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1045 results
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Human medicine European public assessment report (EPAR): Iclusig (updated)
ponatinib, Leukemia, Myeloid, Leukemia, Lymphoid
Date of authorisation: 01/07/2013,
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, Revision: 21, Authorised, Last updated: 29/07/2021
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Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)
Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Hawaii/70/2019 (H1N1)pdm09-like strain (A/Nebraska/14/2019, wild type); A/Hong Kong/45/2019 (H3N2)-like strain (A/Delaware/39/2019, wild type); B/Washington/02/2019-like strain (B/Darwin/7/2019, wild type); B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human
Date of authorisation: 12/12/2018,, Revision: 9, Authorised, Last updated: 29/07/2021
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Human medicine European public assessment report (EPAR): Nerlynx (updated)
neratinib, Breast Neoplasms
Date of authorisation: 31/08/2018,, Revision: 7, Authorised, Last updated: 29/07/2021
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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: 10, Authorised, Last updated: 29/07/2021
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Human medicine European public assessment report (EPAR): Fluad Tetra (updated)
A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/2570/2019 IVR‐215) A/Cambodia/e0826360/2020 (H3N2) - like strain (A/Cambodia/e0826360/2020 IVR‐224) B/Washington/02/2019 – like strain (B/Victoria/705/2018 BVR‐11) B/Phuket/3073/2013 – like strain (B/Phuket/3073/2013 BVR‐1B), Influenza, Human
Date of authorisation: 20/05/2020,, Revision: 2, Authorised, Last updated: 29/07/2021
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Human medicine European public assessment report (EPAR): Ryeqo (updated)
Relugolix, norethisterone acetate, estradiol hemihydrate, Leiomyoma
Date of authorisation: 16/07/2021,, Authorised, Last updated: 29/07/2021
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Human medicine European public assessment report (EPAR): Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited) (updated)
pemetrexed ditromethamine, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 24/04/2017,
, Revision: 7, Withdrawn, Last updated: 29/07/2021
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Human medicine European public assessment report (EPAR): Taltz (updated)
ixekizumab, Psoriasis
Date of authorisation: 25/04/2016,, Revision: 13, Authorised, Last updated: 28/07/2021
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Human medicine European public assessment report (EPAR): Maviret (updated)
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,, , Revision: 13, Authorised, Last updated: 28/07/2021
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Human medicine European public assessment report (EPAR): Wakix (updated)
pitolisant, Narcolepsy
Date of authorisation: 31/03/2016,, , Revision: 11, Authorised, Last updated: 28/07/2021
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Human medicine European public assessment report (EPAR): Respreeza (updated)
Human alpha1-proteinase inhibitor, Genetic Diseases, Inborn, Lung Diseases
Date of authorisation: 20/08/2015,, Revision: 9, Authorised, Last updated: 28/07/2021
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Human medicine European public assessment report (EPAR): Orphacol (updated)
cholic acid, Digestive System Diseases, Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012,, , 
, Revision: 10, Authorised, Last updated: 28/07/2021
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Human medicine European public assessment report (EPAR): Orkambi (updated)
Lumacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 18/11/2015,, Revision: 25, Authorised, Last updated: 28/07/2021
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Human medicine European public assessment report (EPAR): Rekambys (updated)
rilpivirine, HIV Infections
Date of authorisation: 17/12/2020,, Revision: 1, Authorised, Last updated: 28/07/2021
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Human medicine European public assessment report (EPAR): Imfinzi (updated)
durvalumab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 21/09/2018,, Revision: 8, Authorised, Last updated: 27/07/2021
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Human medicine European public assessment report (EPAR): Skysona (updated)
elivaldogene autotemcel, Adrenoleukodystrophy
Date of authorisation: 16/07/2021,, , Authorised, Last updated: 27/07/2021
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Human medicine European public assessment report (EPAR): Portrazza (updated)
necitumumab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 15/02/2016,, Revision: 3, Withdrawn, Last updated: 27/07/2021
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Human medicine European public assessment report (EPAR): Verquvo (updated)
Vericiguat, Heart Failure
Date of authorisation: 16/07/2021,, Authorised, Last updated: 27/07/2021
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Human medicine European public assessment report (EPAR): Fulphila (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018,, 
, Revision: 7, Authorised, Last updated: 26/07/2021
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Human medicine European public assessment report (EPAR): Lenalidomide Mylan (updated)
lenalidomide, Multiple Myeloma
Date of authorisation: 18/12/2020,, Revision: 2, Authorised, Last updated: 26/07/2021
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Human medicine European public assessment report (EPAR): Tadalafil Mylan (updated)
tadalafil, Erectile Dysfunction
Date of authorisation: 21/11/2014,, Revision: 12, Authorised, Last updated: 26/07/2021
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Human medicine European public assessment report (EPAR): Spikevax (previously 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: 10, Authorised, Last updated: 26/07/2021
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Human medicine European public assessment report (EPAR): Keytruda (updated)
Pembrolizumab, Melanoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Urologic Neoplasms, Squamous Cell Carcinoma of Head and Neck
Date of authorisation: 17/07/2015,, Revision: 36, Authorised, Last updated: 23/07/2021
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Human medicine European public assessment report (EPAR): Palforzia (updated)
defatted powder of Arachis hypogaea L., semen (peanuts), Peanut Hypersensitivity
Date of authorisation: 17/12/2020,, Revision: 1, Authorised, Last updated: 23/07/2021
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Human medicine European public assessment report (EPAR): Rasagiline Mylan (updated)
rasagiline tartrate, Parkinson Disease
Date of authorisation: 04/04/2016,, Revision: 4, Authorised, Last updated: 23/07/2021