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51 results
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Human medicine European public assessment report (EPAR): Ofev
nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015,
, Revision: 17, Authorised, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Onpattro
patisiran sodium, Amyloidosis, Familial
Date of authorisation: 27/08/2018,
, , 
, Revision: 8, Authorised, Last updated: 04/12/2020
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Human medicine European public assessment report (EPAR): Oxervate
Recombinant human nerve growth factor, Keratitis
Date of authorisation: 06/07/2017,, , , Authorised, Last updated: 25/07/2017
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Veterinary medicine European public assessment report (EPAR): Poulvac Flufend H5N3 RG
recombinant inactivated avian influenza virus, Chicken, Ducks
Date of authorisation: 01/09/2006,, 
, Revision: 8, Withdrawn, Last updated: 07/05/2012
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Human medicine European public assessment report (EPAR): Praxbind
idarucizumab, Hemorrhage
Date of authorisation: 20/11/2015,, Revision: 9, Authorised, Last updated: 08/02/2021
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Human medicine European public assessment report (EPAR): Prepandrix
A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 14/05/2008,, Revision: 13, Withdrawn, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Soliris
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007,, , Revision: 29, Authorised, Last updated: 01/07/2020
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Human medicine European public assessment report (EPAR): Sovaldi
Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014,, , Revision: 21, Authorised, Last updated: 14/08/2020
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Human medicine European public assessment report (EPAR): Spinraza
nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017,, , , Revision: 11, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Sylvant
siltuximab, Giant Lymph Node Hyperplasia
Date of authorisation: 22/05/2014,, , Revision: 10, Authorised, Last updated: 08/10/2019
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Human medicine European public assessment report (EPAR): Tagrisso
osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,, , Revision: 12, Authorised, Last updated: 16/10/2020
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Human medicine European public assessment report (EPAR): Takhzyro
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,, , , Revision: 4, Authorised, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Tegsedi
inotersen sodium, Amyloidosis
Date of authorisation: 05/07/2018,, , , Revision: 6, Authorised, Last updated: 16/10/2020
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Human medicine European public assessment report (EPAR): Verkazia
ciclosporin, Conjunctivitis, Keratitis
Date of authorisation: 06/07/2018,, , Revision: 4, Authorised, Last updated: 10/07/2020
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Human medicine European public assessment report (EPAR): Vidaza (updated)
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008,, Revision: 21, Authorised, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Viekirax
Ombitasvir, paritaprevir, ritonavir, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, , Revision: 22, Authorised, Last updated: 12/03/2021
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Human medicine European public assessment report (EPAR): Vosevi
Sofosbuvir, velpatasvir, voxilaprevi, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,, , Revision: 9, Authorised, Last updated: 08/06/2020
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Human medicine European public assessment report (EPAR): Vpriv
velaglucerase alfa, Gaucher Disease
Date of authorisation: 26/08/2010,, , Revision: 14, Authorised, Last updated: 26/02/2021
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Veterinary medicine European public assessment report (EPAR): Zulvac 1 Bovis
inactivated bluetongue virus, serotype 1, Cattle
Date of authorisation: 05/08/2011,, Revision: 7, Withdrawn, Last updated: 30/03/2020
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Veterinary medicine European public assessment report (EPAR): Zulvac 1 Ovis
inactivated bluetongue virus, serotype-1, Sheep
Date of authorisation: 05/08/2011,, Revision: 6, Withdrawn, Last updated: 01/04/2020
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Veterinary medicine European public assessment report (EPAR): Zulvac 1+8 Bovis
inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP, inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02, Cattle
Date of authorisation: 08/03/2012,, Revision: 6, Authorised, Last updated: 23/10/2019
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Human medicine European public assessment report (EPAR): Zynteglo
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: 3, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Zytiga
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,, Revision: 23, Authorised, Last updated: 21/12/2020
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Referral: Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)
daclatasvir, dasabuvir, sofosbuvir, ledipasvir, simeprevir, ombitasvir, paritaprevir, ritonavir, associated names: Sovaldi, Olysio, Viekirax, Harvoni, Exviera, Daklinza, Article 20 procedures
Status: European Commission final decision, opinion/position date: 15/12/2016, EC decision date: 23/02/2017, Last updated: 09/03/2017 -
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Referral: Lartruvo
olaratumab, associated names: Lartruvo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 31/01/2019, EC decision date: 19/07/2019, Last updated: 22/08/2019