List of medicinal products under additional ... - Europa

1 21 January 2022 EMA/245297/2013 Rev. 96*For the UK, as from 1st January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NIProduct nameActive substance (s)Reason (s) on listMarketing authorisation holder (s)Link to product informationDate of inclusionAbevmybevacizumabNew biologicalMylan IRE Healthcare vicleucelNew biological, new active substance, conditional marketing authorisation, PASS Bristol-Myers Squibb Pharma 2021 AdakveocrizanlizumabNew biological, new active substance, conditional marketing authorisationNovartis Europharm 2020 AdcetrisBrentuximab vedotin Conditional marketing authorisationTakeda Pharma A/ 2013 AdynoviRurioctocog alfa pegolNew active substance and new biological, PASS Baxalta Innovations 2018 AdtralzatralokinumabNew active substance and new biologicalLeo Pharma A/ TetraInfluenza vaccine (split virion, inactivated)New biologicalSeqirus Netherlands 2020 AimovigErenumabNew active substance and new biologicalNovartis Europharm 2018 AJOVYF remanezumab New active substance and new biologicalTeva GmbH 2019 AklieftrifaroteneNew active substance Galderma Nordic 2021 AlecensaAlectinibNew active substanceRoche Registration GmbH 2017 AlofiselDarvadstrocelNew active substance and new biologicalTakeda Pharma A/ 2018 AlunbrigBrigatinibNew active substanceTakeda Pharma A/S 2018 AlymsysbevacizumabNew biologicalMabxience Research biologicalAmgen Europe 2017 AmsparityAdalimumabNew biological Pfizer Europe MA 2020 Human Medicines DivisionTo note: All products added to the list in January 2022 are shown in red font.

2 All products removed from the list are shown with a strikethrough for the period of one month after which they are excluded. For products newly added to the list, EMA will update the 'Product details' section of the medicine page on EMA's corporate website when it publishes the revised summary of product of medicinal products under additional monitoringRelated Information: additional monitoring explained: Pharmacovigilance Practice Module on additional monitoring: agency of the European Union Official addressDomenico Scarlattilaan 6 1083 HS Amsterdam The NetherlandsAddress for visits and deliveries Refer to us a question Go to Telephone +31 (0)88 781 6000 Official addressDomenico Scarlattilaan 6 1083 HS Amsterdam The NetherlandsAddress for visits and deliveries Refer to us a question Go to Telephone +31 (0)88 781 6000#Classified as public by the European Medicines AgencyProduct nameActive substance (s)Reason (s) on listMarketing authorisation holder (s)Link to product informationDate of inclusionAnoro ElliptaUmeclidinium bromide/vilanterol trifenatatePASS1 GlaxoSmithKline (Ireland) 2014 Artesunate Amivas artesunateNew active substance Amivas Ireland LtdNot availableDec/21 AspavelipegcetacoplanNew active substance Swedish Orphan Biovitrum AB (publ)

3 2022 AtrianceNelarabineAuthorised under exceptional circumstancesNovartis Europharm 2013 AxuminFluciclovine (18F)New active substanceBlue Earth Diagnostics Ltd 2017 AybintiobevacizumabNew biological Samsung Bioepis NL 2020 AYVAKYT avapritinibNew active substance, condictional marketing authorisationBlueprint Medicines (Netherlands) 2020 Batrevac Tetra Influenza virus surface antigens, inactivated (haemagglutinin and neuraminidase)New biological Mylan Healthcare availableSeptember 2019 BavencioAvelumabNew active substance and new biological,Merck Europe 2017 BenlystaBelimumab PASS1 Glaxo Group 2013 BeovuBrolucizumabNew active substance and new biological Novartis Europharm 2020 BesponsaInotuzumab ozogamicin New active substance and new biologicalPfizer Europe MA 2017 BesremiRopeginterferon alfa-2bNew active substance and new biologicalAOP Orphan Pharmaceuticals 2019 BiktarvyBictegravir / emtricitabine / tenofovir alafenamideNew active substanceGilead Sciences Ireland 2018 BimzelxbimekizumabNew active substance and new biologicalUCB Pharma (also known as BaciThrax in France) Anthrax antigen filtrateNew biologicalEmergent Sales and Marketing Germany 2018 BLENREP belantamab mafodotinNew active substance, New biological, Conditional marketing authorisationGlaxoSmithKline (Ireland)

4 2020 BlincytoBlinatumomabPASS1 Amgen Europe 2015 BlitzimaRituximabNew biologicalCelltrion Healthcare Hungary Kft. 2017 BylvayOdevixibatNew active substance, authorised under exceptional circumastancesAlbireo 2021 Bosulif BosutinibConditional authorisationPfizer Europe MA 2013 BraftoviEncorafenibNew active substancePierre Fabre 2018 Bretaris GenuairAclidinium bromidePASS1 AstraZeneca AB 2013 Brimica GenuairAclidinium bromide/formoterol fumarate dihydratePASS1 AstraZeneca AB 2014 Brineura Cerliponase alfaNew active substance, authorised under exceptional circumstances, PASS BioMarin International 2017 Brukinsa zanubrutinibNew active substanceBeiGene Ireland LimitedNot availableDec/21#Classified as public by the European Medicines AgencyProduct nameActive substance (s)Reason (s) on listMarketing authorisation holder (s)Link to product informationDate of inclusionByfavoremimazolamNew active substancePAION Netherlands 2021 CabliviCaplacizumab New active substance and new biologicalAblynx 2018 CalquenceacalabrutinibNew active substanceAstraZeneca 2020 CaprelsaVandetanibConditional authorisationGenzyme Europe 2013 Cegfila (previously Pegfilgrastim Mundipharma)PegfilgrastimNew biologicalMundipharma Corporation (Ireland) 2020 CepleneHistamine dihydrochlorideAuthorised under exceptional circumstancesNoventia Pharma Srl 2013 CerdelgaEliglustatPASS1 Genzyme Europe 2015 Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)

5 Chenodeoxycholic acidAuthorised under exceptional circumstancesLeadiant 2017 Choriongonadotrophin Genevrierchorionic gonadotropin New biologicalLaboratoires Gen vrierN/AJanuary 2022 CibinqoabrocitinibNew active substancePfizer Europe MA 2022 Cidofovir 75 mg/ml Concentrate for Solution for InfusionCidofovirPASS1 Emcure Pharma UK 2016 Cinryzec1 inhibitor, humanPASS1 Shire Services BVBA 2013 Colevanceenoxaparin sodiumNew biologicalVenipharmN/AJanuary 2022 Combined hormonal contraceptives containing chlormadinone (For full list of products see Annex IX)Chlormadinone Ethinylestradiol, Chlormadinone Acetate EthinylestradiolPASS1 Various (For full list see Annex IX) 2014 ComirnatyCOVID-19 mRNA Vaccine (nucleoside modified)Conditional marketing authorisation / New active substance and new biologicalBioNTech Manufacturing active substanceSecura Bio Vaccine JanssenCOVID-19 vaccine ( [recombinant])Conditional marketing authorisation / New active substance, /new biologicalJanssen-Cilag International active substance, new biological and conditional authorisationKyowa Kirin Holdings 2018 CutaquigHuman normal immunoglobulinNew BiologicalOctapharma 2019 Cyproterone acetate and Ethinylestradiol containing medicinal products (For full list of products see Annex I)Cyproterone acetate and Ethinylestradiol PASS1 Various (For full list see Annex I)

6 2013 Darzalex DaratumumabNew active substance and new biologicalJanssen-Cilag International NV 2016 DaurismoGlasdegibNew active substancePfizer Europe MA 2020 DaxasRoflumilastPASS1 AstraZeneca 2013 DectovaZanamivirAuthorised under exceptional circumstancesGlaxoSmithKline Trading Services 2019 DefitelioDefibrotideAuthorised under exceptional circumstancesGentium 2013 DelstrigoDoravirine / Lamivudine / Tenofovir disoproxilNew active substanceMerck Sharp & Dohme 2018#Classified as public by the European Medicines AgencyProduct nameActive substance (s)Reason (s) on listMarketing authorisation holder (s)Link to product informationDate of inclusionDeltybaDelamanidConditional authorisationOtsuka Novel products GmbH 2014 DengvaxiaDengue tetravalent vaccine (live, attenuated) New active substance and new biologicalSanofi Pasteur 2019 Descovy Emtricitabine/tenofovir alafenamideNew active substanceGilead Sciences Ireland 2016 DopteletAvatrombopagNew active substanceSwedish Orphan Biovitrum AB (publ) 2019 Duaklir GenuairAclidinium bromide/formoterol fumarate dihydratePASS1 AstraZeneca 2014 DupixentDupilumabNew active substance and new biologicalSanofi-Aventis 2017 Drovelisdrospirenone/estetrolNew active substanceGedeon Richter 2021 Eklira Genuair Aclidinium bromidePASS1 AstraZeneca 2013 ElapraseIdursulfaseAuthorised under exceptional circumstancesShire Human Genetic Therapies 2013 Elebrato ElliptaFluticasone furoate/umeclidinium/vilanterolNew active substanceGlaxoSmithKline Trading Services Limited 2018 EflueldaQuadrivalent Influenza Vaccine (Split Virion, Inactivated)

7 New biologicalSanofi 2021 ELZONRIS tagraxofuspNew active substance and new biological,Authorised under exceptional circumstancesStemline Therapeutics 2021 Emgality GalcanezumabNew active substance and new biologicalEli Lilly Netherland 2018 ENANPLUS (also known in some EU countries as Skudexa, Skudexum and Lenizak)Tramadol hydrochloride/ dexketoprofenPASS1 LABORATORIOS 2018 Enhertutrastuzumab deruxtecanNew biological, new active substance, conditional marketing authorisationDaiichi Sankyo Europe 2021 EnspryngsatralizumabNew active substance, new biologicalRoche Registration 2021 Enoxaparin Becat (also known in some EU countries as Losima, Enoxaparin Rovi, Crusia and Arovi)Enoxaparin sodiumNew biologicalLaboartorios Farmac uticos Rovi, 2018 EpclusaSofosbuvir/velpatasvirPASS1 Gilead Sciences Ireland 2016 Erelzi Etanercept New biologicalSandoz GmbH 2017 ErleadaApalutamideNew active substanceJanssen-Cilag International NV 2019 ErveboEbola Zaire Vaccine (rVSV G-ZEBOV-GP, live)New active substance, new biologicalMerck Sharp & Dohme 2019 EsperoctTuroctocog alfa pegolNew active substance, new biological, PASS1 Novo Nordisk A/ 2019 EvkeezaevinacumabNew active substance, new biological, PASS1, authorised under exceptional circumstancesRegeneron Ireland Designated Activity Company (DAC)

8 2021 EvrenzoroxadustatNew active substanceAstellas Pharma Europe 2021 EvrysdirisdiplamNew active substance, conditional marketing authorisationRoche Registration 2021 EvenityRomosozumabNew active substance, new biologicalUCB Pharma 2020#Classified as public by the European Medicines AgencyProduct nameActive substance (s)Reason (s) on listMarketing authorisation holder (s)Link to product informationDate of inclusionEvoltraClofarabineAuthorised under exceptional circumstancesGenzyme Europe 2013 ExjadeDeferasiroxPASS1 Novartis Europharm 2013 ExvieraDasabuvirPASS1 AbbVie Deutschland GmbH & Co. 2015 FasenraBenralizumabNew active substance and new biologicalAstraZeneca AB 2018 FetcrojaCefiderocolNew active substanceShionogi 2020 FinteplafenfluraminePASS1 Zogenix ROI 2021 FirdapseAmifampridineAuthorised under exceptional circumstancesBioMarin Europe 2013 FlixabiInfliximabNew biologicalSamsung Bioepis UK Limited 2016 Fluad TetraInfluenza vaccine (surface antigen, inactivated, adjuvanted)New biologicalSeqirus Netherlands 2020 Flucelvax TetraInfluenza vaccine (surface antigen, inactivated, prepared in cell cultures)New biologicalSeqirus Netherlands 2019 FotivdaTivozanibNew active substanceEUSA Pharma (Netherlands)

9 2017 FulphilaPegfilgrastimNew biologicalViatris Limited 2018 GavretoPralsetinibNew active substance and under conditional marketing authorisationRoche Registration 2021 GiaprezaAngiotensin II acetateNew active substancePAION Deutschland 2019 GivlaariGivosiranNew active substanceAlnylam Netherlands 2020 GlivecImatinibPASS1 Novartis Europharm Limited 2014 GlyxambiEmpagliflozin/linagliptinNew active substanceBoehringer Ingelheim International 2017 GrasustekPegfilgrastimNew biological Juta Pharma 2019 HalimatozAdalimumabNew biologicalSandoz 2018 HarvoniLedipasvir/sofosbuvirNew active substance, PASS1 Gilead Sciences Ireland UC 2014 HefiyaAdalimumabNew biologicalSandoz 2018 HemlibraEmicizumabNew active substance and new biologicalRoche Registration 2018 HerzumaTrastuzumabNew biologicalCelltrion Healthcare Hungary Kft. 2018 HepaxaneEnoxaparin sodiumNew biologicalChemi availableNovember 2018 Hepcludexbulevirtidenew active substance, conditional MAGilead Sciences Ireland 2020 Heplisav Bhepatitis B surface antigenNew biologicalDynavax 2021#Classified as public by the European Medicines AgencyProduct nameActive substance (s)Reason (s) on listMarketing authorisation holder (s)Link to product informationDate of inclusionHoloclarEx vivo expanded autologous human corneal epithelial cells containing stem cellsConditional marketing authorisationChiesi Farmaceutici , 2015 HukyndraAdalimumabNew biologicalSTADA Arzneimittel AGNot availableNovember 2021 HulioAdalimumabNew biologicalViatris 2018 Hydroxyethyl starch (HES)-containing medicinal products (For full list see Annex V)Hydroxyethyl starchPASS1 Various (For full list see Annex V)

10 2014 HyQviaHuman normal immunoglobulinPASS1 Baxalta Innovations GmbH 2013 HyrimozAdalimumabNew biologicalSandoz 2018 IclusigPonatinibPASS1 Incyte Biosciences Distribution 2018 IdacioAdalimumabNew biologicalFresenius Kabi Deutschland GmbH 2019 IdefiriximlifidaseNew biologicalHansa Biopharma active substance and new biologicalAlmirall 2018 ImcivreeSetmelanotideNew active substanceRhythm Pharmaceuticals Netherlands July 2021 ImfinziDurvalumabNew active substance and new biologicalAstraZeneca 2018 Imnovid (formerly Pomalidomide Celgene)PomalidomidePASS1 Celgene Europe Limited 2013 ImraldiAdalimumabNew biologicalSamsung Bioepis UK Limited 2017 ImvanexModified Vaccinia Ankara virus Bavarian Nordic (MVA-BN) live virusAuthorised under exceptional circumstancesBavarian Nordic A/ 2013 IncrelexMecaserminAuthorised under exceptional circumstancesIpsen 2013 Incruse ElliptaUmeclidinium bromidePASS1 GlaxoSmithKlein (Ireland) 2014 Influvac TetraInfluenza vaccine (surface antigen, inactivated)New biologicalMylan IRE Healthcare