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Biosimilar medicines: marketing authorisation

Biosimilar medicines: marketing authorisation

Feb 19, 2025 0

Biosimilar medicines: marketing authorisation

Human medicines European public assessment report (EPAR): Neupro, rotigotine, Date of authorisation: 15/02/2006, Revision: 35, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 19, 2025 0

Human medicines European public assessment report (EPAR): Neupro, rotigotine, Da...

Human medicines European public assessment report (EPAR): Blenrep, belantamab mafodotin, Date of authorisation: 25/08/2020, Revision: 8, Status: Withdrawn

Human medicines European public assessment report (EPAR...

Feb 19, 2025 0

Human medicines European public assessment report (EPAR): Blenrep, belantamab ma...

Orphan designation: Humanised monoclonal antibody targeting B-cell maturation antigen conjugated with maleimidocaproyl monomethyl auristatin F Treatment of multiple myeloma, 16/10/2017 Withdrawn

Orphan designation: Humanised monoclonal antibody targe...

Feb 19, 2025 0

Orphan designation: Humanised monoclonal antibody targeting B-cell maturation an...

Human medicines European public assessment report (EPAR): Galvus, vildagliptin, Date of authorisation: 25/09/2007, Revision: 25, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 19, 2025 0

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

Human medicines European public assessment report (EPAR): Erbitux, cetuximab, Date of authorisation: 29/06/2004, Revision: 33, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 19, 2025 0

Human medicines European public assessment report (EPAR): Erbitux, cetuximab, Da...

Type-IA variations: questions and answers

Type-IA variations: questions and answers

Feb 19, 2025 0

Type-IA variations: questions and answers

Human medicines European public assessment report (EPAR): Ravicti, glycerol phenylbutyrate, Date of authorisation: 26/11/2015, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 18, 2025 0

Human medicines European public assessment report (EPAR): Ravicti, glycerol phen...

Human medicines European public assessment report (EPAR): Iclusig, ponatinib, Date of authorisation: 01/07/2013, Revision: 26, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 18, 2025 0

Human medicines European public assessment report (EPAR): Iclusig, ponatinib, Da...

Human medicines European public assessment report (EPAR): Ebvallo, tabelecleucel, Date of authorisation: 16/12/2022, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 18, 2025 0

Human medicines European public assessment report (EPAR): Ebvallo, tabelecleucel...

Human medicines European public assessment report (EPAR): Avamys, fluticasone furoate, Date of authorisation: 11/01/2008, Revision: 24, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 18, 2025 0

Human medicines European public assessment report (EPAR): Avamys, fluticasone fu...

Human medicines European public assessment report (EPAR): Cimzia, certolizumab pegol, Date of authorisation: 01/10/2009, Revision: 36, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 18, 2025 0

Human medicines European public assessment report (EPAR): Cimzia, certolizumab p...

Human medicines European public assessment report (EPAR): Iclusig, ponatinib, Date of authorisation: 01/07/2013, Revision: 25, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 18, 2025 0

Human medicines European public assessment report (EPAR): Iclusig, ponatinib, Da...

Human medicines European public assessment report (EPAR): Flucelvax Tetra, influenza vaccine (surface antigen, inactivated, prepared in cell cultures), Date of authorisation: 12/12/2018, Revision: 17, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 18, 2025 0

Human medicines European public assessment report (EPAR): Flucelvax Tetra, influ...

Artificial intelligence

Artificial intelligence

Feb 18, 2025 0

Artificial intelligence

Human medicines European public assessment report (EPAR): Imjudo, tremelimumab, Date of authorisation: 20/02/2023, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 18, 2025 0

Human medicines European public assessment report (EPAR): Imjudo, tremelimumab, ...

Human medicines European public assessment report (EPAR): Spexotras, trametinib, Date of authorisation: 05/01/2024, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 18, 2025 0

Human medicines European public assessment report (EPAR): Spexotras, trametinib,...

Human medicines European public assessment report (EPAR): Vyndaqel, tafamidis, Date of authorisation: 16/11/2011, Revision: 30, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 18, 2025 0

Human medicines European public assessment report (EPAR): Vyndaqel, tafamidis, D...

Human medicines European public assessment report (EPAR): GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.), budesonide,formoterol fumarate dihydrate, Date of authorisation: 03/04/2020, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 18, 2025 0

Human medicines European public assessment report (EPAR): GoResp Digihaler (prev...

Checklist for the submission of Type IA and Type IB (wi...

Feb 18, 2025 0

Checklist for the submission of Type IA and Type IB (without linguistic review) ...

Type-IB variations: questions and answers

Type-IB variations: questions and answers

Feb 18, 2025 0

Type-IB variations: questions and answers

Worksharing: questions and answers

Worksharing: questions and answers

Feb 18, 2025 0

Worksharing: questions and answers

Changing the labelling and package leaflet (Article 61(3) notifications)

Changing the labelling and package leaflet (Article 61(...

Feb 18, 2025 0

Changing the labelling and package leaflet (Article 61(3) notifications)

Type-II variations: questions and answers

Type-II variations: questions and answers

Feb 18, 2025 0

Type-II variations: questions and answers

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