Medicines

Fulltext search

For help on how to get the results you want, see our search tips.

Search results

845 results

Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Direct healthcare professional communication Remove Direct healthcare professional communication filter

Medicine type Exceptional circumstances Remove Exceptional circumstances filter Additional monitoring Remove Additional monitoring filter Generic Remove Generic filter Conditional approval Remove Conditional approval filter

Categories Human Remove Human filter

Sort by

List item

Human medicine European public assessment report (EPAR): Fluad Tetra

A/Darwin/9/2021 (H3N2) - like strain (A/Darwin/6/2021, IVR-227) / A/Victoria/4897/2022 (H1N1) pdm09-like strain (A/Victoria/4897/2022, IVR-238) / B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, BVR-1B) / Influenza virus B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26), Influenza, Human
Date of authorisation: 20/05/2020, , Revision: 7, Authorised, Last updated: 04/08/2023
List item

Human medicine European public assessment report (EPAR): Capecitabine Accord

capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012, , Revision: 16, Authorised, Last updated: 03/08/2023
List item

Human medicine European public assessment report (EPAR): Idefirix

Imlifidase, Desensitization, Immunologic; Kidney Transplantation
Date of authorisation: 25/08/2020, , , , Revision: 4, Authorised, Last updated: 01/08/2023
List item

Human medicine European public assessment report (EPAR): Sogroya

Somapacitan, Growth
Date of authorisation: 31/03/2021, , , Revision: 2, Authorised, Last updated: 31/07/2023
List item

Human medicine European public assessment report (EPAR): Ztalmy

Ganaxolone, Epileptic Syndromes; Spasms, Infantile
Date of authorisation: 26/07/2023, , , Authorised, Last updated: 31/07/2023
List item

Human medicine European public assessment report (EPAR): Oprymea

pramipexole dihydrochloride monohydrate, Parkinson Disease
Date of authorisation: 12/09/2008, , Revision: 22, Authorised, Last updated: 31/07/2023
List item

Human medicine European public assessment report (EPAR): Omvoh

Mirikizumab, Colitis, Ulcerative
Date of authorisation: 26/05/2023, , Revision: 1, Authorised, Last updated: 31/07/2023
List item

Human medicine European public assessment report (EPAR): Terrosa

teriparatide, Osteoporosis
Date of authorisation: 04/01/2017, , , Revision: 6, Authorised, Last updated: 28/07/2023
List item

Human medicine European public assessment report (EPAR): Luxturna

voretigene neparvovec, Leber Congenital Amaurosis; Retinitis Pigmentosa
Date of authorisation: 22/11/2018, , , Revision: 7, Authorised, Last updated: 28/07/2023
List item

Human medicine European public assessment report (EPAR): Heplisav B

hepatitis B surface antigen, Hepatitis B
Date of authorisation: 18/02/2021, , Revision: 4, Authorised, Last updated: 27/07/2023
List item

Human medicine European public assessment report (EPAR): Cabazitaxel Accord

cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020, , Revision: 5, Authorised, Last updated: 27/07/2023
List item

Human medicine European public assessment report (EPAR): Gefitinib Mylan

gefitinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 27/09/2018, , Revision: 6, Authorised, Last updated: 27/07/2023
List item

Human medicine European public assessment report (EPAR): Abecma

idecabtagene vicleucel, Multiple Myeloma; Neoplasms; Cancer; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Infectious Mononucleosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases
Date of authorisation: 18/08/2021, , , , Revision: 6, Authorised, Last updated: 27/07/2023
List item

Human medicine European public assessment report (EPAR): Tecvayli

Teclistamab, Multiple Myeloma
Date of authorisation: 23/08/2022, , , Revision: 1, Authorised, Last updated: 27/07/2023
List item

Human medicine European public assessment report (EPAR): Revestive

teduglutide, Malabsorption Syndromes
Date of authorisation: 30/08/2012, , , Revision: 22, Authorised, Last updated: 27/07/2023
List item

Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan

emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 16/12/2016, , Revision: 14, Authorised, Last updated: 27/07/2023
List item

Human medicine European public assessment report (EPAR): Xofluza

Baloxavir marboxil, Influenza, Human
Date of authorisation: 07/01/2021, , Revision: 4, Authorised, Last updated: 27/07/2023
List item

Human medicine European public assessment report (EPAR): Jyseleca

filgotinib maleate, Arthritis, Rheumatoid
Date of authorisation: 24/09/2020, , , Revision: 10, Authorised, Last updated: 27/07/2023
List item

Human medicine 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
Date of authorisation: 16/11/2020, , Revision: 3, Authorised, Last updated: 26/07/2023
List item

Human medicine European public assessment report (EPAR): Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto)

lenalidomide hydrochloride monohydrate, Multiple Myeloma; Myelodysplastic Syndromes; Lymphoma, Follicular; Lymphoma, Mantle-Cell
Date of authorisation: 11/02/2021, , Revision: 4, Authorised, Last updated: 26/07/2023
List item

Human medicine European public assessment report (EPAR): Kaftrio

ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020, , , Revision: 15, Authorised, Last updated: 26/07/2023
List item

Human medicine European public assessment report (EPAR): Alymsys

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021, , , Revision: 6, Authorised, Last updated: 26/07/2023
List item

Human medicine European public assessment report (EPAR): Carvykti

ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022, , , , Revision: 4, Authorised, Last updated: 26/07/2023
List item

Human medicine European public assessment report (EPAR): Miglustat Dipharma

miglustat, Gaucher Disease
Date of authorisation: 18/02/2019, , Revision: 7, Authorised, Last updated: 26/07/2023
List item

Human medicine European public assessment report (EPAR): Brukinsa

zanubrutinib, Waldenstrom Macroglobulinemia
Date of authorisation: 22/11/2021, , Revision: 6, Authorised, Last updated: 25/07/2023