|
30/06/2022 |
Public consultation: Draft report on the development of a harmonised approach to exposure assessment methodologies for residues from veterinary medicinal products, feed additives and pesticides in food of animal origin |
|
30/06/2022 |
Human medicines European public assessment report (EPAR): Januvia, sitagliptin, Diabetes Mellitus, Type 2, 20/03/2007, 30, Authorised |
|
30/06/2022 |
News and press releases: Assessing dietary exposure to residues of veterinary medicines, feed additives and pesticides in food of animal origin in the EU |
|
30/06/2022 |
Other: Declaration of interest: Irene Rager
|
|
30/06/2022 |
Agenda: Agenda - Clinical Trials Information System (CTIS) webinar: Six months of CTIS and looking forward
|
|
30/06/2022 |
Human medicines European public assessment report (EPAR): Tadalafil Mylan, tadalafil, Erectile Dysfunction, 21/11/2014,  , 14, Authorised |
|
30/06/2022 |
Human medicines European public assessment report (EPAR): Memantine ratiopharm, memantine hydrochloride, Alzheimer Disease, 12/06/2013, , 8, Authorised |
|
30/06/2022 |
Orphan designation: Rezafungin acetate
for the: Treatment of invasive candidiasis, 06/01/2021, Positive |
|
30/06/2022 |
Orphan designation: Recombinant human monoclonal antibody to insulin receptor
for the: Treatment of congenital hyperinsulinism, 14/07/2016, Positive |
|
30/06/2022 |
Other: Annual list of contract modifications 2021
|
|
30/06/2022 |
Other: Annual list of contractors 2021 - contract values Euro 15,000 - 139,000
|
|
30/06/2022 |
Other: Annual list of specific contracts based on framework contracts - 2021
|
|
29/06/2022 |
Human medicines European public assessment report (EPAR): Saxenda, liraglutide, Obesity; Overweight, 23/03/2015, 12, Authorised |
|
29/06/2022 |
Orphan designation: 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate (enasidenib)
for the: Treatment of acute myeloid leukaemia, 28/04/2016, Positive |
|
29/06/2022 |
Human medicines European public assessment report (EPAR): Rotarix, human rotavirus, live attenuated, Immunization; Rotavirus Infections, 21/02/2006, 40, Authorised |
|
29/06/2022 |
Human medicines European public assessment report (EPAR): Luminity, perflutren, Echocardiography, 20/09/2006, 16, Authorised |
|
29/06/2022 |
Data quality framework for medicines regulation
, Online, 13:00 - 17:15 Amsterdam time (CEST), from 07/04/2022 to 07/04/2022 |
|
29/06/2022 |
Report: Report - Data quality framework for medicines regulation
|
|
29/06/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Isavuconazonium sulfate, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0134/2013 |
|
29/06/2022 |
Agenda: Agenda of the CHMP meeting 16-19 May 2022
|
|
28/06/2022 |
News and press releases: Call for companies to register their Industry Single Point of Contact (i-SPOC) on supply and availability |
|
28/06/2022 |
EPAR - Public assessment report: Pirfenidone AET : EPAR - Public Assessment Report
|
|
28/06/2022 |
Other: Records of data processing activity for the certification of medicinal products
|
|
28/06/2022 |
Public Statement: Possible use of the vaccine Jynneos against infection by monkeypox virus
|
|
28/06/2022 |
Human medicines European public assessment report (EPAR): Prasugrel Mylan, prasugrel besilate, Myocardial Infarction; Acute Coronary Syndrome; Angina, Unstable, 15/05/2018, , 8, Authorised |
|
28/06/2022 |
Human medicines European public assessment report (EPAR): Starlix, nateglinide, Diabetes Mellitus, Type 2, 03/04/2001, 15, Withdrawn |
|
28/06/2022 |
News and press releases: Monkeypox: EMA starts review for Imvanex |
|
28/06/2022 |
Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical trial sponsors - November 2022
, Online, 09:00 - 13:00 Amsterdam time (CET) , from 14/11/2022 to 15/11/2022 |
|
28/06/2022 |
Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical trial sponsors - October 2022
, Online, 14:00 - 18:00 Amsterdam time (CEST) , from 24/10/2022 to 25/10/2022 |
|
28/06/2022 |
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - September 2022
, Online, 09:00 - 13:00 Amsterdam time (CEST), from 26/09/2022 to 28/09/2022 |
|
28/06/2022 |
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - October 2022
, Online, 14:00 - 18:00 Amsterdam time (CEST), from 26/10/2022 to 28/10/2022 |
|
28/06/2022 |
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - November 2022
, Online, 09:00 - 13:00 Amsterdam time (CET), from 16/11/2022 to 18/11/2022 |
|
28/06/2022 |
Human medicines European public assessment report (EPAR): Sildenafil Actavis, sildenafil, Erectile Dysfunction, 10/12/2009, , 15, Authorised |
|
28/06/2022 |
EPAR - Procedural steps taken before authorisation: Starlix : EPAR - Procedural steps taken before authorisation
|
|
28/06/2022 |
EPAR - Steps taken after authorisation when a cutoff date has been used: Starlix : EPAR - Steps taken after authorisation when a cutoff date has been used
|
|
28/06/2022 |
EPAR - Overview: Starlix : EPAR - Summary for the public
|
|
28/06/2022 |
EPAR - All authorised presentations: Starlix : EPAR - All Authorised presentations
|
|
27/06/2022 |
Human medicines European public assessment report (EPAR): Bronchitol, mannitol, Cystic Fibrosis, 13/04/2012, 19, Authorised |
|
27/06/2022 |
Human medicines European public assessment report (EPAR): Optison, perflutren, Echocardiography, 17/05/1998, 19, Authorised |
|
27/06/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Tislelizumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0142/2019 |
|
27/06/2022 |
Report: Key performance indicators (KPIs) to monitor the European clinical trials environment (1 - 31 May 2022, edition 2)
|
|
27/06/2022 |
Olaparib product-specific bioequivalence guidance |
|
27/06/2022 |
Ursodeoxycholic acid product-specific bioequivalence guidance |
|
27/06/2022 |
Human medicines European public assessment report (EPAR): Kiovig, human normal immunoglobulin (IVIg), Purpura, Thrombocytopenic, Idiopathic; Bone Marrow Transplantation; Immunologic Deficiency Syndromes; Guillain-Barre Syndrome; Mucocutaneous Lymph Node Syndrome, 18/01/2006, 26, Authorised |
|
27/06/2022 |
Outcomes of imposed non-interventional post-authorisation safety studies |
|
27/06/2022 |
Human medicines European public assessment report (EPAR): Votubia, everolimus, Tuberous Sclerosis, 02/09/2011,  , 30, Authorised |
|
27/06/2022 |
Human medicines European public assessment report (EPAR): Afinitor, everolimus, Carcinoma, Renal Cell; Breast Neoplasms; Pancreatic Neoplasms, 02/08/2009, 30, Authorised |
|
27/06/2022 |
Other: Example files - production release version 1.6.5 June 2022 - Veterinary Medicinal Products Regulation: Union Product Database
|
|
27/06/2022 |
Other: Release notes - production release version 1.6.5 June 2022 - Veterinary Medicinal Products Regulation: Union Product Database
|
|
27/06/2022 |
Clinical Trials Information System (CTIS) sponsor end user training programme - November 2022
, Online, 14:00 - 18:30 Amsterdam time (CET), from 07/11/2022 to 10/11/2022 |
|
27/06/2022 |
Clinical Trials Information System (CTIS) sponsor end user training programme - September 2022
, Online, 09:00 - 13:30 Amsterdam time (CEST), from 20/09/2022 to 23/09/2022 |
|
27/06/2022 |
Scientific guideline: Ibrutinib hard capsules 140 mg and film-coated tablets 140, 280, 420 & 560 mg product-specific bioequivalence guidance
|
|
27/06/2022 |
Ibrutinib product-specific bioequivalence guidance |
|
27/06/2022 |
Enzalutamide product-specific bioequivalence guidance |
|
27/06/2022 |
Scientific guideline: Enzalutamide soft capsule 40 mg and film-coated tablet 40 mg & 80 mg product-specific bioequivalence guidance
|
|
26/06/2022 |
Medicine Shortages Single Point of Contact (SPOC) Working Party |
|
24/06/2022 |
Human medicines European public assessment report (EPAR): Mycophenolate mofetil Teva, mycophenolate mofetil, Graft Rejection, 21/02/2008, , 25, Authorised |
|
24/06/2022 |
Human medicines European public assessment report (EPAR): Levetiracetam Sun, levetiracetam, Epilepsy, 14/12/2011, , 17, Authorised |
|
24/06/2022 |
Periodic safety update single assessment: Hydroxyethyl starch : PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0031
|
|
24/06/2022 |
Periodic safety update single assessment: Hydroxyethyl starch : CMDh Divergent position - EMEA/H/N/PSR/J/0031
|
|
24/06/2022 |
Periodic safety update single assessment: Hydroxyethyl starch : CMDh Scientific conclusions and Conditions for lifting the suspension of the marketing authorisations - EMEA/H/N/PSR/J/0031
|
|
24/06/2022 |
Periodic safety update single assessment: Hydroxyethyl starch : List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0031
|
|
24/06/2022 |
Agenda: Agenda - First industry standing group (ISG) meeting
|
|
24/06/2022 |
Other: European Medicines Agency’s data protection on notice for certificates of medicinal products
|
|
24/06/2022 |
Other: Records of data processing activity for testimonials for career page (public)
|
|
24/06/2022 |
Other: Record of data processing activity regarding hotel and travel bookings (public)
|
|
24/06/2022 |
Human medicines European public assessment report (EPAR): Desloratadine ratiopharm, desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal, 13/01/2012, , 12, Authorised |
|
24/06/2022 |
Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 May 2022
, European Medicines Agency, Amsterdam, the Netherlands, from 10/05/2022 to 12/05/2022 |
|
24/06/2022 |
News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2022 |
|
24/06/2022 |
Summary of opinion: Lonquex, lipegfilgrastim, 23/06/2022, Positive |
|
24/06/2022 |
Summary of opinion: Zerbaxa, ceftolozane, tazobactam, 23/06/2022, Positive |
|
24/06/2022 |
News and press releases: First gene therapy to treat severe haemophilia A |
|
24/06/2022 |
Other: Records of data processing activity relating to the switchboard recording system (public)
|
|
24/06/2022 |
Human medicines European public assessment report (EPAR): Sildenafil ratiopharm, sildenafil, Erectile Dysfunction, 23/12/2009, , 19, Authorised |
|
24/06/2022 |
VICH GL20 Efficacy of anthelmintics: specific recommendations for felines - Scientific guideline |
|
24/06/2022 |
VICH GL12 Efficacy of anthelmintics: specific recommendations for bovines - Scientific guideline |
|
24/06/2022 |
Human medicines European public assessment report (EPAR): Efmody, hydrocortisone, Adrenal Hyperplasia, Congenital, 27/05/2021, 2, Authorised |
|
24/06/2022 |
VICH GL16 Efficacy of anthelmintics: specific requirements for porcines - Scientific guideline |
|
24/06/2022 |
VICH GL19 Efficacy of anthelmintics: specific recommendations for canines - Scientific guideline |
|
24/06/2022 |
VICH GL14 Efficacy of anthelmintics: specific requirements for caprines - Scientific guideline |
|
24/06/2022 |
VICH GL13 Efficacy of anthelmintics: specific requirements for ovines - Scientific guideline |
|
24/06/2022 |
VICH GL21 Efficacy of anthelmintics: specific recommendations for chickens - Scientific guideline |
|
24/06/2022 |
VICH GL15 Efficacy of anthelmintics: specific recommendations for equines - Scientific guideline |
|
24/06/2022 |
Scientific guideline: VICH GL21: Efficacy of anthelmintics: specific recommendations for chickens – gallus gallus - Revision 1
|
|
24/06/2022 |
Scientific guideline: VICH GL20: Efficacy of anthelmintics: specific recommendations for felines - Revision 1
|
|
24/06/2022 |
Scientific guideline: VICH GL19: Efficacy of anthelmintics: specific recommendations for canines - Revision 1
|
|
24/06/2022 |
Scientific guideline: VICH GL16: Efficacy of anthelmintics: specific recommendations for porcines - Revision 1
|
|
24/06/2022 |
Scientific guideline: VICH GL15: Efficacy of anthelmintics: specific recommendations for equines - Revision 1
|
|
24/06/2022 |
Scientific guideline: VICH GL14: Efficacy of anthelmintics: specific recommendations for caprines - Revision 1
|
|
24/06/2022 |
Scientific guideline: VICH GL13: Efficacy of anthelmintics: specific recommendations for ovines - Revision 1
|
|
24/06/2022 |
Scientific guideline: VICH GL12: Efficacy of anthelmintics: specific recommendations for bovines - Revision 1
|
|
24/06/2022 |
VICH GL7 Efficacy of anthelmintics: general requirements - Scientific guideline |
|
24/06/2022 |
Scientific guideline: VICH GL7 Efficacy of anthelmintics: general requirements - Revision 1
|
|
24/06/2022 |
Data requirements for veterinary medicinal products intended to reduce the risk of transmission of vector-borne pathogens in dogs and cats - Scientific guideline |
|
24/06/2022 |
Overview of comments: Overview of comments received on the ‘Guideline on data requirements for veterinary medicinal products for the prevention of transmission of vector-borne diseases in dogs and cats’ (EMA/CVMP/EWP/278031/2015)
|
|
24/06/2022 |
Scientific guideline: Guideline on data requirements for veterinary medicinal products intended to reduce the risk of transmission of vector-borne pathogens in dogs and cats
|
|
24/06/2022 |
EudraVigilance Veterinary |
|
24/06/2022 |
Other: Call for comments on the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) standard list for EudraVigilance Veterinary (EVVet)
|
|
24/06/2022 |
Regulatory and procedural guideline: Non-current Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) low level terms (LLT) and codes
|
|
24/06/2022 |
Regulatory and procedural guideline: Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) terminology for reporting suspected adverse reactions in animals and humans
|
|
24/06/2022 |
Template or form: Template for submission of comments for the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) standard list for EudraVigilance Veterinary (EVVet)
|
|
24/06/2022 |
Requirements for the production and control of immunological veterinary medicinal products - Scientific guideline |
|
23/06/2022 |
News and press releases: EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU |
|
23/06/2022 |
News and press releases: EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17 |
|
23/06/2022 |
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, 31, Authorised |
|
23/06/2022 |
Human medicines European public assessment report (EPAR): Myfenax, mycophenolate mofetil, Graft Rejection, 21/02/2008, , 26, Authorised |
|
23/06/2022 |
Orphan designation: Mosunetuzumab
for the: Treatment of follicular lymphoma, 12/11/2021, Positive |
|
23/06/2022 |
Report: Annual activity report 2021
|
|
23/06/2022 |
EPAR - Public assessment report: Lunsumio : EPAR - Public Assessment Report
|
|
23/06/2022 |
Maximum Residue Limits - Report: Bambermycin (poultry): European public maximum-residue-limit assessment report (EPMAR) - CVMP
|
|
23/06/2022 |
Regulatory and procedural guideline: Procedural guidance for variant strain(s) update to vaccines intended for protection against human coronavirus
|
|
22/06/2022 |
Regulatory and procedural guideline: Checklist for annual updates for parallel distribution: guidance for industry
|
|
22/06/2022 |
Orphan designation: Chimeric locked nucleic acid deoxynucleoside phosphorothioate-linked oligonucleotide inhibitor directed against microRNA-155-5p
for the: Treatment of cutaneous T-cell lymphoma, 22/05/2017, Withdrawn |
|
22/06/2022 |
Orphan designation: Protein-based delivery vector carrying a DNA payload encoding an RNA-guided nuclease that targets stx genes of Shiga toxin-producing Escherichia coli
for the: Prevention of haemolytic uraemic syndrome, 21/08/2020, Positive |
|
22/06/2022 |
Orphan designation: Modified messenger ribonucleic acid encoding human propionyl-coenzyme A carboxylase alpha and beta subunits encapsulated into lipid nanoparticle
for the: Treatment of propionic acidaemia, 24/04/2019, Positive |
|
22/06/2022 |
Orphan designation: Modified mRNA encoding human methylmalonyl-coenzyme A mutase encapsulated into lipid nanoparticles
for the: Treatment of methylmalonic acidaemia, 25/05/2018, Positive |
|
22/06/2022 |
Human medicines European public assessment report (EPAR): Givlaari, Givosiran, Porphyrias, Hepatic, 02/03/2020, ,  , 4, Authorised |
|
22/06/2022 |
Orphan designation: Synthetic signal peptide of human mucin-1 (amino acids 1-21)
for the: Treatment of plasma cell myeloma, 15/01/2015, Positive |
|
22/06/2022 |
Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical trial sponsors - June 2022
, Online, 14:00 - 18:00 Amsterdam time (CEST) , from 30/06/2022 to 01/07/2022 |
|
22/06/2022 |
Periodic safety update single assessment: Alfentanil : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000082/202109
|
|
22/06/2022 |
Periodic safety update single assessment: Alfentanil : List of nationally authorised medicinal products - PSUSA/00000082/202109
|
|
21/06/2022 |
Periodic safety update single assessment: Piretanide : List of nationally authorised medicinal products - PSUSA/00002433/202110
|
|
21/06/2022 |
Periodic safety update single assessment: Milrinone : List of nationally authorised medicinal products - PSUSA/00002064/202110
|
|
21/06/2022 |
Agenda: Agenda of the PDCO meeting 21-24 June 2022
|
|
21/06/2022 |
Periodic safety update single assessment: Benzydamine: List of nationally authorised medicinal products - PSUSA/00000375/202110
|
|
21/06/2022 |
Summary of opinion: Vegzelma, bevacizumab, 23/06/2022, Positive |
|
21/06/2022 |
Herbal medicinal product: Taraxaci officinalis radix, Taraxaci officinalis radix, F: Assessment finalised
|
|
21/06/2022 |
Human medicines European public assessment report (EPAR): Torisel, Temsirolimus, Carcinoma, Renal Cell; Lymphoma, Mantle-Cell, 19/11/2007, 33, Authorised |
|
20/06/2022 |
News and press releases: Global regulators work towards strengthening collaboration on observational research beyond COVID-19 pandemic |
|
20/06/2022 |
Transfer of marketing authorisation: questions and answers |
|
20/06/2022 |
Renewal and annual re-assessment of marketing authorisation |
|
20/06/2022 |
Periodic safety update single assessment: Amlodipine / rosuvastatin, perindopril / amlodipine / rosuvastatin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010434/202107
|
|
20/06/2022 |
Periodic safety update single assessment: Amlodipine / rosuvastatin, perindopril / amlodipine / rosuvastatin : List of nationally authorised medicinal products - PSUSA/00010434/202107
|
|
20/06/2022 |
Template or form: Information required for identification of a need for pre-authorisation GCP inspections
|
|
20/06/2022 |
Agenda: Agenda of the CHMP meeting 20-23 June 2022
|
|
20/06/2022 |
Other: European Medicines Agency’s data protection notice concerning the processing of patient and product traceability data for Zynteglo following the withdrawal of the marketing authorisation
|
|
20/06/2022 |
Orphan designation: Heterologous human adult liver-derived stem cells
for the: Treatment of argininosuccinic aciduria, 16/03/2022, Positive |
|
20/06/2022 |
Orphan designation: Emactuzumab
for the: Treatment of tenosynovial giant cell tumour, localised and diffuse type, 16/03/2022, Positive |
|
17/06/2022 |
News and press releases: EMA Management Board: highlights of June 2022 meeting |
|
17/06/2022 |
Human medicines European public assessment report (EPAR): Gefitinib Mylan, gefitinib, Carcinoma, Non-Small-Cell Lung, 27/09/2018, , 5, Authorised |
|
17/06/2022 |
News and press releases: Start of rolling review for adapted Spikevax COVID-19 vaccine |
|
17/06/2022 |
Summary of opinion: Bravecto, fluralaner, 15/06/2022, Positive |
|
17/06/2022 |
Summary of opinion: Cortaderm, hydrocortisone aceponate, 15/06/2022, Positive |
|
17/06/2022 |
News and press releases: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-15 June 2022 |
|
17/06/2022 |
Summary of opinion: Coxatab, firocoxib, 15/06/2022, Positive |
|
17/06/2022 |
Summary of opinion: Evanovo, Eimeria acervulina, strain 044, live / Eimeria maxima, strain 013, live / Eimeria praecox, strain 007, live / Eimeria tenella, strain 004, live, 15/06/2022, Positive |
|
17/06/2022 |
Summary of opinion: DogStem, equine umbilical cord-derived mesenchymal stem cells, 15/06/2022, Positive |
|
17/06/2022 |
COVID-19 vaccine safety update: COVID-19 vaccines - Safety update: 17 June 2022
|
|
17/06/2022 |
Human medicines European public assessment report (EPAR): Sprycel, dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive, 20/11/2006, 41, Authorised |
|
17/06/2022 |
Human medicines European public assessment report (EPAR): Xtandi, enzalutamide, Prostatic Neoplasms, 21/06/2013, 26/04/2013, 21, Authorised |
|
17/06/2022 |
Withdrawn application: Sitoiganap, autologous glioma tumor cell lysates (inactivated), allogeneic glioma tumor cell lysates (inactivated), allogeneic glioma tumor cells (inactivated), autologous glioma tumor cells (inactivated), Date of withdrawal: 02/05/2022, Initial authorisation |
|
17/06/2022 |
Minutes: Minutes of the CHMP meeting 19-22 April 2022
|
|
16/06/2022 |
Human medicines European public assessment report (EPAR): Zynrelef, bupivacaine, meloxicam, Pain, Postoperative, 24/09/2020, 1, Authorised |
|
16/06/2022 |
Periodic safety update single assessment: Brimonidine (except for the centrally authorised product) : List of nationally authorised medicinal products - PSUSA/00000430/202109
|
|
16/06/2022 |
Orphan designation: Adeno-associated virus vector serotype 2 expressing the human MT-ND4 codon-optimised gene
for the: Treatment of Leber’s hereditary optic neuropathy, 14/01/2022, Positive |
|
16/06/2022 |
Periodic safety update single assessment: Hydrochlorothiazide / olmesartan : List of nationally authorised medicinal products - PSUSA/00002209/202110
|
|
16/06/2022 |
Periodic safety update single assessment: Amlodipine / perindopril : List of nationally authorised medicinal products - PSUSA/00000179/202110
|
|
16/06/2022 |
Orphan designation: (S)-12-fluoro-4-(2-methylpyridin-3-yl)-7a,8,13,14-tetrahydro-7H-[1,2,4]triazolo[4',3':1,6]pyrido[3,2-b]benzofuro[4,3-fg][1,4]oxazonine
for the: Treatment of sickle cell disease, 16/03/2022, Positive |
|
16/06/2022 |
Orphan designation: Tropatepine hydrochloride
for the: Treatment of narcolepsy, 16/03/2022, Positive |
|
16/06/2022 |
Orphan designation: Codergocrine mesilate, oxitriptan
for the: Treatment of fragile X syndrome, 16/03/2022, Positive |
|
16/06/2022 |
Orphan designation: Dersimelagon
for the: Treatment of erythropoietic protoporphyria, 16/03/2022, Positive |
|
16/06/2022 |
Human medicines European public assessment report (EPAR): Sondelbay, teriparatide, Osteoporosis, 24/03/2022, ,  , Authorised |
|
16/06/2022 |
Orphan designation: Hymecromone
for the: Treatment of spinal cord injury, 16/03/2022, Positive |
|
16/06/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human beta-glucuronidase (rhGUS, UX003), PM: decision on the application for modification of an agreed PIP, P/0202/2016 |
|
16/06/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Humanized anti-CD19, Fc engineered, monoclonal antibody (XmAb5871), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0274/2019 |
|
16/06/2022 |
Periodic safety update single assessment: Diclofenac / omeprazole : List of nationally authorised medicinal products - PSUSA/00010461/202109
|
|
16/06/2022 |
Minutes: PDCO minutes of the 19-22 April 2022 meeting
|
|
16/06/2022 |
Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system
, Online, 09:00 - 18:00 Amsterdam time (CEST), from 22/06/2022 to 24/06/2022 |
|
16/06/2022 |
Minutes: Minutes of the 115th meeting of the Management Board: 16-17 March 2022
|
|
16/06/2022 |
Stakeholders and Communication |
|
16/06/2022 |
Other: Organisation chart: Stakeholders and Communication
|
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16/06/2022 |
Direct healthcare professional communication (DHPC): Imlygic (talimogene laherparepvec): Special considerations to minimize the potential occurrence of adverse events in HSV-1 seronegative patients receiving vials from affected lots: Injections from Imlygic 106 PFU/mL vials from the affected lot numbers ..., Active substance: talimogene laherparepvec, DHPC type: Adverse event, Quality defect, Last updated: 16/06/2022 |
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16/06/2022 |
Direct healthcare professional communication (DHPC): Dexmedetomidine: Increased risk of mortality in intensive care unit (ICU) patients ≤65 years, Active substance: Dexmedetomidine hydrochloride, DHPC type: Safety signal, Last updated: 16/06/2022 |
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16/06/2022 |
Periodic safety update single assessment: Brimonidine/timolol : List of nationally authorised medicinal products - PSUSA/00000431/202109
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15/06/2022 |
Other: Validation checklist for initial marketing authorisation applications - biologicals other than immunologicals (applicable to submissions under Regulation (EU) 2019/6)
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15/06/2022 |
Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system
, Online, 09:00 - 13:30 Amsterdam time (CET), from 30/11/2022 to 02/12/2022 |
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15/06/2022 |
Human medicines European public assessment report (EPAR): Kyprolis, carfilzomib, Multiple Myeloma, 19/11/2015, ,  , 20, Authorised |
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15/06/2022 |
Periodic safety update single assessment: Clevidipine : List of nationally authorised medicinal products - PSUSA/00010288/202111
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15/06/2022 |
Periodic safety update single assessment: Lacidipine : List of nationally authorised medicinal products - PSUSA/00001815/202110
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15/06/2022 |
Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system
, Online, 14:00 - 18:00 Amsterdam time (CEST), from 05/10/2022 to 07/10/2022 |
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15/06/2022 |
Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d., emtricitabine, tenofovir disoproxil succinate, HIV Infections, 28/04/2017, , 9, Authorised |
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15/06/2022 |
News and press releases: Start of rolling review for adapted Comirnaty COVID-19 vaccine |
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15/06/2022 |
Template or form: Declaration on the qualification of an enterprise as a micro, small or medium-sized enterprise (SME)
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15/06/2022 |
Template or form: Guidance for usage of application form related to Article 16 of the Staff Regulations
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15/06/2022 |
Agenda: Agenda of the CAT meeting 15-17 June 2022
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15/06/2022 |
Orphan designation: Chimeric peptide of human glucagon-like peptide-1, glucagon and gastric inhibitory polypeptide analogues linked to a human immunoglobulin Fc fragment
for the: Treatment of primary biliary cholangitis, 14/01/2022, Positive |
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15/06/2022 |
Orphan designation: Sirolimus
for the: Treatment of bronchiolitis obliterans syndrome (BOS), 14/01/2022, Positive |
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15/06/2022 |
Other: European Union E2B (R3) code lists
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15/06/2022 |
Orphan designation: Trans N-ethyl-2-((4-(7-((4-(ethylsulfonamido)cyclohexyl)methyl)-2,7-diazaspiro[3.5]nonan-2-yl)pyrimidin-5-yl)oxy)-5-fluoro-N-isopropylbenzamide sesquifumarate
for the: Treatment of acute myeloid leukaemia, 14/01/2022, Positive |
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15/06/2022 |
Human medicines European public assessment report (EPAR): Levetiracetam Hospira, levetiracetam, Epilepsy, 07/01/2014, , 23, Authorised |
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15/06/2022 |
Orphan designation: Azithromycin dihydrate
for the: Prevention of bronchopulmonary dysplasia, 14/01/2022, Positive |
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15/06/2022 |
Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course on using the EudraVigilance system
, Online, from 12/09/2022 to 16/09/2022 |
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15/06/2022 |
Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course on using the EudraVigilance system
, Online, from 10/10/2022 to 14/10/2022 |
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15/06/2022 |
Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course on using the EudraVigilance system
, Online, from 24/10/2022 to 28/10/2022 |
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15/06/2022 |
Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course on using the EudraVigilance system
, Online, from 21/11/2022 to 25/11/2022 |
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15/06/2022 |
Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course on using the EudraVigilance system
, Online, from 05/12/2022 to 09/12/2022 |
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15/06/2022 |
Orphan designation: melatonin
for the: Treatment of pre-eclampsia, 14/01/2022, Positive |
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15/06/2022 |
Orphan designation: Adeno-associated viral vector serotype 9 containing the human SURF1 gene
for the: Treatment of Leigh syndrome, 12/11/2021, Positive |
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15/06/2022 |
Orphan designation: Olverembatinib
for the: Treatment of chronic myeloid leukaemia, 12/11/2021, Positive |
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14/06/2022 |
Periodic safety update single assessment: Letrozole : List of nationally authorised medicinal products - PSUSA/00001842/202110
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14/06/2022 |
Human medicines European public assessment report (EPAR): Adempas, riociguat, Hypertension, Pulmonary, 27/03/2014, 12, Authorised |
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14/06/2022 |
Orphan designation: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carbamate (riociguat)
for the: Treatment of pulmonary arterial hypertension, 20/12/2007, Withdrawn |
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14/06/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Tabalumab, PM: decision on the application for modification of an agreed PIP, P/0268/2014 |
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14/06/2022 |
Orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride (maralixibat chloride)
for the: Treatment of primary sclerosing cholangitis, 16/01/2014, Withdrawn |
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14/06/2022 |
Orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride (maralixibat chloride)
for the: Treatment of primary biliary cirrhosis, 16/01/2014, Withdrawn |
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14/06/2022 |
Human medicines European public assessment report (EPAR): Vidaza, azacitidine, Myelodysplastic Syndromes, 17/12/2008, , 25, Authorised |
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14/06/2022 |
Orphan review: Recommendation for maintenance of orphan designation at the time of marketing authorisation: Signifor (pasireotide) for the treatment of Cushing’s disease
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14/06/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Expanded human autologous mesenchymal adult stem cells extracted from adipose tissue (CX-401), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/20/2010 |
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14/06/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Insulin peglispro, PM: decision on the application for modification of an agreed PIP, P/0168/2014 |
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14/06/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human heparan-N-sulfatase, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0027/2015 |
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14/06/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Methyl aminolevulinate hydrochloride, PM: decision on the application for modification of an agreed PIP, P/0115/2014 |
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14/06/2022 |
Orphan designation: Adeno-associated viral vector serotype rh10 containing the human cholesterol 24-hydroxylase gene
for the: Treatment of Huntington’s disease, 01/04/2019, Positive |
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14/06/2022 |
Orphan designation: Adeno-associated viral vector serotype 8 containing the human acid alpha-glucosidase gene
for the: Treatment of glycogen storage disease type II (Pompe's disease), 16/04/2018, Positive |
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14/06/2022 |
Orphan designation: pasireotide
for the: Treatment of Cushing's disease, 08/10/2009, Expired |
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14/06/2022 |
Agenda: Agenda of the CVMP meeting 14-15 June 2022
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14/06/2022 |
Agenda: Agenda - Big Data Steering Group and industry stakeholders meeting
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14/06/2022 |
Big Data Steering Group and industry stakeholders meeting
, Online, from 30/05/2022 to 30/05/2022 |
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14/06/2022 |
Periodic safety update single assessment: Rubidium chloride RB-82 : List of nationally authorised medicinal products - PSUSA/00010806/202110
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14/06/2022 |
EPAR - Procedural steps taken before authorisation: Evra : EPAR - Procedural steps taken before authorisation
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14/06/2022 |
EPAR - Steps taken after authorisation when a cutoff date has been used: Evra : EPAR - Steps taken after authorisation when a cutoff date has been used
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13/06/2022 |
Other: European veterinary big data strategy 2022-2027
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13/06/2022 |
News and press releases: Big Data strategy for veterinary medicines in the EU |
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13/06/2022 |
Periodic safety update single assessment: Acetylsalicylic acid / bisoprolol : List of nationally authorised medicinal products - PSUSA/00010287/202111
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13/06/2022 |
Periodic safety update single assessment: Ethinylestradiol / norgestimate : List of nationally authorised medicinal products - PSUSA/00001313/202110
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13/06/2022 |
Periodic safety update single assessment: Olmesartan : List of nationally authorised medicinal products - PSUSA/00002207/202110
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13/06/2022 |
Periodic safety update single assessment: Drospirenone : List of nationally authorised medicinal products - PSUSA/00010853/202111
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13/06/2022 |
Periodic safety update single assessment: Erythromycin / tretinoin : List of nationally authorised medicinal products - PSUSA/00001259/202110
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13/06/2022 |
Other: Standard term lists mapping from Data Elements Guideline (DEG) standard to VICH standard
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13/06/2022 |
Report: Faecal microbiota transplantation EU-IN Horizon Scanning Report
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13/06/2022 |
Periodic safety update single assessment: Dextromethorphan : List of nationally authorised medicinal products - PSUSA/00001009/202111
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13/06/2022 |
Periodic safety update single assessment: Acitretin : List of nationally authorised medicinal products - PSUSA/00000051/202110
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13/06/2022 |
Periodic safety update single assessment: Polystyrene sulfonate : List of nationally authorised medicinal products - PSUSA/00002472/202110
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13/06/2022 |
Periodic safety update single assessment: Magnesium hydroxide : List of nationally authorised medicinal products - PSUSA/00001926/202110
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13/06/2022 |
Orphan designation: Autologous human T cells genetically modified ex-vivo with a lentiviral vector encoding a chimeric antigen receptor for B-cell maturation antigen
for the: Treatment of multiple myeloma, 28/02/2020, Positive |
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13/06/2022 |
Direct healthcare professional communication (DHPC): Defitelio (defibrotide): Do not use for prophylaxis of veno-occlusive disease (VOD) after post-hematopoietic stem-cell transplantation (HSCT), Active substance: defibrotide, DHPC type: Lack of effect, Safety signal, Last updated: 13/06/2022 |
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13/06/2022 |
Periodic safety update single assessment: 13C-methacetin : List of nationally authorised medicinal products - PSUSA/00010846/202110
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10/06/2022 |
News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2022 |
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10/06/2022 |
News and press releases: EMA recommends withdrawal of marketing authorisation for amfepramone medicines |
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10/06/2022 |
Human medicines European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate), clopidogrel (as hydrogen sulfate), Acute Coronary Syndrome; Peripheral Vascular Diseases; Myocardial Infarction; Stroke, 27/07/2009, , 18, Authorised |
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10/06/2022 |
Report: Small and medium-sized enterprise (SME) Office annual report 2021
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10/06/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): arimoclomol citrate, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0012/2021 |
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10/06/2022 |
News and press releases: EMA publishes annual report 2021 |
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10/06/2022 |
Annual Report: 2021 annual report of the European Medicines Agency
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10/06/2022 |
Annual Report: Annexes - 2021 annual report of the European Medicines Agency
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10/06/2022 |
Annual Report: Annex 10 - 2021 annual report of the European Medicines Agency – CHMP opinions on initial evaluations and extensions of therapeutic indication
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10/06/2022 |
Human medicines European public assessment report (EPAR): Levetiracetam ratiopharm, levetiracetam, Epilepsy, 26/08/2011, , 14, Authorised |
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10/06/2022 |
Human medicines European public assessment report (EPAR): Zyllt, clopidogrel (as hydrogen sulfate), Peripheral Vascular Diseases; Stroke; Acute Coronary Syndrome; Myocardial Infarction, 28/09/2009, , 16, Authorised |
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10/06/2022 |
Human medicines European public assessment report (EPAR): Clopidogrel Krka d.d. (previously Zopya), clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Stroke; Myocardial Infarction, 20/09/2009, , 14, Authorised |
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10/06/2022 |
Human medicines European public assessment report (EPAR): Clopidogrel Krka, clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Stroke; Myocardial Infarction, 23/09/2009, , 18, Authorised |
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10/06/2022 |
Human medicines European public assessment report (EPAR): Nuceiva, Botulinum toxin type A, Skin Aging, 27/09/2019, , 4, Authorised |
