What's new

Date	Content
31/10/2022	COVID-19: latest updates
31/10/2022	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, , 19, Authorised
31/10/2022	Orphan designation: N-({Carbamoylmethyl-[3-(2-oxo-pyrrolidin-1-yl)-propyl]-carbamoyl}-methyl)-2-[2-(2-fluoro-phenyl)-ethylamino]-N-isobutyl-acetamide for the: Treatment of optic neuritis, 31/03/2014, Positive
31/10/2022	Orphan designation: Diflunisal for the: Treatment of ATTR amyloidosis, 21/06/2022, Positive
31/10/2022	Human medicines European public assessment report (EPAR): Relistor, methylnaltrexone bromide, Opioid-Related Disorders; Constipation, 01/07/2008, 18, Authorised
28/10/2022	Second European Medicines Agency and Nuclear Medicines Europe bilateral meeting , from 11/10/2022 to 11/10/2022
28/10/2022	Human medicines European public assessment report (EPAR): Edurant, rilpivirine hydrochloride, HIV Infections, 28/11/2011, 20, Authorised
28/10/2022	Other: Quick guide: Clinical Study Reports submission - CTIS Training Programme - Module 13
28/10/2022	Other: FAQs: Clinical Study Reports submission - CTIS training programme Module 13
28/10/2022	Other: Records of data processing activity for the raw data proof-of-concept pilot
28/10/2022	Other: Information about the raw data proof-of-concept pilot for industry
28/10/2022	Other: Pilot participation letter
28/10/2022	Other: Raw data submission cover letter template
28/10/2022	Other: European Medicines Agency’s data protection notice for the Raw data proof-of-concept pilot
28/10/2022	News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 - 27 October 2022
28/10/2022	News and press releases: EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines
28/10/2022	Referrals document: Amfepramone-containing medicinal products Article-31 referral - EMA recommends withdrawal of marketing authorisation for amfepramone medicines
28/10/2022	News and press releases: EMA business hours over All Saints' Day and All Souls' Day, 1 and 2 November
28/10/2022	Report: CAT quarterly highlights and approved ATMPs - October 2022
28/10/2022	Minutes: Minutes of the CAT meeting 7-9 September 2022
28/10/2022	Report: Key performance indicators (KPIs) to monitor the European clinical trials environment (1-30 September 2022, edition 6)
27/10/2022	Human medicines European public assessment report (EPAR): Raxone, idebenone, Optic Atrophy, Hereditary, Leber, 08/09/2015, , , , 8, Authorised
27/10/2022	Periodic safety update single assessment: Alprazolam - List of nationally authorised medicinal products - PSUSA/00000109/202203
27/10/2022	Periodic safety update single assessment: Aviptadil / phentolamine mesilate - List of nationally authorised medicinal products - PSUSA/00010814/202202
27/10/2022	Periodic safety update single assessment: Rocuronium - List of nationally authorised medicinal products - PSUSA-00002656-202202
27/10/2022	Human medicines European public assessment report (EPAR): Myalepta, Metreleptin, Lipodystrophy, Familial Partial, 29/07/2018, , , , 7, Authorised
27/10/2022	Periodic safety update single assessment: Carbomers : List of nationally authorised medicinal products - PSUSA/00000557/202201
27/10/2022	Union Product Database: webinar on variations not requiring assessment (VNRAs) for marketing authorisation holders , Online, 10:00 - 11:30 Amsterdam time (CEST), from 08/09/2022 to 08/09/2022
27/10/2022	Human medicines European public assessment report (EPAR): Sitagliptin SUN, sitagliptin fumarate, Diabetes Mellitus, Type 2, 09/12/2021, , 1, Authorised
26/10/2022	Human medicines European public assessment report (EPAR): Galvus, vildagliptin, Diabetes Mellitus, Type 2, 25/09/2007, 22, Authorised
26/10/2022	Human medicines European public assessment report (EPAR): Tasigna, nilotinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, 19/11/2007, 42, Authorised
26/10/2022	Human medicines European public assessment report (EPAR): Obizur, susoctocog alfa, Hemophilia A, 11/11/2015, , , 10, Authorised
26/10/2022	Human medicines European public assessment report (EPAR): Ibrance, palbociclib, Breast Neoplasms, 09/11/2016, , 14, Authorised
26/10/2022	Other: Composition of the HMA/EMA task force on availability of authorised medicines for human and veterinary use
26/10/2022	Clinical Trials Information System (CTIS) bitesize talk: Notifications - Part 1 , Online, 14:30 - 16:00 Amsterdam time (CEST), from 28/09/2022 to 28/09/2022
26/10/2022	ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline
26/10/2022	Scientific guideline: ICH M11 technical specification - Step 2b
26/10/2022	Scientific guideline: ICH M11 guideline, clinical study protocol template and technical specifications - Step 2b
26/10/2022	Scientific guideline: ICH M11 template - Step 2b
26/10/2022	Guideline on core SmPC, labelling and package leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells - Scientific guideline
26/10/2022	Minutes: PDCO minutes of the 6-9 September 2022 meeting
26/10/2022	Management Board meeting: 6 October 2022 , European Medicines Agency, Amsterdam, the Netherlands, from 06/10/2022 to 06/10/2022
26/10/2022	Human medicines European public assessment report (EPAR): Dzuveo, sufentanil citrate, Pain, 25/06/2018, 5, Authorised
26/10/2022	EPAR - Scientific conclusion: Dzuveo-H-C-PSUSA-00002798-202111 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
25/10/2022	Human medicines European public assessment report (EPAR): RoActemra, tocilizumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Cytokine Release Syndrome; Giant Cell Arteritis; COVID-19 virus infection, 15/01/2009, 40, Authorised
25/10/2022	Human medicines European public assessment report (EPAR): Cometriq, cabozantinib, Thyroid Neoplasms, 21/03/2014, , 26, Authorised
25/10/2022	EPAR - Scientific conclusion: Cometriq-PSUSA-00010180-202111 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
25/10/2022	Human medicines European public assessment report (EPAR): Invanz, ertapenem sodium, Community-Acquired Infections; Streptococcal Infections; Staphylococcal Infections; Gram-Negative Bacterial Infections; Surgical Wound Infection; Pneumonia, Bacterial, 18/04/2002, 26, Authorised
25/10/2022	EPAR - Scientific conclusion: Cabometyx-H-C-PSUSA-00010180-202111: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
25/10/2022	Human medicines European public assessment report (EPAR): Prialt, ziconotide, Injections, Spinal; Pain, 21/02/2005, 29, Authorised
25/10/2022	Bioanalytical method validation - Scientific guideline
25/10/2022	Periodic safety update single assessment: Dexlansoprazole, lansoprazole - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00001827/202112
25/10/2022	Periodic safety update single assessment: Dexlansoprazole, lansoprazole - List of nationally authorised medicinal products - PSUSA/00001827/202112
25/10/2022	EPAR - Scientific conclusion: SomaKit TOC-H-C-PSUSA-00010552-202112 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
25/10/2022	EPAR - Scientific conclusion: Lutathera-H-C-PSUSA-00010643-2202112 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
24/10/2022	Human medicines European public assessment report (EPAR): Vemlidy, tenofovir alafenamide fumarate, Hepatitis B, 09/01/2017, 15, Authorised
24/10/2022	Periodic safety update single assessment: Dexketoprofen / tramadol - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00010468/202201
24/10/2022	Agenda: Agenda of the PRAC meeting 24-27 October 2022
24/10/2022	Other: Quick guide - Part I : How to evaluate a clinical trial application: assessment and decision - CTIS Training Programme - Module 08
24/10/2022	Other: Quick guide - Part II : How to evaluate a clinical trial application: assessment and decision - CTIS Training Programme - Module 08
24/10/2022	PRAC recommendation on signal: PRAC recommendations on signals adopted at the 26-29 September 2022 PRAC meeting
24/10/2022	PRAC recommendation on signal: New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2022 PRAC meeting
24/10/2022	Human medicines European public assessment report (EPAR): Dasatinib Accordpharma, dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive, 24/03/2022, , 1, Authorised
21/10/2022	Human medicines European public assessment report (EPAR): Kalydeco, ivacaftor, Cystic Fibrosis, 23/07/2012, , 34, Authorised
21/10/2022	Human medicines European public assessment report (EPAR): Vazkepa, Icosapent ethyl, Dyslipidemias, 26/03/2021, , 4, Authorised
21/10/2022	Human medicines European public assessment report (EPAR): Jinarc, Tolvaptan, Polycystic Kidney, Autosomal Dominant, 27/05/2015, , 20, Authorised
21/10/2022	Human medicines European public assessment report (EPAR): Iclusig, ponatinib, Leukemia, Myeloid; Leukemia, Lymphoid, 01/07/2013, , , 24, Authorised
21/10/2022	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
21/10/2022	Orphan designation: Ovine specific immunoglobulin (Fab) fragments raised against Vipera berus veno for the: Treatment of snakebite envenomation, 09/10/2015, Positive
21/10/2022	Orphan designation: Adeno-associated virus serotype HSC15 expressing human arylsulfatase A gene for the: treatment of metachromatic leukodystrophy, 26/06/2020, Positive
21/10/2022	Orphan designation: Variant of recombinant human fibroblast growth factor 19 for the: Treatment of primary biliary cirrhosis, 22/08/2014, Positive
21/10/2022	Treatments and vaccines for COVID-19
21/10/2022	EMA regular press briefing on COVID-19 and monkeypox , Online, 11:00 - 11:30 Amsterdam time (CEST), from 26/10/2022 to 26/10/2022
21/10/2022	Periodic safety update single assessment: Bupropion : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000461/202112
21/10/2022	Periodic safety update single assessment: Bupropion : List of nationally authorised medicinal products - PSUSA/00000461/202112
21/10/2022	Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate salt for the: Treatment of beta thalassaemia intermedia and major, 24/08/2018, Withdrawn
21/10/2022	Periodic safety update single assessment: Botulinum toxin a : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000426/202112
21/10/2022	Periodic safety update single assessment: Botulinum toxin a : List of nationally authorised medicinal products - PSUSA/00000426/202112
21/10/2022	Newsletter: Clinical Trials Highlights - October 2022
21/10/2022	Template or form: Signal assessment report - template
21/10/2022	Periodic safety update single assessment: Valaciclovir : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003086/202112
21/10/2022	Periodic safety update single assessment: Valaciclovir : List of nationally authorised medicinal products - PSUSA/00003086/202112
20/10/2022	Human medicines European public assessment report (EPAR): Firazyr, icatibant, Angioedemas, Hereditary, 11/07/2008, 21, Authorised
20/10/2022	Human medicines European public assessment report (EPAR): Vpriv, velaglucerase alfa, Gaucher Disease, 26/08/2010, , 19, Authorised
20/10/2022	Human medicines European public assessment report (EPAR): Thalidomide Lipomed, Thalidomide, Multiple Myeloma, 19/09/2022, Authorised
20/10/2022	Human medicines European public assessment report (EPAR): Lorviqua, Lorlatinib, Carcinoma, Non-Small-Cell Lung, 06/05/2019, , , 10, Authorised
20/10/2022	Human medicines European public assessment report (EPAR): Isentress, Raltegravir, HIV Infections, 19/12/2007, , 42, Authorised
20/10/2022	Human medicines European public assessment report (EPAR): Ravicti, glycerol phenylbutyrate, Urea Cycle Disorders, Inborn, 26/11/2015, , 15, Authorised
19/10/2022	News and press releases: EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from 6 months of age
19/10/2022	Summary of opinion: Comirnaty, tozinameran, riltozinameran and tozinameran, famtozinameran and tozinameran, COVID-19 mRNA Vaccine (nucleoside modified), 19/10/2022, Positive
19/10/2022	Human medicines European public assessment report (EPAR): Bavencio, avelumab, Neuroendocrine Tumors, 18/09/2017, , 14, Authorised
19/10/2022	News and press releases: EMA recommends approval of second adapted Spikevax vaccine
19/10/2022	Periodic safety update single assessment: Ciclosporin (systemic use) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000745/202112
19/10/2022	Periodic safety update single assessment: Ciclosporin (systemic use) : List of nationally authorised medicinal products - PSUSA/00000745/202112
19/10/2022	Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 October 2022
19/10/2022	Direct healthcare professional communication (DHPC): Ozempic (semaglutide) solution for injection in pre-filled pen: supply shortage, Active substance: semaglutide, DHPC type: Medicine shortage, Last updated: 19/10/2022
18/10/2022	Human medicines European public assessment report (EPAR): Idacio, adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid, 02/04/2019, , , 10, Authorised
18/10/2022	Human medicines European public assessment report (EPAR): Glubrava, metformin hydrochloride, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 11/12/2007, 19, Withdrawn
18/10/2022	Human medicines European public assessment report (EPAR): Saphnelo, anifrolumab, Lupus Erythematosus, Systemic, 14/02/2022, , 1, Authorised
18/10/2022	Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 19 October 2022 , Online, from 19/10/2022 to 19/10/2022
18/10/2022	Periodic safety update single assessment: Betamethasone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000391/202101
18/10/2022	Human medicines European public assessment report (EPAR): Evrenzo, Roxadustat, Anemia; Kidney Failure, Chronic, 18/08/2021, , 2, Authorised
18/10/2022	Human medicines European public assessment report (EPAR): Norvir, ritonavir, HIV Infections, 25/08/1996, 68, Authorised
18/10/2022	Human medicines European public assessment report (EPAR): Deltyba, Delamanid, Tuberculosis, Multidrug-Resistant, 27/04/2014, 25/07/2013, , , , 22, Authorised
17/10/2022	Referral: Rubraca , rucaparib, Article 20 procedures, European Commission final decision, 21/07/2022, 21/09/2022, 17/10/2022
17/10/2022	Human medicines European public assessment report (EPAR): Trazimera, trastuzumab, Stomach Neoplasms; Breast Neoplasms, 26/07/2018, , , 11, Authorised
17/10/2022	Human medicines European public assessment report (EPAR): Reyataz, atazanavir (as sulfate), HIV Infections, 01/03/2004, 53, Authorised
17/10/2022	Interested Parties to the HMPC
17/10/2022	Report: Hearing with the Association of the European Self-Medication Industry (AESGP) during the HMPC May 2022 meeting
17/10/2022	Human medicines European public assessment report (EPAR): Opdualag, nivolumab, Relatlimab, Melanoma, 15/09/2022, , Authorised
17/10/2022	Human medicines European public assessment report (EPAR): Glidipion (previously Pioglitazone Actavis Group), pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 15/03/2012, , 8, Withdrawn
17/10/2022	Human medicines European public assessment report (EPAR): Sustiva, efavirenz, HIV Infections, 28/05/1999, 46, Authorised
17/10/2022	Human medicines European public assessment report (EPAR): Glustin, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 11/10/2000, 28, Withdrawn
17/10/2022	Human medicines European public assessment report (EPAR): BeneFIX, Nonacog alfa, Hemophilia B, 27/08/1997, 42, Authorised
17/10/2022	Multi-stakeholder workshop: Patient experience data in medicines development and regulatory decision-making , European Medicines Agency, Amsterdam, the Netherlands, from 21/09/2022 to 21/09/2022
17/10/2022	Human medicines European public assessment report (EPAR): Nplate, romiplostim, Purpura, Thrombocytopenic, Idiopathic, 04/02/2009, 26, Authorised
17/10/2022	Human medicines European public assessment report (EPAR): Memantine Mylan, memantine hydrochloride, Alzheimer Disease, 21/04/2013, , 9, Authorised
14/10/2022	Regulatory and procedural guideline: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance with track-changes
14/10/2022	Template or form: CHMP protocol assistance scientific advice briefing document template
14/10/2022	Scientific advice and protocol assistance
14/10/2022	Report: European Medicines Agency mid-year report 2022 (January-June 2022)
14/10/2022	Summary of opinion: Lyumjev (previously Liumjev), insulin lispro, 13/10/2022, Positive
14/10/2022	News and press releases: First therapy to treat transplant patients with post-transplant lymphoproliferative disease
14/10/2022	News and press releases: New vaccine to protect people in the EU and worldwide against dengue
14/10/2022	Summary of opinion: Xydalba, dalbavancin, 13/10/2022, Positive
14/10/2022	Summary of opinion: Libtayo, cemiplimab, 13/10/2022, Positive
14/10/2022	News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2022
14/10/2022	Herbal medicinal product: Tribuli terrestris herba, Tribuli terrestris herba, D: Draft under discussion
14/10/2022	Other: Notification on arrangements for requesting EMA certificates through urgent and standard procedure for December 2022
14/10/2022	Other: Instructor's guide: How to create, submit and withdraw a Clinical Trial Application - CTIS Training Programme - Module 10
14/10/2022	Scientific guideline: Reflection paper on criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation (EU) 2019/6
14/10/2022	Overview of comments: Overview of comments received on 'Reflection paper on criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation 2019/6'
13/10/2022	Human medicines European public assessment report (EPAR): Quofenix, delafloxacin meglumine, Community-Acquired Infections, 16/12/2019, , 5, Authorised
13/10/2022	Report: Medicinal products for human use: monthly figures - September 2022
13/10/2022	Report: Applications for new human medicines under evaluation by the CHMP: October 2022
13/10/2022	Orphan designation: Teclistamab for the: Treatment of multiple myeloma, 19/07/2022, Withdrawn
13/10/2022	Human medicines European public assessment report (EPAR): Rivastigmine 1 A Pharma, rivastigmine, Alzheimer Disease; Dementia; Parkinson Disease, 11/12/2009, 14, Authorised
13/10/2022	Human medicines European public assessment report (EPAR): Vabysmo, Faricimab, Wet Macular Degeneration; Macular Edema; Diabetes Complications, 15/09/2022, , Authorised
13/10/2022	Human medicines European public assessment report (EPAR): Oxlumo, Lumasiran sodium, Hyperoxaluria, Primary, 19/11/2020, , , 3, Authorised
13/10/2022	Human medicines European public assessment report (EPAR): Rivastigmine Sandoz, rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease, 10/12/2009, 13, Authorised
13/10/2022	Human medicines European public assessment report (EPAR): Rivastigmine Hexal, rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease, 11/12/2009, 14, Authorised
13/10/2022	EPAR - All authorised presentations: Rivastigmine Sandoz : EPAR - All Authorised presentations
13/10/2022	EPAR - All authorised presentations: Rivastigmine Hexal : EPAR - All Authorised presentations
12/10/2022	Newsletter: Human medicines highlights - September 2022
12/10/2022	Newsletter: Human medicines highlights - September 2022
12/10/2022	Orphan designation: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide for the: Treatment of meningioma, 06/06/2012, Positive
12/10/2022	Orphan designation: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide for the: Treatment of schwannoma, 06/06/2012, Positive
12/10/2022	Human medicines European public assessment report (EPAR): Evkeeza, Evinacumab, Hypercholesterolemia, 17/06/2021, , , 2, Authorised
12/10/2022	Human medicines European public assessment report (EPAR): Ritonavir Mylan, ritonavir, HIV Infections, 09/11/2017, , 13, Authorised
12/10/2022	Minutes: Minutes of the 116th meeting of the Management Board: 15-16 June 2022
12/10/2022	Orphan designation: synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2'-fluoro and thirty-five 2'-O-methyl nucleoside residues in the sequence, which is covalently linked via a phosphodiester group to a ligand containing three N-acetylgalactosamine residues (Vutrisiran) for the: Treatment of transthyretin-mediated amyloidosis (ATTR amyloidosis), 25/05/2018, Positive
12/10/2022	Report: Pilot on early dialogue with patient organisations for orphan marketing authorisation applications: Outcome Report
12/10/2022	DADI PDF electronic application forms (eAF) training webinar , Online, 11:00 - 12:30 Amsterdam time (CEST), from 02/09/2022 to 02/09/2022
12/10/2022	DADI PDF electronic application forms (eAF) training webinar , Online, 11:00 - 12:30 Amsterdam time (CEST), from 26/07/2022 to 26/07/2022
12/10/2022	Orphan designation: [Gly2]-recombinant human glucagon-like peptide for the: Treatment of short bowel syndrome, 12/12/2001, Positive
12/10/2022	Paediatric Committee (PDCO): 11-14 October 2022 , Virtual meeting, from 11/10/2022 to 14/10/2022
12/10/2022	Clinical Trials Information System (CTIS): Walk-in clinic , Online, 16:00 - 16:45 Amsterdam time (CEST), from 20/09/2022 to 20/09/2022
12/10/2022	Human medicines European public assessment report (EPAR): Blenrep, belantamab mafodotin, Multiple Myeloma, 25/08/2020, , , , 4, Authorised
12/10/2022	Human medicines European public assessment report (EPAR): Xyrem, sodium oxybate, Cataplexy; Narcolepsy, 13/10/2005, 36, Authorised
11/10/2022	IRIS for Good Pharmacovigilance practice (GVP) inspections training session for industry users , Online, 10:00 - 11:30 Amsterdam time (CEST), from 07/09/2022 to 07/09/2022
11/10/2022	Minutes: Minutes of the European Medicines Agency/European Network for Health Technology Assessment meeting - June 2022
11/10/2022	Human medicines European public assessment report (EPAR): Azarga, brinzolamide, timolol maleate, Glaucoma, Open-Angle; Ocular Hypertension, 25/11/2008, 16, Authorised
11/10/2022	Human medicines European public assessment report (EPAR): Nucala, Mepolizumab, Asthma, 01/12/2015, 18, Authorised
11/10/2022	Human medicines European public assessment report (EPAR): Tygacil, Tigecycline, Bacterial Infections; Skin Diseases, Bacterial; Soft Tissue Infections, 24/04/2006, 34, Authorised
11/10/2022	Other: European Medicines Agency practical guidance on the application form for centralised type IA and IB variations
11/10/2022	Human medicines European public assessment report (EPAR): Privigen, human normal immunoglobulin (IVIg), Purpura, Thrombocytopenic, Idiopathic; Bone Marrow Transplantation; Immunologic Deficiency Syndromes; Guillain-Barre Syndrome; Mucocutaneous Lymph Node Syndrome, 24/04/2008, 30, Authorised
11/10/2022	EMA Account Management training webinar , Online, 10:30 - 12:30 Amsterdam time (CEST), from 03/10/2022 to 03/10/2022
11/10/2022	Orphan designation: Adeno-associated virus serotype HSC 15 expressing human iduronate 2-sulfatase for the: Treatment of mucopolysaccharidosis type II (Hunter Syndrome), 16/03/2022, Positive
11/10/2022	Human medicines European public assessment report (EPAR): Hetlioz, tasimelteon, Sleep Disorders, Circadian Rhythm, 03/07/2015, , 9, Authorised
11/10/2022	Orphan designation: Adeno-associated virus serotype HSC15, containing human homology arms, expressing human phenylalanine hydroxylase for the: Treatment of phenylalanine hydroxylase deficiency, 16/03/2022, Positive
11/10/2022	Orphan designation: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase for the: Treatment of phenylalanine hydroxylase deficiency, 14/12/2018, Positive
11/10/2022	Orphan designation: 4-hydroxy-2,2,6,6-tetramethylpiperidine-N-oxyl for the: Treatment of familial cerebral cavernous malformations, 12/12/2017, Positive
11/10/2022	Orphan designation: Recombinant adeno-associated viral vector expressing the human CNGA3 gene for the: Treatment of achromatopsia caused by mutations in the CNGA3 gene, 09/10/2015, Positive
11/10/2022	Orphan designation: Adeno-associated viral vector serotype rh10 containing the human factor IX gene for the treatment of haemophilia B- for the: Treatment of haemophilia B, 14/12/2015, Withdrawn
11/10/2022	Human medicines European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane), Para-aminosalicylic acid, Tuberculosis, 07/04/2014, , 10, Authorised
11/10/2022	Other: IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants
10/10/2022	News and press releases: High-quality data to empower data-driven medicines regulation in the European Union
10/10/2022	Opinion/decision on a Paediatric investigation plan (PIP): Nonacog alfa, PM: decision on the application for modification of an agreed PIP, P/0021/2016
10/10/2022	Opinion/decision on a Paediatric investigation plan (PIP): Recombinant porcine factor VIII, B-domain deleted, W: decision granting a waiver in all age groups for all conditions or indications, P/0040/2012
10/10/2022	Human medicines European public assessment report (EPAR): Silodyx, silodosin, Prostatic Hyperplasia, 29/01/2010, 16, Authorised
10/10/2022	Regulatory and procedural guideline: Data Quality Framework for EU medicines regulation
10/10/2022	Agenda: Agenda of the CHMP meeting 10-13 October 2022
10/10/2022	Other: Highlights of the fifth EMA - Medicines for Europe bilateral meeting
10/10/2022	Other: Release notes - production release version 1.6.10 October 2022 - Veterinary Medicinal Products Regulation: Union Product Database
10/10/2022	ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals - Scientific guideline
10/10/2022	Scientific guideline: ICH: S 1 B 9R1): Testing for carcinogenicity of pharmaceuticals - Step 5
10/10/2022	ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - Scientific guideline
10/10/2022	Scientific guideline: ICH: Q 5 A (R2): Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - Step 2b
10/10/2022	Other: Terms of reference of the HMA/EMA task force on availability of authorised medicines for human and veterinary use
10/10/2022	Work programme: Work programme until 2025 of the HMA/EMA task force on availability of authorised medicines for human and veterinary use
10/10/2022	Human medicines European public assessment report (EPAR): Cinryze, C1 inhibitor (human), Angioedemas, Hereditary, 15/06/2011, , 23, Authorised
07/10/2022	News and press releases: EMA Management Board: highlights of October 2022 meeting
07/10/2022	Other: Assessment of patient, consumer and healthcare professional organisations’ compliance with EMA eligibility criteria
07/10/2022	Summary of opinion: Mometamax Ultra, gentamicin, posaconazole, mometasone furoate, 06/10/2022, Positive
07/10/2022	News and press releases: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 4-6 October 2022
07/10/2022	Summary of opinion: Simparica, sarolaner, 06/10/2022, Positive
07/10/2022	Minutes: Minutes of the PRAC meeting 10-13 January 2022
07/10/2022	Summary of opinion: MiPet Easecto, sarolaner, 06/10/2022, Positive
07/10/2022	Summary of opinion: Meloxoral, meloxicam, 06/10/2022, Positive
07/10/2022	Periodic safety update single assessment: Glipizide : List of nationally authorised medicinal products - PSUSA/00001535/202201
06/10/2022	Regulatory and procedural guideline: Member states contact points for translations review
06/10/2022	Periodic safety update single assessment: Ketoprofen (all formulations except topical) : List of nationally authorised medicinal products - PSUSA/00001809/202201
06/10/2022	COVID-19 vaccines: studies for approval
06/10/2022	COVID-19 treatments: research and development
06/10/2022	COVID-19 vaccines: research and development
06/10/2022	Periodic safety update single assessment: Moxonidine : List of nationally authorised medicinal products - PSUSA/00002095/202201
06/10/2022	Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , Online, 09:00 - 11:15 Amsterdam time (CEST), from 14/09/2022 to 14/09/2022
06/10/2022	Orphan designation: Recombinant adeno-associated viral vector containing the human retinoschisin gene for the: Treatment of X-linked juvenile retinoschisis, 12/03/2013, Positive
06/10/2022	Scientific guideline: Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates
06/10/2022	Orphan designation: Recombinant adeno-associated viral vector containing human alpha-1 antitrypsin gene for the: Treatment of congenital alpha-1 antitrypsin deficiency, 20/03/2007, Positive
06/10/2022	Orphan designation: N-[(1R)-1-phenylethyl]-6-{1H-pyrazolo[3,4-d]pyrimidin-4-yl}quinazolin-2-amine for the: Treatment of fragile X syndrome, 20/04/2017, Positive
06/10/2022	DARWIN EU Advisory Board meeting: 6 July 2022 , Online, from 06/07/2022 to 06/07/2022
06/10/2022	Regulatory and procedural guideline: Guidance on parallel EMA / EUnetHTA 21 Joint Scientific Consultation
06/10/2022	Template or form: Parallel consultation: briefing document template
06/10/2022	Template or form: Template - Translations required with the submission of an application for transfer of orphan medicinal product designation
06/10/2022	Template or form: Template - Translations required with the submission of an application for orphan medicinal product designation
06/10/2022	Periodic safety update single assessment: Amlodipine / atorvastatin : List of nationally authorised medicinal products - PSUSA/00000177/202201
06/10/2022	Scientific guideline: ICH guideline E19 on a selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials - Step5
06/10/2022	Human medicines European public assessment report (EPAR): Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune), reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain, Influenza, Human, 20/05/2016, , , 9, Authorised
06/10/2022	Human medicines European public assessment report (EPAR): Prolia, denosumab, Bone Resorption; Osteoporosis, Postmenopausal, 26/05/2010, 26, Authorised
05/10/2022	Agenda: Agenda - First European Medicines Agency - European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) bilateral meeting
05/10/2022	News and press releases: Chair of the European Network of Paediatric Research at EMA re-elected
05/10/2022	Human medicines European public assessment report (EPAR): Bylvay, Odevixibat, Cholestasis, Intrahepatic, 16/07/2021, , , , 2, Authorised
05/10/2022	News and press releases: Call for expression of interest for civil society representatives to participate in the work of EMA’s Paediatric Committee
05/10/2022	Human medicines European public assessment report (EPAR): Vildagliptin / Metformin hydrochloride Accord, metformin hydrochloride, vildagliptin, Diabetes Mellitus, Type 2, 24/03/2022, , , 1, Authorised
05/10/2022	Supply shortage: Natpar (parathyroid hormone) supply shortage
05/10/2022	Periodic safety update single assessment: Lisdexamfetamine : List of nationally authorised medicinal products - PSUSA/00010289/202202
05/10/2022	Periodic safety update single assessment: Acetylsalicylic acid : List of nationally authorised medicinal products - PSUSA/00000039/202202
05/10/2022	Periodic safety update single assessment: Donepezil : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001160/202111
05/10/2022	Periodic safety update single assessment: Donepezil : List of nationally authorised medicinal products - PSUSA/00001160/202111
05/10/2022	Periodic safety update single assessment: Lorazepam : List of nationally authorised medicinal products - PSUSA/00001909/202201
05/10/2022	Human medicines European public assessment report (EPAR): Lenalidomide Mylan, lenalidomide, Multiple Myeloma, 18/12/2020, , 7, Authorised
05/10/2022	Other: FAQs: How to evaluate a CT application - CTIS Training Programme - Module 06
05/10/2022	Human medicines European public assessment report (EPAR): Heplisav B, hepatitis B surface antigen, Hepatitis B, 18/02/2021, , 2, Authorised
04/10/2022	Other: Nominations to the Network Portfolio Advisory Group
04/10/2022	European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting , European Medicines Agency, Amsterdam, the Netherlands, from 22/09/2022 to 22/09/2022
04/10/2022	Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) meetings
04/10/2022	Minutes: Minutes of CHMP written procedure 16-19 August 2022
04/10/2022	Pharmacovigilance Risk Assessment Committee (PRAC): 29 November-2 December 2021 , European Medicines Agency, Amsterdam, the Netherlands, from 29/11/2021 to 02/12/2021
04/10/2022	Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt (momelotinib) for the: Treatment of primary myelofibrosis, 05/08/2011, Positive
04/10/2022	Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt (momelotinib) for the: Treatment of post-polycythaemia vera myelofibrosis, 05/08/2011, Positive
04/10/2022	Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt (momelotinib) for the: Treatment of post-essential thrombocythaemia myelofibrosis, 05/08/2011, Positive
04/10/2022	Direct healthcare professional communication (DHPC): Natpar (parathyroid hormone): Discontinuation of manufacturing at the end of 2024 and update on 100mcg shortage, Active substance: parathyroid hormone, DHPC type: Medicine shortage, Last updated: 04/10/2022
04/10/2022	Orphan designation: Recombinant human parathyroid hormone for the: Treatment of hypoparathyroidism, 16/01/2014, Positive
04/10/2022	Orphan designation: Recombinant human IgG1 kappa light chain monoclonal antibody targeting plasma kallikrein (lanadelumab) for the: Treatment of hereditary angioedema, 09/10/2015, Positive
04/10/2022	Orphan designation: Recombinant human arylsulfatase A for the: treatment of metachromatic leukodystrophy, 26/11/2010, Positive
04/10/2022	Human medicines European public assessment report (EPAR): Xeljanz, Tofacitinib, Arthritis, Rheumatoid, 22/03/2017, 25/04/2013, , 26, Authorised
04/10/2022	Veterinary medicines European public assessment report (EPAR): Activyl Tick Plus, indoxacarb, permethrin, 09/01/2012, 9, Withdrawn
04/10/2022	Human medicines European public assessment report (EPAR): Firmagon, degarelix, Prostatic Neoplasms, 17/02/2009, 19, Authorised
03/10/2022	Human medicines European public assessment report (EPAR): Ocrevus, ocrelizumab, Multiple Sclerosis, 08/01/2018, 14, Authorised