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Human medicine European public assessment report (EPAR): Soliris
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007,
, 
, Revision: 33, Authorised, Last updated: 14/11/2022
under the supervision of a doctor who has experience in the … infusion-related reactions, the doctor may slow down or stop the … -
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Human medicine European public assessment report (EPAR): Brineura
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,
, , , 
, Revision: 6, Authorised, Last updated: 16/08/2022
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Brineura … treatment. The rating was done by doctors who gave patients individual … -
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Human medicine European public assessment report (EPAR): Exviera
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, Revision: 25, Authorised, Last updated: 12/08/2022
leaflet or contact their doctor or pharmacist. Expand section … started and monitored by a doctor experienced in managing patients … the EPAR) or contact your doctor or pharmacist. List item … -
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Human medicine European public assessment report (EPAR): Kanuma
sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015,, , , Revision: 8, Authorised, Last updated: 21/06/2022
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Kanuma … should be supervised by a doctor experienced in the treatment … -
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Human medicine European public assessment report (EPAR): Kisplyx
lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016,, Revision: 17, Authorised, Last updated: 17/06/2022
started and supervised by a doctor who has experience in using … package leaflet or contact your doctor or pharmacist. How does … started and supervised by a doctor who has experience in using … -
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Human medicine European public assessment report (EPAR): Kyprolis
carfilzomib, Multiple Myeloma
Date of authorisation: 19/11/2015,, , Revision: 20, Authorised, Last updated: 15/06/2022
treatment must be supervised by a doctor experienced in the treatment … package leaflet or contact your doctor or pharmacist. How does Kyprolis … treatment must be supervised by a doctor experienced in the treatment … -
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Human medicine European public assessment report (EPAR): Vidaza
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008,, Revision: 25, Authorised, Last updated: 14/06/2022
under the supervision of a doctor experienced in the use of … the EPAR) or contact your doctor or pharmacist. List item … -
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Human medicine European public assessment report (EPAR): Oxervate
Recombinant human nerve growth factor, Keratitis
Date of authorisation: 06/07/2017,, , , Revision: 1, Authorised, Last updated: 04/04/2022
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Oxervate … have been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Ofev
nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015,, Revision: 22, Authorised, Last updated: 26/04/2022
treatment should be started by a doctor experienced in the diagnosis … package leaflet or contact your doctor or pharmacist. How does Ofev … -
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Human medicine European public assessment report (EPAR): Spinraza
nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017,, , Revision: 13, Authorised, Last updated: 02/02/2022
leaflet or contact their doctor or pharmacist. Expand section … treatment should be started by a doctor with experience in the treatment … directly into the spine) by a doctor or nurse experienced in carrying … -
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Human medicine European public assessment report (EPAR): Verkazia
ciclosporin, Conjunctivitis; Keratitis
Date of authorisation: 06/07/2018,, , Revision: 6, Authorised, Last updated: 25/01/2022
leaflet or contact their doctor or pharmacist. Expand section … the EPAR) or contact your doctor or pharmacist. List item … leaflet or contact their doctor or pharmacist. What is … -
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Human medicine European public assessment report (EPAR): Ketoconazole HRA
Ketoconazole, Cushing Syndrome
Date of authorisation: 18/11/2014,, , , Revision: 10, Authorised, Last updated: 07/06/2021
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Ketoconazole … started and supervised by a doctor experienced in treating patients … -
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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
marketing-authorisation holder. Summary documents Prepandrix : EPAR - Summary … the EPAR) or contact your doctor or pharmacist. This summary … -
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Human medicine European public assessment report (EPAR): Lartruvo
Olaratumab, Sarcoma
Date of authorisation: 09/11/2016,, , 
, Revision: 3, Withdrawn, Last updated: 02/09/2019
need. Product information documents contain: summary of product … -
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Human medicine European public assessment report (EPAR): Daklinza
daclatasvir dihydrochloride, Hepatitis C, Chronic
Date of authorisation: 22/08/2014,, Revision: 15, Withdrawn, Last updated: 30/08/2019
need. Product information documents contain: summary of product … -
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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: 22/08/2019treated with Lartruvo, your doctor will consider the most appropriate … treatment with Lartruvo, doctors should consider the available … -
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Referral: Zynteglo
betibeglogene autotemcel, associated names: Zynteglo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 22/07/2021, EC decision date: 16/09/2021, Last updated: 08/07/2022 -
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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: 09/03/2017C virus infections, your doctor will monitor you closely … hepatitis B. • Tell your doctor if you have or have had hepatitis … infection. Speak to your doctor if you have any question … -
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Orphan designation: Recombinant human IgG1 kappa light chain monoclonal antibody targeting plasma kallikrein (lanadelumab) for: Treatment of hereditary angioedema
Date of designation: 09/10/2015, Positive, Last updated: 04/10/2022Documents related to this orphan designation … -
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Orphan designation: Chimeric anti-interleukin-6 monoclonal antibody (siltuximab) for: Treatment of Castleman's disease
Date of designation: 30/11/2007, Positive, Last updated: 26/08/2021Documents related to this orphan designation … scientific content of the document reflects the outcome of the … -
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Orphan designation: (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid for: Treatment of progressive familial intrahepatic cholestasis
Date of designation: 17/07/2012, Positive, Last updated: 28/07/2021Documents related to this orphan designation … -
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Orphan designation: Risdiplam for: Treatment of spinal muscular atrophy
Date of designation: 26/02/2019, Positive, Last updated: 04/05/2021Documents related to this orphan designation … -
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Orphan designation: Ketoconazole for: Treatment of Cushing's syndrome
Date of designation: 23/04/2012, Positive, Last updated: 22/09/2020Documents related to this orphan designation … scientific content of the document reflects the outcome of the … -
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Orphan designation: carfilzomib for: Treatment of multiple myeloma
Date of designation: 03/06/2008, Positive, Last updated: 02/12/2015opinion please refer to the PDF document below. Expand section Collapse … has provided satisfactory documentation to justify the assumption … scientific content of the document reflects the outcome of the … -
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Orphan designation: ciclosporin for: Treatment of vernal keratoconjunctivitis
Date of designation: 06/04/2006, Positive, Last updated: 12/07/2018please refer to the PDF document below … scientific content of the document reflects the outcome of the …