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129 results

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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Withdrawn applications Remove Withdrawn applications filter Referrals Remove Referrals filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Paediatric investigation plans Remove Paediatric investigation plans filter

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Human medicine European public assessment report (EPAR): COVID-19 Vaccine Moderna (updated)

CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) 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: 06/01/2021, , , Revision: 2, Authorised, Last updated: 07/05/2021
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: 2, Authorised, Last updated: 07/05/2021
List item

Human medicine European public assessment report (EPAR): Translarna (updated)

Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014, , , , Revision: 19, Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Evoltra (updated)

clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006, , , Revision: 30, Authorised, Last updated: 04/05/2021
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Human medicine European public assessment report (EPAR): Ninlaro (updated)

ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016, , , , Revision: 10, Authorised, Last updated: 30/04/2021
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: 6, Authorised, Last updated: 29/04/2021
List item

Human medicine European public assessment report (EPAR): Lorviqua (updated)

Lorlatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2019, , , Revision: 5, Authorised, Last updated: 29/04/2021
List item

Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)

ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021, , , Revision: 6, Authorised, Last updated: 28/04/2021
List item

Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) (updated)

dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017, , , , Revision: 9, Authorised, Last updated: 26/04/2021
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Human medicine European public assessment report (EPAR): Obizur (updated)

susoctocog alfa, Hemophilia A
Date of authorisation: 11/11/2015, , , Revision: 7, Authorised, Last updated: 23/04/2021
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Human medicine European public assessment report (EPAR): Natpar (updated)

parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017, , , , Revision: 9, Authorised, Last updated: 23/04/2021
List item

Human medicine European public assessment report (EPAR): Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune) (updated)

reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain, Influenza, Human
Date of authorisation: 20/05/2016, , , Revision: 7, Authorised, Last updated: 23/04/2021
List item

Human medicine European public assessment report (EPAR): Zolgensma (updated)

onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020, , , , Revision: 2, Authorised, Last updated: 19/04/2021
List item

Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK) (updated)

Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020, , , , Revision: 3, Authorised, Last updated: 09/04/2021
List item

Human medicine European public assessment report (EPAR): Rubraca (updated)

rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018, , , Revision: 6, Authorised, Last updated: 09/04/2021
List item

Human medicine European public assessment report (EPAR): Brineura (updated)

cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017, , , , , Revision: 5, Authorised, Last updated: 08/04/2021
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Human medicine European public assessment report (EPAR): Libtayo

Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019, , , Revision: 6, Authorised, Last updated: 07/04/2021
List item

Human medicine European public assessment report (EPAR): Cometriq

cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014, , , , Revision: 21, Authorised, Last updated: 29/03/2021
List item

Human medicine European public assessment report (EPAR): Strensiq

asfotase alfa, Hypophosphatasia
Date of authorisation: 28/08/2015, , , , Revision: 14, Authorised, Last updated: 25/03/2021
List item

Human medicine European public assessment report (EPAR): Deltyba

Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013, , , , Revision: 15, Authorised, Last updated: 23/03/2021
List item

Human medicine European public assessment report (EPAR): Blenrep

belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020, , , , Revision: 2, Authorised, Last updated: 17/03/2021
List item

Human medicine European public assessment report (EPAR): Naglazyme

galsulfase, Mucopolysaccharidosis VI
Date of authorisation: 23/01/2006, , , Revision: 18, Authorised, Last updated: 17/03/2021
List item

Human medicine European public assessment report (EPAR): Foclivia

influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 18/10/2009, , Revision: 11, Authorised, Last updated: 10/03/2021
List item

Human medicine European public assessment report (EPAR): Vyndaqel

tafamidis, Amyloidosis
Date of authorisation: 16/11/2011, , , , Revision: 18, Authorised, Last updated: 02/03/2021
List item

Human medicine European public assessment report (EPAR): Ondexxya

andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019, , , Revision: 8, Authorised, Last updated: 01/03/2021

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129 results

Human medicine European public assessment report (EPAR): COVID-19 Vaccine Moderna (updated)

Human medicine European public assessment report (EPAR): COVID-19 Vaccine Janssen (updated)

Human medicine European public assessment report (EPAR): Translarna (updated)

Human medicine European public assessment report (EPAR): Evoltra (updated)

Human medicine European public assessment report (EPAR): Ninlaro (updated)

Human medicine European public assessment report (EPAR): Comirnaty (updated)

Human medicine European public assessment report (EPAR): Lorviqua (updated)

Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)

Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) (updated)

Human medicine European public assessment report (EPAR): Obizur (updated)

Human medicine European public assessment report (EPAR): Natpar (updated)

Human medicine European public assessment report (EPAR): Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune) (updated)

Human medicine European public assessment report (EPAR): Zolgensma (updated)

Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK) (updated)

Human medicine European public assessment report (EPAR): Rubraca (updated)

Human medicine European public assessment report (EPAR): Brineura (updated)

Human medicine European public assessment report (EPAR): Libtayo

Human medicine European public assessment report (EPAR): Cometriq

Human medicine European public assessment report (EPAR): Strensiq

Human medicine European public assessment report (EPAR): Deltyba

Human medicine European public assessment report (EPAR): Blenrep

Human medicine European public assessment report (EPAR): Naglazyme

Human medicine European public assessment report (EPAR): Foclivia

Human medicine European public assessment report (EPAR): Vyndaqel

Human medicine European public assessment report (EPAR): Ondexxya