|
29/07/2022 |
Human medicines European public assessment report (EPAR): Zubsolv, Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate, Opioid-Related Disorders, 10/11/2017, 8, Authorised |
|
29/07/2022 |
Human medicines European public assessment report (EPAR): Entecavir Accord, Entecavir, Hepatitis B, Chronic, 25/09/2017,  , 5, Authorised |
|
29/07/2022 |
EPAR - Assessment report - Variation: Nuvaxovid-H-C-005808-II-0009 : EPAR - Assessment report - Variation
|
|
29/07/2022 |
Human medicines European public assessment report (EPAR): Vaborem, meropenem trihydrate, vaborbactam, Urinary Tract Infections; Bacteremia; Bacterial Infections; Respiratory Tract Infections; Pneumonia; Pneumonia, Ventilator-Associated, 20/11/2018,  , 6, Authorised |
|
29/07/2022 |
Report: CAT quarterly highlights and approved ATMPs - July 2022
|
|
29/07/2022 |
Human medicines European public assessment report (EPAR): Tigecycline Accord, Tigecycline, Soft Tissue Infections; Intraabdominal Infections; Bacterial Infections; Skin Diseases, Infectious, 17/04/2020, , 4, Authorised |
|
29/07/2022 |
Report: Key performance indicators (KPIs) to monitor the European clinical trials environment (1 - 30 June 2022, edition 3)
|
|
28/07/2022 |
EMA webinar for fact checkers: Safety of COVID-19 vaccines and therapeutics
, Online, 15:45 - 17:00 Amsterdam time (CEST), from 22/03/2022 to 22/03/2022 |
|
28/07/2022 |
Orphan designation: (S)-ethyl 2-amino-3-(4-(2-amino-6((R)-1-(4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phenyl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)phenyl)propanoate
for the: Treatment of carcinoid syndrome, 30/05/2016, Positive |
|
28/07/2022 |
Human medicines European public assessment report (EPAR): Amversio, betaine, Homocystinuria, 05/05/2022, , , Authorised |
|
28/07/2022 |
Human medicines European public assessment report (EPAR): Supemtek, Influenza A virus subtype H1N1 haemagglutinin, recombinant, Influenza A virus subtype H3N2 haemagglutinin, recombinant, Influenza B virus Victoria lineage haemagglutinin, recombinant, Influenza B virus Yamagata lineage haemagglutinin, recombinant, Influenza, Human, 16/11/2020, , 2, Authorised |
|
28/07/2022 |
Boric acid and borates |
|
28/07/2022 |
Webinar on submissions of parallel distribution notifications for centrally authorised products (CAPs)
, Online, 16:00-17:30 Amsterdam time (CEST), from 09/06/2022 to 09/06/2022 |
|
28/07/2022 |
Opinion on medicine for use outside EU: Insulatard, Insulin human (RDNA), Diabetes Mellitus, 22/04/2022, Positive opinion |
|
28/07/2022 |
News and press releases: Big data use for public health: publication of Big Data Steering Group workplan 2022-25 |
|
27/07/2022 |
COVID-19 treatments: Article 18 and Article 5(3) reviews |
|
27/07/2022 |
News and press releases: EMA reviewing data on sabizabulin for COVID-19 |
|
27/07/2022 |
Other: Product Management Service (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 8 Annex I: Complete representation
|
|
27/07/2022 |
Regulatory and procedural guideline: Product Management Service (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 8
|
|
27/07/2022 |
Regulatory and procedural guideline: Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2
|
|
27/07/2022 |
Human medicines European public assessment report (EPAR): Pemetrexed Sandoz, pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma, 18/09/2015, , 7, Authorised |
|
27/07/2022 |
Orphan designation: Recombinant human acid sphingomyelinase (also known as olipudase alfa)
for the: Treatment of Niemann-Pick disease, 24/06/2022, Positive |
|
27/07/2022 |
Human medicines European public assessment report (EPAR): Pemetrexed Fresenius Kabi, pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma, 22/07/2016, , 13, Authorised |
|
27/07/2022 |
Periodic safety update reports (PSURs) |
|
27/07/2022 |
News and press releases: EMA response to the monkeypox public health emergency |
|
27/07/2022 |
Human medicines European public assessment report (EPAR): Grepid, clopidogrel (as besilate), Peripheral Vascular Diseases; Stroke; Myocardial Infarction, 27/07/2009, , 25, Authorised |
|
27/07/2022 |
Veterinary medicines European public assessment report (EPAR): Bovilis BTV8, bluetongue virus vaccine, serotype 8 (inactivated), 06/09/2010, 4, Withdrawn |
|
27/07/2022 |
Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 18-21 July 2022
|
|
26/07/2022 |
Human medicines European public assessment report (EPAR): Rhokiinsa, Netarsudil, Glaucoma, Open-Angle; Ocular Hypertension, 19/11/2019, , 2, Authorised |
|
26/07/2022 |
Chemistry of active substances (chemistry of new active substances) - Scientific guideline |
|
26/07/2022 |
Direct healthcare professional communication (DHPC): Hydroxyethyl starch (HES) solutions for infusion: suspension of marketing authorisations due to continued use in contraindicated patient populations with increased risk of serious harm, Active substance: hydroxyethyl starch, DHPC type: Post-authorisation measure, Last updated: 26/07/2022 |
|
26/07/2022 |
News and press releases: Hydroxyethyl-starch solutions for infusion recommended for suspension from the market |
|
26/07/2022 |
Human medicines European public assessment report (EPAR): Ziextenzo, pegfilgrastim, Neutropenia, 22/11/2018, ,  , 5, Authorised |
|
26/07/2022 |
Human medicines European public assessment report (EPAR): Kovaltry, octocog alfa, Hemophilia A, 18/02/2016, 11, Authorised |
|
26/07/2022 |
Newsletter: Digital Application Dataset Integration (DADI) newsletter - Issue 1
|
|
25/07/2022 |
Human medicines European public assessment report (EPAR): Fotivda, tivozanib, Carcinoma, Renal Cell, 24/08/2017, , 8, Authorised |
|
25/07/2022 |
Other: Agnes Saint-Raymond - Assessment outcome of occupational activities after leaving the service (July 2022)
|
|
25/07/2022 |
Human medicines European public assessment report (EPAR): Afstyla, lonoctocog alfa, Hemophilia A, 04/01/2017, 10, Authorised |
|
25/07/2022 |
News and press releases: EMA Paediatric Committee elects Brian Aylward as its new Chair |
|
25/07/2022 |
Newsletter: Clinical Trials Highlights - July 2022
|
|
25/07/2022 |
Orphan designation: Moxetumomab pasudotox
for the: Treatment of B-lymphoblastic leukaemia/lymphoma, 19/07/2022, Withdrawn |
|
25/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Cometriq, cabozantinib, PM: decision on the application for modification of an agreed PIP, P/0282/2021 |
|
25/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Rezolsta, darunavir,cobicistat, PM: decision on the application for modification of an agreed PIP, P/0254/2021 |
|
25/07/2022 |
Orphan designation: Adeno-associated viral vector serotype 9 containing the human SMN gene (onasemnogene abeparvovec)
for the: Treatment of spinal muscular atrophy, 19/06/2015, Positive |
|
25/07/2022 |
Human medicines European public assessment report (EPAR): Rapamune, Sirolimus, Graft Rejection; Kidney Transplantation, 13/03/2001, 46, Authorised |
|
25/07/2022 |
Summary of opinion: Genvoya, elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide, 21/07/2022, Positive |
|
22/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Tremfya, Guselkumab, PM: decision on the application for modification of an agreed PIP, P/0250/2021 |
|
22/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Vemlidy, Tenofovir alafenamide (as fumarate), PM: decision on the application for modification of an agreed PIP, P/0269/2021 |
|
22/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Ralinepag, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0244/2021 |
|
22/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Bardoxolone methyl, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0280/2021 |
|
22/07/2022 |
Human medicines European public assessment report (EPAR): Tremfya, Guselkumab, Psoriasis, 10/11/2017, 8, Authorised |
|
22/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Finerenone, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0243/2021 |
|
22/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Invokana, canagliflozin, PM: decision on the application for modification of an agreed PIP, P/0268/2021 |
|
22/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Maralixibat chloride, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0245/2021 |
|
22/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Autologous selected renal cells, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0265/2021 |
|
22/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Human papilloma virus type 16 E6 071-095,human papilloma virus type 16 E6 001-032,human papilloma virus type 16 E6 055-080,human papilloma virus type 16 E6 091-122,Human Papilloma Virus Type 16 E6 109-140,Human Papilloma Virus Type 16 E6 019-050,Human Papilloma Virus Type 16 E6 041-065,Human Papilloma Virus Type 16 E6 085-109,Human Papilloma Virus Type 16 E6 127-158,human papilloma virus type 16 E7 064-098,Human Papilloma Virus Type 16 E7 022-056,Human Papilloma Virus Type 16 E7 001-035, W: decision granting a waiver in all age groups for all conditions or indications, P/0251/2021 |
|
22/07/2022 |
Veterinary medicinal products for zootechnical purposes - Scientific guideline |
|
22/07/2022 |
Human medicines European public assessment report (EPAR): ProQuad, virus, live attenuated, measles, virus, live attenuated, mumps, virus, live attenuated, rubella, virus, live attenuated, varicella, Chickenpox; Rubella; Measles; Mumps; Immunization, 05/04/2006, 31, Authorised |
|
22/07/2022 |
Regulatory and procedural guideline: Draft guideline on the application of Article 34 of Regulation (EU) 2019/6 - Classification of veterinary medicinal products (prescription status)
|
|
22/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Adeno-associated viral vector serotype 8 containing the human glucose-6-phosphatase gene (DTX401), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0278/2021 |
|
22/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Gavreto, pralsetinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0271/2021 |
|
22/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Recombinant monoclonal antibody to sialic acid-binding Ig-like lectin 8 (AK002), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0277/2021 |
|
22/07/2022 |
Summary of opinion: Imcivree, setmelanotide, 21/07/2022, Positive |
|
22/07/2022 |
News and press releases: EMA recommends restricting use of cancer medicine Rubraca |
|
22/07/2022 |
News and press releases: EMA recommends approval of Imvanex for the prevention of monkeypox disease |
|
22/07/2022 |
News and press releases: Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making |
|
22/07/2022 |
Human medicines European public assessment report (EPAR): Zinforo, Ceftaroline fosamil, Community-Acquired Infections; Skin Diseases, Infectious; Pneumonia, 22/08/2012, 26, Authorised |
|
22/07/2022 |
Opinion on medicine for use outside EU: Actrapid, insulin human, Diabetes Mellitus, 22/04/2022, Positive opinion |
|
21/07/2022 |
Human medicines European public assessment report (EPAR): Sugammadex Fresenius Kabi, sugammadex sodium, Neuromuscular Blockade, 15/07/2022, , Authorised |
|
21/07/2022 |
Report: CAT quarterly highlights and approved ATMPs - April 2022
|
|
21/07/2022 |
Human medicines European public assessment report (EPAR): Xgeva, denosumab, Fractures, Bone; Neoplasm Metastasis, 13/07/2011, 23, Authorised |
|
21/07/2022 |
Committee for Herbal Medicinal Products (HMPC): 16-18 May 2022
, Online, from 16/05/2022 to 18/05/2022 |
|
21/07/2022 |
Human medicines European public assessment report (EPAR): Kapruvia, difelikefalin, Pruritus, 25/04/2022, , 1, Authorised |
|
21/07/2022 |
Scientific guideline: Draft ICH guideline M12 on drug interaction studies - Step 2b
|
|
21/07/2022 |
Committee meeting report: COMP meeting report on the review of applications for orphan designation: July 2022
|
|
21/07/2022 |
Paediatric Committee (PDCO): 17-20 May 2022
, Virtual meeting, from 17/05/2022 to 20/05/2022 |
|
21/07/2022 |
Minutes: PCDO minutes of the 17-20 May 2022 meeting
|
|
21/07/2022 |
Management Board meetings |
|
20/07/2022 |
Human medicines European public assessment report (EPAR): Ganfort, bimatoprost, timolol, Glaucoma, Open-Angle; Ocular Hypertension, 19/05/2006, 23, Authorised |
|
20/07/2022 |
Human medicines European public assessment report (EPAR): Ozurdex, dexamethasone, Macular Edema; Uveitis, 26/07/2010, 18, Authorised |
|
20/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0242/2021 |
|
20/07/2022 |
Human medicines European public assessment report (EPAR): Lumigan, bimatoprost, Glaucoma, Open-Angle; Ocular Hypertension, 08/03/2002, 37, Authorised |
|
20/07/2022 |
Human medicines European public assessment report (EPAR): Ganirelix Gedeon Richter, ganirelix acetate, Reproductive Techniques, Assisted; Ovulation Induction; Infertility, Female, 15/07/2022, , Authorised |
|
20/07/2022 |
Regulatory and procedural guideline: List of substances and products subject to worksharing for signal management
|
|
20/07/2022 |
Minutes: Minutes of the PRAC meeting 30 August - 2 September 2021
|
|
19/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Enhertu, trastuzumab deruxtecan, W: decision granting a waiver in all age groups for all conditions or indications, P/0275/2021 |
|
19/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Human immunoglobulin G1 constant region - human ectodysplasin-A1 receptor-binding domain fusion protein, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0284/2021 |
|
19/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): trastuzumab deruxtecan, W: decision granting a waiver in all age groups for all conditions or indications, P/0259/2021 |
|
19/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): trastuzumab deruxtecan, W: decision granting a waiver in all age groups for all conditions or indications, P/0279/2021 |
|
19/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Patritumab deruxtecan, W: decision granting a waiver in all age groups for all conditions or indications, P/0276/2021 |
|
19/07/2022 |
Orphan designation: for the: Treatment of primary sclerosing cholangitis, 13/04/2022, Positive |
|
19/07/2022 |
Orphan designation: tiratricol
for the: Treatment of resistance to thyroid hormone type beta, 13/04/2022, Positive |
|
19/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Vupanorse, W: decision granting a waiver in all age groups for all conditions or indications, P/0256/2021 |
|
19/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Zibotentan,dapagliflozin propanediol monohydrate, W: decision granting a waiver in all age groups for all conditions or indications, P/0249/2021 |
|
19/07/2022 |
Orphan designation: Cannabidiol
for the: Treatment of epilepsy with myoclonic-atonic seizures, 13/04/2022, Positive |
|
19/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): [18F]CTT1057, W: decision granting a waiver in all age groups for all conditions or indications, P/0258/2021 |
|
19/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): mannitol, W: decision granting a waiver in all age groups for all conditions or indications, P/0262/2021 |
|
19/07/2022 |
Human medicines European public assessment report (EPAR): Zeffix, lamivudine, Hepatitis B, Chronic, 29/07/1999, 29, Authorised |
|
19/07/2022 |
Guidance documents |
|
19/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Selatogrel, W: decision granting a waiver in all age groups for all conditions or indications, P/0263/2021 |
|
19/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Anti-C1s Humanized IgG4 Monoclonal Antibody, W: decision granting a waiver in all age groups for all conditions or indications, P/0252/2021 |
|
19/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Allogeneic skin-derived ATP-binding cassette, sub-family B, member 5 (ABCB5)-positive mesenchymal stem cells (allo-APZ2-EB), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0247/2021 |
|
19/07/2022 |
Orphan designation: Adeno-associated virus serotype C102 containing the human GLA gene
for the: Treatment of Fabry disease, 13/04/2022, Positive |
|
19/07/2022 |
Orphan designation: Adeno-associated viral vector serotype 8 encoding B-domain deleted liver specific codon optimized bioengineered chimeric human porcine factor VIII, under a synthetic hepatic combinatorial bundle promoter
for the: Treatment of haemophilia A, 13/04/2022, Positive |
|
19/07/2022 |
Orphan designation: Obecabtagene autoleucel
for the: Treatment of acute lymphoblastic leukaemia, 13/04/2022, Positive |
|
19/07/2022 |
Orphan designation: Devimistat
for the: Treatment of biliary tract cancer, 13/04/2022, Positive |
|
19/07/2022 |
Orphan designation: N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine
for the: Treatment in solid organ transplantation, 13/04/2022, Positive |
|
19/07/2022 |
Orphan designation: arimoclomol citrate
for the: Treatment of inclusion body myositis, 18/07/2022, Withdrawn |
|
19/07/2022 |
Orphan designation: Arimoclomol
for the: Treatment of amyotrophic lateral sclerosis, 18/07/2022, Withdrawn |
|
19/07/2022 |
Orphan designation: Belzupacap sarotalocan
for the: Treatment of uveal melanoma, 13/04/2022 |
|
19/07/2022 |
Orphan designation: Adeno-associated virus vector serotype 9 encoding human gigaxonin gene
for the: Treatment of giant axonal neuropathy, 13/04/2022, Positive |
|
19/07/2022 |
Orphan designation: Humanised anti-CD37 monoclonal antibody conjugated to maytansinoid DM1 (naratuximab emtansine)
for the: Treatment of diffuse large B-cell lymphoma, 18/07/2022, Withdrawn |
|
19/07/2022 |
Orphan designation: Norucholic acid
for the: Treatment of primary biliary cholangitis, 13/04/2022, Positive |
|
19/07/2022 |
Orphan designation: Sirolimus
for the: Treatment of tuberous sclerosis, 20/06/2017, Positive |
|
19/07/2022 |
Agenda: Agenda of the PDCO meeting 19-22 July 2022
|
|
18/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Cotadutide, PM: decision on the application for modification of an agreed PIP, P/0273/2021 |
|
18/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Garadacimab, PM: decision on the application for modification of an agreed PIP, P/0274/2021 |
|
18/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Rilzabrutinib, PM: decision on the application for modification of an agreed PIP, P/0272/2021 |
|
18/07/2022 |
Orphan designation: Adeno-associated virus serotype 9 containing human MYBPC3 gene
for the: Treatment of Hypertrophic cardiomyopathy due to mutations in the MYBPC3 gene encoding cardiac myosin-binding protein C, 13/04/2022, Positive |
|
18/07/2022 |
Human medicines European public assessment report (EPAR): Potactasol, topotecan, Uterine Cervical Neoplasms; Small Cell Lung Carcinoma, 06/01/2011, , 10, Authorised |
|
18/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): MenQuadfi, Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid,N. meningitidis serogroup C polysaccharide conjugated to tetanus toxoid,N. meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid,N. meningitidis serogroup W polysaccharide conjugated to tetanus toxoid (MenACYW), PM: decision on the application for modification of an agreed PIP, P/0285/2021 |
|
18/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Vaborem, meropenem trihydrate,vaborbactam, PM: decision on the application for modification of an agreed PIP, P/0260/2021 |
|
18/07/2022 |
Orphan designation: Glofitamab
for the: Treatment of mantle cell lymphoma, 13/04/2022, Positive |
|
18/07/2022 |
PRAC recommendation on signal: New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 March 2022 PRAC
|
|
18/07/2022 |
Newsletter: Human medicines highlights - July 2022
|
|
18/07/2022 |
First industry standing group (ISG) meeting
, Online, from 21/06/2022 to 21/06/2022 |
|
18/07/2022 |
Other: Meeting summary - First industry standing group (ISG) meeting
|
|
18/07/2022 |
Agenda: Agenda of the CHMP meeting 18-21 July 2022
|
|
15/07/2022 |
Human medicines European public assessment report (EPAR): Episalvan, Betulae cortex, Wounds and Injuries; Wound Healing, 14/01/2016, 7, Withdrawn |
|
15/07/2022 |
Other: European Medicines Agency’s data protection notice for EudraVigilance Human (EV)
|
|
15/07/2022 |
Other: Record of data processing activity for EudraVigilance (public)
|
|
15/07/2022 |
Digital application dataset integration (DADI) and Product Management Service (PMS) webinar - Variations form for human medicinal products - What will happen at go-live
, Online, 10:00 - 12:00 Amsterdam time (CEST), from 16/05/2022 to 16/05/2022 |
|
15/07/2022 |
Human medicines European public assessment report (EPAR): Elmiron, pentosan polysulfate sodium, Cystitis, Interstitial, 02/06/2017, 14, Authorised |
|
15/07/2022 |
Report: Technology Capability Investment Plan - Becoming a digital hub for the European medicines regulator network
|
|
15/07/2022 |
Information management |
|
15/07/2022 |
News and press releases: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 12-14 July 2022 |
|
15/07/2022 |
Summary of opinion: Lotilaner Elanco, lotilaner, 14/07/2022, Positive |
|
15/07/2022 |
Human medicines European public assessment report (EPAR): Zonisamide Mylan, zonisamide, Epilepsy, 31/03/2016, , 8, Authorised |
|
15/07/2022 |
News and press releases: Towards better prevention of medicine shortages in the EU |
|
15/07/2022 |
Other: Good practice guidance for patient and healthcare professional organisations on the prevention of shortages of medicines for human use
|
|
14/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): COVID-19 Vaccine (inactivated, adjuvanted) Valneva, SARS-CoV-2 virus, beta-propiolactone inactivated adjuvanted with CpG 1018 (VLA2001), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0184/2022 |
|
14/07/2022 |
Human medicines European public assessment report (EPAR): M-M-RVaxPro, measles virus Enders’ Edmonston strain (live, attenuated), mumps virus Jeryl Lynn (level B) strain (live, attenuated), rubella virus Wistar RA 27/3 strain (live, attenuated), Rubella; Mumps; Immunization; Measles, 05/05/2006, 30, Authorised |
|
14/07/2022 |
Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA
for the: Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive |
|
14/07/2022 |
Orphan designation: Autologous CD34+ cells transduced with a lentiviral vector containing the human SGSH gene
for the: Treatment of mucopolysaccharidosis, type IIIA (Sanfilippo A syndrome), 10/06/2014, Positive |
|
14/07/2022 |
Orphan designation: Autologous haematopoietic cells genetically modified with a lentiviral vector containing the human gp91(phox) gene
for the: Treatment of X-linked chronic granulomatous disease, 09/02/2012, Positive |
|
14/07/2022 |
Orphan designation: Autologous CD34+ cells transfected with lentiviral vector containing the human arylsulfatase A cDNA
for the: treatment of metachromatic leukodystrophy, 13/04/2007, Positive |
|
14/07/2022 |
Leaflet: Info-cards: What can you do when it comes to shortages of medicines?
|
|
14/07/2022 |
European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting
, Online, from 01/06/2022 to 02/06/2022 |
|
14/07/2022 |
Leaflet: Factsheet: Towards better prevention of medicine shortages
|
|
14/07/2022 |
Orphan designation: Autologous CD34+ cells transfected with retroviral vector containing adenosine deaminase gene
for the: Treatment of severe combined immunodeficiency (SCID) due to adenosine deaminase (ADA) deficiency, 26/08/2005, Positive |
|
14/07/2022 |
Human medicines European public assessment report (EPAR): Dexdor, Dexmedetomidine hydrochloride, Conscious Sedation, 15/09/2011, 15, Authorised |
|
14/07/2022 |
Orphan designation: antisense oligonucleotide targeting exon 73 in the COL7A1 gene
for the: Treatment of epidermolysis bullosa, 12/10/2017, Positive |
|
14/07/2022 |
Orphan designation: Darinaparsin
for the: Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated), 15/04/2011, Positive |
|
13/07/2022 |
Regulatory and procedural guideline: Appendix 1 to INS-GCP-4 procedure for reporting of GCP inspections requested by the CHMP: GCP inspection report
|
|
13/07/2022 |
Other: Joint controllership arrangement with regard to EudraVigilance Human (EV)
|
|
13/07/2022 |
Periodic safety update single assessment: Caffeine / ergotamine : List of nationally authorised medicinal products - PSUSA/00000485/202111
|
|
13/07/2022 |
Human medicines European public assessment report (EPAR): Bevespi Aerosphere, glycopyrronium, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, 18/12/2018, 5, Authorised |
|
13/07/2022 |
Human medicines European public assessment report (EPAR): Copiktra, duvelisib, Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Follicular, 19/05/2021, , 2, Authorised |
|
13/07/2022 |
News and press releases: EMA re-elected as chair of ICMRA from October 2022 |
|
13/07/2022 |
Periodic safety update single assessment: Bisoprolol / hydrochlorothiazide : List of nationally authorised medicinal products - PSUSA/00000420/202111
|
|
13/07/2022 |
Human medicines European public assessment report (EPAR): Aripiprazole Accord, aripiprazole, Schizophrenia; Bipolar Disorder, 15/11/2015, , 15, Authorised |
|
13/07/2022 |
Veterinary product information templates |
|
13/07/2022 |
Good clinical practice (GCP) inspection procedures |
|
13/07/2022 |
Periodic safety update single assessment: Sodium oxybate (intravenous use) : List of nationally authorised medicinal products - PSUSA/0010613/202110
|
|
13/07/2022 |
Periodic safety update single assessment: Ciprofibrate : List of nationally authorised medicinal products - PSUSA/00000771/202112
|
|
12/07/2022 |
Human medicines European public assessment report (EPAR): Jalra, vildagliptin, Diabetes Mellitus, Type 2, 19/11/2008, 23, Authorised |
|
12/07/2022 |
Periodic safety update single assessment: Asparaginase, crisantaspase (nationally authorised products) : List of nationally authorised medicinal products - PSUSA/00003161/202108
|
|
12/07/2022 |
Reflection paper on the use of measurable residual disease as a clinical endpoint in multiple myeloma studies - Scientific guideline |
|
12/07/2022 |
Periodic safety update single assessment: Carmustine (implant) : List of nationally authorised medicinal products - PSUSA/00010348/202109
|
|
12/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Gardasil, human papillomavirus type 6 L1 protein,human papillomavirus type 11 L1 protein,human papillomavirus type 16 L1 protein,human papillomavirus type 18 L1 protein, PM: decision on the application for modification of an agreed PIP, P/13/2010 |
|
12/07/2022 |
Scientific guideline: Reflection paper on the use of measurable residual disease as a clinical endpoint in multiple myeloma studies
|
|
12/07/2022 |
Clinical Trials Information System (CTIS): Walk-in clinic - 5 May 2022
, Online, 15:00 - 15:45 Amsterdam time (CEST), from 05/05/2022 to 05/05/2022 |
|
12/07/2022 |
Other: Contact details of national competent authorities for requests to use a sticker to place the Unique Identifier on the outer/immediate packaging of centrally approved products
|
|
12/07/2022 |
Orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor (axicabtagene ciloleucel)
for the: Treatment of follicular lymphoma, 11/11/2015, Positive |
|
12/07/2022 |
Mock-ups and specimens |
|
12/07/2022 |
News and press releases: EMA launches pilot project on analysis of raw data from clinical trials |
|
12/07/2022 |
Agenda: Agenda - DARWIN EU Advisory Board meeting: 20 April 2022
|
|
12/07/2022 |
DARWIN EU Advisory Board meeting: 20 April 2022
, Online, from 20/04/2022 to 20/04/2022 |
|
12/07/2022 |
Human medicines European public assessment report (EPAR): Crixivan, indinavir sulfate ethanolate, HIV Infections, 04/10/1996, 39, Withdrawn |
|
12/07/2022 |
Committee for Medicinal Products for Veterinary Use (CVMP): 12-14 July 2022
, European Medicines Agency, Amsterdam, the Netherlands, from 12/07/2022 to 14/07/2022 |
|
12/07/2022 |
Agenda: Agenda of the CVMP meeting 12-14 July 2022
|
|
11/07/2022 |
News and press releases: ECDC and EMA update recommendations on additional booster doses of mRNA COVID-19 vaccines |
|
11/07/2022 |
Human medicines European public assessment report (EPAR): Naglazyme, galsulfase, Mucopolysaccharidosis VI, 23/01/2006, 19, Authorised |
|
08/07/2022 |
Report: Applications for new human medicines under evaluation by the CHMP: July 2022
|
|
08/07/2022 |
Other: European Union example instances - E2B(R3) testing files
|
|
08/07/2022 |
Organisation Management System (OMS) Trouble Shooting Session for CTIS users - June 2022
, Online, 14:00 - 15:00 Amsterdam time (CEST), from 30/06/2022 to 30/06/2022 |
|
08/07/2022 |
Periodic safety update single assessment: Ceftobiprole : List of nationally authorised medicinal products - PSUSA/00010734/202111
|
|
08/07/2022 |
Regulatory and procedural guideline: EU Individual Case Safety Report (ICSR) implementation guide business rules spreadsheets
|
|
08/07/2022 |
Other: Agnes Saint-Raymond - Assessment outcome of occupational activities after leaving the service (June 2022)
|
|
08/07/2022 |
Other: List of the main therapeutic groups (MTGs) in crisis preparedness
|
|
08/07/2022 |
Human medicines European public assessment report (EPAR): Clopidogrel TAD, clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Stroke; Myocardial Infarction, 23/09/2009, , 15, Authorised |
|
08/07/2022 |
News and press releases: Further measures to identify and address medicine shortages during public health emergencies adopted |
|
08/07/2022 |
Orphan designation: adeno-associated virus serotype 9 vector containing human n-acetylgalactosamine-6-sulfate sulfatase gene
for the: Treatment of mucopolysaccharidosis type IVA (Morquio A Syndrome), 09/01/2020, Positive |
|
08/07/2022 |
Orphan designation: Adeno-associated viral vector serotype 9 containing the human sulfamidase gene
for the: Treatment of mucopolysaccharidosis, type IIIA (Sanfilippo A syndrome), 21/06/2011, Positive |
|
08/07/2022 |
Orphan designation: Recombinant human monoclonal antibody binding to vascular adhesion protein-1
for the: Treatment of primary sclerosing cholangitis, 19/03/2015, Positive |
|
08/07/2022 |
News and press releases: Medicines containing nomegestrol or chlormadinone: PRAC recommends new measures to minimise risk of meningioma |
|
08/07/2022 |
News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 July 2022 |
|
08/07/2022 |
Periodic safety update single assessment: Cefazolin : List of nationally authorised medicinal products - PSUSA/00000589/202111
|
|
08/07/2022 |
Referral: Zynteglo
, betibeglogene autotemcel, Article 20 procedures, European Commission final decision, 22/07/2021, 16/09/2021, 08/07/2022 |
|
08/07/2022 |
Periodic safety update single assessment: Quinine : List of nationally authorised medicinal products - PSUSA/00002598/202111
|
|
08/07/2022 |
Periodic safety update single assessment: Metoclopramide : List of nationally authorised medicinal products - PSUSA/00002036/202111
|
|
07/07/2022 |
Management Board meeting: 16-17 March 2022
, European Medicines Agency, Amsterdam, the Netherlands, from 16/03/2022 to 17/03/2022 |
|
07/07/2022 |
Report: OPEN Pilot: One-year review and recommendations
|
|
07/07/2022 |
EMA regular press briefing on COVID-19
, Online, 15:00 - 15:30 Amsterdam time (CEST), from 07/07/2022 to 07/07/2022 |
|
06/07/2022 |
EMA workshop on thrombosis with thrombocytopenia syndrome
, Online, from 27/06/2022 to 27/06/2022 |
|
06/07/2022 |
Human medicines European public assessment report (EPAR): Levetiracetam Teva, levetiracetam, Epilepsy, 25/08/2011, , 19, Authorised |
|
06/07/2022 |
Human medicines European public assessment report (EPAR): Ibandronic Acid Sandoz, ibandronic acid, Breast Neoplasms; Neoplasm Metastasis; Fractures, Bone, 26/07/2011, , 9, Authorised |
|
06/07/2022 |
Human medicines European public assessment report (EPAR): Ucedane, carglumic acid, Hyperammonemia; Amino Acid Metabolism, Inborn Errors, 23/06/2017, , 11, Authorised |
|
06/07/2022 |
Human medicines European public assessment report (EPAR): Vectibix, panitumumab, Colorectal Neoplasms, 03/12/2007, 34, Authorised |
|
05/07/2022 |
Human medicines European public assessment report (EPAR): Iressa, gefitinib, Carcinoma, Non-Small-Cell Lung, 24/06/2009, 15, Authorised |
|
05/07/2022 |
Human medicines European public assessment report (EPAR): Zavicefta, avibactam sodium, ceftazidime pentahydrate, Pneumonia, Bacterial; Soft Tissue Infections; Pneumonia; Urinary Tract Infections; Gram-Negative Bacterial Infections, 23/06/2016, , 14, Authorised |
|
05/07/2022 |
Human medicines European public assessment report (EPAR): Senstend, lidocaine, prilocaine, Premature Ejaculation, 14/11/2019, Withdrawn |
|
05/07/2022 |
Human medicines European public assessment report (EPAR): Imatinib Actavis, imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma, 17/04/2013, , 13, Withdrawn |
|
05/07/2022 |
Periodic safety update single assessment: Meningococcal group c polysaccharide conjugate vaccine : List of nationally authorised medicinal products -
|
|
05/07/2022 |
Orphan designation: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide
for the: Treatment of neurofibromatosis type 2, 26/04/2012, Positive |
|
05/07/2022 |
Periodic safety update single assessment: Zidovudine - List of nationally authorised medicinal products - PSUSA/00003143/202109
|
|
05/07/2022 |
Periodic safety update single assessment: Clindamycin : List of nationally authorised medicinal products - PSUSA/00000795/202110
|
|
05/07/2022 |
Periodic safety update single assessment: Isopropyl alcohol / propyl alcohol / mecetronium ethyl sulfate : List of nationally authorised medicinal products - PSUSA/00010108/202109
|
|
05/07/2022 |
Periodic safety update single assessment: Benzalkonium chloride / chlorhexidine digluconate : List of nationally authorised medicinal products - PSUSA/00010070/202111
|
|
04/07/2022 |
Human medicines European public assessment report (EPAR): Sildenafil Teva, sildenafil, Erectile Dysfunction, 30/11/2009, , 17, Authorised |
|
04/07/2022 |
Agenda: Agenda of the PRAC meeting 4-7 July 2022
|
|
04/07/2022 |
Orphan designation: dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w) (birch bark extract)
for the: Treatment of epidermolysis bullosa, 23/02/2011, Positive |
|
04/07/2022 |
Orphan designation: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amNide
for the: Treatment of microscopic polyangiitis (avacopan), 19/11/2014, Positive |
|
04/07/2022 |
Orphan designation: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide (avacopan)
for the: Treatment of granulomatosis with polyangiitis, 19/11/2014, Positive |
|
01/07/2022 |
Human medicines European public assessment report (EPAR): Uptravi, Selexipag, Hypertension, Pulmonary, 12/05/2016, 13, Authorised |
|
01/07/2022 |
Orphan designation: Human autologous mesenchymal adult stem cells extracted from adipose tissue
for the: Treatment of anal fistula, 26/08/2005, Withdrawn |
|
01/07/2022 |
Orphan designation: Setmelanotide
for the: Treatment of Alström syndrome, 09/01/2020, Positive |
|
01/07/2022 |
Orphan designation: Setmelanotide
for the: Treatment of leptin receptor deficiency, 19/11/2018, Positive |
|
01/07/2022 |
Orphan designation: Setmelanotide
for the: Treatment of pro-opiomelanocortin deficiency, 14/07/2016, Positive |
|
01/07/2022 |
Orphan designation: Setmelanotide
for the: Treatment of Prader-Willi syndrome, 27/06/2016, Positive |
|
01/07/2022 |
News and press releases: Global regulators agree on key principles on adapting vaccines to tackle virus variants |
|
01/07/2022 |
Human medicines European public assessment report (EPAR): Cuprymina, copper (64Cu) chloride, Radionuclide Imaging, 23/08/2012, 8, Authorised |
|
01/07/2022 |
Human medicines European public assessment report (EPAR): Levetiracetam Actavis, levetiracetam, Epilepsy, 03/10/2011, , 18, Authorised |
|
01/07/2022 |
Human medicines European public assessment report (EPAR): Zostavax, varicella-zoster virus (live, attenuated), Herpes Zoster; Immunization, 19/05/2006, 33, Authorised |
|
01/07/2022 |
Human medicines European public assessment report (EPAR): Ristfor, sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 15/03/2010, 25, Authorised |
|
01/07/2022 |
Template or form: Application form for initial consultation by a notified body on a companion diagnostic
|
|
01/07/2022 |
Human medicines European public assessment report (EPAR): Clopidogrel Taw Pharma (previously Clopidogrel Mylan), clopidogrel hydrochloride, Peripheral Vascular Diseases; Stroke; Myocardial Infarction; Acute Coronary Syndrome, 21/09/2009, , 20, Authorised |
|
01/07/2022 |
Overview of comments: Submitted comments on 'Draft guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics'
|
|
01/07/2022 |
Template or form: Application form for follow-up consultation procedure by a notified body on a companion diagnostic
|
|
01/07/2022 |
Other: Questions & answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies
|
|
01/07/2022 |
Template or form: Consultation on companion diagnostic - Assessment report template
|
|
01/07/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ cells transduced with lentiviral vector encoding the human beta-globin gene, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0236/2020 |
|
01/07/2022 |
Scientific guideline: Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics
|
|
01/07/2022 |
Human medicines European public assessment report (EPAR): Thalidomide BMS (previously Thalidomide Celgene), Thalidomide, Multiple Myeloma, 16/04/2008, 30, Authorised |
|
01/07/2022 |
Report: European Medicines Agency’s interaction with industry stakeholders - Biennial report 2010-2021
|
|
01/07/2022 |
Human medicines European public assessment report (EPAR): Levetiracetam Actavis Group, levetiracetam, Epilepsy, 04/12/2011, , 16, Authorised |
|
01/07/2022 |
Human medicines European public assessment report (EPAR): Ristaben, sitagliptin, Diabetes Mellitus, Type 2, 15/03/2010, 24, Authorised |
|
01/07/2022 |
Human medicines European public assessment report (EPAR): Samsca, Tolvaptan, Inappropriate ADH Syndrome, 02/08/2009, 15, Authorised |
|
01/07/2022 |
Quality of medicines questions and answers: Part 2 |
