Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2019 to 30 April 2019 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2019-05-24
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2019180EN.01000101.xml










24.5.2019   


EN


Official Journal of the European Union


C 180/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2019 to 30 April 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 180/01)






—



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




2.4.2019


Idacio


adalimumab







Fresenius Kabi Deutschland GmbH




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






EU/1/19/1356


Solution for injection


L04AB04


4.4.2019




2.4.2019


Kromeya


adalimumab







Fresenius Kabi Deutschland GmbH




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






EU/1/19/1357


Solution for injection


L04AB04


4.4.2019




2.4.2019


Vizimpro


dacomitinib







Pfizer Europe MA EEIG




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






EU/1/19/1354


Film-coated tablet


L01XE47


4.4.2019




26.4.2019


Dectova


zanamivir







GlaxoSmithKline Trading Services Limited




Currabinny, Carrigaline, County Cork, Ireland






EU/1/18/1349


Solution for infusion


J05AH01


30.4.2019




26.4.2019


Ondexxya


andexanet alfa







Portola Netherlands B.V.




Prins Bernhardplein 200, 1097 JB, Amsterdam, Netherlands






EU/1/18/1345


Powder for solution for infusion


V03AB38


30.4.2019




26.4.2019


Skyrizi


risankizumab







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1361


Solution for injection


L04AC


30.4.2019




26.4.2019


Zynquista


sotagliflozin







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/19/1363


Film-coated tablet


A10BK06


30.4.2019










—



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




2.4.2019


Afinitor







Novartis Europharm Limited




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






EU/1/09/538


4.4.2019




2.4.2019


Betmiga







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/12/809


4.4.2019




2.4.2019


Capecitabine Accord







Accord Healthcare S.L.U.




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






EU/1/12/762


4.4.2019




2.4.2019


Clopidogrel BGR







Laboratoires BIOGARAN




15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France






EU/1/09/558


4.4.2019




2.4.2019


Copalia







Novartis Europharm Limited




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






EU/1/06/372


4.4.2019




2.4.2019


Dafiro







Novartis Europharm Limited




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






EU/1/06/371


4.4.2019




2.4.2019


Deltyba







Otsuka Novel Products GmbH




Erika-Mann-Straße 21, 80636 München, Deutschland






EU/1/13/875


4.4.2019




2.4.2019


Eliquis







Bristol-Myers Squibb/Pfizer EEIG




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






EU/1/11/691


4.4.2019




2.4.2019


Empliciti







Bristol-Myers Squibb Pharma EEIG




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






EU/1/16/1088


4.4.2019




2.4.2019


Exforge HCT







Novartis Europharm Limited




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






EU/1/09/569


4.4.2019




2.4.2019


Gazyvaro







Roche Registration GmbH




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






EU/1/14/937


4.4.2019




2.4.2019


Irbesartan Zentiva







Zentiva k.s.




U kabelovny 130, 10237 Praha 10, Česká republika






EU/1/06/376


4.4.2019




2.4.2019


Karvea







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/97/049


4.4.2019




2.4.2019


Karvezide







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/98/085


4.4.2019




2.4.2019


Lumark







IDB Holland B.V.




Weverstraat 17, 5111 PV Baarle-Nassau, Nederland






EU/1/15/1013


4.4.2019




2.4.2019


NULOJIX







Bristol-Myers Squibb/Pfizer EEIG




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






EU/1/11/694


4.4.2019




2.4.2019


Opdivo







Bristol-Myers Squibb Pharma EEIG




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






EU/1/15/1014


4.4.2019




2.4.2019


Steglatro







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/18/1267


4.4.2019




2.4.2019


Steglujan







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/18/1266


4.4.2019




2.4.2019


Sylvant







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/14/928


4.4.2019




2.4.2019


Vidaza







Celgene Europe B.V.




Winthontlaan 6 N, 3526 KV Utrecht, Nederland






EU/1/08/488


4.4.2019




2.4.2019


Yervoy







Bristol-Myers Squibb Pharma EEIG




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






EU/1/11/698


4.4.2019




2.4.2019


Zonisamide Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/16/1093


4.4.2019




2.4.2019


Zykadia







Novartis Europharm Limited




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






EU/1/15/999


4.4.2019




8.4.2019


Actraphane







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/02/229


10.4.2019




8.4.2019


BiResp Spiromax







Teva Pharma B.V.




Swensweg 5, 2031GA Haarlem, Nederland






EU/1/14/921


10.4.2019




8.4.2019


Capecitabine medac







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/12/802


10.4.2019




8.4.2019


DuoResp Spiromax







Teva Pharma B.V.




Swensweg 5, 2031GA Haarlem, Nederland






EU/1/14/920


10.4.2019




8.4.2019


Iressa







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/09/526


10.4.2019




8.4.2019


Lantus







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/00/134


10.4.2019




8.4.2019


Lynparza







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/14/959


10.4.2019




8.4.2019


M-M-RVAXPRO







MSD VACCINS




162 avenue Jean Jaurès, 69007 Lyon, France






EU/1/06/337


10.4.2019




8.4.2019


Orencia







Bristol-Myers Squibb Pharma EEIG




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






EU/1/07/389


10.4.2019




8.4.2019


Riarify







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/18/1275


10.4.2019




8.4.2019


Ritemvia







Celltrion Healthcare Hungary Kft.




Váci út 1-3. WestEnd Office Building B torony, 10 62 Budapest, Magyarország






EU/1/17/1207


10.4.2019




8.4.2019


Stribild







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/13/830


10.4.2019




8.4.2019


Tybost







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/13/872


10.4.2019




8.4.2019


Viread







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/01/200


10.4.2019




8.4.2019


Zerit







Bristol-Myers Squibb Pharma EEIG




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






EU/1/96/009


10.4.2019




9.4.2019


Esbriet







Roche Registration GmbH




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






EU/1/11/667


11.4.2019




9.4.2019


Ifirmacombi







Krka d. d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/11/673


11.4.2019




9.4.2019


Rituzena







Celltrion Healthcare Hungary Kft.




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






EU/1/17/1206


11.4.2019




9.4.2019


Trydonis







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/18/1274


11.4.2019




11.4.2019


Aprovel







Sanofi Clir SNC




54 rue La Boétie, 75008 Paris, France






EU/1/97/046


15.4.2019




11.4.2019


Cervarix







GlaxoSmithKline Biologicals S.A.




rue de l’Institut 89, 1330 Rixensart, Belgique






EU/1/07/419


15.4.2019




11.4.2019


CoAprovel







Sanofi Clir SNC




54 rue La Boétie, 75008 Paris, France






EU/1/98/086


15.4.2019




11.4.2019


Copalia HCT







Novartis Europharm Limited




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






EU/1/09/575


15.4.2019




11.4.2019


Dafiro HCT







Novartis Europharm Limited




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






EU/1/09/574


15.4.2019




11.4.2019


Ebilfumin







Actavis Group PTC ehf.




Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland






EU/1/14/915


15.4.2019




11.4.2019


Exforge







Novartis Europharm Limited




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






EU/1/06/370


15.4.2019




11.4.2019


Irbesartan/Hydrochlorothiazide Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/583


15.4.2019




11.4.2019


Irbesartan Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/576


15.4.2019




11.4.2019


Lamivudine Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/566


15.4.2019




11.4.2019


Leganto







UCB Pharma S.A.




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






EU/1/11/695


15.4.2019




11.4.2019


Lokelma







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/17/1173


15.4.2019




11.4.2019


Neparvis







Novartis Europharm Limited




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






EU/1/16/1103


15.4.2019




11.4.2019


Pemetrexed Lilly







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/15/1034


15.4.2019




11.4.2019


Pregabalin Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/15/1021


15.4.2019




11.4.2019


Spherox







CO.DON AG




Warthestraße 21, 14513 Teltow, Deutschland






EU/1/17/1181


15.4.2019




11.4.2019


Starlix







Novartis Europharm Limited




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






EU/1/01/174


15.4.2019




11.4.2019


Truxima







Celltrion Healthcare Hungary Kft.




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






EU/1/16/1167


15.4.2019




11.4.2019


Zutectra







Biotest Pharma GmbH




Landsteinerstraße 5, 63303 Dreieich, Deutschland






EU/1/09/600


15.4.2019




15.4.2019


Ecansya







Krka d. d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/12/763


17.4.2019




15.4.2019


Entresto







Novartis Europharm Limited




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






EU/1/15/1058


17.4.2019




15.4.2019


Ifirmasta







Krka d. d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/08/480


17.4.2019




15.4.2019


Irbesartan HCT Zentiva







Zentiva k.s.




U kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/06/377


17.4.2019




15.4.2019


Yargesa







Piramal Critical Care B.V.




Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland






EU/1/17/1176


17.4.2019




17.4.2019


Amlodipine/ Valsartan Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/16/1092


24.4.2019




17.4.2019


Caelyx







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/96/011


24.4.2019




17.4.2019


Cimzia







UCB Pharma S.A.




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






EU/1/09/544


24.4.2019




17.4.2019


Clopidogrel Apotex







Apotex Europe B.V.




Archimedesweg 2, 2333 CN Leiden, Nederland






EU/1/09/568


24.4.2019




17.4.2019


Clopidogrel HCS







HCS bvba




H. Kennisstraat 53, 2650 Edegem, België






EU/1/10/651


24.4.2019




17.4.2019


Cuprymina







SPARKLE S.r.l.




Località Cavallino, 62010 Montecosaro (MC), Italia






EU/1/12/784


24.4.2019




17.4.2019


Miglustat Dipharma







Dipharma B.V.




Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland






EU/1/18/1346


24.4.2019




17.4.2019


Pandemic influenza vaccine H5N1 AstraZeneca







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/16/1089


24.4.2019




17.4.2019


Rydapt







Novartis Europharm Limited




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






EU/1/17/1218


24.4.2019




17.4.2019


Semglee







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/18/1270


24.4.2019




17.4.2019


SonoVue







Bracco International B.V.




Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland






EU/1/01/177


24.4.2019




17.4.2019


Zubsolv







Orexo AB




Box 303, 751 05 Uppsala, Sverige






EU/1/17/1233


24.4.2019




24.4.2019


Orphacol







Laboratoires CTRS




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






EU/1/13/870


26.4.2019




26.4.2019


Aimovig







Novartis Europharm Limited




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






EU/1/18/1293


30.4.2019




26.4.2019


Ameluz







Biofrontera Bioscience GmbH




Hemmelrather Weg 201, 51377 Leverkusen, Deutschland






EU/1/11/740


30.4.2019




26.4.2019


Kyprolis







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/15/1060


30.4.2019




26.4.2019


Lonquex







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/13/856


30.4.2019




26.4.2019


Nuwiq







Octapharma AB




Lars Forssells gata 23, 112 75 Stockholm, Sverige






EU/1/14/936


30.4.2019




26.4.2019


Oncaspar







Les Laboratoires Servier




50 rue Carnot, 92284 Suresnes Cedex, France






EU/1/15/1070


30.4.2019




26.4.2019


Picato







LEO Laboratories Ltd




285 Cashel Road, Crumlin, Dublin 12, Ireland






EU/1/12/796


30.4.2019




26.4.2019


RotaTeq







MSD VACCINS




162 avenue Jean Jaurès, 69007 Lyon, France






EU/1/06/348


30.4.2019




26.4.2019


Spectrila







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/15/1072


30.4.2019




29.4.2019


Abilify







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland






EU/1/04/276


1.5.2019




29.4.2019


ABILIFY MAINTENA







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland






EU/1/13/882


1.5.2019




29.4.2019


Aripiprazole Sandoz







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/15/1029


2.5.2019




29.4.2019


Humira







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/03/256


2.5.2019




29.4.2019


Kaletra







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/01/172


2.5.2019




29.4.2019


Lemtrada







Sanofi Belgium




Leonardo Da Vincilaan 19, B-1831 Diegem, België






EU/1/13/869


2.5.2019




29.4.2019


Maviret







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/17/1213


2.5.2019




29.4.2019


Miglustat Gen.Orph







Gen.Orph




185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France






EU/1/17/1232


2.5.2019




29.4.2019


Natpar







Shire Pharmaceuticals Ireland Limited




Block 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland






EU/1/15/1078


1.5.2019




29.4.2019


Norvir







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/96/016


2.5.2019




29.4.2019


Repatha







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/15/1016


1.5.2019




30.4.2019


Zydelig







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/14/938


3.5.2019










—



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




2.4.2019


Numient







Amneal Pharma Europe Ltd




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






EU/1/15/1044


4.4.2019




10.4.2019


Rituzena







Celltrion Healthcare Hungary Kft.




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






EU/1/17/1206


12.4.2019




11.4.2019


Topotecan Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/552


15.4.2019




15.4.2019


Airexar Spiromax







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/16/1123


17.4.2019










—



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




17.4.2019


Chanhold


selamectin







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, Ireland






EU/2/19/236


Spot-on solution


QP54AA05


24.4.2019




23.4.2019


Forceris


toltrazuril/gleptoferron







Ceva Santé Animale




10 avenue de la Ballastière, 33500 Libourne, France






EU/2/19/235


Suspension for injection


QP51AJ51


25.4.2019




26.4.2019


Felisecto Plus


selamectin/sarolaner







Zoetis Belgium S.A.




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






EU/2/19/238


Spot-on solution


QP54AA55


30.4.2019




26.4.2019


ReproCyc ParvoFLEX


Porcine parvovirosis vaccine (inactivated)







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/19/237


Suspension for injection


QI09AA02


30.4.2019










—



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




8.4.2019


Versican Plus DHPPi/L4







Zoetis Belgium S.A.




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






EU/2/14/164


10.4.2019




8.4.2019


Versican Plus DHPPi/L4R







Zoetis Belgium S.A.




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






EU/2/14/163


10.4.2019




8.4.2019


Versican Plus L4







Zoetis Belgium S.A.




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






EU/2/14/171


10.4.2019




11.4.2019


Convenia







Zoetis Belgium S.A.




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






EU/2/06/059


15.4.2019




11.4.2019


Suvaxyn PRRS MLV







Zoetis Belgium S.A.




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






EU/2/17/215


15.4.2019




11.4.2019


Versican Plus Pi/L4







Zoetis Belgium S.A.




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






EU/2/14/172


15.4.2019




23.4.2019


Innovax-ILT







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/15/182


25.4.2019




26.4.2019


ERYSENG PARVO







Laboratorios Hipra, S.A.




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






EU/2/14/167


30.4.2019




26.4.2019


ProZinc







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/2/13/152


30.4.2019




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




NEDERLAND






(1)  OJ L 136, 30.4.2004, p. 1.