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Date Content
31/03/2023 Minutes: Minutes of the PRAC meeting 4-7 July 2022
31/03/2023 Human medicines European public assessment report (EPAR): Sotyktu, Deucravacitinib, Psoriasis, 24/03/2023, Additional monitoring, Authorised
31/03/2023 European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting , Online, European Medicines Agency, Amsterdam, the Netherlands, from 03/03/2023 to 03/03/2023
31/03/2023 Herbal medicinal product: Fragariae folium, Fragariae folium, C: ongoing call for scientific data
31/03/2023 Scientific guideline: Guideline on Quality Aspects of Pharmaceutical Veterinary Medicines for administration via drinking water - Draft Annex on compatibility studies between veterinary medicinal products and biocidal products
31/03/2023 Newsletter: CTIS newsflash – 31 March 2023
31/03/2023 Agenda: Agenda - Union Product Database – Volume of sales webinar for UPD industry users
31/03/2023 Human medicines European public assessment report (EPAR): Dzuveo, sufentanil citrate, Pain, 25/06/2018, 6, Authorised
31/03/2023 Other: European Medicines Agency guidance to support the preparation of the PRIME kick-off meeting and submission readiness meeting
31/03/2023 Template or form: PRIME regulatory roadmap and product development tracker
31/03/2023 News and press releases: Regulatory information – adjusted fees for applications to EMA from 1 April 2023
31/03/2023 Other: Explanatory note on general fees payable to the European Medicines Agency as of 1 April 2023
31/03/2023 Regulatory and procedural guideline: Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 1 April 2023
31/03/2023 Minutes: Minutes of the PRAC meeting 24-27 October 2022
31/03/2023 Minutes: Minutes of the PRAC meeting 7-10 June 2022
31/03/2023 Human medicines European public assessment report (EPAR): Lydisilka, estetrol monohydrate, drospirenone, Contraceptives, Oral, 19/05/2021, 3, Authorised
31/03/2023 Human medicines European public assessment report (EPAR): Capecitabine Medac, capecitabine, Colorectal Neoplasms, 19/11/2012, Generic, 13, Authorised
31/03/2023 Other: Annex to interim measures regarding notification of pharmacovigilance alerts by marketing authorisation holders under Regulation (EU) 2019/6: contact points
31/03/2023 Human medicines European public assessment report (EPAR): Drovelis, drospirenone, estetrol monohydrate, Contraceptives, Oral, 19/05/2021, 4, Authorised
31/03/2023 Human medicines European public assessment report (EPAR): Grasustek, pegfilgrastim, Neutropenia, 20/06/2019, Additional monitoring, Biosimilar, 4, Authorised
31/03/2023 Herbal medicinal product: Malvae folium, Malvae folium, C: ongoing call for scientific data
31/03/2023 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Malvae folium
31/03/2023 Human medicines European public assessment report (EPAR): Mycamine, micafungin, Candidiasis, 25/04/2008, 18, Authorised
31/03/2023 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27 - 30 March 2023
31/03/2023 Human medicines European public assessment report (EPAR): Kesimpta, Ofatumumab, Multiple Sclerosis, Relapsing-Remitting, 26/03/2021, Additional monitoring, 6, Authorised
31/03/2023 Herbal medicinal product: Soiae oleum raffinatum, Soiae oleum raffinatum, C: ongoing call for scientific data
31/03/2023 Herbal medicinal product: Malvae sylvestris flos, Malvae sylvestris flos, C: ongoing call for scientific data
31/03/2023 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Malvae sylvestris flos
31/03/2023 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Soiae oleum raffinatum
31/03/2023 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Matricariae aetheroleum
31/03/2023 Herbal medicinal product: Matricariae aetheroleum, Matricariae aetheroleum, C: ongoing call for scientific data
31/03/2023 Newsletter: Big Data highlights - Issue 5
31/03/2023 Herbal medicinal product: Lecithinum ex soya, Lecithinum ex soya, C: ongoing call for scientific data
31/03/2023 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Lecithinum ex soya - Revision 1
31/03/2023 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Fragariae folium - Revision 1
30/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Verquvo, Vericiguat, PM: decision on the application for modification of an agreed PIP, P/0454/2022
30/03/2023 News and press releases: EMA recommends approval of Bimervax as a COVID-19 booster vaccine
30/03/2023 Human medicines European public assessment report (EPAR): Dasatinib Accord, dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive, 24/03/2022, Generic, 1, Withdrawn
30/03/2023 Human medicines European public assessment report (EPAR): Dasatinib Accordpharma, dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive, 24/03/2022, Generic, 1, Withdrawn
30/03/2023 Public information on medicine shortages
30/03/2023 Quarterly system demo - Q1 2023 , Online, 09:00 - 13:00 Amsterdam time (CET), from 22/03/2023 to 22/03/2023
30/03/2023 Minutes: Meeting Summary of the Medicine Shortages (SPOC) Working Party 15 February 2023
30/03/2023 Minutes: Meeting Summary of the Medicine Shortages (SPOC) Working Party 18 January 2023
30/03/2023 Minutes: Meeting Summary of the Medicine Shortages (SPOC) Working Party 13 December 2022
30/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Givinostat, PM: decision on the application for modification of an agreed PIP, P/0513/2022
30/03/2023 Other: Records of data processing for Data Analysis and Real World Interrogation Network (DARWIN EU®)
30/03/2023 Direct healthcare professional communication (DHPC): Updated recommendations to minimise the risks of malignancy, major adverse cardiovascular events, serious infections, venous thromboembolism and mortality with use of Janus kinase inhibitors (JAKi), Active substance: Abrocitinib, filgotinib, Baricitinib, upadacitinib, Tofacitinib, DHPC type: Referral - Article 20 procedure, Last updated: 30/03/2023
29/03/2023 Human medicines European public assessment report (EPAR): Tepadina, thiotepa, Hematopoietic Stem Cell Transplantation, 15/03/2010, 19, Authorised
29/03/2023 Report: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 13-15 March 2023
29/03/2023 Agenda: Agenda of the PDCO meeting 28-31 March 2023
29/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Vitrakvi, Larotrectinib, PM: decision on the application for modification of an agreed PIP, P/0487/2021
29/03/2023 Human medicines European public assessment report (EPAR): Azacitidine Accord, azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute, 13/02/2020, Generic, 6, Authorised
29/03/2023 Human medicines European public assessment report (EPAR): Imvanex, modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine; Monkeypox virus, 31/07/2013, Additional monitoring, Exceptional circumstances, 25, Authorised
29/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Tabelecleucel, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0490/2020
29/03/2023 Human medicines European public assessment report (EPAR): Alecensa, alectinib hydrochloride, Carcinoma, Non-Small-Cell Lung, 16/02/2017, Additional monitoring, 14, Authorised
29/03/2023 Other: Network ICT Advisory Committee (NICTAC) - List of nominated members
29/03/2023 Human medicines European public assessment report (EPAR): Sancuso, granisetron, Vomiting; Cancer, 20/04/2012, 14, Authorised
29/03/2023 Human medicines European public assessment report (EPAR): Puregon, follitropin beta, Infertility; Hypogonadism, 02/05/1996, 34, Authorised
29/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Soticlestat, PM: decision on the application for modification of an agreed PIP, P/0491/2021
29/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Cyclophosphamide, PM: decision on the application for modification of an agreed PIP, P/0490/2021
29/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Flucelvax Tetra, Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage) [QIVc], PM: decision on the application for modification of an agreed PIP, P/0492/2021
29/03/2023 Orphan designation: Iodine (131I) iobenguane for the: Treatment of neuroblastoma, 31/01/2008, Positive
29/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Deferoxamine (mesylate),histidine,tryptophan,aspartic acid,n-acetyl-histidine (monohydrate),glycine,alpha-ketoglutaric acid,arginine,potassium chloride,magnesium chloride (hexahydrate),calcium chloride (dihydrate),sodium chloride,alanine,3,4-dimethoxy-N-methylbenzohydroxamic acid (Custodiol-N), PM: decision on the application for modification of an agreed PIP, P/0484/2021
29/03/2023 Human medicines European public assessment report (EPAR): Azopt, brinzolamide, Glaucoma, Open-Angle; Ocular Hypertension, 09/03/2000, 28, Authorised
29/03/2023 Human medicines European public assessment report (EPAR): Sivextro, tedizolid phosphate, Soft Tissue Infections; Skin Diseases, Bacterial, 23/03/2015, 21, Authorised
29/03/2023 Human medicines European public assessment report (EPAR): Nyvepria, pegfilgrastim, Neutropenia, 18/11/2020, Additional monitoring, Biosimilar, 5, Authorised
29/03/2023 Human medicines European public assessment report (EPAR): Eucreas, vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 14/11/2007, 23, Authorised
29/03/2023 Human medicines European public assessment report (EPAR): Memantine Mylan, memantine hydrochloride, Alzheimer Disease, 21/04/2013, Generic, 10, Authorised
29/03/2023 Human medicines European public assessment report (EPAR): Mimpara, cinacalcet hydrochloride, Hypercalcemia; Parathyroid Neoplasms; Hyperparathyroidism, 22/10/2004, 25, Authorised
29/03/2023 Human medicines European public assessment report (EPAR): Arsenic trioxide Mylan, Arsenic trioxide, Leukemia, Promyelocytic, Acute, 01/04/2020, Generic, 4, Authorised
29/03/2023 Referral: Pholcodine-containing medicinal products , pholcodine, Article 107i procedures, European Commission final decision, 14/12/2022, 06/03/2023, 29/03/2023
28/03/2023 Other: Nominations to the Network Portfolio Advisory Group
28/03/2023 Other: Questions and answers on describing adverse events in the product information (summary of product characteristics (SPC) and package leaflet (PL))
28/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0121/2021
28/03/2023 Human medicines European public assessment report (EPAR): Deferasirox Mylan, deferasirox, Iron Overload; beta-Thalassemia, 26/09/2019, Generic, 9, Authorised
28/03/2023 News and press releases: DARWIN EU® has completed its first studies and is calling for new data partners
28/03/2023 Data Analysis and Real World Interrogation Network (DARWIN EU)
28/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Aimovig, erenumab, PM: decision on the application for modification of an agreed PIP, P/0475/2021
28/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Cresemba, Isavuconazonium sulfate, PM: decision on the application for modification of an agreed PIP, P/0479/2021
28/03/2023 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/0559/2021
28/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Breyanzi, Lisocabtagene maraleucel, PM: decision on the application for modification of an agreed PIP, P/0558/2021
28/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Lydisilka, Estetrol,drospirenone, PM: decision on the application for modification of an agreed PIP, P/0561/2021
28/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Palovarotene, PM: decision on the application for modification of an agreed PIP, P/0562/2021
28/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Fully human IgG1 RB-1 YTE anti-RSV F monoclonal antibody (MK-1654), PM: decision on the application for modification of an agreed PIP, P/0554/2021
27/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Glycopyrronium bromide, PM: decision on the application for modification of an agreed PIP, P/0467/2022
27/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Bavencio, avelumab, PM: decision on the application for modification of an agreed PIP, P/0546/2021
27/03/2023 Other: Records of data processing activity relating to staff engagement surveys (public)
27/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues (DCR-PHXC), PM: decision on the application for modification of an agreed PIP, P/0541/2021
27/03/2023 ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - Scientific guideline
27/03/2023 Orphan designation: edaravone for the: Treatment of amyotrophic lateral sclerosis, 16/12/2014, Positive
27/03/2023 Fifth EMA-EFPIA annual bilateral meeting , Hybrid, 14:00 - 16:00 Amsterdam time (CET), from 07/02/2023 to 07/02/2023
27/03/2023 Herbal medicinal product: Hippocastani cortex, Hippocastani cortex, F: Assessment finalised
27/03/2023 Report: List of withdrawn medicinal products in accordance with Art. 123(4) of the Directive (1 January - 31 December 2022)
27/03/2023 Other: About us - European Medicines Agency (EMA)
27/03/2023 Orphan designation: Recombinant adeno-associated viral vector containing the human RPGR gene for the: Treatment of retinitis pigmentosa caused by mutations in the RPGR gene, 30/05/2016, Positive
27/03/2023 Orphan designation: (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidine-3-yl)chroman-2-carboxamide hydrochloride for the: Treatment of maternally-inherited diabetes and deafness, 28/06/2019, Positive
27/03/2023 Orphan designation: (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride for the: Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes, 10/08/2015, Positive
27/03/2023 Orphan designation: (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride for the: Treatment of Leigh syndrome, 15/10/2014, Positive
27/03/2023 Direct healthcare professional communication (DHPC): Pholcodine-containing medicinal products no longer available on the EU market, Active substance: Pholcodine, DHPC type: Referral - Article 107i procedure, Last updated: 27/03/2023
27/03/2023 Orphan designation: Autologous CD34+ cells transfected with lentiviral vector containing the Wiskott-Aldrich syndrome protein gene (etuvetidigene autotemcel) for the: Treatment of Wiskott-Aldrich syndrome, 06/06/2012, Positive
27/03/2023 Orphan designation: Adeno-associated viral vector serotype LK03 encoding human ornithine transcarbamylase for the: Treatment of ornithine transcarbamylase deficiency, 20/03/2017, Positive
24/03/2023 Fourth Industry Standing Group (ISG) meeting , Online, from 21/03/2023 to 21/03/2023
24/03/2023 Referral procedures: human medicines
24/03/2023 Human medicines European public assessment report (EPAR): Imraldi, adalimumab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Hidradenitis Suppurativa; Arthritis, 24/08/2017, Biosimilar, 20, Authorised
24/03/2023 Summary of opinion: Newflend ND H9, turkey herpes virus, strain rHVT/ND expressing Newcastle disease virus, live, 23/03/2023, Positive
24/03/2023 News and press releases: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 March 2023
24/03/2023 Human medicines European public assessment report (EPAR): Xromi, hydroxycarbamide, Anemia, Sickle Cell, 01/07/2019, 6, Authorised
24/03/2023 Human medicines European public assessment report (EPAR): Giapreza, Angiotensin II acetate, Hypotension; Shock, 23/08/2019, Additional monitoring, 3, Authorised
24/03/2023 Human medicines European public assessment report (EPAR): Kanjinti, trastuzumab, Stomach Neoplasms; Breast Neoplasms, 16/05/2018, Biosimilar, 10, Authorised
24/03/2023 Handling competing interests
24/03/2023 Other: Fergus Sweeney - Assessment outcome of occupational activities after leaving the service (March 2023)
24/03/2023 Other: Agnes Saint-Raymond - Assessment outcome of occupational activities after leaving the service (March 2023)
24/03/2023 Other: Acceptability of IU as abbreviation for International Units in the strength of human medicinal products
24/03/2023 Orphan designation: Soluble recombinant human fibroblast growth factor receptor 3 for the: Treatment of achondroplasia, 27/02/2017, Withdrawn
24/03/2023 Other: European Union herbal monographs: Overview of recommendations for the uses of herbal medicinal products in the paediatric population
24/03/2023 Human medicines European public assessment report (EPAR): Taxotere, docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Stomach Neoplasms; Breast Neoplasms, 27/11/1995, 50, Authorised
24/03/2023 Human medicines European public assessment report (EPAR): Myocet liposomal (previously Myocet), doxorubicin hydrochloride, Breast Neoplasms, 13/07/2000, 24, Authorised
24/03/2023 Orphan designation: miglustat for the: Treatment of glycogen storage disease type II (Pompe's disease), 11/01/2019, Withdrawn
24/03/2023 Human medicines European public assessment report (EPAR): Enspryng, satralizumab, Neuromyelitis Optica, 24/06/2021, Orphan, 2, Authorised
24/03/2023 Human medicines European public assessment report (EPAR): Tamiflu, oseltamivir, Influenza, Human, 20/06/2002, 42, Authorised
24/03/2023 Other: HMPC meetings in 2025 and 2026
24/03/2023 Cancer Medicines Forum: kick-off meeting , Online, 08:30 - 12:30 Amsterdam time (CEST), from 31/03/2022 to 31/03/2022
24/03/2023 Cancer Medicines Forum: June 2022 , Online, from 28/06/2022 to 28/06/2022
24/03/2023 Cancer Medicines Forum: December 2022 , Online, from 20/12/2022 to 20/12/2022
23/03/2023 EIC / EMA Info Day: Regulatory support for the development of innovative medicines and technologies , Online, 09:00 - 12:30 Amsterdam time (CET), from 31/01/2023 to 31/01/2023
23/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Censavudine, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0103/2022
23/03/2023 Orphan designation: Autologous CD34+ cells transduced with a lentiviral vector encoding the human NCF1 gene for the: Treatment of chronic granulomatous disease, 13/01/2023, Positive
23/03/2023 Orphan designation: Adeno-associated viral vector serotype 2 containing the human SLC6A3 gene for the: Treatment of dopamine transporter deficiency syndrome, 13/01/2023, Positive
23/03/2023 Orphan designation: Efzofitimod for the: Treatment of sarcoidosis, 13/01/2023, Positive
23/03/2023 Orphan designation: Opelconazole for the: Treatment of invasive aspergillosis, 13/01/2023, Positive
23/03/2023 Orphan designation: Autologous hematopoietic cells genetically modified with a lentiviral vector containing the human RAG2 gene for the: Treatment of recombination-activating gene 2 deficient severe combined immunodeficiency, 13/01/2023, Positive
23/03/2023 Orphan designation: Nanatinostat, Valganciclovir for the: Treatment of diffuse large B-cell lymphoma, 13/01/2023, Positive
23/03/2023 Orphan designation: Retifanlimab for the: Treatment of Merkel cell carcinoma, 13/01/2023, Positive
23/03/2023 Orphan designation: N1,N14-diethyl-3S,12S-dihydroxyhomospermine tetrahydrochloride for the: Treatment of pancreatic cancer, 13/01/2023, Positive
23/03/2023 Orphan designation: Octreotide acetate for the: Treatment of carcinoid syndrome, 13/01/2023, Positive
23/03/2023 Orphan designation: 3-(1-(2',3'-dimethoxy-[1,1'-biphenyl]-4-yl)-1H-1,2,3-triazol-4-yl)benzoic acid for the: Treatment of Duchenne muscular dystrophy, 13/01/2023, Positive
23/03/2023 Orphan designation: Vorasidenib hemicitrate hemihydrate for the: Treatment of glioma, 13/01/2023, Positive
23/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Idefirix, Imlifidase, PM: decision on the application for modification of an agreed PIP, P/0076/2022
23/03/2023 Agenda: Agenda of the CAT meeting 22-23 March 2023
23/03/2023 National registers of authorised medicines
23/03/2023 Periodic safety update single assessment: Clindamycin phosphate / tretinoin : List of nationally authorised medicinal products - PSUSA/00010080/202207
22/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Adakveo, Crizanlizumab, PM: decision on the application for modification of an agreed PIP, P/0533/2021
22/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Biktarvy, bictegravir,emtricitabine,tenofovir alafenamide, PM: decision on the application for modification of an agreed PIP, P/0528/2021
22/03/2023 Human medicines European public assessment report (EPAR): Kadcyla, trastuzumab emtansine, Breast Neoplasms, 15/11/2013, 15, Authorised
22/03/2023 Clinical Trials Information System (CTIS) bitesize talk: Document and personal data in CTIS , Online, 14:30 - 16:00 Amsterdam time (CET), from 23/02/2023 to 23/02/2023
22/03/2023 Human medicines European public assessment report (EPAR): Polivy, polatuzumab vedotin, Lymphoma, B-Cell, 16/01/2020, Orphan, Additional monitoring, Conditional approval, 5, Authorised
22/03/2023 Other: Rules for reimbursement of expenses for delegates attending meetings with effect from 17 March 2023
22/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): (Z)-N-(3-bromo-4- fluorophenyl)-N-hydroxy-4-(2-(sulfamoylamino)ethylamino)-1,2,5-oxadiazole-3-carboximidamide, PM: decision on the application for modification of an agreed PIP, P/0246/2018
22/03/2023 Template or form: QRD Appendix I - Adverse event (PhV) MSs reporting details
22/03/2023 Human medicines European public assessment report (EPAR): NovoRapid, insulin aspart, Diabetes Mellitus, 07/09/1999, 32, Authorised
22/03/2023 News and press releases: Advancing regulatory science in the EU – mid-point report published
22/03/2023 Periodic safety update single assessment: Diltiazem - CMDh Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA/00001084/202205
22/03/2023 Periodic safety update single assessment: Diltiazem - List of nationally authorised medicinal products - PSUSA/00001084/202205
22/03/2023 Human medicines European public assessment report (EPAR): Keppra, levetiracetam, Epilepsy, 29/09/2000, 53, Authorised
22/03/2023 Human medicines European public assessment report (EPAR): Imcivree, Setmelanotide, Obesity, 16/07/2021, Orphan, Additional monitoring, 7, Authorised
22/03/2023 Enpr-EMA Coordinating Group meeting , Online, 15:00 - 16:30 Amsterdam time (CET), from 15/02/2023 to 15/02/2023
21/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, upadacitinib, PM: decision on the application for modification of an agreed PIP, P/0510/2021
21/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Molgramostim, PM: decision on the application for modification of an agreed PIP, P/0509/2021
21/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Plegridy, peginterferon beta-1a, PM: decision on the application for modification of an agreed PIP, P/0359/2022
21/03/2023 Report: 2022 Annual Report on EudraVigilance for the European Parliament, the Council and the Commission
21/03/2023 Human medicines European public assessment report (EPAR): MicardisPlus, Telmisartan, hydrochlorothiazide, Hypertension, 19/04/2002, 33, Authorised
21/03/2023 Human medicines European public assessment report (EPAR): Lamivudine/Zidovudine Teva, lamivudine, zidovudine, HIV Infections, 28/02/2011, Generic, 16, Withdrawn
21/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Cotadutide, PM: decision on the application for modification of an agreed PIP, P/0506/2021
21/03/2023 Human medicines European public assessment report (EPAR): Vihuma, simoctocog alfa, Hemophilia A, 13/02/2017, Additional monitoring, 8, Authorised
21/03/2023 Human medicines European public assessment report (EPAR): Nuwiq, simoctocog alfa, Hemophilia A, 22/07/2014, 13, Authorised
21/03/2023 Human medicines European public assessment report (EPAR): Elocta, efmoroctocog alfa, Hemophilia A, 18/11/2015, 12, Authorised
21/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Lumasiran (ALN-GO1), PM: decision on the application for modification of an agreed PIP, P/0505/2021
21/03/2023 Human medicines European public assessment report (EPAR): Inrebic, fedratinib dihydrochloride monohydrate, Myeloproliferative Disorders; Primary Myelofibrosis, 08/02/2021, Orphan, Additional monitoring, 4, Authorised
21/03/2023 Human medicines European public assessment report (EPAR): Symtuza, darunavir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections, 21/09/2017, 17, Authorised
21/03/2023 Orphan designation: Recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB linked to the human IgG1 Fc domain (luspatercept) for the: Treatment of beta thalassaemia intermedia and major, 29/07/2014, Positive
21/03/2023 Human medicines European public assessment report (EPAR): Nevirapine Teva, nevirapine, HIV Infections, 30/11/2009, Generic, 11, Withdrawn
21/03/2023 Periodic safety update single assessment: Ethinylestradiol / norethisterone : List of nationally authorised medicinal products - PSUSA/00001312/202208
21/03/2023 Periodic safety update single assessment: Alprostadil (indicated in peripheral arterial occlusive diseases) - List of nationally authorised medicinal products - PSUSA/00000111/202207
21/03/2023 EPAR - Public assessment report: Nevirapine Teva : EPAR - Public assessment report
20/03/2023 Human medicines European public assessment report (EPAR): Alkindi, hydrocortisone, Adrenal Insufficiency, 09/02/2018, 8, Authorised
20/03/2023 Human medicines European public assessment report (EPAR): Zomarist, vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 30/11/2008, 23, Authorised
20/03/2023 Human medicines European public assessment report (EPAR): Erivedge, vismodegib, Carcinoma, Basal Cell, 12/07/2013, 26/04/2013, 15, Authorised
20/03/2023 Clinical Trials Information System (CTIS): Walk-in clinic - November 2023 , Online, 16:00 - 17:00 Amsterdam time (CET), from 15/11/2023 to 15/11/2023
20/03/2023 Clinical Trials Information System (CTIS): Walk-in clinic - December 2023 , Online, 16:00 - 17:00 Amsterdam time (CET), from 13/12/2023 to 13/12/2023
20/03/2023 Periodic safety update single assessment: Beclometasone formoterol (inhalative application) - List of nationally authorised medicinal products - PSUSA/00010068/202207
20/03/2023 Periodic safety update single assessment: Triamcinolone topical and nasal formulations - List of nationally authorised medicinal products - PSUSA/00003017/202207
20/03/2023 Minutes: Minutes of the HMPC 23-25 January 2023 meeting
20/03/2023 Agenda: Agenda of the CVMP meeting 21-23 March 2023
20/03/2023 Other: European Medicines Agency's data protection notice for use of Microsoft Intune for personal and corporate-owned devices
20/03/2023 Other: European Medicines Agency's data protection notice for Microsoft Edge
20/03/2023 Other: Records of data processing activity for the use of Microsoft Intune
20/03/2023 Other: Records of data processing activity for the use of Microsoft Edge
20/03/2023 Human medicines European public assessment report (EPAR): Nubeqa, darolutamide, Prostatic Neoplasms, Castration-Resistant, 27/03/2020, Additional monitoring, 4, Authorised
20/03/2023 Minutes: Minutes - Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (23 February 2023)
20/03/2023 Other: Outcome of written procedures finalised during the period from 6 December 2022 to 8 March 2023
20/03/2023 Human medicines European public assessment report (EPAR): Pregabalin Pfizer, pregabalin, Anxiety Disorders; Epilepsy, 10/04/2014, 29, Authorised
20/03/2023 Agenda: Agenda for the 119th meeting of the Management Board: 16 March 2023
20/03/2023 Human medicines European public assessment report (EPAR): Pregabalin Zentiva k.s., pregabalin, Anxiety Disorders; Neuralgia; Epilepsy, 27/02/2017, Generic, 13, Withdrawn
20/03/2023 Periodic safety update single assessment: Diclofenac / misoprostol : List of nationally authorised medicinal products - PSUSA/00001040/202207
17/03/2023 Periodic safety update single assessment: Pilocarpine (non-ophthalmic formulations) : List of nationally authorised medicinal products - PSUSA/00002409/202207
17/03/2023 News and press releases: EMA Management Board: highlights of March 2023 meeting
17/03/2023 Newsletter: CTIS newsflash – 17 March 2023
17/03/2023 Periodic safety update single assessment: Fluvoxamine : List of nationally authorised medicinal products - PSUSA/00001458/202207
17/03/2023 EPAR - Overview: Zolgensma : EPAR - Medicine overview
17/03/2023 Human medicines European public assessment report (EPAR): Herceptin, trastuzumab, Stomach Neoplasms; Breast Neoplasms, 28/08/2000, 42, Authorised
17/03/2023 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13 - 16 March 2023
17/03/2023 Human medicines European public assessment report (EPAR): Avastin, bevacizumab, Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Ovarian Neoplasms; Colorectal Neoplasms; Carcinoma, Renal Cell, 12/01/2005, 63, Authorised
17/03/2023 Human medicines European public assessment report (EPAR): Miglustat Gen.Orph, miglustat, Gaucher Disease, 09/11/2017, Generic, 9, Authorised
17/03/2023 Periodic safety update single assessment: Triazolam : List of nationally authorised medicinal products - PSUSA/00003023/202207
17/03/2023 Periodic safety update single assessment: Amikacin (except for centrally authorised products) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000143/202206
17/03/2023 Periodic safety update single assessment: Amikacin (except for centrally authorised products) : List of nationally authorised medicinal products - PSUSA/00000143/202206
16/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Halaven, Eribulin, PM: decision on the application for modification of an agreed PIP, P/0535/2021
16/03/2023 Periodic safety update single assessment: Fludarabine : List of nationally authorised medicinal products - PSUSA/00001406/202208
16/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Stivarga, regorafenib, PM: decision on the application for modification of an agreed PIP, P/0495/2021
16/03/2023 Periodic safety update single assessment: Poliovirus type 1 / poliovirus type 2 / poliovirus type 3 vaccine (oral, live, attenuated), poliovirus type 1 / poliovirus type... : List of nationally authorised medicinal products - PSUSA/00010801/202207
16/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Praluent, Alirocumab, PM: decision on the application for modification of an agreed PIP, P/0550/2021
16/03/2023 Periodic safety update single assessment: Human coagulation factor IX : List of nationally authorised medicinal products - PSUSA/00001617/202207
16/03/2023 Periodic safety update single assessment: Fosfomycin (IV formulation) : List of nationally authorised medicinal products - PSUSA/00010336/202207
16/03/2023 Periodic safety update single assessment: Fosfomycin (oral formulation) : List of nationally authorised medicinal products - PSUSA/00010326/202207
16/03/2023 Periodic safety update single assessment: Diphtheria/tetanus/poliomyelitis (inactivated) vaccine (adsorbed, reduced antigens(s) content) : List of nationally authorised medicinal products - PSUSA/00001127/202208
16/03/2023 Periodic safety update single assessment: Cefadroxil : List of nationally authorised medicinal products - PSUSA/00000584/202207
16/03/2023 Human medicines European public assessment report (EPAR): Trulicity, dulaglutide, Diabetes Mellitus, Type 2, 21/11/2014, 17, Authorised
16/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Evenity, Romosozumab, PM: decision on the application for modification of an agreed PIP, P/0551/2021
16/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan, PM: decision on the application for modification of an agreed PIP, P/0480/2021
16/03/2023 Referral: Gelisia and associated names , timolol maleate, Genoptol,Gelisia,Timolol sifi 1 mg/g gel oftalmico, Article 29(4) referrals, European Commission final decision, 15/12/2022, 27/02/2023, 16/03/2023
16/03/2023 Report: Medicinal products for human use: monthly figures - February 2023
15/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Jakavi, Ruxolitinib (phosphate), PM: decision on the application for modification of an agreed PIP, P/0527/2021
15/03/2023 Human medicines European public assessment report (EPAR): Elzonris, tagraxofusp, Lymphoma, 07/01/2021, Orphan, Additional monitoring, Exceptional circumstances, 6, Authorised
15/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Fycompa, perampanel, PM: decision on the application for modification of an agreed PIP, P/0521/2021
15/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Bilastine, PM: decision on the application for modification of an agreed PIP, P/0506/2022
15/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Methoxyflurane, PM: decision on the application for modification of an agreed PIP, P/0525/2021
15/03/2023 Other: Records of data processing activity (public) for the EMA intranet
15/03/2023 Human medicines European public assessment report (EPAR): NeoRecormon, epoetin beta, Kidney Failure, Chronic; Anemia; Cancer; Blood Transfusion, Autologous, 16/07/1997, 33, Authorised
15/03/2023 Supply shortage: Ozempic (semaglutide) supply shortage
15/03/2023 News and press releases: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 December 2022
14/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Xydalba, dalbavancin hydrochloride, PM: decision on the application for modification of an agreed PIP, P/0522/2021
14/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Acetylcysteine,paracetamol,phenylephrine, W: decision granting a waiver in all age groups for all conditions or indications, P/0557/2021
14/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ramipril,amlodipine (as besylate), W: decision granting a waiver in all age groups for all conditions or indications, P/0513/2021
14/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Adagrasib, W: decision granting a waiver in all age groups for all conditions or indications, P/0511/2021
14/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Adavosertib, W: decision granting a waiver in all age groups for all conditions or indications, P/0512/2021
14/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Human normal immunoglobulin, W: decision granting a waiver in all age groups for all conditions or indications, P/0501/2021
14/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Humanised IgG2k Fc-modified bispecific antibody against CD3 and BCMA (PF-06863135), W: decision granting a waiver in all age groups for all conditions or indications, P/0564/2021
14/03/2023 Orphan designation: Autologous T-cells transduced with a lentiviral vector encoding a chimeric antigen receptor against CD7 for the: Treatment of acute lymphoblastic leukaemia, 09/12/2022, Positive
14/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Loncastuximab tesirine, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0400/2021
14/03/2023 Direct healthcare professional communication (DHPC): Myalepta (metreleptin) 5.8 mg vial: shortage and mitigation plan, Active substance: Metreleptin, DHPC type: Medicine shortage, Last updated: 14/03/2023
14/03/2023 Template or form: Day 80 assessment report - New active substance status template - Rev. 03. 23
14/03/2023 Template or form: CHMP and rapporteurs' joint assessment report on derogation applicable to similar orphan products - Rev. 03.23
14/03/2023 Template or form: CHMP and Rapporteurs' assessment report template on Similarity Rev. 03.23
14/03/2023 Other: Annex to the working arrangement between the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC)
14/03/2023 Report: Implementing measures under Article Art 115(5) of Regulation (EU) 2019/6 as regards the list of substances which are essential for the treatment of equine species and for which the withdrawal period for equine species shall be six months
14/03/2023 Other: Annex to the evaluation guide for good-manufacturing-practice regulatory compliance programme: Audit checklist
14/03/2023 Other: Evaluation guide for good-manufacturing-practice regulatory compliance programme: Audit checklist
13/03/2023 Other: Release notes - production release version 1.6.20 March 2023 - Veterinary Medicinal Products Regulation: Union Product Database
13/03/2023 Agenda: Agenda of the PRAC meeting 13-16 March 2023
13/03/2023 Periodic safety update single assessment: Bemiparin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000312/202204