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EMEA-003501-PIP01-23

EMEA-003501-PIP01-23

Feb 19, 2025 0

EMEA-003501-PIP01-23

EMEA-003500-PIP01-23

EMEA-003500-PIP01-23

Feb 19, 2025 0

EMEA-003500-PIP01-23

EMEA-003392-PIP01-23

EMEA-003392-PIP01-23

Feb 19, 2025 0

EMEA-003392-PIP01-23

EMEA-003350-PIP01-23

EMEA-003350-PIP01-23

Feb 19, 2025 0

EMEA-003350-PIP01-23

EMEA-003182-PIP01-22-M01

EMEA-003182-PIP01-22-M01

Feb 19, 2025 0

EMEA-003182-PIP01-22-M01

EMEA-002904-PIP01-20-M01

EMEA-002904-PIP01-20-M01

Feb 19, 2025 0

EMEA-002904-PIP01-20-M01

Opinion/decision on a Paediatric investigation plan (PIP): Feraccru, ferric maltol, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Blood and lymphatic system disorders, PIP number: P/0503/2023

Opinion/decision on a Paediatric investigation plan (PI...

Feb 19, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Feraccru, ferric malt...

PSUSA/00000434/202407

PSUSA/00000434/202407

Feb 19, 2025 0

PSUSA/00000434/202407

Human medicines European public assessment report (EPAR): Obgemsa, vibegron, Date of authorisation: 27/06/2024, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 19, 2025 0

Human medicines European public assessment report (EPAR): Obgemsa, vibegron, Dat...

Human medicines European public assessment report (EPAR): Pluvicto, lutetium (177Lu) vipivotide tetraxetan, Date of authorisation: 09/12/2022, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 19, 2025 0

Human medicines European public assessment report (EPAR): Pluvicto, lutetium (17...

Human medicines European public assessment report (EPAR): Zoely, nomegestrol,estradiol, Date of authorisation: 26/07/2011, Revision: 25, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 19, 2025 0

Human medicines European public assessment report (EPAR): Zoely, nomegestrol,est...

Human medicines European public assessment report (EPAR): Vevizye, ciclosporin, Date of authorisation: 19/09/2024, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 19, 2025 0

Human medicines European public assessment report (EPAR): Vevizye, ciclosporin, ...

Human medicines European public assessment report (EPAR): Prevenar 20 (previously Apexxnar), pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed), Date of authorisation: 14/02/2022, Revision: 10, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 19, 2025 0

Human medicines European public assessment report (EPAR): Prevenar 20 (previousl...

EMA workshop on the challenges in drug development, regulation and clinical practice for immunoglobulins, Online, European Medicines Agency, Amsterdam, the Netherlands, from 5 March 2025, 14:00 (CET) to 5 March 2025, 18:00 (CET)

EMA workshop on the challenges in drug development, reg...

Feb 19, 2025 0

EMA workshop on the challenges in drug development, regulation and clinical prac...

Human medicines European public assessment report (EPAR): Pregabalin Sandoz, pregabalin, Date of authorisation: 19/06/2015, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 19, 2025 0

Human medicines European public assessment report (EPAR): Pregabalin Sandoz, pre...

Finding clinical trials with the ACT EU Trial Map, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 7 March 2025, 13:30 (CET) to 7 March 2025, 14:30 (CET)

Finding clinical trials with the ACT EU Trial Map, Onli...

Feb 19, 2025 0

Finding clinical trials with the ACT EU Trial Map, Online, European Medicines Ag...

Human medicines European public assessment report (EPAR): Balversa, Erdafitinib, Date of authorisation: 22/08/2024, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 19, 2025 0

Human medicines European public assessment report (EPAR): Balversa, Erdafitinib,...

Human medicines European public assessment report (EPAR): Apretude, cabotegravir, Date of authorisation: 15/09/2023, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 19, 2025 0

Human medicines European public assessment report (EPAR): Apretude, cabotegravir...

Human medicines European public assessment report (EPAR): Thyrogen, thyrotropin alfa, Date of authorisation: 09/03/2000, Revision: 32, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 19, 2025 0

Human medicines European public assessment report (EPAR): Thyrogen, thyrotropin ...

Clinical Trial Information System (CTIS) - Sponsor hand...

Feb 19, 2025 0

Clinical Trial Information System (CTIS) - Sponsor handbook

Human medicines European public assessment report (EPAR): Nemluvio, nemolizumab, Date of authorisation: 12/02/2025, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 19, 2025 0

Human medicines European public assessment report (EPAR): Nemluvio, nemolizumab,...

Human medicines European public assessment report (EPAR): Siiltibcy, Mycobacterium tuberculosis derived antigens (rdESAT-6 / rCFP-10), Date of authorisation: 13/01/2025, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 19, 2025 0

Human medicines European public assessment report (EPAR): Siiltibcy, Mycobacteri...

Assessment templates and guidance

Assessment templates and guidance

Feb 19, 2025 0

Assessment templates and guidance

Generic and hybrid applications

Generic and hybrid applications

Feb 19, 2025 0

Generic and hybrid applications

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