Biopharma

Quality Working Party

Quality Working Party

Feb 9, 2025 0

Quality Working Party

Rheumatology/Immunology Working Party

Rheumatology/Immunology Working Party

Feb 9, 2025 0

Rheumatology/Immunology Working Party

Haematology Working Party

Haematology Working Party

Feb 9, 2025 0

Haematology Working Party

Human medicines European public assessment report (EPAR): Repaglinide Krka, repaglinide, Date of authorisation: 03/11/2009, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Repaglinide Krka, repa...

Questions and answers clinic on post-authorisation procedure management in IRIS, Online, from 8 January 2025, 14:00 (CET) to 8 January 2025, 15:00 (CET)

Questions and answers clinic on post-authorisation proc...

Feb 9, 2025 0

Questions and answers clinic on post-authorisation procedure management in IRIS,...

Human medicines European public assessment report (EPAR): Vueway, Gadopiclenol, Date of authorisation: 07/12/2023, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Vueway, Gadopiclenol, ...

Human medicines European public assessment report (EPAR): Elucirem, Gadopiclenol, Date of authorisation: 07/12/2023, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Elucirem, Gadopiclenol...

Human medicines European public assessment report (EPAR): Truxima, rituximab, Date of authorisation: 17/02/2017, Revision: 23, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Truxima, rituximab, Da...

Human medicines European public assessment report (EPAR): Vabysmo, faricimab, Date of authorisation: 15/09/2022, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Vabysmo, faricimab, Da...

Human medicines European public assessment report (EPAR): Cejemly, sugemalimab, Date of authorisation: 24/07/2024, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Cejemly, sugemalimab, ...

Human medicines European public assessment report (EPAR): Alkindi, hydrocortisone, Date of authorisation: 09/02/2018, Revision: 10, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Alkindi, hydrocortison...

Human medicines European public assessment report (EPAR): Rapamune, sirolimus, Date of authorisation: 13/03/2001, Revision: 48, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Rapamune, sirolimus, D...

Human medicines European public assessment report (EPAR): Nivestim, filgrastim, Date of authorisation: 07/06/2010, Revision: 31, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Nivestim, filgrastim, ...

Human medicines European public assessment report (EPAR): Remicade, infliximab, Date of authorisation: 13/08/1999, Revision: 66, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Remicade, infliximab, ...

Human medicines European public assessment report (EPAR): Hukyndra, adalimumab, Date of authorisation: 15/11/2021, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Hukyndra, adalimumab, ...

Human medicines European public assessment report (EPAR): Kisqali, ribociclib, Date of authorisation: 22/08/2017, Revision: 20, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Kisqali, ribociclib, D...

Human medicines European public assessment report (EPAR): Jalra, vildagliptin, Date of authorisation: 19/11/2008, Revision: 25, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Jalra, vildagliptin, D...

Human medicines European public assessment report (EPAR): Xiliarx, vildagliptin, Date of authorisation: 19/11/2008, Revision: 24, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Xiliarx, vildagliptin,...

Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d., emtricitabine,tenofovir disoproxil, Date of authorisation: 28/04/2017, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovi...

Human medicines European public assessment report (EPAR): Ponvory, ponesimod, Date of authorisation: 19/05/2021, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Ponvory, ponesimod, Da...

Human medicines European public assessment report (EPAR): Ilaris, canakinumab, Date of authorisation: 23/10/2009, Revision: 33, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Ilaris, canakinumab, D...

Human medicines European public assessment report (EPAR): Urorec, silodosin, Date of authorisation: 29/01/2010, Revision: 19, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Urorec, silodosin, Dat...

Clinical Trials Information System (CTIS) bitesize talk: Change of sponsor in CTIS, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 5 March 2025, 15:30 (CET) to 5 March 2025, 17:00 (CET)

Clinical Trials Information System (CTIS) bitesize talk...

Feb 9, 2025 0

Clinical Trials Information System (CTIS) bitesize talk: Change of sponsor in CT...

Questions and answers clinic on post-authorisation procedure management in IRIS - 17 Jan 2025, Online, from 17 January 2025, 10:00 (CET) to 17 January 2025, 11:00 (CET)

Questions and answers clinic on post-authorisation proc...

Feb 9, 2025 0

Questions and answers clinic on post-authorisation procedure management in IRIS ...

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