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Good Manufacturing Practice (GMP) / Distribution Practice Practice (GDP) Inspectors Working Group

Good Manufacturing Practice (GMP) / Distribution Practi...

Mar 27, 2025 0

Good Manufacturing Practice (GMP) / Distribution Practice Practice (GDP) Inspect...

Human medicines European public assessment report (EPAR): Brukinsa, zanubrutinib, Date of authorisation: 22/11/2021, Revision: 10, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 27, 2025 0

Human medicines European public assessment report (EPAR): Brukinsa, zanubrutinib...

$Human medicines European public assessment report (EPAR): Strimvelis, autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence, Date of authorisation: 26/05/2016, Revision: 11, Status: Authorised$

Human medicines European public assessment report (EPAR...

Mar 27, 2025 0

Human medicines European public assessment report (EPAR): Strimvelis, autologous...

Human medicines European public assessment report (EPAR): Eurneffy, epinephrine, Date of authorisation: 22/08/2024, Revision: 4, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 27, 2025 0

Human medicines European public assessment report (EPAR): Eurneffy, epinephrine,...

Human medicines European public assessment report (EPAR): Rozlytrek, entrectinib, Date of authorisation: 31/07/2020, Revision: 10, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 27, 2025 0

Human medicines European public assessment report (EPAR): Rozlytrek, entrectinib...

Human medicines European public assessment report (EPAR): Ontozry, cenobamate, Date of authorisation: 26/03/2021, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 27, 2025 0

Human medicines European public assessment report (EPAR): Ontozry, cenobamate, D...

Human medicines European public assessment report (EPAR): Vegzelma, bevacizumab, Date of authorisation: 17/08/2022, Revision: 10, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 26, 2025 0

Human medicines European public assessment report (EPAR): Vegzelma, bevacizumab,...

Human medicines European public assessment report (EPAR): Korjuny, catumaxomab, Date of authorisation: 10/02/2025, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 26, 2025 0

Human medicines European public assessment report (EPAR): Korjuny, catumaxomab, ...

Human medicines European public assessment report (EPAR): Columvi, glofitamab, Date of authorisation: 07/07/2023, Revision: 4, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 26, 2025 0

Human medicines European public assessment report (EPAR): Columvi, glofitamab, D...

Human medicines European public assessment report (EPAR): Kadcyla, trastuzumab emtansine, Date of authorisation: 15/11/2013, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 26, 2025 0

Human medicines European public assessment report (EPAR): Kadcyla, trastuzumab e...

Human medicines European public assessment report (EPAR): Uplizna, inebilizumab, Date of authorisation: 25/04/2022, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 26, 2025 0

Human medicines European public assessment report (EPAR): Uplizna, inebilizumab,...

EU Implementation Guide (IG) on veterinary medicines pr...

Mar 26, 2025 0

EU Implementation Guide (IG) on veterinary medicines product data in the Union P...

Human medicines European public assessment report (EPAR): Lopinavir/Ritonavir Viatris (previously Ritonavir Mylan), lopinavir,ritonavir, Date of authorisation: 14/01/2016, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 26, 2025 0

Human medicines European public assessment report (EPAR): Lopinavir/Ritonavir Vi...

Human medicines European public assessment report (EPAR): Nimvastid, rivastigmine, Date of authorisation: 11/05/2009, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 26, 2025 0

Human medicines European public assessment report (EPAR): Nimvastid, rivastigmin...

Human medicines European public assessment report (EPAR): Cosentyx, secukinumab, Date of authorisation: 14/01/2015, Revision: 40, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 26, 2025 0

Human medicines European public assessment report (EPAR): Cosentyx, secukinumab,...

EMEA-003589-PIP01-24

EMEA-003589-PIP01-24

Mar 26, 2025 0

EMEA-003589-PIP01-24

EMEA-003512-PIP01-23

EMEA-003512-PIP01-23

Mar 26, 2025 0

EMEA-003512-PIP01-23

EMEA-003458-PIP01-23

EMEA-003458-PIP01-23

Mar 26, 2025 0

EMEA-003458-PIP01-23

Human medicines European public assessment report (EPAR): Samsca, tolvaptan, Date of authorisation: 02/08/2009, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 26, 2025 0

Human medicines European public assessment report (EPAR): Samsca, tolvaptan, Dat...

Human medicines European public assessment report (EPAR): Xenpozyme, olipudase alfa, Date of authorisation: 24/06/2022, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 26, 2025 0

Human medicines European public assessment report (EPAR): Xenpozyme, olipudase a...

EMEA-003402-PIP01-23

EMEA-003402-PIP01-23

Mar 26, 2025 0

EMEA-003402-PIP01-23

EMEA-003027-PIP02-23

EMEA-003027-PIP02-23

Mar 26, 2025 0

EMEA-003027-PIP02-23

Human medicines European public assessment report (EPAR): Nyxoid, naloxone, Date of authorisation: 09/11/2017, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 26, 2025 0

Human medicines European public assessment report (EPAR): Nyxoid, naloxone, Date...

Human medicines European public assessment report (EPAR): Cyramza, ramucirumab, Date of authorisation: 19/12/2014, Revision: 20, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 26, 2025 0

Human medicines European public assessment report (EPAR): Cyramza, ramucirumab, ...

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