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

Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016, , , , Revision: 16, Authorised, Last updated: 03/08/2021
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Human medicine European public assessment report (EPAR): Ontozry (updated)

cenobamate, Epilepsy
Date of authorisation: 26/03/2021, , Revision: 2, Authorised, Last updated: 03/08/2021
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Human medicine European public assessment report (EPAR): Ninlaro (updated)

ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016, , , , Revision: 11, Authorised, Last updated: 03/08/2021
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Human medicine European public assessment report (EPAR): Nyvepria (updated)

pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020, , , Revision: 3, Authorised, Last updated: 03/08/2021
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Human medicine European public assessment report (EPAR): Phesgo (updated)

pertuzumab, trastuzumab, Breast Neoplasms
Date of authorisation: 21/12/2020, , Revision: 1, Authorised, Last updated: 03/08/2021
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Human medicine European public assessment report (EPAR): Calquence (updated)

Acalabrutinib, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 05/11/2020, , Revision: 1, Authorised, Last updated: 02/08/2021
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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: 30/07/2021
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Human medicine European public assessment report (EPAR): Trumenba (updated)

Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily A; Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily B, Meningitis, Meningococcal
Date of authorisation: 24/05/2017, , Revision: 10, Authorised, Last updated: 30/07/2021
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Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)

A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Washington/19/2020, wild type); A/Cambodia/e0826360/2020 (H3N2)-like strain (A/Tasmania/503/2020, 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): Sarclisa (updated)

Isatuximab, Multiple Myeloma
Date of authorisation: 30/05/2020, , Revision: 2, Authorised, Last updated: 29/07/2021
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Human medicine European public assessment report (EPAR): Blenrep (updated)

belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020, , , , Revision: 2, Authorised, Last updated: 29/07/2021
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Human medicine European public assessment report (EPAR): Iclusig (updated)

ponatinib, Leukemia, Myeloid, Leukemia, Lymphoid
Date of authorisation: 01/07/2013, , , , Revision: 21, 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): Bylvay (updated)

Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021, , , , Authorised, Last updated: 28/07/2021
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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