|
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 |
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 confirms recommendation to withdraw marketing authorisations 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
|
|
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 |
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): Obizur, susoctocog alfa, Hemophilia A, 11/11/2015, , , 10, 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 |
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 |
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 |
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 |
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: New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2022 PRAC meeting
|
|
24/10/2022 |
PRAC recommendation on signal: PRAC recommendations on signals adopted at the 26-29 September 2022 PRAC meeting
|
|
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: 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: Variant of recombinant human fibroblast growth factor 19
for the: Treatment of primary biliary cirrhosis, 22/08/2014, Positive |
|
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): Thalidomide Lipomed, Thalidomide, Multiple Myeloma, 19/09/2022, Authorised |
|
20/10/2022 |
Human medicines European public assessment report (EPAR): Isentress, Raltegravir, HIV Infections, 19/12/2007, , 42, 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 |
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 |
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): Norvir, ritonavir, HIV Infections, 25/08/1996, 68, 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 |
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): 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 |
|
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 |
Report: European Medicines Agency mid-year report 2022 (January-June 2022)
|
|
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: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2022 |
|
14/10/2022 |
News and press releases: New vaccine to protect people in the EU and worldwide against dengue |
|
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 |
|
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 |
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 - September 2022
, Online, 16:00 - 16:45 Amsterdam time (CEST), from 20/09/2022 to 20/09/2022 |
|
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 |
EMA Account Management training webinar
, Online, 10:30 - 12:30 Amsterdam time (CEST), from 03/10/2022 to 03/10/2022 |
|
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: 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: 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 |
|
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 S1B(R1) Guideline on testing for carcinogenicity of pharmaceuticals Step 5
|
|
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 |
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 |
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 |
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 |
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 |
|
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 |
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 |
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
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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
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05/10/2022 |
Periodic safety update single assessment: Donepezil : List of nationally authorised medicinal products - PSUSA/00001160/202111
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05/10/2022 |
Periodic safety update single assessment: Lorazepam : List of nationally authorised medicinal products - PSUSA/00001909/202201
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05/10/2022 |
Other: FAQs: How to evaluate a CT application - CTIS Training Programme - Module 06
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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 |
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04/10/2022 |
Minutes: Minutes of CHMP written procedure 16-19 August 2022
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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 |
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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 |
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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 |
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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 |
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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 |
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04/10/2022 |
Orphan designation: Recombinant human parathyroid hormone
for the: Treatment of hypoparathyroidism, 16/01/2014, Positive |
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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 |
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04/10/2022 |
Orphan designation: Recombinant human arylsulfatase A
for the: treatment of metachromatic leukodystrophy, 26/11/2010, Positive |
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04/10/2022 |
Veterinary medicines European public assessment report (EPAR): Activyl Tick Plus, indoxacarb, permethrin, 09/01/2012, 9, Withdrawn |
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04/10/2022 |
Human medicines European public assessment report (EPAR): Firmagon, degarelix, Prostatic Neoplasms, 17/02/2009, 19, Authorised |
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03/10/2022 |
Human medicines European public assessment report (EPAR): Rayvow, lasmiditan succinate, Migraine Disorders, 17/08/2022, , Authorised |
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03/10/2022 |
Veterinary medicines European public assessment report (EPAR): Nobilis OR Inac, inactivated whole cell suspension of Ornithobacterium rhinotracheale serotype A, strain B3263/91, 24/01/2003, 7, Withdrawn |
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03/10/2022 |
Human medicines European public assessment report (EPAR): Aflunov, influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23), Influenza, Human; Immunization; Disease Outbreaks, 28/11/2010, 15, Authorised |
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03/10/2022 |
Herbal medicinal product: Agropyri repentis rhizoma, Agropyri repentis rhizoma, F: Assessment finalised
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03/10/2022 |
Meeting of the CTTI/FDA Patient Engagement Collaborative (PEC) and EMA Patients and Consumers Working Party (PCWP)
, Online, from 15/07/2022 to 15/07/2022 |
