2020


Lokelma


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/17/1173


5.5.2020




28.4.2020


Myalepta


Amryt Pharmaceuticals DAC
90 Harcourt Street, Dublin 2, Ireland


EU/1/18/1276


29.4.2020




28.4.2020


Nitisinone MDK


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


EU/1/17/1217


1.5.2020




28.4.2020


OCALIVA


Intercept Pharma International Limited
Ormond Building, 31 — 36 Ormond Quay Upper, Dublin 7, Ireland


EU/1/16/1139


29.4.2020




28.4.2020


Ruconest


Pharming Group N.V.
Darwinweg 24, 2333 CR Leiden, Nederland


EU/1/10/641


29.4.2020




28.4.2020


Strensiq


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


EU/1/15/1015


29.4.2020




28.4.2020


Zynteglo


bluebird bio (Netherlands) B.V.
Stadsplateau 7, WTC Utrecht, 3521 AZ Utrecht, Nederland


EU/1/19/1367


30.4.2020




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









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




14.4.2020


Osseor


Les Laboratoires Servier
50 rue Carnot, 92284 Suresnes Cedex, France


EU/1/04/287


15.4.2020




14.4.2020


Protelos


Les Laboratoires Servier
50 rue Carnot, 92284 Suresnes Cedex, France


EU/1/04/288


15.4.2020




—   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




24.4.2020


Tulaven


tulathromycin


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


EU/2/20/251


Solution for injection


QJ01FA94


27.4.2020




24.4.2020


Tulissin


tulathromycin


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


EU/2/20/252


Solution for injection


QJ01FA94


27.4.2020




24.4.2020


Vectormune FP ILT + AE


Fowlpox, avian infectious laryngotracheitis vaccine (live, recombinant) and avian encephalomyelitis vaccine (live)


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


EU/2/20/250


Lyophilisate and solvent for suspension for injection


Pending


27.4.2020




—   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




1.4.2020


Comfortis


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


EU/2/10/115


3.4.2020




1.4.2020


Nobivac LeuFel


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


EU/2/17/217


3.4.2020




8.4.2020


Acticam


Ecuphar NV
Legeweg 157-i, 8020 Oostkamp, België


EU/2/08/088


22.4.2020




8.4.2020


Fevaxyn Pentofel


Zoetis Belgium S.A.
rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/96/002


15.4.2020




8.4.2020


Inflacam


Chanelle Pharmaceuticals Manufacturing Limited
Loughrea, Co. Galway, Ireland


EU/2/11/134


15.4.2020




8.4.2020


MiPet Easecto


Zoetis Belgium S.A.
rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/17/220


16.4.2020




8.4.2020


RESPIPORC FLUpan H1N1


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


EU/2/17/209


14.4.2020




8.4.2020


Vectra 3D


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


EU/2/13/156


14.4.2020




8.4.2020


Versican Plus DHPPi


Zoetis Belgium S.A.
rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/14/169


15.4.2020




8.4.2020


Versican Plus DHPPi/L4


Zoetis Belgium S.A.
rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/14/164


15.4.2020




8.4.2020


Versican Plus DHPPi/L4R


Zoetis Belgium S.A.
rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/14/163


15.4.2020




8.4.2020


Versican Plus L4


Zoetis Belgium S.A.
rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/14/171


15.4.2020




8.4.2020


Versican Plus Pi


Zoetis Belgium S.A.
rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/14/168


15.4.2020




8.4.2020


Versican Plus Pi/L4


Zoetis Belgium S.A.
rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/14/172


15.4.2020




8.4.2020


Versican Plus Pi/L4R


Zoetis Belgium S.A.
rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/14/173


15.4.2020




16.4.2020


Arti-Cell Forte


Global Stem cell Technology (G.S.T.) NV
Noorwegenstraat 4, 9940 Evergem, België


EU/2/18/228


17.4.2020




24.4.2020


Canigen L4


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


EU/2/15/183


27.4.2020




24.4.2020


Innovax-ILT


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


EU/2/15/182


28.4.2020




24.4.2020


SevoFlo


Zoetis Belgium S.A.
rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/02/035


27.4.2020




24.4.2020


Sileo


Orion Corporation
Orionintie 1, 02200 Espoo, Suomi


EU/2/15/181


29.4.2020




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









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




8.4.2020


Suvaxyn PCV


Zoetis Belgium S.A.
rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/09/099


15.4.2020




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




NETHERLANDS






(1)  OJ L 136, 30.4.2004, p. 1.