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P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) (17) Apply P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) filter PM: decision on the application for modification of an agreed PIP (150) Apply PM: decision on the application for modification of an agreed PIP filter RPM: decision refers to a refusal on the application for modification of an agreed PIP (1) Apply RPM: decision refers to a refusal on the application for modification of an agreed PIP filter RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) (1) Apply RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) filter W: decision granting a waiver in all age groups for all conditions or indications (37) Apply W: decision granting a waiver in all age groups for all conditions or indications filter

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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Paediatric investigation plans Remove Paediatric investigation plans filter

Medicine type Additional monitoring Remove Additional monitoring filter Accelerated assessment Remove Accelerated assessment filter Exceptional circumstances Remove Exceptional circumstances filter Biosimilar Remove Biosimilar filter

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

Tucatinib, Breast Neoplasms; Neoplasm Metastasis
Date of authorisation: 11/02/2021, , Revision: 3, Authorised, Last updated: 27/02/2023
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Human medicine European public assessment report (EPAR): Veltassa (updated)

patiromer sorbitex calcium, Hyperkalemia
Date of authorisation: 19/07/2017, , Revision: 7, Authorised, Last updated: 24/02/2023
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Human medicine European public assessment report (EPAR): Pelmeg (updated)

pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018, , , Revision: 7, Authorised, Last updated: 24/02/2023
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Human medicine European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma) (updated)

pegfilgrastim, Neutropenia
Date of authorisation: 19/12/2019, , , Revision: 7, Authorised, Last updated: 24/02/2023
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK) (updated)

Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020, , , , Revision: 7, Authorised, Last updated: 24/02/2023
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Human medicine European public assessment report (EPAR): Evenity (updated)

Romosozumab, Osteoporosis
Date of authorisation: 09/12/2019, , Revision: 3, Authorised, Last updated: 23/02/2023
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Human medicine European public assessment report (EPAR): Qinlock (updated)

ripretinib, Gastrointestinal Stromal Tumors
Date of authorisation: 18/11/2021, , , Revision: 2, Authorised, Last updated: 23/02/2023
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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: 13, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Ilumetri (updated)

tildrakizumab, Psoriasis
Date of authorisation: 17/09/2018, , Revision: 8, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Hyrimoz (updated)

adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Crohn Disease; Skin Diseases, Papulosquamous
Date of authorisation: 26/07/2018, , , Revision: 10, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Lamzede (updated)

velmanase alfa, alpha-Mannosidosis
Date of authorisation: 23/03/2018, , , , Revision: 6, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Natpar (updated)

parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017, , , , Revision: 14, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Trodelvy (updated)

Sacituzumab govitecan, Breast Neoplasms; Triple Negative Breast Neoplasms
Date of authorisation: 22/11/2021, , Revision: 2, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Verzenios (updated)

abemaciclib, Breast Neoplasms
Date of authorisation: 26/09/2018, , Revision: 9, Authorised, Last updated: 22/02/2023
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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: 35, Authorised, Last updated: 21/02/2023
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Human medicine European public assessment report (EPAR): Pifeltro (updated)

doravirine, HIV Infections
Date of authorisation: 22/11/2018, , Revision: 7, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Delstrigo (updated)

doravirine, lamivudine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 22/11/2018, , Revision: 10, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Tezspire (updated)

tezepelumab, Asthma
Date of authorisation: 19/09/2022, , Revision: 2, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Nexpovio (updated)

Selinexor, Multiple Myeloma
Date of authorisation: 26/03/2021, , Revision: 7, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Piqray (updated)

Alpelisib, Breast Neoplasms
Date of authorisation: 27/07/2020, , Revision: 8, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Oxbryta (updated)

Voxelotor, Anemia; Anemia, Hemolytic; Anemia, Sickle Cell
Date of authorisation: 14/02/2022, , , Revision: 2, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Yselty (updated)

linzagolix choline, Leiomyoma
Date of authorisation: 14/06/2022, , Revision: 2, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Remsima (updated)

infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013, , Revision: 32, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Sixmo (updated)

Buprenorphine hydrochloride, Opioid-Related Disorders
Date of authorisation: 19/06/2019, , Revision: 4, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Kerendia (updated)

Finerenone, Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2
Date of authorisation: 16/02/2022, , Revision: 1, Authorised, Last updated: 20/02/2023