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823 results

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

Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016, , , Revision: 14, Authorised, Last updated: 31/03/2021
List item

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

adalimumab, Hidradenitis Suppurativa, Psoriasis, Crohn Disease, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, Arthritis, Psoriatic
Date of authorisation: 16/09/2018, , , Revision: 5, Authorised, Last updated: 30/03/2021
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: 4, Authorised, Last updated: 30/03/2021
List item

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: 1, Authorised, Last updated: 30/03/2021
List item

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

trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 26/07/2018, , , Revision: 7, Authorised, Last updated: 29/03/2021
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Human medicine European public assessment report (EPAR): Cometriq (updated)

cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014, , , , Revision: 21, Authorised, Last updated: 29/03/2021
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Human medicine European public assessment report (EPAR): Ocrevus (updated)

ocrelizumab, Multiple Sclerosis
Date of authorisation: 08/01/2018, , Revision: 10, Authorised, Last updated: 29/03/2021
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Human medicine European public assessment report (EPAR): Axumin (updated)

Fluciclovine (18F), Prostatic Neoplasms, Radionuclide Imaging
Date of authorisation: 21/05/2017, , Revision: 11, Authorised, Last updated: 25/03/2021
List item

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

Crisaborole, Dermatitis, Atopic
Date of authorisation: 27/03/2020, , Revision: 3, Authorised, Last updated: 25/03/2021
List item

Human medicine European public assessment report (EPAR): Telmisartan Teva (updated)

telmisartan, Hypertension
Date of authorisation: 25/01/2010, , Revision: 11, Authorised, Last updated: 25/03/2021
List item

Human medicine European public assessment report (EPAR): Zoledronic Acid Hospira (updated)

zoledronic acid monohydrate, Hypercalcemia
Date of authorisation: 19/11/2012, , Revision: 17, Authorised, Last updated: 25/03/2021
List item

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

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): Lenvima (updated)

lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015, , , Revision: 15, Authorised, Last updated: 25/03/2021
List item

Human medicine European public assessment report (EPAR): Deferiprone Lipomed (updated)

Deferiprone, Iron Overload, beta-Thalassemia
Date of authorisation: 19/09/2018, , Revision: 3, Authorised, Last updated: 25/03/2021
List item

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

alemtuzumab, Multiple Sclerosis
Date of authorisation: 12/09/2013, , , Revision: 11, Authorised, Last updated: 25/03/2021
List item

Human medicine European public assessment report (EPAR): Bortezomib Fresenius Kabi (updated)

bortezomib, Multiple Myeloma
Date of authorisation: 14/11/2019, , Revision: 4, Authorised, Last updated: 24/03/2021
List item

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

Naldemedine tosilate, Constipation
Date of authorisation: 18/02/2019, , Revision: 5, Authorised, Last updated: 24/03/2021
List item

Human medicine European public assessment report (EPAR): Bortezomib Hospira (updated)

bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016, , Revision: 10, Authorised, Last updated: 24/03/2021
List item

Human medicine European public assessment report (EPAR): Bortezomib Accord (updated)

bortezomib, Multiple Myeloma
Date of authorisation: 20/07/2015, , Revision: 9, Authorised, Last updated: 24/03/2021
List item

Veterinary medicine European public assessment report (EPAR): Acticam (updated)

meloxicam, Dogs, Cats
Date of authorisation: 09/12/2008, , Revision: 9, Withdrawn, Last updated: 24/03/2021
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Veterinary medicine European public assessment report (EPAR): Kriptazen (updated)

halofuginone, Calves, newborn
Date of authorisation: 08/02/2019, , Revision: 1, Authorised, Last updated: 24/03/2021
List item

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

Angiotensin II acetate, Hypotension, Shock
Date of authorisation: 23/08/2019, , Revision: 1, Authorised, Last updated: 23/03/2021
List item

Human medicine European public assessment report (EPAR): Ambrisentan Mylan (updated)

ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019, , Revision: 2, Authorised, Last updated: 23/03/2021
List item

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

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): Olanzapine Mylan (updated)

olanzapine, Schizophrenia, Bipolar Disorder
Date of authorisation: 06/10/2008, , Revision: 16, Authorised, Last updated: 23/03/2021

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823 results

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

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

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

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

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

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

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

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

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

Human medicine European public assessment report (EPAR): Telmisartan Teva (updated)

Human medicine European public assessment report (EPAR): Zoledronic Acid Hospira (updated)

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

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

Human medicine European public assessment report (EPAR): Deferiprone Lipomed (updated)

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

Human medicine European public assessment report (EPAR): Bortezomib Fresenius Kabi (updated)

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

Human medicine European public assessment report (EPAR): Bortezomib Hospira (updated)

Human medicine European public assessment report (EPAR): Bortezomib Accord (updated)

Veterinary medicine European public assessment report (EPAR): Acticam (updated)

Veterinary medicine European public assessment report (EPAR): Kriptazen (updated)

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

Human medicine European public assessment report (EPAR): Ambrisentan Mylan (updated)

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

Human medicine European public assessment report (EPAR): Olanzapine Mylan (updated)