For help on how to get the results you want, see our search tips.
393 results
Medicine type
Generic Remove Generic filter
Conditional approval Remove Conditional approval filter
Accelerated assessment Remove Accelerated assessment filter
Biosimilar Remove Biosimilar filter
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Referrals Remove Referrals filter
Authorisation status
Authorised Remove Authorised filter
-
List item
Human medicine European public assessment report (EPAR): Cabazitaxel Accord (updated)
cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020,
, Revision: 1, Authorised, Last updated: 26/01/2022
-
List item
Human medicine European public assessment report (EPAR): Cinacalcet Accordpharma (updated)
cinacalcet hydrochloride, Hyperparathyroidism
Date of authorisation: 03/04/2020,, Revision: 2, Authorised, Last updated: 26/01/2022
-
List item
Human medicine European public assessment report (EPAR): Arsenic trioxide medac (updated)
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 17/09/2020,, Revision: 1, Authorised, Last updated: 26/01/2022
-
List item
Human medicine European public assessment report (EPAR): Kalydeco (updated)
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,
, 
, Revision: 31, Authorised, Last updated: 26/01/2022
-
List item
Human medicine European public assessment report (EPAR): Harvoni (updated)
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,
, , Revision: 24, Authorised, Last updated: 25/01/2022
-
List item
Human medicine European public assessment report (EPAR): Hukyndra (updated)
adalimumab, Arthritis, Psoriatic; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Colitis, Ulcerative; Crohn Disease; Hidradenitis Suppurativa; Psoriasis; Spondylitis, Ankylosing; Uveitis
Date of authorisation: 15/11/2021,
, Revision: 1, Authorised, Last updated: 25/01/2022
-
List item
Human medicine European public assessment report (EPAR): Verkazia (updated)
ciclosporin, Conjunctivitis; Keratitis
Date of authorisation: 06/07/2018,, , Revision: 6, Authorised, Last updated: 25/01/2022
-
List item
Human medicine European public assessment report (EPAR): Ruxience (updated)
rituximab, Leukemia, Lymphocytic, Chronic, B-Cell; Arthritis, Rheumatoid; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 01/04/2020,, , Revision: 6, Authorised, Last updated: 24/01/2022
-
List item
Human medicine European public assessment report (EPAR): Pelmeg (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018,, , Revision: 7, Authorised, Last updated: 24/01/2022
-
List item
Human medicine European public assessment report (EPAR): Azacitidine Accord (updated)
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 13/02/2020,, Revision: 3, Authorised, Last updated: 24/01/2022
-
List item
Human medicine European public assessment report (EPAR): Zoledronic Acid Accord (updated)
zoledronic acid monohydrate, Hypercalcemia; Fractures, Bone; Cancer
Date of authorisation: 16/01/2014,, Revision: 9, Authorised, Last updated: 24/01/2022
-
List item
Veterinary medicine European public assessment report (EPAR): Imoxat (updated)
imidacloprid, moxidectin, Cats; Dogs; Ferrets
Date of authorisation: 07/12/2021,, Authorised, Last updated: 24/01/2022
-
List item
Human medicine European public assessment report (EPAR): Repaglinide Accord (updated)
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 22/12/2011,, Revision: 7, Authorised, Last updated: 21/01/2022
-
List item
Human medicine European public assessment report (EPAR): Kanjinti (updated)
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 16/05/2018,, , Revision: 9, Authorised, Last updated: 21/01/2022
-
List item
Human medicine European public assessment report (EPAR): Ocaliva (updated)
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,, , 
, Revision: 12, Authorised, Last updated: 21/01/2022
-
List item
Human medicine European public assessment report (EPAR): Movymia (updated)
teriparatide, Osteoporosis
Date of authorisation: 11/01/2017,, Revision: 10, Authorised, Last updated: 20/01/2022
-
List item
Human medicine European public assessment report (EPAR): Zynteglo (updated)
Autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,, , , , Revision: 5, Authorised, Last updated: 20/01/2022
-
List item
Human medicine European public assessment report (EPAR): COVID-19 Vaccine Janssen (updated)
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021,, , Revision: 16, Authorised, Last updated: 20/01/2022
-
List item
Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,, , Revision: 19, Authorised, Last updated: 20/01/2022
-
List item
Human medicine European public assessment report (EPAR): Desloratadine ratiopharm (updated)
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 13/01/2012,, Revision: 10, Authorised, Last updated: 20/01/2022
-
List item
Human medicine European public assessment report (EPAR): Pregabalin Zentiva (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 17/07/2015,, Revision: 12, Authorised, Last updated: 20/01/2022
-
List item
Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (updated)
efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 08/02/2018,, Revision: 7, Authorised, Last updated: 19/01/2022
-
List item
Human medicine European public assessment report (EPAR): Inhixa (updated)
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016,, Revision: 21, Authorised, Last updated: 19/01/2022
-
List item
Human medicine European public assessment report (EPAR): Takhzyro (updated)
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,, , , Revision: 7, Authorised, Last updated: 19/01/2022
-
List item
Human medicine European public assessment report (EPAR): Evrysdi (updated)
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,, , Revision: 1, Authorised, Last updated: 19/01/2022