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29/07/2022 Human medicines European public assessment report (EPAR): Zubsolv, Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate, Opioid-Related Disorders, 10/11/2017, 8, Authorised
29/07/2022 Human medicines European public assessment report (EPAR): Entecavir Mylan, entecavir monohydrate, Hepatitis B, 18/09/2017, Generic, 5, Authorised
29/07/2022 Human medicines European public assessment report (EPAR): Entecavir Accord, Entecavir, Hepatitis B, Chronic, 25/09/2017, Generic, 5, Authorised
29/07/2022 EPAR - Assessment report - Variation: Nuvaxovid-H-C-005808-II-0009 : EPAR - Assessment report - Variation
29/07/2022 Human medicines European public assessment report (EPAR): Vaborem, meropenem trihydrate, vaborbactam, Urinary Tract Infections; Bacteremia; Bacterial Infections; Respiratory Tract Infections; Pneumonia; Pneumonia, Ventilator-Associated, 20/11/2018, Additional monitoring, 6, Authorised
29/07/2022 Report: CAT quarterly highlights and approved ATMPs - July 2022
29/07/2022 Human medicines European public assessment report (EPAR): Tigecycline Accord, Tigecycline, Soft Tissue Infections; Intraabdominal Infections; Bacterial Infections; Skin Diseases, Infectious, 17/04/2020, Generic, 4, Authorised
29/07/2022 Report: Key performance indicators (KPIs) to monitor the European clinical trials environment (1 - 30 June 2022, edition 3)
29/07/2022 Human medicines European public assessment report (EPAR): Yuflyma, adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid, 11/02/2021, Biosimilar, 8, Authorised
28/07/2022 EMA webinar for fact checkers: Safety of COVID-19 vaccines and therapeutics , Online, 15:45 - 17:00 Amsterdam time (CEST), from 22/03/2022 to 22/03/2022
28/07/2022 Orphan designation: (S)-ethyl 2-amino-3-(4-(2-amino-6((R)-1-(4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phenyl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)phenyl)propanoate for the: Treatment of carcinoid syndrome, 30/05/2016, Positive
28/07/2022 Human medicines European public assessment report (EPAR): Amversio, betaine, Homocystinuria, 05/05/2022, Additional monitoring, Generic, Authorised
28/07/2022 Human medicines European public assessment report (EPAR): Supemtek, Influenza A virus subtype H1N1 haemagglutinin, recombinant, Influenza A virus subtype H3N2 haemagglutinin, recombinant, Influenza B virus Victoria lineage haemagglutinin, recombinant, Influenza B virus Yamagata lineage haemagglutinin, recombinant, Influenza, Human, 16/11/2020, Additional monitoring, 2, Authorised
28/07/2022 Boric acid and borates
28/07/2022 Webinar on submissions of parallel distribution notifications for centrally authorised products (CAPs) , Online, 16:00-17:30 Amsterdam time (CEST), from 09/06/2022 to 09/06/2022
28/07/2022 Opinion on medicine for use outside EU: Insulatard, Insulin human (RDNA), Diabetes Mellitus, 22/04/2022, Positive opinion
28/07/2022 News and press releases: Big data use for public health: publication of Big Data Steering Group workplan 2022-25
27/07/2022 News and press releases: EMA reviewing data on sabizabulin for COVID-19
27/07/2022 COVID-19 treatments: Article 18 and Article 5(3) reviews
27/07/2022 Other: Product Management Service (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 8 Annex I: Complete representation
27/07/2022 Regulatory and procedural guideline: Product Management Service (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 8
27/07/2022 Regulatory and procedural guideline: Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2
27/07/2022 Human medicines European public assessment report (EPAR): Pemetrexed Sandoz, pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma, 18/09/2015, Generic, 7, Authorised
27/07/2022 Orphan designation: Recombinant human acid sphingomyelinase (also known as olipudase alfa) for the: Treatment of Niemann-Pick disease, 24/06/2022, Positive
27/07/2022 Human medicines European public assessment report (EPAR): Xenpozyme, Olipudase alfa, Acid sphingomyelinase deficiency (ASMD) type A/B or type B, 24/06/2022, Orphan, Additional monitoring, Authorised
27/07/2022 Human medicines European public assessment report (EPAR): Pemetrexed Fresenius Kabi, pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma, 22/07/2016, Generic, 13, Authorised
27/07/2022 Periodic safety update reports (PSURs)
27/07/2022 News and press releases: EMA response to the monkeypox public health emergency
27/07/2022 Human medicines European public assessment report (EPAR): Grepid, clopidogrel (as besilate), Peripheral Vascular Diseases; Stroke; Myocardial Infarction, 27/07/2009, Generic, 25, Authorised
27/07/2022 Veterinary medicines European public assessment report (EPAR): Bovilis BTV8, bluetongue virus vaccine, serotype 8 (inactivated), 06/09/2010, 4, Withdrawn
27/07/2022 Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 18-21 July 2022
26/07/2022 Human medicines European public assessment report (EPAR): Granpidam, sildenafil citrate, Hypertension, Pulmonary, 14/11/2016, Generic, 7, Authorised
26/07/2022 Human medicines European public assessment report (EPAR): Rybelsus, semaglutide, Diabetes Mellitus, Type 2, 03/04/2020, Additional monitoring, 4, Authorised
26/07/2022 Human medicines European public assessment report (EPAR): Fintepla, Fenfluramine hydrochloride, Epilepsies, Myoclonic, 18/12/2020, Orphan, Additional monitoring, 3, Authorised
26/07/2022 Human medicines European public assessment report (EPAR): Rhokiinsa, Netarsudil, Glaucoma, Open-Angle; Ocular Hypertension, 19/11/2019, Additional monitoring, 2, Authorised
26/07/2022 Human medicines European public assessment report (EPAR): Cablivi, Caplacizumab, Purpura, Thrombotic Thrombocytopenic, 30/08/2018, Orphan, Additional monitoring, 6, Authorised
26/07/2022 Chemistry of active substances (chemistry of new active substances) - Scientific guideline
26/07/2022 Direct healthcare professional communication (DHPC): Hydroxyethyl starch (HES) solutions for infusion: suspension of marketing authorisations due to continued use in contraindicated patient populations with increased risk of serious harm, Active substance: hydroxyethyl starch, DHPC type: Post-authorisation measure, Last updated: 26/07/2022
26/07/2022 News and press releases: Hydroxyethyl-starch solutions for infusion recommended for suspension from the market
26/07/2022 Human medicines European public assessment report (EPAR): Ziextenzo, pegfilgrastim, Neutropenia, 22/11/2018, Additional monitoring, Biosimilar, 5, Authorised
26/07/2022 Human medicines European public assessment report (EPAR): Kovaltry, octocog alfa, Hemophilia A, 18/02/2016, 11, Authorised
26/07/2022 Newsletter: DADI newsletter - Issue 1
26/07/2022 Human medicines European public assessment report (EPAR): Revestive, teduglutide, Malabsorption Syndromes, 30/08/2012, Orphan, Additional monitoring, 20, Authorised
25/07/2022 Human medicines European public assessment report (EPAR): Fotivda, tivozanib, Carcinoma, Renal Cell, 24/08/2017, Additional monitoring, 8, Authorised
25/07/2022 Human medicines European public assessment report (EPAR): Pradaxa, Dabigatran etexilate mesilate, Arthroplasty, Replacement; Venous Thromboembolism, 17/03/2008, 38, Authorised
25/07/2022 Other: Agnes Saint-Raymond - Assessment outcome of occupational activities after leaving the service (July 2022)
25/07/2022 Human medicines European public assessment report (EPAR): Afstyla, lonoctocog alfa, Hemophilia A, 04/01/2017, 10, Authorised
25/07/2022 News and press releases: EMA Paediatric Committee elects Brian Aylward as its new Chair
25/07/2022 Newsletter: Clinical Trials Highlights - July 2022
25/07/2022 Human medicines European public assessment report (EPAR): Orkambi, Lumacaftor, ivacaftor, Cystic Fibrosis, 18/11/2015, Additional monitoring, 29, Authorised
25/07/2022 Orphan designation: Moxetumomab pasudotox for the: Treatment of B-lymphoblastic leukaemia/lymphoma, 19/07/2022, Withdrawn
25/07/2022 Human medicines European public assessment report (EPAR): Trelegy Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive, 15/11/2017, 9, Authorised
25/07/2022 Human medicines European public assessment report (EPAR): Mayzent, Siponimod fumaric acid, Multiple Sclerosis, Relapsing-Remitting, 13/01/2020, Additional monitoring, 8, Authorised
25/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Cometriq, cabozantinib, PM: decision on the application for modification of an agreed PIP, P/0282/2021
25/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Rezolsta, darunavir,cobicistat, PM: decision on the application for modification of an agreed PIP, P/0254/2021
25/07/2022 Orphan designation: Adeno-associated viral vector serotype 9 containing the human SMN gene (onasemnogene abeparvovec) for the: Treatment of spinal muscular atrophy, 19/06/2015, Positive
25/07/2022 Human medicines European public assessment report (EPAR): Rapamune, Sirolimus, Graft Rejection; Kidney Transplantation, 13/03/2001, 46, Authorised
25/07/2022 Summary of opinion: Genvoya, elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide, 21/07/2022, Positive
22/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Tremfya, guselkumab, PM: decision on the application for modification of an agreed PIP, P/0250/2021
22/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Nemolizumab, PM: decision on the application for modification of an agreed PIP, P/0253/2021
22/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Vemlidy, Tenofovir alafenamide (as fumarate), PM: decision on the application for modification of an agreed PIP, P/0269/2021
22/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Bardoxolone methyl, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0280/2021
22/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Ralinepag, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0244/2021
22/07/2022 Human medicines European public assessment report (EPAR): Tremfya, guselkumab, Psoriasis, 10/11/2017, 8, Authorised
22/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Finerenone, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0243/2021
22/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Evenity, Romosozumab, PM: decision on the application for modification of an agreed PIP, P/0255/2021
22/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Invokana, canagliflozin, PM: decision on the application for modification of an agreed PIP, P/0268/2021
22/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Tivicay, Dolutegravir (DTG), PM: decision on the application for modification of an agreed PIP, P/0267/2021
22/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Maralixibat chloride, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0245/2021
22/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Autologous selected renal cells, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0265/2021
22/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Human papilloma virus type 16 E6 071-095,human papilloma virus type 16 E6 001-032,human papilloma virus type 16 E6 055-080,human papilloma virus type 16 E6 091-122,Human Papilloma Virus Type 16 E6 109-140,Human Papilloma Virus Type 16 E6 019-050,Human Papilloma Virus Type 16 E6 041-065,Human Papilloma Virus Type 16 E6 085-109,Human Papilloma Virus Type 16 E6 127-158,human papilloma virus type 16 E7 064-098,Human Papilloma Virus Type 16 E7 022-056,Human Papilloma Virus Type 16 E7 001-035, W: decision granting a waiver in all age groups for all conditions or indications, P/0251/2021
22/07/2022 Veterinary medicinal products for zootechnical purposes - Scientific guideline
22/07/2022 Human medicines European public assessment report (EPAR): ProQuad, virus, live attenuated, measles, virus, live attenuated, mumps, virus, live attenuated, rubella, virus, live attenuated, varicella, Chickenpox; Rubella; Measles; Mumps; Immunization, 05/04/2006, 31, Authorised
22/07/2022 Regulatory and procedural guideline: Draft guideline on the application of Article 34 of Regulation (EU) 2019/6 - Classification of veterinary medicinal products (prescription status)
22/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Adeno-associated viral vector serotype 8 containing the human glucose-6-phosphatase gene (DTX401), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0278/2021
22/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Gavreto, pralsetinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0271/2021
22/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Recombinant monoclonal antibody to sialic acid-binding Ig-like lectin 8 (AK002), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0277/2021
22/07/2022 Summary of opinion: Imcivree, setmelanotide, 21/07/2022, Positive
22/07/2022 News and press releases: EMA recommends restricting use of cancer medicine Rubraca
22/07/2022 News and press releases: EMA recommends approval of Imvanex for the prevention of monkeypox disease
22/07/2022 Summary of opinion: Celdoxome pegylated liposomal, doxorubicin hydrochloride, 21/07/2022, Positive
22/07/2022 Human medicines European public assessment report (EPAR): Mekinist, trametinib, Melanoma, 30/06/2014, 28, Authorised
22/07/2022 News and press releases: Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making
22/07/2022 Human medicines European public assessment report (EPAR): Zinforo, Ceftaroline fosamil, Community-Acquired Infections; Skin Diseases, Infectious; Pneumonia, 22/08/2012, 26, Authorised
22/07/2022 Opinion on medicine for use outside EU: Actrapid, insulin human, Diabetes Mellitus, 22/04/2022, Positive opinion
21/07/2022 Human medicines European public assessment report (EPAR): Sugammadex Fresenius Kabi, sugammadex sodium, Neuromuscular Blockade, 15/07/2022, Generic, Authorised
21/07/2022 Report: CAT quarterly highlights and approved ATMPs - April 2022
21/07/2022 Human medicines European public assessment report (EPAR): Xgeva, denosumab, Fractures, Bone; Neoplasm Metastasis, 13/07/2011, 23, Authorised
21/07/2022 Committee for Herbal Medicinal Products (HMPC): 16-18 May 2022 , Online, from 16/05/2022 to 18/05/2022
21/07/2022 Human medicines European public assessment report (EPAR): Kapruvia, difelikefalin, Pruritus, 25/04/2022, Additional monitoring, 1, Authorised
21/07/2022 Scientific guideline: Draft ICH guideline M12 on drug interaction studies - Step 2b
21/07/2022 Committee meeting report: COMP meeting report on the review of applications for orphan designation: July 2022
21/07/2022 Paediatric Committee (PDCO): 17-20 May 2022 , Virtual meeting, from 17/05/2022 to 20/05/2022
21/07/2022 Minutes: PCDO minutes of the 17-20 May 2022 meeting
21/07/2022 Human medicines European public assessment report (EPAR): Otezla, apremilast, Arthritis, Psoriatic; Psoriasis, 15/01/2015, 19, Authorised
21/07/2022 Management Board meetings
20/07/2022 Human medicines European public assessment report (EPAR): Cimzia, Certolizumab pegol, Arthritis, Rheumatoid, 01/10/2009, 33, Authorised
20/07/2022 Human medicines European public assessment report (EPAR): Ganfort, bimatoprost, timolol, Glaucoma, Open-Angle; Ocular Hypertension, 19/05/2006, 23, Authorised
20/07/2022 Human medicines European public assessment report (EPAR): Ozurdex, dexamethasone, Macular Edema; Uveitis, 26/07/2010, 18, Authorised
20/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0242/2021
20/07/2022 Human medicines European public assessment report (EPAR): Lumigan, bimatoprost, Glaucoma, Open-Angle; Ocular Hypertension, 08/03/2002, 37, Authorised
20/07/2022 Human medicines European public assessment report (EPAR): Kineret, anakinra, Arthritis, Rheumatoid, 08/03/2002, 32, Authorised
20/07/2022 Human medicines European public assessment report (EPAR): Ganirelix Gedeon Richter, ganirelix acetate, Reproductive Techniques, Assisted; Ovulation Induction; Infertility, Female, 15/07/2022, Generic, Authorised
20/07/2022 Human medicines European public assessment report (EPAR): Stivarga, regorafenib, Colorectal Neoplasms, 26/08/2013, 18, Authorised
20/07/2022 Regulatory and procedural guideline: List of substances and products subject to worksharing for signal management
20/07/2022 Minutes: Minutes of the PRAC meeting 30 August - 2 September 2021
19/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Enhertu, trastuzumab deruxtecan, W: decision granting a waiver in all age groups for all conditions or indications, P/0275/2021
19/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Human immunoglobulin G1 constant region - human ectodysplasin-A1 receptor-binding domain fusion protein, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0284/2021
19/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): trastuzumab deruxtecan, W: decision granting a waiver in all age groups for all conditions or indications, P/0259/2021
19/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): trastuzumab deruxtecan, W: decision granting a waiver in all age groups for all conditions or indications, P/0279/2021
19/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Patritumab deruxtecan, W: decision granting a waiver in all age groups for all conditions or indications, P/0276/2021
19/07/2022 Orphan designation: for the: Treatment of primary sclerosing cholangitis, 13/04/2022, Positive
19/07/2022 Orphan designation: tiratricol for the: Treatment of resistance to thyroid hormone type beta, 13/04/2022, Positive
19/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Vupanorse, W: decision granting a waiver in all age groups for all conditions or indications, P/0256/2021
19/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Zibotentan,dapagliflozin propanediol monohydrate, W: decision granting a waiver in all age groups for all conditions or indications, P/0249/2021
19/07/2022 Orphan designation: Cannabidiol for the: Treatment of epilepsy with myoclonic-atonic seizures, 13/04/2022, Positive
19/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): [18F]CTT1057, W: decision granting a waiver in all age groups for all conditions or indications, P/0258/2021
19/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): mannitol, W: decision granting a waiver in all age groups for all conditions or indications, P/0262/2021
19/07/2022 Human medicines European public assessment report (EPAR): Zeffix, lamivudine, Hepatitis B, Chronic, 29/07/1999, 29, Authorised
19/07/2022 Guidance documents
19/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Selatogrel, W: decision granting a waiver in all age groups for all conditions or indications, P/0263/2021
19/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Anti-C1s Humanized IgG4 Monoclonal Antibody, W: decision granting a waiver in all age groups for all conditions or indications, P/0252/2021
19/07/2022 Human medicines European public assessment report (EPAR): Azacitidine Accord, azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute, 13/02/2020, Generic, 5, Authorised
19/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Allogeneic skin-derived ATP-binding cassette, sub-family B, member 5 (ABCB5)-positive mesenchymal stem cells (allo-APZ2-EB), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0247/2021
19/07/2022 Orphan designation: Adeno-associated virus serotype C102 containing the human GLA gene for the: Treatment of Fabry disease, 13/04/2022, Positive
19/07/2022 Orphan designation: Adeno-associated viral vector serotype 8 encoding B-domain deleted liver specific codon optimized bioengineered chimeric human porcine factor VIII, under a synthetic hepatic combinatorial bundle promoter for the: Treatment of haemophilia A, 13/04/2022, Positive
19/07/2022 Orphan designation: Obecabtagene autoleucel for the: Treatment of acute lymphoblastic leukaemia, 13/04/2022, Positive
19/07/2022 Orphan designation: Devimistat for the: Treatment of biliary tract cancer, 13/04/2022, Positive
19/07/2022 Orphan designation: N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine for the: Treatment in solid organ transplantation, 13/04/2022, Positive
19/07/2022 Orphan designation: arimoclomol citrate for the: Treatment of inclusion body myositis, 18/07/2022, Withdrawn
19/07/2022 Orphan designation: Arimoclomol for the: Treatment of amyotrophic lateral sclerosis, 18/07/2022, Withdrawn
19/07/2022 Orphan designation: Belzupacap sarotalocan for the: Treatment of uveal melanoma, 13/04/2022
19/07/2022 Orphan designation: Adeno-associated virus vector serotype 9 encoding human gigaxonin gene for the: Treatment of giant axonal neuropathy, 13/04/2022, Positive
19/07/2022 Orphan designation: Humanised anti-CD37 monoclonal antibody conjugated to maytansinoid DM1 (naratuximab emtansine) for the: Treatment of diffuse large B-cell lymphoma, 18/07/2022, Withdrawn
19/07/2022 Orphan designation: Norucholic acid for the: Treatment of primary biliary cholangitis, 13/04/2022, Positive
19/07/2022 Orphan designation: Sirolimus for the: Treatment of tuberous sclerosis, 20/06/2017, Positive
19/07/2022 Agenda: Agenda of the PDCO meeting 19-22 July 2022
18/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Cotadutide, PM: decision on the application for modification of an agreed PIP, P/0273/2021
18/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Garadacimab, PM: decision on the application for modification of an agreed PIP, P/0274/2021
18/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Rilzabrutinib, PM: decision on the application for modification of an agreed PIP, P/0272/2021
18/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222), PM: decision on the application for modification of an agreed PIP, P/0266/2021
18/07/2022 Orphan designation: Adeno-associated virus serotype 9 containing human MYBPC3 gene for the: Treatment of Hypertrophic cardiomyopathy due to mutations in the MYBPC3 gene encoding cardiac myosin-binding protein C, 13/04/2022, Positive
18/07/2022 Human medicines European public assessment report (EPAR): Potactasol, topotecan, Uterine Cervical Neoplasms; Small Cell Lung Carcinoma, 06/01/2011, Generic, 10, Authorised
18/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Bis-choline tetrathiomolybdate, PM: decision on the application for modification of an agreed PIP, P/0261/2021
18/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Cotadutide, PM: decision on the application for modification of an agreed PIP, P/0270/2021
18/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): MenQuadfi, Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid,N. meningitidis serogroup C polysaccharide conjugated to tetanus toxoid,N. meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid,N. meningitidis serogroup W polysaccharide conjugated to tetanus toxoid (MenACYW), PM: decision on the application for modification of an agreed PIP, P/0285/2021
18/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Takhzyro, Lanadelumab (DX-2930), PM: decision on the application for modification of an agreed PIP, P/0264/2021
18/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Alpivab, Peramivir, PM: decision on the application for modification of an agreed PIP, P/0257/2021
18/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Vaborem, meropenem trihydrate,vaborbactam, PM: decision on the application for modification of an agreed PIP, P/0260/2021
18/07/2022 Orphan designation: Glofitamab for the: Treatment of mantle cell lymphoma, 13/04/2022, Positive
18/07/2022 PRAC recommendation on signal: New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 March 2022 PRAC
18/07/2022 Newsletter: Human medicines highlights - July 2022
18/07/2022 First industry standing group (ISG) meeting , Online, from 21/06/2022 to 21/06/2022
18/07/2022 Other: Meeting summary - First industry standing group (ISG) meeting
18/07/2022 Agenda: Agenda of the CHMP meeting 18-21 July 2022
15/07/2022 Human medicines European public assessment report (EPAR): Hefiya, adalimumab, Spondylitis, Ankylosing; Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis, 26/07/2018, Additional monitoring, Biosimilar, 10, Authorised
15/07/2022 Human medicines European public assessment report (EPAR): Episalvan, Betulae cortex, Wounds and Injuries; Wound Healing, 14/01/2016, 7, Withdrawn
15/07/2022 EPAR - Product Information: Hefiya : EPAR - Product Information
15/07/2022 Other: European Medicines Agency’s Data Protection Notice for EudraVigilance Human (EV)
15/07/2022 Other: Record of data processing activity for EudraVigilance (public)
15/07/2022 Digital application dataset integration (DADI) and Product Management Service (PMS) webinar - Variations form for human medicinal products - What will happen at go-live , Online, 10:00 - 12:00 Amsterdam time (CEST), from 16/05/2022 to 16/05/2022
15/07/2022 Human medicines European public assessment report (EPAR): Elmiron, pentosan polysulfate sodium, Cystitis, Interstitial, 02/06/2017, 14, Authorised
15/07/2022 Report: Technology Capability Investment Plan - Becoming a digital hub for the European medicines regulator network
15/07/2022 Information management
15/07/2022 News and press releases: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 12-14 July 2022
15/07/2022 Summary of opinion: Lotilaner Elanco, lotilaner, 14/07/2022, Positive
15/07/2022 Human medicines European public assessment report (EPAR): Zonisamide Mylan, zonisamide, Epilepsy, 31/03/2016, Generic, 8, Authorised
15/07/2022 News and press releases: Towards better prevention of medicine shortages in the EU
15/07/2022 Other: Good practice guidance for patient and healthcare professional organisations on the prevention of shortages of medicines for human use
14/07/2022 Human medicines European public assessment report (EPAR): Synagis, palivizumab, Respiratory Syncytial Virus Infections, 13/08/1999, 44, Authorised
14/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): COVID-19 Vaccine (inactivated, adjuvanted) Valneva, SARS-CoV-2 virus, beta-propiolactone inactivated adjuvanted with CpG 1018 (VLA2001), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0184/2022
14/07/2022 Human medicines European public assessment report (EPAR): M-M-RVaxPro, measles virus Enders’ Edmonston strain (live, attenuated), mumps virus Jeryl Lynn (level B) strain (live, attenuated), rubella virus Wistar RA 27/3 strain (live, attenuated), Rubella; Mumps; Immunization; Measles, 05/05/2006, 30, Authorised
14/07/2022 Orphan designation: Autologous CD34+ cells transduced with a lentiviral vector containing the human ADA gene for the: Treatment of adenosine-deaminase-deficient severe combined immunodeficiency, 07/06/2013, Positive
14/07/2022 Orphan designation: Autologous CD34+ cells transfected with lentiviral vector containing the Wiskott-Aldrich syndrome protein gene for the: Treatment of Wiskott-Aldrich syndrome, 06/06/2012, Positive
14/07/2022 Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA for the: Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive
14/07/2022 Orphan designation: Autologous CD34+ cells transduced with a lentiviral vector containing the human SGSH gene for the: Treatment of mucopolysaccharidosis, type IIIA (Sanfilippo A syndrome), 10/06/2014, Positive
14/07/2022 Orphan designation: Autologous haematopoietic cells genetically modified with a lentiviral vector containing the human gp91(phox) gene for the: Treatment of X-linked chronic granulomatous disease, 09/02/2012, Positive
14/07/2022 Orphan designation: Autologous CD34+ cells transfected with lentiviral vector containing the human arylsulfatase A cDNA for the: treatment of metachromatic leukodystrophy, 13/04/2007, Positive
14/07/2022 Leaflet: Info-cards: What can you do when it comes to shortages of medicines?
14/07/2022 European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting , Online, from 01/06/2022 to 02/06/2022
14/07/2022 Leaflet: Factsheet: Towards better prevention of medicine shortages
14/07/2022 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
14/07/2022 Human medicines European public assessment report (EPAR): Dexdor, dexmedetomidine hydrochloride, Conscious Sedation, 15/09/2011, 15, Authorised
14/07/2022 Orphan designation: antisense oligonucleotide targeting exon 73 in the COL7A1 gene for the: Treatment of epidermolysis bullosa, 12/10/2017, Positive
14/07/2022 Orphan designation: Darinaparsin for the: Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated), 15/04/2011, Positive
13/07/2022 Regulatory and procedural guideline: Appendix 1 to INS-GCP-4 procedure for reporting of GCP inspections requested by the CHMP: GCP inspection report
13/07/2022 Other: Joint controllership arrangement with regard to EudraVigilance Human (EV)
13/07/2022 Periodic safety update single assessment: Caffeine / ergotamine : List of nationally authorised medicinal products - PSUSA/00000485/202111
13/07/2022 Human medicines European public assessment report (EPAR): Bevespi Aerosphere, glycopyrronium, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, 18/12/2018, 5, Authorised
13/07/2022 Human medicines European public assessment report (EPAR): Copiktra, duvelisib, Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Follicular, 19/05/2021, Additional monitoring, 2, Authorised
13/07/2022 News and press releases: EMA re-elected as chair of ICMRA from October 2022
13/07/2022 Human medicines European public assessment report (EPAR): Evoltra, clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 29/05/2006, Additional monitoring, Exceptional circumstances, 31, Authorised
13/07/2022 Periodic safety update single assessment: Bisoprolol / hydrochlorothiazide : List of nationally authorised medicinal products - PSUSA/00000420/202111
13/07/2022 Human medicines European public assessment report (EPAR): Aripiprazole Accord, aripiprazole, Schizophrenia; Bipolar Disorder, 15/11/2015, Generic, 15, Authorised
13/07/2022 Veterinary product information templates
13/07/2022 Good clinical practice (GCP) inspection procedures
13/07/2022 Periodic safety update single assessment: Sodium oxybate (intravenous use) : List of nationally authorised medicinal products - PSUSA/0010613/202110
13/07/2022 Human medicines European public assessment report (EPAR): Veyvondi, vonicog alfa, von Willebrand Diseases, 31/08/2018, Additional monitoring, 5, Authorised
13/07/2022 Periodic safety update single assessment: Ciprofibrate : List of nationally authorised medicinal products - PSUSA/00000771/202112
12/07/2022 Human medicines European public assessment report (EPAR): Jalra, vildagliptin, Diabetes Mellitus, Type 2, 19/11/2008, 23, Authorised
12/07/2022 Periodic safety update single assessment: Asparaginase, crisantaspase (nationally authorised products) : List of nationally authorised medicinal products - PSUSA/00003161/202108
12/07/2022 Reflection paper on the use of measurable residual disease as a clinical endpoint in multiple myeloma studies - Scientific guideline
12/07/2022 Periodic safety update single assessment: Carmustine (implant) : List of nationally authorised medicinal products - PSUSA/00010348/202109
12/07/2022 Opinion/decision on a Paediatric investigation plan (PIP): Gardasil, human papillomavirus type 6 L1 protein,human papillomavirus type 11 L1 protein,human papillomavirus type 16 L1 protein,human papillomavirus type 18 L1 protein, PM: decision on the application for modification of an agreed PIP, P/13/2010
12/07/2022 Scientific guideline: Reflection paper on the use of measurable residual disease as a clinical endpoint in multiple myeloma studies
12/07/2022 Clinical Trials Information System (CTIS): Walk-in clinic , Online, 15:00 - 15:45 Amsterdam time (CEST), from 05/05/2022 to 05/05/2022
12/07/2022 Human medicines European public assessment report (EPAR): Ceprotin, human protein C, Purpura Fulminans; Protein C Deficiency, 15/07/2001, 17, Authorised
12/07/2022 Other: Contact details of national competent authorities for requests to use a sticker to place the Unique Identifier on the outer/immediate packaging of centrally approved products
12/07/2022 Orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor (axicabtagene ciloleucel) for the: Treatment of follicular lymphoma, 11/11/2015, Positive
12/07/2022 Mock-ups and specimens
12/07/2022 Other: Contact details of national competent authorities for requests of translation exemptions falling under Art. 63.3 of Directive 2001/83/EC and cases of shortages
12/07/2022 News and press releases: EMA launches pilot project on analysis of raw data from clinical trials
12/07/2022 Human medicines European public assessment report (EPAR): Trodelvy, Sacituzumab govitecan, Breast Neoplasms; Triple Negative Breast Neoplasms, 22/11/2021, Additional monitoring, 1, Authorised
12/07/2022 Agenda: Agenda - DARWIN EU Advisory Board meeting: 20 April 2022
12/07/2022 DARWIN EU Advisory Board meeting: 20 April 2022 , Online, from 20/04/2022 to 20/04/2022
12/07/2022 Human medicines European public assessment report (EPAR): Crixivan, indinavir sulfate ethanolate, HIV Infections, 04/10/1996, 39, Withdrawn
12/07/2022 Committee for Medicinal Products for Veterinary Use (CVMP): 12-14 July 2022 , European Medicines Agency, Amsterdam, the Netherlands, from 12/07/2022 to 14/07/2022
12/07/2022 Agenda: Agenda of the CVMP meeting 12-14 July 2022
11/07/2022 Human medicines European public assessment report (EPAR): Darzalex, Daratumumab, Multiple Myeloma, 20/05/2016, Orphan, Accelerated assessment, 19, Authorised
11/07/2022 News and press releases: ECDC and EMA update recommendations on additional booster doses of mRNA COVID-19 vaccines
11/07/2022 Human medicines European public assessment report (EPAR): Azopt, brinzolamide, Glaucoma, Open-Angle; Ocular Hypertension, 09/03/2000, 26, Authorised
11/07/2022 Human medicines European public assessment report (EPAR): Naglazyme, galsulfase, Mucopolysaccharidosis VI, 23/01/2006, 19, Authorised
08/07/2022 Report: Applications for new human medicines under evaluation by the CHMP: July 2022
08/07/2022 Other: European Union example instances - E2B(R3) testing files
08/07/2022 Human medicines European public assessment report (EPAR): Dovprela (previously Pretomanid FGK), Pretomanid, Tuberculosis, Multidrug-Resistant, 31/07/2020, Orphan, Additional monitoring, Conditional approval, 6, Authorised
08/07/2022 Organisation Management System (OMS) Trouble Shooting Session for CTIS users - June 2022 , Online, 14:00 - 15:00 Amsterdam time (CEST), from 30/06/2022 to 30/06/2022
08/07/2022 Periodic safety update single assessment: Ceftobiprole : List of nationally authorised medicinal products - PSUSA/00010734/202111
08/07/2022 Regulatory and procedural guideline: EU Individual Case Safety Report (ICSR) implementation guide business rules spreadsheets
08/07/2022 Other: Agnes Saint-Raymond - Assessment outcome of occupational activities after leaving the service (June 2022)
08/07/2022 Other: List of the main therapeutic groups (MTGs) in crisis preparedness
08/07/2022 Human medicines European public assessment report (EPAR): Clopidogrel TAD, clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Stroke; Myocardial Infarction, 23/09/2009, Generic, 15, Authorised
08/07/2022 News and press releases: Further measures to identify and address medicine shortages during public health emergencies adopted
08/07/2022 Orphan designation: adeno-associated virus serotype 9 vector containing human n-acetylgalactosamine-6-sulfate sulfatase gene for the: Treatment of mucopolysaccharidosis type IVA (Morquio A Syndrome), 09/01/2020, Positive
08/07/2022 Orphan designation: Adeno-associated viral vector serotype 9 containing the human sulfamidase gene for the: Treatment of mucopolysaccharidosis, type IIIA (Sanfilippo A syndrome), 21/06/2011, Positive
08/07/2022 Orphan designation: Recombinant human monoclonal antibody binding to vascular adhesion protein-1 for the: Treatment of primary sclerosing cholangitis, 19/03/2015, Positive
08/07/2022 News and press releases: Medicines containing nomegestrol or chlormadinone: PRAC recommends new measures to minimise risk of meningioma
08/07/2022 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 July 2022
08/07/2022 Periodic safety update single assessment: Cefazolin : List of nationally authorised medicinal products - PSUSA/00000589/202111
08/07/2022 Referral: Zynteglo , betibeglogene autotemcel, Article 20 procedures, European Commission final decision, 22/07/2021, 16/09/2021, 08/07/2022
08/07/2022 Periodic safety update single assessment: Quinine : List of nationally authorised medicinal products - PSUSA/00002598/202111
08/07/2022 Periodic safety update single assessment: Metoclopramide : List of nationally authorised medicinal products - PSUSA/00002036/202111
07/07/2022 Human medicines European public assessment report (EPAR): Xofigo, radium (223Ra) dichloride, Prostatic Neoplasms, 13/11/2013, Additional monitoring, 12, Authorised
07/07/2022 Human medicines European public assessment report (EPAR): Nemdatine, memantine, Alzheimer Disease, 22/04/2013, 22/02/2013, Generic, 11, Authorised
07/07/2022 Management Board meeting: 16-17 March 2022 , European Medicines Agency, Amsterdam, the Netherlands, from 16/03/2022 to 17/03/2022
07/07/2022 Report: OPEN Pilot: One-year review and recommendations
07/07/2022 EMA regular press briefing on COVID-19 , Online, 15:00 - 15:30 Amsterdam time (CEST), from 07/07/2022 to 07/07/2022
07/07/2022 Human medicines European public assessment report (EPAR): Evenity, Romosozumab, Osteoporosis, 09/12/2019, Additional monitoring, 2, Authorised
07/07/2022 Template or form: Template for sections A to E for the scientific part of the application for orphan designation
06/07/2022 Human medicines European public assessment report (EPAR): Abiraterone Krka , abiraterone acetate, Prostatic Neoplasms, 24/06/2021, Generic, 1, Authorised
06/07/2022 Human medicines European public assessment report (EPAR): Epclusa, Sofosbuvir, velpatasvir, Hepatitis C, Chronic, 06/07/2016, Accelerated assessment, 18, Authorised