List of medicinal products under additional monitoring - …€¦ · XLS file · Web view · 2018-04-26List of medicinal products under additional monitoring Related Information:

27 June 2018EMA/245297/2013 Rev.57

List of medicinal products under additional monitoringRelated Information:

To note: All products added to the list in June 2018 are shown in red font. All products removed from the list are shown with a strikethrough for the period of one month after which they are excluded.

Product name Active Substance (s) Reason (s) on list Marketing Authorisation Holder (s) Link to Product Information

Abasaglar (previously Abasria) Insulin glargine New biological Eli Lilly Nederland B.V. October 2014

Standardised allergen extract from house dust mites New Biological ALK-Abelló A/S May 2016

Accofil Filgrastim New biological Accord Healthcare Limited October 2014

Adcetris Brentuximab vedotin Takeda Pharma A/S April 2013

Adempas Riociguat New active substance Bayer AG April 2014

Adynovi Rurioctocog alfa pegol Baxalta Innovations GmbH January 2018

Afstyla lonoctocog alfa CSL Behring GmbH January 2017

Aitaro Standardised allergen extract from house dust mites New Biological ALK-Abelló A/S https://portal.dimdi.de/amispb/doc/pei/Web/2613636-spcde-20170401.pdf June 2016

Akynzeo Netupitant/palonosetron New active substance Helsinn Birex Pharmaceuticals Ltd June 2015

Alecensa Alectinib New active substance Roche Registration GmbH March 2017

Alofisel Darvadstrocel Takeda Pharma A/S April 2018

Alpivab Peramivir New active substance BioCryst UK Ltd. May 2018

Alprolix Eftrenonacog alfa Swedish Orphan Biovitrum AB (publ) May 2016

Amgevita Adalimumab New biological Amgen Europe B.V. April 2017

Standardised allergen extract from house dust mites New Biological ALK-Abelló A/S https://portal.dimdi.de/amispb/doc/pei/Web/2613637-spcde-20170401.pdf July 2016

AMITIZA 24 microgram soft capsules Lubiproston New active substance Sucampo Pharma Europe Ltd. September 2015

Inspections & Human Medicines Pharmacovigilance

Additional monitoring explained: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000365.jsp

Good Pharmacovigilance Practice Module on additional monitoring:http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp

Date of Inclusion

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002835/human_med_001790.jsp&mid=WC0b01ac058001d124

Acarizax (also known in some EU countries as MITIZAX) https://portal.dimdi.de/amispb/doc/pei/Web/2613318-spcde-20170401.pdf


New active substance and new biological, conditional marketing authorisation http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002455/human_med_001588.jsp&mid=WC0b01ac058001d124


New active substance and new biological, PASS¹http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004195/human_med_002204.jsp&mid=WC0b01ac058001d124

New active substance and new biological http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004075/human_med_002055.jsp&mid=WC0b01ac058001d124



New active substance and new biologicalhttp://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004258/human_med_002222.jsp&mid=WC0b01ac058001d124




Amitend (also known in some EU countries as ACARIZAX)

http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1459748713655.pdf

http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000365.jsp

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp


https://portal.dimdi.de/amispb/doc/pei/Web/2613318-spcde-20170401.pdf









Product name Active Substance (s) Reason (s) on list Marketing Authorisation Holder (s) Link to Product InformationDate of Inclusion

Anoro Umeclidinium bromide/vilanterol trifenatate Glaxo Group Ltd June 2014

Apleek Ethinyl estradiol/gestodene Bayer Pharma AG September 2014

Atriance Nelarabine Authorised under exceptional circumstances Novartis Europharm Limited April 2013

ATryn Anti-thrombin alpha Authorised under exceptional circumstances Laboratoire français du Fractionnement et des Biotechnologies April 2013

Teriflunomide New active substance October 2013

Axumin New active substance Blue Earth Diagnostics Ltd June 2017

Bavencio Avelumab Merck Serono Europe Limited September 2017

Bemfola Follitropin alfa New biological Gedeon Richter Plc. May 2014

Benepali Etanercept New biological Samsung Bioepis UK Limited January 2016

Benlysta Belimumab Glaxo Group Ltd April 2013

Besponsa Inotuzumab ozogamicin Pfizer Limited July 2017

Bexsero GSK Vaccines S.r.l. April 2013

Anthrax antigen filtrate New biological Emergent Sales and Marketing Germany GmbH June 2018

Blincyto Blinatumomab Amgen Europe B.V. December 2015

Blitzima Rituximab New biological Celltrion Healthcare Hungary Kft. July 2017

Bosulif Bosutinib New active substance, conditional authorisation Pfizer Limited April 2013

Bretaris Genuair Aclidinium bromide AstraZeneca AB April 2013

Brimica Genuair Aclidinium bromide/formoterol fumarate dihydrate AstraZeneca AB December 2014

Brineura Cerliponase alfa BioMarin International Limited June 2017

Brintellix Vortioxetine New active substance H. Lundbeck A/S February 2014

Briviact Brivaracetam New active substance UCB Pharma S.A. January 2016

Cabometyx Cabozantinib New active substance Ipsen Pharma September 2016

Caprelsa Vandetanib Conditional authorisation Genzyme Europe B.V. April 2013

Ceplene Histamine dihydrochloride Authorised under exceptional circumstances Noventia Pharma Srl April 2013

Cerdelga Eliglustat Genzyme Europe B.V. February 2015

New active substance, PASS1 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002751/human_med_001754.jsp&mid=WC0b01ac058001d124

PASS1 http://www.hpra.ie/img/uploaded/swedocuments/LicenseSPC_PA1410-069-001_04042014155117.pdf



Aubagio* Sanofi-aventis Groupe http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002514/human_med_001645.jsp&mid=WC0b01ac058001d124

Fluciclovine (18F)http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004197/human_med_002100.jsp&mid=WC0b01ac058001d124

New active substance and new biological, conditional marketing authorisation




PASS1 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002015/human_med_001466.jsp&mid=WC0b01ac058001d124


Meningococcal group-B vaccine (rDNA, component, adsorbed) New active substance and new biological http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002333/human_med_001614.jsp&mid=WC0b01ac058001d124

BioThrax (also known as BaciThrax in France) https://portal.dimdi.de/amispb/doc/pei/Web/2604178-spcen-20180401.pdf






New active substance, authorised under exceptional circumstances, PASS¹









http://www.hpra.ie/img/uploaded/swedocuments/LicenseSPC_PA1410-069-001_04042014155117.pdf








https://portal.dimdi.de/amispb/doc/pei/Web/2604178-spcen-20180401.pdf












Chenodeoxycholic acid sigma-tau Chenodeoxycholic acid Authorised under exceptional circumstances, PASS¹ Sigma-tau Arzeimittel GmbH April 2017

Cidofovir Emcure Pharma UK Limited May 2016

Cilostazol September 2013

Cinqaero Reslizumab Teva Pharmaceuticals Limited September 2016

Cinryze c1 inhibitor, human Shire Services BVBA April 2013

Cluvot Human plasma coagulation factor XIII New biological CSL Behring GmbH https://portal.dimdi.de/amispb/doc/pei/Web/2613030-spcde-20180101.pdf May 2015

Coagadex Human coagulation factor X New biological Bio Products Laboratory Ltd April 2016

June 2014

Cometriq Cabozantinib New active substance, conditional authorisation Ipsen Pharma May 2014

Corlentor Ivabradine Les Laboratoires Servier February 2015

Cosentyx Secukinumab Novartis Europharm Limited February 2015

Cotellic Cobimetinib New active substance Roche Registration GmbH December 2015

Cresemba Isavuconazole New active substance Basilea Medical Ltd November 2015

CRYSVITA Burosumab Kyowa Kirin Limited March 2018

Immunglobulin New biological Baxalta Innovations GmbH, Austria http://mri.cts-mrp.eu/Human/Product/Details/47869 September 2017

Cyltezo Adalimumab New biological Boehringer Ingelheim International GmbH November 2017

Cyproterone acetate and Ethinylestradiol August 2013

Cyramza Ramucirumab Eli Lilly Nederland B.V. February 2015

Daklinza Daclatasvir Bristol-Myers Squibb Pharma EEIG September 2014

Darzalex Daratumumab Janssen-Cilag International NV June 2016

Daxas Roflumilast AstraZeneca AB June 2013

Defitelio Defibrotide Authorised under exceptional circumstances Gentium S.p.A. November 2013

Deltyba Delamanid New active substance, conditional authorisation Otsuka Novel Products GmbH May 2014


Cidofovir 75 mg/ml Concentrate for Solution for Infusion PASS1 http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1466141046287.pdf

Cilostazol-containing medicinal products (For full list of products see Annex VIII) PASS1 Various (For full list see Annex VIII) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Cilostazol-containing_medicines/human_referral_000338.jsp&mid=WC0b01ac05805c516f




Combined hormonal contraceptives containing chlormadinone (For full list of products see Annex IX)Chlormadinone Ethinylestradiol, Chlormadinone Acetate Ethinylestradiol PASS1 Various (For full list see Annex IX) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Combined_hormonal_contraceptives/human_referral_prac_000016.jsp&mid=WC0b01ac05805c516f


PASS1 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Corlentor_and_Procoralan/human_referral_prac_000044.jsp&mid=WC0b01ac05805c516f&source=homeMedSearch&category=human




New active substance and new biological, PASS¹http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004275/human_med_002224.jsp&mid=WC0b01ac058001d124

Cuvitru 200 mg/ml solution for injection (also known in some EU countries as Ventygard)


Cyproterone acetate and Ethinylestradiol containing medicinal products (For full list of products see Annex I)PASS1 Various (For full list see Annex I) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Cyproterone-_and_ethinylestradiol-containing_medicines/human_referral_prac_000017.jsp&mid=WC0b01ac05805c516f








http://www.ema.europa.eu/docs/en_GB/document_library/Medicines_under_additional_monitoring/2014/05/WC500167756.pdf


http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Cilostazol-containing_medicines/human_referral_000338.jsp&mid=WC0b01ac05805c516f






http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Combined_hormonal_contraceptives/human_referral_prac_000016.jsp&mid=WC0b01ac05805c516f


http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Corlentor_and_Procoralan/human_referral_prac_000044.jsp&mid=WC0b01ac05805c516f&source=homeMedSearch&category=human






http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Cyproterone-_and_ethinylestradiol-containing_medicines/human_referral_prac_000017.jsp&mid=WC0b01ac05805c516f








Descovy Emtricitabine/tenofovir alafenamide New active substance Gilead Sciences Ireland UC May 2016

Dexamfetamine sulphate September 2014

Dinutuximab beta Apeiron Dinutuximab beta EUSA Pharma (UK) Limited May 2017

Domperidone July 2014

Duaklir Genuair Aclidinium bromide/formoterol fumarate dihydrate AstraZeneca AB December 2014

Dupixent Dupilumab Sanofi-Aventis groupe October 2017

Dapagliflozin/metfomin New active substance AstraZeneca AB November 2015

Eklira Genuair Aclidinium bromide AstraZeneca AB April 2013

Elaprase Idursulfase Authorised under exceptional circumstances Shire Human Genetic Therapies AB April 2013

Elebrato Ellipta Fluticasone furoate/umeclidinium/vilanterol New active substance GlaxoSmithKline Trading Services Limited May 2018

Elocta Efmoroctocog alfa Swedish Orphan Biovitrum AB (publ) December 2015

Elvanse Lisdexamphetamine New active substance Shire Pharmaceutical Contracts Limited April 2013

Empliciti Elotuzumab Bristol-Myers Squibb Pharma EEIG May 2016

Tramadol hydrochloride/ dexketoprofen LABORATORIOS MENARINI https://cima.aemps.es/cima/dochtml/p/80925/P_80925.html April 2018

EndolucinBeta Lutetium (177 Lu) chloride New active substance ITG Isotope Technologies Garching GmbH July 2016

Entresto Sacubitril/valsartan New active substance Novartis Europharm Limited December 2015

Entyvio Vedolizumab Takeda Pharma A/S June 2014

Epclusa Sofosbuvir/velpatasvir New active substance Gilead Sciences Ireland UC July 2016

Eperzan Albiglutide GlaxoSmithKline Trading Services Limited April 2014

Episalvan Birch bark extract New active substance Birken AG January 2016

Erelzi Etanercept New biological Sandoz GmbH July 2017

Erivedge Vismodegib New active substance Roche Registration GmbH August 2013

Eurartesim Dihydroartemisinin/piperaquine phosphate Alfasigma S.p.A. April 2013

Evoltra Clofarabine Authorised under exceptional circumstances Genzyme Europe B.V. April 2013


Dexamed and associated names (dexamfetamine sulphate-containing medicinal products in the EU) (For full list of products see Annex XII)PASS1 Various (For full list see Annex XII) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Dexamed_and_associated_names/human_referral_000373.jsp&mid=WC0b01ac05805c516f

New biological, authorised under exceptional circumstances, PASS¹


Domperidone-containing medicinal products (For full list of products see Annex X) PASS1 Various (For full list see Annex X) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Domperidone-containing_medicines/human_referral_prac_000021.jsp&mid=WC0b01ac05805c516f



Ebymect ** http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004162/human_med_001926.jsp&mid=WC0b01ac058001d124







ENANPLUS (also known in some EU countries as Skudexa, Skudexum and Lenizak) PASS1












http://www.ema.europa.eu/docs/en_GB/document_library/Medicines_under_additional_monitoring/2014/09/WC500173883.xls

http://www.ema.europa.eu/docs/en_GB/document_library/Medicines_under_additional_monitoring/2014/09/WC500173883.xls

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Dexamed_and_associated_names/human_referral_000373.jsp&mid=WC0b01ac05805c516f



http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Domperidone-containing_medicines/human_referral_prac_000021.jsp&mid=WC0b01ac05805c516f


















Evotaz Atazanavir / cobicistat New active substance Bristol-Myers Squibb Pharma EEIG July 2015

Exjade Deferasirox Novartis Europharm Limited April 2013

Exviera Dasabuvir AbbVie Deutschland GmbH & Co. KG February 2015

Farydak Panobinostat New active substance Novartis Europharm Limited September 2015

Fasenra Benralizumab AstraZeneca AB January 2018

Fexeric Ferric citrate coordination complex Keryx Biopharma UK Ltd. October 2015

Fiasp Insulin aspart New biological Novo Nordisk A/S March 2017

FibClot Human Fibrinogen New Biological https://portal.dimdi.de/amispb/doc/pei/Web/2613347-spcde-20180401.pdf July 2016

Fibryga Human Fibrinogen New biological Octapharma GmbH July 2017

Firdapse Amifampridine Authorised under exceptional circumstances BioMarin Europe Ltd April 2013

Flixabi Infliximab New biological Samsung Bioepis UK Limited June 2016

Fluenz Tetra Influenza vaccine (live attenuated, nasal) New biological AstraZeneca AB January 2014

Flupirtine February 2014

Fotivda Tivozanib New active substance EUSA Pharma (UK) Limited September 2017

Galafold Migalastat New active substance Amicus Therapeutics UK Ltd June 2016

GalliaPharm New active substance Eckert & Ziegler Radiopharma GmbH April 2016

Gardasil 9 MSD VACCINS June 2015

Gazyvaro Obinutuzumab Roche Registration Limited September 2014

Genvoya New active substance Gilead Sciences Ireland UC December 2015

Gilenya Fingolimod hydrochloride Novartis Europharm Limited April 2013

Glivec Imatinib Novartis Europharm Limited September 2014

Glyxambi Empagliflozin/linagliptin New active substance Boehringer Ingelheim International GmbH May 2017

Grastofil Filgrastim New biological Apotex Europe B.V. November 2013

Harvoni Ledipasvir/sofosbuvir Gilead Sciences Ireland UC December 2014








Laboratoire Français du Fractionnement et des Biotechnologies





Flupirtine-containing medicinal products (For full list of products see Annex VI) PASS1 Various (For full list see Annex VI) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Flupirtine-containing_medicines/human_referral_prac_000019.jsp&mid=WC0b01ac05805c516f



Germanium (68Ge) chloride/gallium (68Ga) chloride http://www.produktresume.dk/docushare/dsweb/Get/Document-33097/Galliapharm%2C+radionuclide+generator.docx

Human papillomavirus 9-valent vaccine (recombinant, adsorbed) New active substance and new biological http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003852/human_med_001863.jsp&mid=WC0b01ac058001d124


Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004042/human_med_001940.jsp&mid=WC0b01ac058001d124


















http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Flupirtine-containing_medicines/human_referral_prac_000019.jsp&mid=WC0b01ac05805c516f


http://www.produktresume.dk/docushare/dsweb/Get/Document-33097/Galliapharm%2C+radionuclide+generator.docx










Hemlibra Emicizumab Roche Registration GmbH March 2018

Herzuma Trastuzumab New biological Celltrion Healthcare Hungary Kft. February 2018

Hetlioz Tasimelteon New active substance Vanda Pharmaceuticals Limited July 2015

Holoclar Chiesi Farmaceutici S.P.A. March 2015

Hydroxyethyl starch January 2014

HyQvia Human normal immunoglobulin Baxalta Innovations GmbH September 2013

Iblias Octocog alfa New biological Bayer AG March 2016

Ibrance Palbociclib New active substance Pfizer Limited November 2016

Iclusig Ponatinib Incyte Biosciences Distribution B.V. August 2013

Idelvion Albutrepenonacog alfa CSL Behring GmbH June 2016

IMBRUVICA Ibrutinib New active substance Janssen-Cilag International NV November 2014

Imlygic Talimogene laherparepvec Amgen Europe B.V. January 2016

Imnovid (formerly Pomalidomide Celgene) Pomalidomide Celgene Europe Limited September 2013

Imraldi Adalimumab New biological Samsung Bioepis UK Limited September 2017

Imvanex Authorised under exceptional circumstances Bavarian Nordic A/S September 2013

Increlex Mecasermin Authorised under exceptional circumstances Ipsen Pharma April 2013

Alogliptin/pioglitazone New active substance Takeda Pharma A/S October 2013

Incruse Umeclidinium bromide Glaxo Group Ltd May 2014

Inflectra Infliximab New biological Hospira UK Limited October 2013

Inhixa Enoxaparin sodium New biological Techdow Europe AB September 2016

Insulin lispro Sanofi Insulin lispro New biological Sanofi-Aventis groupe September 2017

Intrarosa Prasterone Endoceutics Ltd. February 2018

January 2014

Intuniv Guanfacine Shire Pharmaceuticals Ireland Limited September 2015




Ex vivo expanded autologous human corneal epithelial cells containing stem cells


Hydroxyethyl starch (HES)-containing medicinal products (For full list see Annex V) PASS1 Various (For full list see Annex V) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Hydroxyethyl_starch-containing_medicines/human_referral_prac_000029.jsp&mid=WC0b01ac05805c516f










Modified Vaccinia Ankara virus – Bavarian Nordic (MVA-BN) live virus http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002596/human_med_001666.jsp&mid=WC0b01ac058001d124


Incresync* http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002178/human_med_001694.jsp&mid=WC0b01ac058001d124






Intravenous iron-containing medicinal products (For full list see Annex III)Ferric carboxymaltose, iron dextran, sodium ferric gluconate, iron isomaltoside, iron sucrose PASS1 Various (For full list see Annex III) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Intravenous_iron-containing_medicinal_products/human_referral_000343.jsp&mid=WC0b01ac05805c516f






http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Hydroxyethyl_starch-containing_medicines/human_referral_prac_000029.jsp&mid=WC0b01ac05805c516f

















http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Intravenous_iron-containing_medicinal_products/human_referral_000343.jsp&mid=WC0b01ac05805c516f



Invokana Canagliflozin New active substance Janssen-Cilag International NV December 2013

Human normal immunoglobulin New biological Laboratoire Francais du Fractionnement et des Biotechnologies https://portal.dimdi.de/amispb/doc/pei/Web/2613314-spcde-20170301.pdf September 2016

Ivabradine Anpharm Ivabradine ANPHARM Przedsiębiorstwo Farmaceutyczne S.A. September 2015

IPSEN PHARMA June 2014

Jardiance Empagliflozin New active substance Boehringer Ingelheim International GmbH June 2014

Levonorgestrel Bayer AB November 2013

Jinarc Tolvaptan Otsuka Pharmaceutical Europe Ltd. June 2015

Juluca Dolutegravir / rilpivirine New active substance ViiV Healthcare UK Limited May 2018

Kadcyla Trastuzumab emtansine Roche Registration GmbH December 2013

Kalydeco Ivacaftor Vertex Pharmaceuticals (U.K.) Ltd. April 2013

Kanjinti Trastuzumab New biological Amgen Europe B.V. May 2018

Kanuma Sebelipase alfa Alexion Europe SAS September 2015

Kengrexal Cangrelor New active substance Chiesi Farmaceutici S.P.A. April 2015

Ketoconazole HRA Ketoconazole Laboratoire HRA Pharma December 2014

Kevzara Sarilumab Sanofi-Aventis groupe July 2017

Keytruda Pembrolizumab Merck Sharp & Dohme B.V. July 2015

Kisplyx Lenvatinib New active substance Eisai Europe Limited September 2016

Kisqali Ribociclib New active substance Novartis Europharm Limited September 2017

Kolbam (previously Cholic Acid FGK) Cholic acid Authorised under exceptional circumstances Retrophin Europe Limited May 2014

Kovaltry Octocog alfa New biological Bayer AG March 2016

Kyntheum Brodalumab Leo Pharma A/S July 2017

Kyprolis Carfilzomib New active substance Amgen Europe B.V. November 2015

Lamzede Velmanase alfa Chiesi Farmaceutici S.p.A. April 2018

Lartruvo Olaratumab New active substance, conditional authorisation Eli Lilly Nederland B.V. November 2016

Latuda Lurasidone New active substance Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A. April 2014


Iqymune (also known in some EU countries as OPTIGLOBIN)


Izinova (also known in some EU countries as Eziclen)

Sodium sulphate anhydrous, magnesium sulphate heptahydrate, potassium sulphate PASS1 http://agence-prd.ansm.sante.fr/php/ecodex/frames.php?specid=65236258&typedoc=R&ref=R0222102.htm


Jaydess (also known in some EU countries as Fleree) PASS1 https://docetp.mpa.se/LMF/Jaydess%20intrauterine%20delivery%20system%20ENG%20SmPC.doc






New active substance and new biological, PASS1 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004004/human_med_001896.jsp&mid=WC0b01ac058001d124











New active substance, authorised under exceptional circumstances






http://agence-prd.ansm.sante.fr/php/ecodex/frames.php?specid=65236258&typedoc=R&ref=R0222102.htm


https://docetp.mpa.se/LMF/Jaydess%20intrauterine%20delivery%20system%20ENG%20SmPC.doc















Laventair Umeclidinium bromide/vilanterol trifenatate Glaxo Group Ltd June 2014

Lemtrada Alemtuzumab New biological Genzyme Therapeutics Ltd October 2013

Lenvima Lenvatinib New active substance Eisai Europe Limited June 2015

Lifmior Etanercept New biological Pfizer Limited February 2017

Lixiana Edoxaban New active substance Daiichi Sankyo Europe GmbH July 2015

Lojuxta Lomitapide Authorised under exceptional circumstances Aegerion Pharmaceuticals Limited September 2013

Lokelma Sodium zirconium cyclosilicate New active substance AstraZeneca AB April 2018

Lonquex Lipegfilgrastim UAB "Sicor Biotech" September 2013

Lonsurf Trifluridine / tipiracil New active substance Les Laboratoires Servier May 2016

Lumark Lutetium, isotope of mass 177 New active substance IDB Holland B.V. July 2015

Lusduna Insulin glargine New biological Merck Sharp & Dohme B.V. January 2017

Lutathera New active substance Advanced Accelerator Applications October 2017

Lymphoseek Tilmanocept New active substance Norgine B.V. December 2014

Lynparza Olaparib New active substance AstraZeneca AB February 2015

MACI² New active substance Vericel Denmark ApS August 2013

Maviret Glecaprevir / pibrentasvir AbbVie Deutschland GmbH & Co. KG September 2017

Methylphenidate hydrochloride Medice Arzneimittel Püttner GmbH Co. KG Not available May 2018

Mekinist Trametinib New active substance Novartis Europharm Limited September 2014

Menotrophin New biological Laboratoires Genévrier SA March 2015

Moventig Naloxegol New active substance Kyowa Kirin Limited January 2015

Movymia Teriparatide New biological STADA Arzneimittel AG January 2017

Mvasi bevacizumab New biological Amgen Europe B.V. January 2018

Mylotarg Gemtuzumab ozogamicin Pfizer Limited May 2018

Mysimba Naltrexone / bupropion Orexigen Therapeutics Ireland Limited April 2015

Naglazyme Galsulfase Authorised under exceptional circumstances BioMarin Europe Ltd April 2013












Lutetium (177Lu) oxodotreotidehttp://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004123/human_med_002163.jsp&mid=WC0b01ac058001d124



Matrix applied characterised autologous cultured chondrocytes http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002522/human_med_001660.jsp&mid=WC0b01ac058001d124


Medikinet retard 10 / 20 / 30 / 40 / 5 / 50 / 60 mg PASS1


Meriofert (also known in some EU countries as Fertinorm and Eigenorm) http://www.produktresume.dk/docushare/dsweb/Get/Document-34320/Meriofert+Set%2C+pulver+og+solvens+til+injektionsv%C3%A6ske%2C+opl%C3%B8sning+75+IE+og+150+IE.docx





















http://www.produktresume.dk/docushare/dsweb/Get/Document-34320/Meriofert+Set%2C+pulver+og+solvens+til+injektionsv%C3%A6ske%2C+opl%C3%B8sning+75+IE+og+150+IE.docx






Natpar Parathyroid hormone Conditional authorisation Shire Pharmaceuticals Ireland Limited May 2017

Neoparin Enoxaparinum natricum New biological April 2016

Neparvis Sacubitril / valsartan New active substance Novartis Europharm Limited June 2016

Neuraceq Florbetaben (18F) New active substance Piramal Imaging Limited March 2014

NexoBrid MediWound Germany GmbH April 2013

Ninlaro Ixazomib New active substance, conditional authorisation Takeda Pharma A/S November 2016

NovoEight Turoctocog alfa Novo Nordisk A/S December 2013

Nucala Mepolizumab GlaxoSmithKline Trading Services Limited January 2016

September 2014

Nuwiq Simoctocog alfa Octapharma AB September 2014

Obizur Susoctocog alfa Baxalta Innovations GmbH November 2015

Ocaliva Obeticholic acid New active substance, conditional authorisation Intercept Pharma Ltd January 2017

Ocrevus Ocrelizumab Roche Registration GmbH January 2018

Odefsey Emtricitabine / rilpivirine / tenofovir alafenamide New active substance Gilead Sciences Ireland UC June 2016

Odomzo Sonidegib New active substance Sun Pharmaceutical Industries Europe BV September 2015

Ofev Nintedanib New active substance Boehringer Ingelheim International GmbH February 2015

Olumiant Baricitinib New active substance Eli Lilly Nederland B.V. February 2017

Oncaspar Pegaspargase New biological Baxalta Innovations GmbH January 2016

Ongentys Opicapone New active substance Bial - Portela & Cª, SA July 2016

Ontruzant Trastuzumab New biological Samsung Bioepis UK Limited November 2017

Opdivo Nivolumab New active substance Bristol-Myers Squibb Pharma EEIG July 2015

Opsumit Macitentan New active substance Actelion Registration Ltd February 2014

Optimark Gadoversetamide Mallinckrodt Deutschland GmbH April 2013


SciencePharma spółka z ograniczoną odpowiedzialnością spółka komandytowa http://www.leki-informacje.pl/sites/default/files/Charakterystyka-20160219000000-1576_N-20160308000147.pdf



Concentrate of proteolytic enzymes enriched in bromelain PASS1 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002246/human_med_001582.jsp&mid=WC0b01ac058001d124




Numeta G16%E medicinal products in the European Union (For full list of products see Annex XI)

Alanine, arginine, aspartic acid, calcium chloride, cysteine, glucose monohydrate, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, magnesium acetate, methionine, olive oil, ornithine hydrochloride, henylalanine, potassium acetate, proline, serine, sodium chloride, sodium glycerophosphate, soybean oil, taurine, threonine, tryptophan, tyrosine, valine PASS1 Baxter (For full list see Annex XI) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Numeta_G13E_and_Numeta_G16E_emulsion_for_infusion/human_referral_prac_000027.jsp&mid=WC0b01ac05805c516f


New active substance, authorised under exceptional circumstances http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002792/human_med_001918.jsp&mid=WC0b01ac058001d124














http://www.leki-informacje.pl/sites/default/files/Charakterystyka-20160219000000-1576_N-20160308000147.pdf









http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Numeta_G13E_and_Numeta_G16E_emulsion_for_infusion/human_referral_prac_000027.jsp&mid=WC0b01ac05805c516f














Orbactiv Oritavancin New active substance The Medicines Company UK Limited April 2015

Orkambi Lumacaftor/Ivacaftor Vertex Pharmaceuticals (Europe) Limited December 2015

Orphacol Cholic acid Authorised under exceptional circumstances Laboratoires CTRS October 2013

Osseor Strontium ranelate Les Laboratoires Servier August 2013

Otezla Apremilast New active substance Celgene Europe Limited February 2015

Oxervate Cenegermin Dompé farmaceutici S.p.A. July 2017

Ozanex (also known in some EU countries as Ozenoxacin New active substance Ferrer Internacional S.A. November 2017

Ozempic Semaglutide Novo Nordisk A/S February 2018

AstraZeneca AB June 2016

Panzyga Human normal immunoglobulin New Biological Octapharma GmbH https://portal.dimdi.de/amispb/doc/pei/Web/2613595-spcde-20170501.pdf July 2016

Parsabiv Etelcalcetide New active substance Amgen Europe B.V. November 2016

Penthrox Methoxyflurane Medical Developments UK Ltd June 2016

Pixuvri Pixantrone New active substance, conditional authorisation CTI Life Sciences Ltd April 2013

Plegridy Peginterferon beta-1a Biogen Idec Limited September 2014

Portrazza Necitumumab Eli Lilly Nederland B.V. March 2016

Praluent Alirocumab Sanofi-Aventis Groupe October 2015

Praxbind Idarucizumab Boehringer Ingelheim International GmbH December 2015

Prevymis Letermovir New active substance Merck Sharp & Dohme Limited January 2018

Procoralan Ivabradine Les Laboratoires Servier February 2015

Protelos Strontium ranelate Les Laboratoires Servier August 2013

Saxagliptin / dapagliflozin New active substance AstraZeneca AB July 2016

Quinsair Levofloxacin Chiesi Farmaceutici S.p.A. April 2015

Ragwizax New Biological ALK-Abelló A/S April 2018

Landiolol New active substance AOP Orphan Pharmaceuticals Not available July 2016

Ravicti Glycerol phenylbutyrate Horizon Pharma Ireland Limited January 2016







https://cima.aemps.es/cima/dochtml/ft/82357/FichaTecnica_82357.html


Pandemic influenza vaccine H5N1 AstraZeneca

Pandemic influenza vaccine (H5N1) (live attenuated, nasal)



PASS1 http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1467955147758.pdf







PASS1 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Corlentor_and_Procoralan/human_referral_prac_000044.jsp&mid=WC0b01ac05805c516f&source=homeMedSearch&category=human


Qtern** http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004057/human_med_002000.jsp&mid=WC0b01ac058001d124


Standardised allergen extract of pollen from Short Ragweed (Ambrosia artemisiifolia) https://portal.dimdi.de/amispb/doc/pei/Web/2613788-spcde-20180101.pdf

Rapibloc (also known in some EU countries as RAPLOC and Runrapiq)







https://cima.aemps.es/cima/dochtml/ft/82357/FichaTecnica_82357.html









http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Corlentor_and_Procoralan/human_referral_prac_000044.jsp&mid=WC0b01ac05805c516f&source=homeMedSearch&category=human







Raxone Idebenone Authorised under exceptional circumstances Santhera Pharmaceuticals (Deutschland) GmbH September 2015

Reagila Cariprazine New active substance Gedeon Richter Plc. July 2017

Refixia Nonacog beta pegol Novo Nordisk A/S June 2017

Rekovelle Follitropin delta New biological Ferring Pharmaceuticals A/S May 2017

Relvar Ellipta Fluticasone furoate/vilanterol trifenatate Glaxo Group Ltd December 2013

Remsima Infliximab New biological Celltrion Healthcare Hungary Kft. October 2013

Repatha Evolocumab Amgen Europe B.V. September 2015

Respreeza Human alpha1-proteinase inhibitor New biological CSL Behring GmbH September 2015

Revestive Teduglutide Shire Pharmaceuticals Ireland Limited April 2013

Revinty Ellipta Fluticasone furoate/vilanterol trifenatate Glaxo Group Ltd May 2014

Revlimid Lenalidomide Celgene Europe Limited June 2014

Rezolsta Darunavir/cobicistat New active substance Janssen-Cilag International NV February 2015

Ritemvia Rituximab New biological Celltrion Healthcare Hungary Kft. July 2017

Rixathon Rituximab New biological Sandoz GmbH June 2017

Riximyo Rituximab New biological Sandoz GmbH June 2017

Rixubis Nonacog gamma New biological Baxalta Innovations GmbH February 2015

Rolufta Umeclidinium GlaxoSmithKline Trading Services Limited March 2017

Roteas Edoxaban New active substance Daiichi Sankyo Europe GmbH May 2017

Rubraca Rucaparib New active substance, conditional marketing authoClovis Oncology UK Limited June 2018

Rydapt Midostaurin New active substance Novartis Europharm Limited October 2017

Saxenda Liraglutide New biological Novo Nordisk A/S April 2015

Scenesse Afamelanotide Clinuvel UK Limited January 2015

Seasonique Levonorgestrel/ethinylestradiol Teva Pharma B.V. Not available June 2015

Segluromet Ertugliflozin / metformin hydrochloride New active substance Merck Sharp & Dohme Limited April 2018

Semglee Insulin glargine New biological Mylan S.A.S. Not yet available April 2018



New active substance and new biological, PASS1http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004178/human_med_002107.jsp&mid=WC0b01ac058001d124



















New active substance, authorised under exceptional circumstances http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002548/human_med_001826.jsp&mid=WC0b01ac058001d124

PASS1


















Senshio Ospemifene Shionogi Limited February 2015

Shingrix Herpes zoster vaccine (recombinant, adjuvanted) GlaxoSmithKline Biologicals S.A. April 2018

Sirturo Bedaquiline New active substance, conditional authorisation Janssen-Cilag International NV March 2014

Sivextro Tedizolid phosphate New active substance Merck Sharp & Dohme Limited April 2015

Adalimumab New biological Amgen Europe B.V. April 2017

SomaKit TOC Edotreotide New active substance Advanced Accelerator Applications December 2016

Somatropin Biopartners Somatropin New biological BioPartners GmbH September 2013

Perflurobutan New active substance GE HEALTHCARE AS Not available November 2016

Sovaldi Sofosbuvir Gilead Sciences International Limited February 2014

Spectrila Asparaginase New biological Medac Gesellschaft für klinische Spezialpräparate mbH January 2016

Spherox CO.DON AG July 2017

Spinraza Nusinersen New active substance Biogen Idec Ltd June 2017

Spiolto Respimat New active substance Boehringer Ingelheim International GmbH September 2016

Steglatro Ertugliflozin New active substance Merck Sharp & Dohme Limited April 2018

Steglujan Ertugliflozin / sitagliptin New active substance Merck Sharp & Dohme Limited April 2018

Regorafenib New active substance Bayer AG September 2013

Strensiq Asfotase alfa Alexion Europe SAS September 2015

Strimvelis GlaxoSmithKline Trading Services Limited June 2016

Olodaterol Boehringer Ingelheim International GmbH February 2015

Suliqua Insulin glargine / lixisenatide Sanofi-Aventis groupe March 2017

Sylvant Siltuximab Janssen-Cilag International NV June 2014

Symtuza New active substance Janssen-Cilag International NV October 2017

Synjardy Empagliflozin/metformin New active substance Boehringer Ingelheim International GmbH June 2015

Tagrisso Osimertinib AstraZeneca AB February 2016

Tramadol hydrochloride/ dexketoprofen GUIDOTTI FARMA https://cima.aemps.es/cima/dochtml/ft/80802/FT_80802.html April 2018





Solymbic *** http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004373/human_med_002076.jsp&mid=WC0b01ac058001d124



Sonazoid powder and solvent for solution of for injection 8 microliter/ml



Spheroids of human autologous matrix-associated chondrocytes New active substance and new biological



Tiotropium Bromide Monohydrate / Olodaterol Hydrochloride http://db.cbg-meb.nl/IB-teksten/h115528.pdf



Stivarga* http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002573/human_med_001684.jsp&mid=WC0b01ac058001d124

New active substance and new biological, authorised under exceptional circumstances http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003794/human_med_001901.jsp&mid=WC0b01ac058001d124

Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence New active substance and new biological, PASS1 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003854/human_med_001985.jsp&mid=WC0b01ac058001d124

Striverdi Respimat (also known in some EU countries as Infortispir Respimat) New active substance, PASS1 http://db.cbg-meb.nl/IB-teksten/h112058.pdf


New active substance and new biological, PASS1http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003708/human_med_001769.jsp&mid=WC0b01ac058001d124

Darunavir / cobicistat / emtricitabine / tenofovir alafenamide




TAKUDEX (also known in some EU countries as Dextra) PASS1









http://db.cbg-meb.nl/IB-teksten/h115528.pdf









Taltz Ixekizumab Eli Lilly Nederland B.V. May 2016

Teicoplanin February 2014

Tecentriq Atezolizumab Roche Registration GmbH October 2017

Terrosa Teriparatide New biological Gedeon Richter Plc. January 2017

Thiocolchicoside January 2014

Thiosix Tioguanin Authorised under exceptional circumstances Teva Nederland B.V. May 2015

Thorinane Enoxaparin sodium New biological Techdow Pharma Netherlands B.V. September 2016

Tivicay Dolutegravir New active substance ViiV Healthcare BV February 2014

Tookad Padeliporfin New active substance Steba Biotech S.A November 2017

Translarna Ataluren New active substance, conditional authorisation PTC Therapeutics Limited September 2014

Trelegy Ellipta Fluticasone furoate/umeclidinium/vilanterol New active substance GlaxoSmithKline Trading Services Limited May 2018

Tremfya Guselkumab Janssen-Cilag International NV November 2017

Triumeq Dolutegravir/abacavir/lamivudine New active substance ViiV Healthcare UK Limited October 2014

Truberzi Eluxadoline New active substance Allergan Pharmaceuticals International Limited October 2016

Trulicity Dulaglutide Eli Lilly Nederland B.V. December 2014

Trumenba Meningococcal group B vaccine (recombinant, componen Pfizer Limited June 2017

Truxima Rituximab New biological Celltrion Healthcare Hungary Kft. March 2017

Tuxella Rituximab New biological Celltrion Healthcare Hungary Kft. July 2017

Tybost Cobicistat New active substance Gilead Sciences Ireland UC October 2013

Tysabri Natalizumab Biogen Idec Limited April 2013

Ultibro Breezhaler Indacaterol/glycopyrronium bromide Novartis Europharm Limited October 2013

Ulunar Breezhaler Indacaterol/glycopyrronium bromide Novartis Europharm Limited July 2014

Uptravi Selexipag New active substance Actelion Registration Ltd June 2016


Targocid and associated names (teicoplanin-containing medicinal products) (For full list see Annex VII)PASS1 Various (For full list see Annex VII) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Targocid_and_associated_names/human_referral_000341.jsp&mid=WC0b01ac05805c516f



Thiocolchicoside-containing medicinal products (For full list see Annex IV) PASS1 Various (For full list see Annex IV)

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Thiocolchicoside-containing_medicines/human_referral_000356.jsp&mid=WC0b01ac05805c516f&source=homeMedSearch&category=human






















http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Targocid_and_associated_names/human_referral_000341.jsp&mid=WC0b01ac05805c516f


















January 2015

Vargatef Nintedanib New active substance Boehringer Ingelheim International GmbH December 2014

Varuby Rolapitant New active substance Tesaro UK Limited May 2017

Vaxelis New biological MCM Vaccine B.V. February 2016

Influenza vaccine (split virion, inactivated) New biological Sanofi Pasteur MSD GmbH https://portal.dimdi.de/amispb/doc/pei/Web/2613624-spcde-20171201.pdf September 2016

Vedrop Authorised under exceptional circumstances Orphan Europe S.A.R.L. April 2013

Velphoro New active substance Vifor Fresenius Medical Care Renal Pharma France September 2014

Veltassa Patiromer New active substance Vifor Fresenius Medical Care Renal Pharma France September 2017

Vemlidy Tenofovir alafenamide New active substance Gilead Sciences Ireland UC January 2017

Venclyxto Venetoclax New active substance, conditional authorisation AbbVie Deutschland GmbH & Co. KG December 2016

Vepacel Nanotherapeutics UK Limited April 2013

VeraSeal Human fibrinogen / human thrombin New biological Instituto Grifols, S.A. November 2017

Viekirax Ombitasvir/paritaprevir/ritonavir AbbVie Deutschland GmbH & Co. KG February 2015

Vihuma Simoctocog alfa Octapharma AB April 2017

Vimizim Elosulfase alfa BioMarin Europe Ltd June 2014

Alogliptin/metformin New active substance Takeda Pharma A/S October 2013

Alogliptin New active substance Takeda Pharma A/S October 2013

Vizamyl Flutemetamol (18F) New active substance GE Healthcare Ltd September 2014

Vokanamet Canagliflozin/metformin hydrochloride New active substance Janssen-Cilag International NV May 2014

Vosevi Sofosbuvir / velpatasvir / voxilaprevir Gilead Sciences Ireland UC September 2017

Vyndaqel Tafamidis Authorised under exceptional circumstances Pfizer Limited April 2013

Wakix Pitolisant hydrochloride Bioprojet Pharma April 2016

Xadago Safinamide New active substance Zambon S.p.A. March 2015

Xagrid Anagrelide Authorised under exceptional circumstances Shire Pharmaceutical Contracts Limited April 2013

Valproate and related substances (sodium valproate, valproic acid, valproate semisodium, valpromide-containing medicinal products) (For full list of products see Annex XIII)Sodium valproate, valproic acid, valproate semisodium, valpromide PASS1 Various (For full list see Annex XIII) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Valproate_and_related_substances/human_referral_prac_000032.jsp&mid=WC0b01ac05805c516f



Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003982/human_med_001962.jsp&mid=WC0b01ac058001d124

Vaxigrip Tetra (also known in some EU countries as quadrivalent influenza vaccine (split virion, inactivated))

Tocofersolan d-alpha tocopheryl polyethylene glycol succinate http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000920/human_med_001129.jsp&mid=WC0b01ac058001d124

Mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002705/human_med_001795.jsp&mid=WC0b01ac058001d124




A/H5N1 pre-pandemic influenza vaccine (whole virion, vero cell derived, inactivated) New active substance and new biological http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002089/human_med_001543.jsp&mid=WC0b01ac058001d124




New active substance and new biological, PASS1 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002779/human_med_001759.jsp&mid=WC0b01ac058001d124

Vipdomet* http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002654/human_med_001695.jsp&mid=WC0b01ac058001d124

Vipidia* http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002182/human_med_001696.jsp&mid=WC0b01ac058001d124










http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Valproate_and_related_substances/human_referral_prac_000032.jsp&mid=WC0b01ac05805c516f





















Xalkori Crizotinib New active substance Pfizer Limited April 2013

Xarelto Rivaroxaban Bayer Pharma AG July 2013

Xeljanz Tofacitinib New active substance Pfizer Limited April 2017

Xermelo Telotristat New active substance Ipsen Pharma September 2017

Xgeva Denosumab New biological Amgen Europe B.V. April 2013

Dapagliflozin/metformin New active substance AstraZeneca AB February 2014

Xofigo Radium Ra 223 dichloride New active substance Bayer AG December 2013

Xoterna Breezhaler Indacaterol/glycopyrronium bromide Novartis Europharm Limited October 2013

Xultophy Insulin degludec/liraglutide New biological Novo Nordisk A/S October 2014

Xydalba Dalbavancin New active substance Allergan Pharmaceuticals International Limited March 2015

Yanimo Respimat New active substance Boehringer Ingelheim International GmbH September 2016

Zalmoxis MolMed S.p.A. September 2016

Zavicefta Ceftazidime / avibactam New active substance Pfizer Ireland Pharmaceuticals July 2016

Zejula Niraparib New active substance TESARO UK LIMITED November 2017

Zepatier Elbasvir / grazoprevir New active substance Merck Sharp & Dohme B.V. September 2016

Zerbaxa Ceftolozane / tazobactam New active substance Merck Sharp & Dohme B.V. September 2015

Ceftobiprole medocaril sodium New active substance Basilea Medical Ltd June 2016

Zinplava Bezlotoxumab Merck Sharp & Dohme B.V. February 2017

Zoely Nomegestrol/Estradiol Teva B.V. January 2014

Zurampic Lesinurad Grünenthal GmbH March 2016

Zydelig Idelalisib New active substance Gilead Sciences Ireland UC October 2014

Zykadia Ceritinib New active substance Novartis Europharm Limited May 2015






Xigduo** http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002672/human_med_001721.jsp&mid=WC0b01ac058001d124





Tiotropium Bromide Monohydrate / Olodaterol Hydrochloride http://db.cbg-meb.nl/IB-teksten/h115529.pdf

Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)





http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003772/human_med_001917.jsp&mid=WC0b01ac058001d124Zevtera 500 mg powder for concentrate for solution for infusion (also known in some EU countries as Mabelio) http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1448606619300.pdf






1 PASS: Post-authorisation safety study. A PASS is defined in Article 1(15) of Directive 2001/83/EC as any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures.

* Aubagio, Incresync, Stivarga, Vipdomet and Vipidia are removed from the additional monitoring list as the condition(s) to the marketing authorisation have been fulfilled.** Five years after the European Union Reference Date (EURD) for dapagliflozin, Ebymect, Qtern and Xigduo are no longer under additional monitoring. They are therefore removed from this list. *** At the marketing authorisation holder's request, the marketing authorisation granted by Decision (2017)2056 of 22/03/2017 for "Solymbic - adalimumab", is withdrawn on 15 June 2018.




















Documents

List of medicinal products under additional monitoring - …€¦ · XLS file · Web view · 2018-04-26List of medicinal products under additional monitoring Related Information: