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Date Content
30/06/2023 Human medicines European public assessment report (EPAR): Cibinqo, Abrocitinib, Dermatitis, Atopic, 09/12/2021, Patient safety, Additional monitoring, 5, Authorised
30/06/2023 Human medicines European public assessment report (EPAR): Trimbow, Beclometasone dipropionate, formoterol fumarate dihydrate, Glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 17/07/2017, 7, Authorised
30/06/2023 Human medicines European public assessment report (EPAR): Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.), formoterol fumarate dihydrate, glycopyrronium, Beclometasone dipropionate, Pulmonary Disease, Chronic Obstructive, 23/04/2018, 4, Authorised
30/06/2023 Human Medicines
30/06/2023 Human medicines European public assessment report (EPAR): Dimethyl fumarate Polpharma, dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting, 13/05/2022, Generic, 4, Authorised
30/06/2023 Human medicines European public assessment report (EPAR): Sibnayal, Potassium citrate monohydrated, Potassium hydrogen carbonate, Acidosis, Renal Tubular, 30/04/2021, 2, Authorised
30/06/2023 Report: Annual accounts: Financial year 2022
30/06/2023 Other: European Medicines Agency Data Protection Notice concerning the EMA Veterinary Awareness Day event on 12-13 September 2023
30/06/2023 Other: European Medicines Agency Data Protection Notice concerning the 3rd Veterinary Stakeholder Forum on 23 November 2023
30/06/2023 Other: Article 57 product data
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Vocabria, Cabotegravir, PM: decision on the application for modification of an agreed PIP, P/0102/2022
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Wakix, pitolisant, PM: decision on the application for modification of an agreed PIP, P/0057/2021
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Entresto, sacubitril,valsartan, PM: decision on the application for modification of an agreed PIP, P/0327/2021
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Mircera, Methoxy polyethylene glycol-epoetin beta, RPM: decision refers to a refusal on the application for modification of an agreed PIP, P/0317/2017
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Mvabea, Multivalent, live, recombinant, non-replicating in human cells, Modified Vaccinia Ankara vectored vaccine, expressing the EBOV Mayinga glycoprotein, the Sudan virus Gulu GP, the Marburg virus Musoke GP, and the Taï Forest virus nucleoprotein [MVA-BN-Filo], PM: decision on the application for modification of an agreed PIP, P/0334/2021
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Lisdexamfetamine dimesilate, PM: decision on the application for modification of an agreed PIP, P/0097/2022
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Zabdeno, Monovalent, live, recombinant, replication-incompetent adenoviral serotype 26 vectored vaccine expressing the full length glycoprotein of the Ebola virus Mayinga variant [Ad26.ZEBOV], PM: decision on the application for modification of an agreed PIP, P/0307/2021
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Kymriah, tisagenlecleucel, PM: decision on the application for modification of an agreed PIP, P/0323/2019
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): human fibrinogen, PM: decision on the application for modification of an agreed PIP, P/0258/2017
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Trulicity, dulaglutide, PM: decision on the application for modification of an agreed PIP, P/0409/2021
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Eliquis, Apixaban, PM: decision on the application for modification of an agreed PIP, P/0198/2020
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ofev, nintedanib, PM: decision on the application for modification of an agreed PIP, P/0438/2021
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Nifurtimox, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0081/2022
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0141/2022
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): artesunate, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0328/2020
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Takhzyro, Lanadelumab (DX-2930), PM: decision on the application for modification of an agreed PIP, P/0214/2022
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Dabrafenib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0423/2020
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): trametinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0424/2020
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Agomelatine, PM: decision on the application for modification of an agreed PIP, P/0115/2021
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Dopamine (hydrochloride), PM: decision on the application for modification of an agreed PIP, P/0209/2022
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab, PM: decision on the application for modification of an agreed PIP, P/0074/2022
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Briviact (in Italy: Nubriveo), Brivaracetam, PM: decision on the application for modification of an agreed PIP, P/0174/2021
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, Baricitinib, PM: decision on the application for modification of an agreed PIP, P/0311/2021
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Recombinant dimer of 6 kD early secretory antigenic target,recombinant 10 kD culture filtrate protein, PM: decision on the application for modification of an agreed PIP, P/0188/2016
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Mekinist, Trametinib (dimethyl sulfoxide), PM: decision on the application for modification of an agreed PIP, P/0392/2020
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Tafinlar, dabrafenib mesilate, PM: decision on the application for modification of an agreed PIP, P/0410/2020
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Moventig, Naloxegol, PM: decision on the application for modification of an agreed PIP, P/0493/2021
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Lixiana, edoxaban tosilate, PM: decision on the application for modification of an agreed PIP, P/0423/2021
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Vipidia, alogliptin, PM: decision on the application for modification of an agreed PIP, P/0257/2020
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Oteseconazole, PM: decision on the application for modification of an agreed PIP, P/0460/2021
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Foclivia, Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), PM: decision on the application for modification of an agreed PIP, P/0188/2020
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Jardiance, empagliflozin, PM: decision on the application for modification of an agreed PIP, P/0283/2021
30/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Trajenta, linagliptin, PM: decision on the application for modification of an agreed PIP, P/0446/2021
30/06/2023 Orphan designation: tasimelteon for the: Treatment of non-24-hour sleep-wake disorders in blind people with no light perception, 23/02/2011, Positive
30/06/2023 Human medicines European public assessment report (EPAR): Mysildecard, sildenafil citrate, Hypertension, Pulmonary, 15/09/2016, Generic, 7, Authorised
30/06/2023 Human medicines European public assessment report (EPAR): Kalydeco, ivacaftor, Cystic Fibrosis, 23/07/2012, Accelerated assessment, 36, Authorised
30/06/2023 Other: Records of data processing activity for the electronic EMA newsletters published via Newsroom
30/06/2023 Other: European Medicines Agency’s Data Protection Notice For the electronic EMA newsletters published via Newsroom
30/06/2023 Periodic safety update single assessment: Carbidopa / levodopa : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000548/202210
30/06/2023 Periodic safety update single assessment: Carbidopa / levodopa : List of nationally authorised medicinal products - PSUSA/00000548/202210
30/06/2023 Procurement activities 2022
30/06/2023 Procurement: Annual list of specific contracts based on framework contracts – 2022
30/06/2023 Procurement: Annual list of contract modifications 2022
30/06/2023 Procurement: Annual list of contractors 2022 - contract values Euro 15,000 - 140,000
29/06/2023 Report: Medicinal products for human use: monthly figures - May 2023
29/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Leniolisib, PM: decision on the application for modification of an agreed PIP, P/0259/2022
29/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Dexmedetomidine hydrochloride, PM: decision on the application for modification of an agreed PIP, P/0248/2022
29/06/2023 SPOR and xEVMPD Stakeholder Engagement Webinars : Service Desk for SPOR and XEVMPD , Online, from 10/10/2023 to 10/10/2023
29/06/2023 SPOR and xEVMPD Stakeholder Engagement Webinars : Substance Management Service (SMS) , Online, from 05/10/2023 to 05/10/2023
29/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Nuvaxovid, Severe acute respiratory syndrome coronavirus 2 recombinant spike protein nanoparticle vaccine/ matrix-M1 adjuvant (NVX-CoV2373), PM: decision on the application for modification of an agreed PIP, P/0250/2022
29/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): 3,5-diamino-6-chloro-N-(N-(4-(4-(2-(hexyl((2S,3R,4R,5R)-2,3,4,5,6- pentahydroxyhexyl)amino)ethoxy)phenyl)butyl)-carbamimidoyl)pyrazine-2-carboxamide/Sodium chloride solution 4.2% (P-1037 inhalation solution), PM: decision on the application for modification of an agreed PIP, P/0206/2022
29/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Spikevax (previously COVID-19 Vaccine Moderna), Elasomeran / imelasomeran Elasomeran, PM: decision on the application for modification of an agreed PIP, P/0256/2022
29/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Veklury, remdesivir, PM: decision on the application for modification of an agreed PIP, P/0221/2022
29/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain,Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain,Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Victoria lineage),Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Yamagata lineage), PM: decision on the application for modification of an agreed PIP, P/0219/2022
29/06/2023 Quarterly system demo - Q2 2023 , Online, 09:00 - 13:00 Amsterdam time (CEST), from 22/06/2023 to 22/06/2023
29/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Brukinsa, zanubrutinib, PM: decision on the application for modification of an agreed PIP, P/0205/2022
29/06/2023 Other: Records of data processing activity for the user test of the Critical Medical Device Shortages (CMDS) system
29/06/2023 Supply shortage: Pazenir (paclitaxel) supply shortage
29/06/2023 Tenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines , Online, 09:30 - 13:30 Amsterdam time (CEST), from 27/06/2023 to 27/06/2023
29/06/2023 Human medicines European public assessment report (EPAR): Matever, levetiracetam, Epilepsy, 03/10/2011, Generic, 27, Authorised
29/06/2023 Presentation: Presentation - Patient engagement from a patient centric drug development to authorisation (M. Mavris, EMA)
29/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab, PM: decision on the application for modification of an agreed PIP, P/0191/2022
29/06/2023 Presentation: Presentation - Update on submission predictability focus group (F. Day, EMA)
29/06/2023 Human medicines European public assessment report (EPAR): Praluent, Alirocumab, Dyslipidemias, 23/09/2015, 20, Authorised
29/06/2023 Presentation: Presentation - Update on RMP publication (E. Cochino, EMA)
29/06/2023 Presentation: Presentation - Update on CHMP AR Revamp project (F. Day, EMA)
29/06/2023 Presentation: Presentation - OPEN – International collaboration (R.Cherif, EMA)
29/06/2023 Human medicines European public assessment report (EPAR): Myalepta, Metreleptin, Lipodystrophy, Familial Partial, 29/07/2018, Orphan, Additional monitoring, Exceptional circumstances, 8, Authorised
29/06/2023 Other: Network ICT Advisory Committee (NICTAC) - Updated Terms of reference
29/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Virus-like particle of SARS-CoV-2 spike protein (recombinant, adjuvant) (CoVLP), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0162/2022
29/06/2023 Supply shortage: Visudyne (verteporfin) supply shortage
28/06/2023 Human medicines European public assessment report (EPAR): Ayvakyt, Avapritinib, Gastrointestinal Stromal Tumors, 24/09/2020, Orphan, Additional monitoring, Conditional approval, 7, Authorised
28/06/2023 Human medicines European public assessment report (EPAR): Zynrelef, bupivacaine, meloxicam, Pain, Postoperative, 24/09/2020, 2, Authorised
28/06/2023 Human medicines European public assessment report (EPAR): Luminity, perflutren, Echocardiography, 20/09/2006, 17, Authorised
28/06/2023 VICH GL18(R2) impurities: residual solvents in new veterinary medicinal products, active substances and excipients - Scientific guideline
28/06/2023 Scientific guideline: VICH GL18(R2) impurities: residual solvents in new veterinary medicinal products, active substances and excipients - Revision 2
28/06/2023 Human medicines European public assessment report (EPAR): Forxiga, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2; Heart Failure, Systolic; Heart Failure; Renal Insufficiency, Chronic, 11/11/2012, 29, Authorised
28/06/2023 Scientific guideline: Overview of comments received on the draft guideline on clinical investigation of medicinal products in the treatment of diabetes mellitus - Revision 2
28/06/2023 Scientific guideline: Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus - Revision 2
28/06/2023 Human medicines European public assessment report (EPAR): Ontozry, cenobamate, Epilepsy, 26/03/2021, Additional monitoring, 5, Authorised
28/06/2023 Human medicines European public assessment report (EPAR): Renvela, sevelamer carbonate, Hyperphosphatemia; Renal Dialysis, 09/06/2009, 26, Authorised
28/06/2023 Human medicines European public assessment report (EPAR): Mylotarg, gemtuzumab ozogamicin, Leukemia, Myeloid, Acute, 19/04/2018, Orphan, 11, Authorised
28/06/2023 Annual reports and work programmes
27/06/2023 Focus group meeting on bacteriophages as veterinary medicines , Online, 09:30-16:30 CEST (Amsterdam time), from 11/05/2023 to 11/05/2023
27/06/2023 Herbal medicinal product: Rubi idaei folium, Rubi idaei folium, F: Assessment finalised
27/06/2023 Orphan designation: Autologous CD34+ cells transfected with retroviral vector containing adenosine deaminase gene for the: Treatment of severe combined immunodeficiency (SCID) due to adenosine deaminase (ADA) deficiency, 26/08/2005, Positive
27/06/2023 Human medicines European public assessment report (EPAR): Multaq, dronedarone, Atrial Fibrillation, 25/11/2009, 19, Authorised
27/06/2023 Standard Operating Procedure - SOP: Standard operating procedure for conducting checks for conflicts of interest of the European Medicines Agency employees assigned duties relating to medicinal products for human or veterinary use
27/06/2023 Human medicines European public assessment report (EPAR): Fasturtec, rasburicase, Hyperuricemia, 23/02/2001, 30, Authorised
27/06/2023 Human medicines European public assessment report (EPAR): Orencia, Abatacept, Arthritis, Psoriatic; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid, 21/05/2007, 38, Authorised
27/06/2023 Regulatory and procedural guideline: Procedural advice on publication of information on withdrawals of applications related to the marketing authorisation of human medicinal products
27/06/2023 Human medicines European public assessment report (EPAR): Temozolomide Accord, temozolomide, Glioma; Glioblastoma, 15/03/2010, Generic, 23, Authorised
27/06/2023 Human medicines European public assessment report (EPAR): Apidra, insulin glulisine, Diabetes Mellitus, 27/09/2004, 32, Authorised
27/06/2023 Periodic safety update single assessment: Famotidine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001350/202209
27/06/2023 Orphan designation: (S)-N-(5-(4-(1-(benzo[d][1,3]dioxol-5-yl)ethyl)piperazin-1-yl)-1,3,4-thiadiazol-2-yl)acetamide, hydrochloride salt for the: Treatment of progressive supranuclear palsy, 09/12/2020, Positive
27/06/2023 Human medicines European public assessment report (EPAR): Ecalta, anidulafungin, Candidiasis, 20/09/2007, 26, Authorised
27/06/2023 Periodic safety update single assessment: Famotidine : List of nationally authorised medicinal products - PSUSA/00001350/202209
27/06/2023 Human medicines European public assessment report (EPAR): Neulasta, pegfilgrastim, Neutropenia; Cancer, 22/08/2002, 38, Authorised
27/06/2023 Orphan designation: Recombinant adeno-associated viral vector expressing the human CNGA3 gene for the: Treatment of achromatopsia caused by mutations in the CNGA3 gene, 09/10/2015, Positive
27/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ribitol, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0387/2021
27/06/2023 Human medicines European public assessment report (EPAR): Clopidogrel Zentiva (previously Clopidogrel Winthrop), clopidogrel, Stroke; Peripheral Vascular Diseases; Myocardial Infarction; Acute Coronary Syndrome, 15/07/2008, 32, Authorised
27/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Rilzabrutinib, PM: decision on the application for modification of an agreed PIP, P/0262/2022
27/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Garadacimab, PM: decision on the application for modification of an agreed PIP, P/0249/2022
27/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): liposomal ciclosporin A (L-CsA), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0231/2022
27/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Invokana, canagliflozin, PM: decision on the application for modification of an agreed PIP, P/0208/2022
27/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Nemolizumab, PM: decision on the application for modification of an agreed PIP, P/0201/2022
27/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Adasuve, loxapine, PM: decision on the application for modification of an agreed PIP, P/0200/2022
27/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Noxafil, posaconazole, PM: decision on the application for modification of an agreed PIP, P/0196/2022
27/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Efinaconazole, PM: decision on the application for modification of an agreed PIP, P/0195/2022
27/06/2023 Human medicines European public assessment report (EPAR): Cymbalta, duloxetine, Anxiety Disorders; Diabetic Neuropathies; Depressive Disorder, Major, 17/12/2004, 32, Authorised
27/06/2023 Human medicines European public assessment report (EPAR): Sunlenca, Lenacapavir sodium, HIV Infections, 17/08/2022, Additional monitoring, 01, Authorised
27/06/2023 Orphan designation: Zanidatamab for the: Treatment of gastric cancer, 13/11/2020, Positive
27/06/2023 Orphan designation: 6-Amino-5-chloro-N-((1R)-1-(5-(((5-chloro-4-(trifluoromethyl)-2-pyridinyl)amino)carbonyl)-2-thiazolyl)ethyl)-4-pyrimidinecarboxamide for the: Treatment of glioma, 20/05/2021, Positive
27/06/2023 Orphan designation: Zanidatamab for the: Treatment of biliary tract cancer, 19/07/2021, Positive
26/06/2023 Human medicines European public assessment report (EPAR): Levetiracetam ratiopharm, levetiracetam, Epilepsy, 26/08/2011, Generic, 15, Authorised
26/06/2023 Periodic safety update single assessment: Clenbuterol : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000794/202209
26/06/2023 Periodic safety update single assessment: Clenbuterol : List of nationally authorised medicinal products - PSUSA/00000794/202209
26/06/2023 EU Network Training Centre (EU NTC)
26/06/2023 Medicines under additional monitoring: Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union
26/06/2023 Medicines under additional monitoring: Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union
26/06/2023 Veterinary medicines European public assessment report (EPAR): Comfortis, spinosad, 11/02/2011, 12, Withdrawn
26/06/2023 Clinical Trials Regulation: progress on implementation
26/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Comirnaty, Tozinameran, PM: decision on the application for modification of an agreed PIP, P/0466/2022
26/06/2023 Orphan designation: Modified mRNA encoding human methylmalonyl-coenzyme A mutase encapsulated into lipid nanoparticles for the: Treatment of methylmalonic acidaemia, 25/05/2018, Withdrawn
23/06/2023 Human medicines European public assessment report (EPAR): Cabometyx , cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular, 09/09/2016, Accelerated assessment, 17, Authorised
23/06/2023 Human medicines European public assessment report (EPAR): Omidria, ketorolac, phenylephrine, Lens Implantation, Intraocular; Pain, Postoperative, 28/07/2015, 8, Authorised
23/06/2023 Human medicines European public assessment report (EPAR): Hexyon, filamentous haemagglutinin, Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate), hepatitis B surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells, poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells, poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, Diphtheria toxoid, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria, 17/04/2013, 22/02/2013, 30, Authorised
23/06/2023 Human medicines European public assessment report (EPAR): Hexacima, hepatitis B surface antigen, Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin, poliovirus (inactivated) type 1 (Mahoney) type 2 (MEF-1) type 3 (Saukett), Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) conjugated to Tetanus protein, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria, 17/04/2013, 22/02/2013, 29, Authorised
23/06/2023 Human medicines European public assessment report (EPAR): Zydelig, Idelalisib, Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell, 18/09/2014, Additional monitoring, 20, Authorised
23/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Methylphenidate (hydrochloride), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0203/2022
23/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Beyfortus, Nirsevimab, PM: decision on the application for modification of an agreed PIP, P/0296/2021
23/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, Upadacitinib (ABT-494), PM: decision on the application for modification of an agreed PIP, P/0263/2022
23/06/2023 Human medicines European public assessment report (EPAR): Beyfortus, nirsevimab, 31/10/2022, Additional monitoring, 3, Authorised
23/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Omecamtiv mecarbil, PM: decision on the application for modification of an agreed PIP, P/0260/2022
23/06/2023 News and press releases: Use of real-world evidence in regulatory decision making – EMA publishes review of its studies
23/06/2023 Development of a guideline on the quality aspects of mRNA vaccines - Scientific guideline
23/06/2023 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 9-12 January 2023 PRAC meeting
23/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): daprodustat, PM: decision on the application for modification of an agreed PIP, P/0242/2022
23/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ninlaro, Ixazomib, PM: decision on the application for modification of an agreed PIP, P/0237/2022
23/06/2023 Product-information templates - Human
23/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Zavicefta, Ceftazidime,Avibactam, PM: decision on the application for modification of an agreed PIP, P/0258/2022
23/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Tenkasi (previously Orbactiv), oritavancin (diphosphate), PM: decision on the application for modification of an agreed PIP, P/0236/2022
23/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Atectura Breezhaler, Indacaterol (acetate),Mometasone furoate, PM: decision on the application for modification of an agreed PIP, P/0226/2022
23/06/2023 Human medicines European public assessment report (EPAR): Respreeza, Human alpha1-proteinase inhibitor, Genetic Diseases, Inborn; Lung Diseases, 20/08/2015, Additional monitoring, 11, Authorised
23/06/2023 Summary of opinion: Refixia, nonacog beta pegol, 22/06/2023, Positive
23/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Heplisav B, Hepatitis B (rDNA) surface antigen adjuvanted, PM: decision on the application for modification of an agreed PIP, P/0245/2022
23/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Vimpat, lacosamide, PM: decision on the application for modification of an agreed PIP, P/0247/2022
23/06/2023 Medicine QA: Outcome of application to extend use of Ofev (nintedanib)
23/06/2023 Minutes: Minutes of the CVMP meeting 15-16 May 2023
23/06/2023 Scientific guideline: Concept paper on the development of a guideline on the quality aspects of mRNA vaccines
23/06/2023 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 June 2023
23/06/2023 Regulatory and procedural guideline: List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animal and humans to veterinary medicinal products
23/06/2023 Summary of opinion: Mircera, methoxy polyethylene glycol-epoetin beta, 22/06/2023, Positive
23/06/2023 Withdrawn application: Dyrupeg, pegfilgrastim, Date of withdrawal: 08/06/2023, Initial authorisation
23/06/2023 Regulatory and procedural guideline: Non-current Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) low level terms (LLT) and codes
23/06/2023 European Surveillance of Veterinary Antimicrobial Consumption (ESVAC)
23/06/2023 Scientific guideline: Guideline on the reporting of antimicrobial sales and use in animals at the EU level – denominators and indicators
23/06/2023 Human medicines European public assessment report (EPAR): Oxlumo, Lumasiran sodium, Hyperoxaluria, Primary, 19/11/2020, Orphan, Additional monitoring, 4, Authorised
23/06/2023 Scientific guideline: Guideline on the development and data requirements of potency tests for veterinary cell-based therapy products and the relation to clinical efficacy
23/06/2023 Scientific guideline: Concept paper for the revision of the guideline on live recombinant vector vaccines for veterinary use
23/06/2023 Human medicines European public assessment report (EPAR): Rivaroxaban Viatris (previously Rivaroxaban Mylan), rivaroxaban, Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation, 12/11/2021, Generic, 4, Authorised
23/06/2023 Human medicines European public assessment report (EPAR): Eliquis, Apixaban, Arthroplasty; Venous Thromboembolism, 18/05/2011, 32, Authorised
23/06/2023 Human medicines European public assessment report (EPAR): Quviviq, daridorexant hydrochloride, Sleep Initiation and Maintenance Disorders, 29/04/2022, Additional monitoring, 5, Authorised
23/06/2023 Human medicines European public assessment report (EPAR): Trevicta (previously Paliperidone Janssen), paliperidone palmitate, Schizophrenia, 05/12/2014, 12, Authorised
23/06/2023 Human medicines European public assessment report (EPAR): Byannli (previously Paliperidone Janssen-Cilag International), paliperidone palmitate, Schizophrenia, 18/06/2020, 3, Authorised
22/06/2023 Human medicines European public assessment report (EPAR): Xeplion, paliperidone palmitate, Schizophrenia, 04/03/2011, 15, Authorised
22/06/2023 Ibuprofen product-specific bioequivalence guidance
22/06/2023 Product-specific bioequivalence guidance
22/06/2023 Tadalafil product-specific bioequivalence guidance
22/06/2023 Agenda: Agenda - European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting - 28 June 2023
22/06/2023 Agenda: Agenda - Healthcare Professionals' Working Party (HCPWP) meeting - 27 June 2023
22/06/2023 Agenda: Agenda - Patients and Consumers Working Party (PCWP) meeting - 27 June 2023
22/06/2023 Paracetamol product-specific bioequivalence guidance
22/06/2023 Human medicines European public assessment report (EPAR): Arexvy, Respiratory Syncytial Virus recombinant glycoprotein F stabilised in the pre-fusion conformation (RSVPreF3) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology, Respiratory Syncytial Virus Infections, 06/06/2023, Authorised
22/06/2023 Human medicines European public assessment report (EPAR): Rizmoic, Naldemedine tosilate, Constipation, 18/02/2019, Additional monitoring, 9, Authorised
22/06/2023 Pirfenidone product-specific bioequivalence guidance
22/06/2023 Bosutinib product-specific bioequivalence guidance
22/06/2023 Fampridine product-specific bioequivalence guidance
22/06/2023 Lurasidone product-specific bioequivalence guidance
22/06/2023 Metformin product-specific bioequivalence guidance
22/06/2023 Human medicines European public assessment report (EPAR): Xerava, eravacycline, Infection; Bacterial Infections, 20/09/2018, 7, Authorised
22/06/2023 News and press releases: ACT EU: creating a better environment for clinical trials through collaboration
22/06/2023 Implementation of the pharmacovigilance legislation
22/06/2023 News and press releases: Report: How EU ensured safety of medicines during COVID-19
22/06/2023 Report: Report on pharmacovigilance tasks from EU Member States and the European Medicines Agency (EMA) 2019-2022
22/06/2023 Minutes: Minutes of the COMP meeting 15-17 May 2023
22/06/2023 Article 5(3) opinions on any scientific matter: human medicines
22/06/2023 Article 141(1) opinions on any scientific matter: veterinary medicines
22/06/2023 Human medicines European public assessment report (EPAR): Rubraca, rucaparib camsylate, Ovarian Neoplasms, 23/05/2018, Patient safety, Additional monitoring, 13, Authorised
22/06/2023 Human medicines European public assessment report (EPAR): Opzelura, ruxolitinib phosphate, Vitiligo, 19/04/2023, 1, Authorised
22/06/2023 Human medicines European public assessment report (EPAR): Levetiracetam Actavis, levetiracetam, Epilepsy, 03/10/2011, Generic, 19, Authorised
22/06/2023 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d., emtricitabine, tenofovir disoproxil succinate, HIV Infections, 28/04/2017, Generic, 10, Authorised
22/06/2023 Human medicines European public assessment report (EPAR): Levetiracetam Actavis Group, levetiracetam, Epilepsy, 04/12/2011, Generic, 18, Authorised
22/06/2023 Minutes: Minutes of the PRAC meeting 13-16 March 2023
21/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Peptide KLBPVQLWV / Peptide SMPPPGTRV / Peptide YLQLVFGIEV / Peptide RLLQETELV / Peptide YLSGADLNL / Peptide LLTFWNPPV / Peptide IMIGHLVGV / Peptide KVAEIVHFL / Peptide KVFGSLAFV / Pan HLA DR-binding epitope D-Ala-Lys-Cha-Val-Ala-Ala-Trp-Thr-Leu-Lys-Ala-Ala-D-Ala (OSE2101), W: decision granting a waiver in all age groups for all conditions or indications, P/0227/2022
21/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Recombinant COVID-19 subunit nanoparticle (adjuvanted with AS03) (GBP510), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0261/2022
21/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Sibeprenlimab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0232/2022
21/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab, PM: decision on the application for modification of an agreed PIP, P/0189/2022
21/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Indapamide,Perindopril (arginine), W: decision granting a waiver in all age groups for all conditions or indications, P/0212/2022
21/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab, PM: decision on the application for modification of an agreed PIP, P/0188/2022
21/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): gabapentin, PM: decision on the application for modification of an agreed PIP, P/0198/2018
21/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Sugemalimab, W: decision granting a waiver in all age groups for all conditions or indications, P/0194/2022
21/06/2023 Herbal medicinal product: Sisymbrii officinalis herba, Sisymbrii officinalis herba, F: Assessment finalised
21/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Anti-TGFbeta fully human monoclonal antibody (NIS793), W: decision granting a waiver in all age groups for all conditions or indications, P/0207/2022
21/06/2023 Herbal medicinal product: Ricini oleum, Ricini oleum, F: Assessment finalised
21/06/2023 Human medicines European public assessment report (EPAR): Rivastigmine Hexal, rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease, 11/12/2009, 15, Authorised
21/06/2023 EPAR - All authorised presentations: Rivastigmine Hexal : EPAR - All Authorised presentations
21/06/2023 Template or form: CHMP protocol assistance scientific advice briefing document template
21/06/2023 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka, emtricitabine, tenofovir disoproxil succinate, HIV Infections, 09/12/2016, Generic, 12, Authorised
21/06/2023 Human medicines European public assessment report (EPAR): Rivastigmine 1 A Pharma, rivastigmine, Alzheimer Disease; Dementia; Parkinson Disease, 11/12/2009, 15, Authorised
21/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Cedazuridine, decitabine, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0217/2022
21/06/2023 Withdrawn application: Tidhesco, ivosidenib, Date of withdrawal: 27/03/2023, Initial authorisation
21/06/2023 Human medicines European public assessment report (EPAR): Sugammadex Mylan, sugammadex sodium, Neuromuscular Blockade, 15/11/2021, Generic, 2, Authorised
21/06/2023 Human medicines European public assessment report (EPAR): Levetiracetam Teva, levetiracetam, Epilepsy, 25/08/2011, Generic, 20, Authorised
21/06/2023 Human medicines European public assessment report (EPAR): Giotrif, afatinib, Carcinoma, Non-Small-Cell Lung, 25/09/2013, 15, Authorised
21/06/2023 Human medicines European public assessment report (EPAR): Levetiracetam Accord, levetiracetam, Epilepsy, 03/10/2011, Generic, 16, Authorised
21/06/2023 Third European Medicines Agency and Nuclear Medicines Europe bilateral meeting , from 15/06/2023 to 15/06/2023
21/06/2023 EPAR - All authorised presentations: Rivastigmine Sandoz : EPAR - All Authorised presentations
20/06/2023 Scientific and technical recommendations: Veterinary Medicines Regulation
20/06/2023 Regulatory and procedural guideline: Scientific advice under Art.107(6) of Reg.(EU)2019/6 for establishment of a list of antimicrobials which shall not be used in accordance with Art. 112, 113 and 114 or which shall only be used in accordance with these articles subject to certain conditions
20/06/2023 Orphan designation: Recombinant self-complementary adeno-associated viral vector serotype 9 containing the human CLN3 gene for the: Treatment of neuronal ceroid lipofuscinosis, 08/10/2009, Withdrawn
20/06/2023 Human medicines European public assessment report (EPAR): Noxafil, posaconazole, Candidiasis; Mycoses; Coccidioidomycosis; Aspergillosis, 25/10/2005, 37, Authorised
20/06/2023 Human medicines European public assessment report (EPAR): Temodal, temozolomide, Glioma; Glioblastoma, 26/01/1999, 37, Authorised
20/06/2023 Agenda: Agenda of the PDCO meeting 20-23 June 2023
20/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Parsaclisib (hydrochloride), W: decision granting a waiver in all age groups for all conditions or indications, P/0240/2022
20/06/2023 Human medicines European public assessment report (EPAR): Prevymis, Letermovir, Cytomegalovirus Infections, 08/01/2018, Orphan, 15, Authorised
20/06/2023 Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections, 08/02/2018, Generic, 10, Authorised
20/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Mixture of 2 synthetic double-stranded N-Acetyl-galactosamine conjugated siRNA oligonucleotides that are directed against hepatitis B virus (JNJ-73763989), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0228/2022
20/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Lonafarnib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0246/2022
20/06/2023 Orphan designation: Recombinant human elafin for the: Treatment of oesophagus carcinoma, 28/01/2010, Positive
20/06/2023 Human medicines European public assessment report (EPAR): Hemgenix, Etranacogene dezaparvovec, Hemophilia B, 20/02/2023, Orphan, Additional monitoring, Conditional approval, 2, Authorised
20/06/2023 Human medicines European public assessment report (EPAR): Ocaliva, Obeticholic acid, Liver Cirrhosis, Biliary, 12/12/2016, Orphan, Additional monitoring, Conditional approval, 17, Authorised
20/06/2023 Human medicines European public assessment report (EPAR): Dexdor, Dexmedetomidine hydrochloride, Conscious Sedation, 15/09/2011, 16, Authorised
20/06/2023 Human medicines European public assessment report (EPAR): Duavive, oestrogens conjugated, bazedoxifene, Postmenopause, 16/12/2014, 15, Authorised
20/06/2023 Human medicines European public assessment report (EPAR): Ximluci, ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications, 09/11/2022, Additional monitoring, Biosimilar, 1, Authorised
19/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Botulinum toxin type A, W: decision granting a waiver in all age groups for all conditions or indications, P/0233/2022
19/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): 224 Radium adsorbed in calcium carbonate microparticles, W: decision granting a waiver in all age groups for all conditions or indications, P/0252/2022
19/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Autologous bone marrow-derived mononuclear cell enriched white blood cells, W: decision granting a waiver in all age groups for all conditions or indications, P/0224/2022
19/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Clonidine, W: decision granting a waiver in all age groups for all conditions or indications, P/0202/2022
19/06/2023 Opinion/decision on a Paediatric investigation plan (PIP): Reparixin, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0210/2022