Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2022 to 30 November 2022 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)
Date: 2022-12-29
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_2022496EN.01000101.xml










29.12.2022   


EN


Official Journal of the European Union


C 496/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2022 to 30 November 2022
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (2))
(2022/C 496/01)
—   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




7.11.2022


Melatonin Neurim


melatonin







RAD Neurim Pharmaceuticals EEC SARL




4 rue de Marivaux, 75002 Paris, France






EU/1/22/1694


Prolonged-release tablet


N05CH01


8.11.2022




9.11.2022


LIVTENCITY


maribavir







Takeda Pharmaceuticals International AG Ireland Branch




50-58 Baggot Street Lower, Block 3 Miesian Plaza, Dublin 2, Co Dublin, D02 Y754, Ireland






EU/1/22/1672


Film-coated tablet


J05AX10


10.11.2022




9.11.2022


Pyrukynd


mitapivat







Agios Netherlands B.V.




Zuidplein 36, Regus Amsterdam WTC, 1077XV Amsterdam, Nederland






EU/1/22/1662


Film-coated tablet


B06AX04


10.11.2022




9.11.2022


Rubraca


rucaparib







Clovis Oncology Ireland Limited




1st Floor, Building Two, The Green, Dublin Airport Central, Dublin Airport, Swords, Co. Dublin, K67 E2H3, Ireland.






EU/1/17/1250


Film-coated tablet


L01XK03


10.11.2022




9.11.2022


Sorafenib Accord


sorafenib







Accord Healthcare S.L.U.




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






EU/1/22/1696


Film-coated tablet


L01EX02


10.11.2022




9.11.2022


Teriflunomide Accord


teriflunomide







Accord Healthcare S.L.U.




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






EU/1/22/1693


Film-coated tablet


L04AA31


10.11.2022




9.11.2022


Teriflunomide Mylan


teriflunomide







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/22/1698


Film-coated tablet


L04AA31


10.11.2022




9.11.2022


Ximluci


ranibizumab







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/22/1691


Solution for injection


S01LA04


11.11.2022




15.11.2022


Enjaymo


sutimlimab







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/22/1687


Solution for infusion


L04AA55


23.11.2022




18.11.2022


Teriparatide SUN


teriparatide







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87, 2132JH Hoofddorp, Nederland






EU/1/22/1697


Solution for injection


H05AA02


22.11.2022




28.11.2022


Caprelsa


vandetanib







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/11/749


Film-coated tablet


L01EX04


30.11.2022




—   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




7.11.2022


Efavirenz/Emtricitabine/Tenofovir disoproxil Krka







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/17/1263


9.11.2022




7.11.2022


EXPAREL liposomal







Pacira Ireland Ltd




Unit 13, Classon House, Dundrum Business Park, Dundrum, Dublin 14, D14W9Y3, Ireland






EU/1/20/1489


9.11.2022




9.11.2022


Aclasta







Sandoz Pharmaceuticals d.d.




Verovškova ulica 57, 1000 Ljubljana, Slovenija






EU/1/05/308


11.11.2022




9.11.2022


Adempas







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/13/907


10.11.2022




9.11.2022


ADYNOVI







Baxalta Innovations GmbH




Industriestraße 67, 1221 Wien, Österreich






EU/1/17/1247


10.11.2022




9.11.2022


Alkindi







Diurnal Europe B.V.




Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland






EU/1/17/1260


10.11.2022




9.11.2022


Darunavir Krka







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/17/1249


15.11.2022




9.11.2022


Dexmedetomidine Accord







Accord Healthcare S.L.U.




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






EU/1/19/1418


10.11.2022




9.11.2022


Elaprase







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/06/365


10.11.2022




9.11.2022


Eylea







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/12/797


10.11.2022




9.11.2022


GHRYVELIN







Consilient Health Ltd




5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland






EU/1/18/1337


16.11.2022




9.11.2022


Hycamtin







Sandoz Pharmaceuticals d.d.




Verovškova ulica 57, 1000 Ljubljana, Slovenija






EU/1/96/027


11.11.2022




9.11.2022


Incruse Ellipta







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/14/922


10.11.2022




9.11.2022


Isturisa







Recordati Rare Diseases




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






EU/1/19/1407


10.11.2022




9.11.2022


Kentera







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/03/270


14.11.2022




9.11.2022


Laventair Ellipta







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/14/899


10.11.2022




9.11.2022


Lucentis







Novartis Europharm Limited




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






EU/1/06/374


11.11.2022




9.11.2022


Memantine ratiopharm







ratiopharm GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/13/836


11.11.2022




9.11.2022


Rilutek







Sanofi Mature IP




54 rue La Boétie, 75008, Paris, France






EU/1/96/010


14.11.2022




9.11.2022


Rolufta Ellipta







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/17/1174


14.11.2022




9.11.2022


Segluromet







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/18/1265


11.11.2022




9.11.2022


Stelara







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/08/494


10.11.2022




9.11.2022


Stocrin







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/99/111


11.11.2022




9.11.2022


Talzenna







Pfizer Europe MA EEIG




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






EU/1/19/1377


10.11.2022




9.11.2022


Torisel







Pfizer Europe MA EEIG




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






EU/1/07/424


10.11.2022




9.11.2022


Vargatef







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/14/954


10.11.2022




9.11.2022


Vyndaqel







Pfizer Europe MA EEIG




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






EU/1/11/717


10.11.2022




10.11.2022


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


11.11.2022




10.11.2022


Spikevax







MODERNA BIOTECH SPAIN, S.L.




Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España






EU/1/20/1507


11.11.2022




11.11.2022


JCOVDEN







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1525


14.11.2022




15.11.2022


Brukinsa







BeiGene Ireland Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Co. Dublin, Ireland






EU/1/21/1576


16.11.2022




15.11.2022


Caprelsa







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/11/749


18.11.2022




15.11.2022


IMBRUVICA







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/14/945


16.11.2022




15.11.2022


Lamivudine Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/566


21.11.2022




15.11.2022


Mylotarg







Pfizer Europe MA EEIG




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






EU/1/18/1277


16.11.2022




15.11.2022


Riluzole Zentiva







Zentiva k.s.




U kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/12/768


18.11.2022




15.11.2022


Steglatro







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/18/1267


17.11.2022




15.11.2022


Tecartus







Kite Pharma EU B.V.




Tufsteen 1, 2132 NT Hoofddorp, Nederland






EU/1/20/1492


22.11.2022




15.11.2022


Xevudy







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/21/1562


16.11.2022




18.11.2022


Anoro Ellipta







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/14/898


22.11.2022




18.11.2022


Aripiprazole Accord







Accord Healthcare S.L.U.




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






EU/1/15/1045


22.11.2022




18.11.2022


Byfavo







PAION Deutschland GmbH




Heussstraße 25, 52078 Aachen, Deutschland






EU/1/20/1505


22.11.2022




18.11.2022


Fasturtec







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/00/170


22.11.2022




18.11.2022


Kevzara







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/17/1196


22.11.2022




18.11.2022


Latuda







Aziende Chimiche Riunite Angelini Francesco — A.C.R.A.F. S.p.A.




Viale Amelia 70, 00181 Roma, Italia






EU/1/14/913


22.11.2022




18.11.2022


LIBTAYO







Regeneron Ireland Designated Activity Company (DAC)




One Warrington Place, Dublin 2, D02 HH27 Ireland






EU/1/19/1376


21.11.2022




18.11.2022


Lyumjev







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/20/1422


22.11.2022




18.11.2022


Matever







Pharmathen S.A.




6 Dervenakion, 15351 Pallini Attiki, Ελλάδα






EU/1/11/711


22.11.2022




18.11.2022


Methylthioninium chloride Proveblue







Provepharm S.A.S.




22 rue Marc Donadille, 13013 Marseille, France






EU/1/11/682


23.11.2022




18.11.2022


Vaborem







Menarini International Operations Luxembourg S.A.




1 avenue de la Gare, 1611 Luxembourg, Luxembourg






EU/1/18/1334


23.11.2022




18.11.2022


Yselty







Theramex Ireland Limited




3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland






EU/1/21/1606


23.11.2022




18.11.2022


Zeposia







Bristol-Myers Squibb Pharma EEIG




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






EU/1/20/1442


21.11.2022




21.11.2022


Aldara







Viatris Healthcare Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/98/080


22.11.2022




21.11.2022


Anagrelide Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/17/1256


22.11.2022




21.11.2022


AUBAGIO







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/13/838


22.11.2022




21.11.2022


Biktarvy







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/18/1289


22.11.2022




21.11.2022


Eucreas







Novartis Europharm Limited




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






EU/1/07/425


22.11.2022




21.11.2022


Imatinib Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/12/808


22.11.2022




21.11.2022


Jylamvo







Therakind (Europe) Limited




Paramount Court, Corrig Road, Sandyford Business Park, Dublin 18, D18 R9C7, Ireland






EU/1/17/1172


24.11.2022




21.11.2022


Lumykras







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/21/1603


23.11.2022




21.11.2022


Multaq







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/09/591


22.11.2022




21.11.2022


Obiltoxaximab SFL







SFL Pharmaceuticals Deutschland GmbH




Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland






EU/1/20/1485


28.11.2022




21.11.2022


Qtern







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/16/1108


22.11.2022




21.11.2022


Skyrizi







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1361


22.11.2022




21.11.2022


Tasmar







Viatris Healthcare Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/97/044


22.11.2022




21.11.2022


Veklury







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/20/1459


21.11.2022




21.11.2022


Voncento







CSL Behring GmbH




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






EU/1/13/857


22.11.2022




21.11.2022


ZALTRAP







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/12/814


22.11.2022




25.11.2022


COVID-19 Vaccine (inactivated, adjuvanted) Valneva







Valneva Austria GmbH




Campus Vienna Biocenter 3, 1030 Wien, Österreich






EU/1/21/1624


25.11.2022




28.11.2022


Adenuric







Menarini International Operations Luxembourg S.A.




1 avenue de la Gare, 1611 Luxembourg, Luxembourg






EU/1/08/447


29.11.2022




28.11.2022


Beromun







BELPHARMA s.a.




2, Rue Albert 1er, L-1117, Luxembourg, Luxembourg






EU/1/99/097


29.11.2022




28.11.2022


Deferasirox Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/19/1386


29.11.2022




28.11.2022


Dengvaxia







Sanofi Pasteur




14 Espace Henry Vallée, 69007 Lyon, France






EU/1/18/1338


29.11.2022




28.11.2022


Dimethyl fumarate Polpharma







Zakłady Farmaceutyczne POLPHARMA S.A.




ul. Pelplińska 19, 83-200 Starogard Gdański, Polska






EU/1/22/1635


2.12.2022




28.11.2022


Docetaxel Accord







Accord Healthcare S.L.U.




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






EU/1/12/769


30.11.2022




28.11.2022


IKERVIS







Santen Oy




Niittyhaankatu 20, 33720 Tampere, Suomi






EU/1/15/990


30.11.2022




28.11.2022


Kivexa







ViiV Healthcare BV




Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland






EU/1/04/298


30.11.2022




28.11.2022


Mircera







Roche Registration GmbH




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






EU/1/07/400


30.11.2022




28.11.2022


Nityr







Cycle Pharmaceuticals (Europe) Ltd




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






EU/1/18/1290


29.11.2022




28.11.2022


Nordimet







Nordic Group B.V.




Siriusdreef 41, 2132 WT Hoofddorp, Nederland






EU/1/16/1124


29.11.2022




28.11.2022


Olanzapine Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/08/475


29.11.2022




28.11.2022


Onpattro







Alnylam Netherlands B.V.




Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland






EU/1/18/1320


2.12.2022




28.11.2022


Paxlovid







Pfizer Europe MA EEIG




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






EU/1/22/1625


28.11.2022




28.11.2022


Pegasys







zr pharma& GmbH




Hietzinger Hauptstrasse 37, 1130 Wien, Österreich






EU/1/02/221


29.11.2022




28.11.2022


Potactasol







Actavis Group PTC ehf.




Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland






EU/1/10/660


29.11.2022




28.11.2022


Praluent







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/15/1031


29.11.2022




28.11.2022


Sixmo







L. Molteni & C. dei F.lli Alitti Soc.Es.S.p.A




Strada Statale 67, 50018 Scandicci (Firenze), Italia






EU/1/19/1369


29.11.2022




28.11.2022


Stivarga







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/13/858


29.11.2022




28.11.2022


Taltz







Eli Lilly and Company (Ireland) Limited




Dunderrow, Kinsale, Co. Cork, Ireland






EU/1/15/1085


2.12.2022




28.11.2022


Zessly







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/18/1280


29.11.2022




28.11.2022


Zoely







Theramex Ireland Limited




3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland






EU/1/11/690


6.12.2022




—   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




18.11.2022


Hepsera







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/03/251


22.11.2022




—   Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 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




22.11.2022


Mometamax Ultra


gentamicin, posaconazole, mometasone furoate







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/22/289


Ear drops, suspension


Pending


24.11.2022




30.11.2022


DogStem


equine umbilical cord mesenchymal stem cells







EquiCord S.L.




103-D Loeches, Polígono Industrial Ventorro del Cano, Alcorcón, 28925 Madrid, España






EU/2/22/285


Suspension for injection


QM09AX90


1.12.2022




—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 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




9.11.2022


BROADLINE







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/13/157


11.11.2022




9.11.2022


Purevax RCPCh FeLV







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/047


10.11.2022




9.11.2022


Zuprevo







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/11/124


10.11.2022




11.11.2022


Bravecto Plus







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/18/224


15.11.2022




11.11.2022


Librela







Zoetis Belgium SA




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






EU/2/20/261


14.11.2022




11.11.2022


Rheumocam







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, Ireland






EU/2/07/078


15.11.2022




11.11.2022


Simparica







Zoetis Belgium S.A.




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






EU/2/15/191


15.11.2022




18.11.2022


Bravecto Plus







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/18/224


21.11.2022




18.11.2022


CircoMax Myco







Zoetis Belgium S.A.




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






EU/2/20/264


22.11.2022




18.11.2022


MiPet Easecto







Zoetis Belgium S.A.




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






EU/2/17/220


21.11.2022




30.11.2022


Arti-Cell Forte







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/18/228


1.12.2022




30.11.2022


CircoMax







Zoetis Belgium S.A.




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






EU/2/21/281


1.12.2022




30.11.2022


Meloxoral







Dechra Regulatory B.V.




Handelsweg 25, 5531 AE Bladel, Nederland






EU/2/10/111


1.12.2022




30.11.2022


ProZinc







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein, Deutschland






EU/2/13/152


8.12.2022




30.11.2022


Simparica Trio







Zoetis Belgium S.A.




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






EU/2/19/243


2.12.2022




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.

(2)  OJ L 4, 7.1.2019, p. 43.