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Opinion/decision on a Paediatric investigation plan (PIP): Qdenga, Dengue tetravalent vaccine (live, attenuated), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations, PIP number: P/0003/2024

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

Mar 13, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Qdenga, Dengue tetrav...

Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, Upadacitinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immune system disorders, PIP number: P/0010/2024

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

Mar 13, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, Upadacitinib,...

EMEA-000205-PIP02-11-M06

EMEA-000205-PIP02-11-M06

Mar 13, 2025 0

EMEA-000205-PIP02-11-M06

Human medicines European public assessment report (EPAR): Zolsketil pegylated liposomal, doxorubicin, Date of authorisation: 31/05/2022, Revision: 4, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 13, 2025 0

Human medicines European public assessment report (EPAR): Zolsketil pegylated li...

European Shortages Monitoring Platform (ESMP) training on crisis and MSSG-led preparedness reporting for marketing authorisation holders (MAHs), Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 19 February 2025, 10:00 (CET) to 19 February 2025, 12:30 (CET)

European Shortages Monitoring Platform (ESMP) training ...

Mar 13, 2025 0

European Shortages Monitoring Platform (ESMP) training on crisis and MSSG-led pr...

Human medicines European public assessment report (EPAR): Naveruclif, paclitaxel, Date of authorisation: 05/01/2024, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 13, 2025 0

Human medicines European public assessment report (EPAR): Naveruclif, paclitaxel...

Human medicines European public assessment report (EPAR): Imraldi, adalimumab, Date of authorisation: 24/08/2017, Revision: 24, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 13, 2025 0

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

EMEA-001213-PIP03-23

EMEA-001213-PIP03-23

Mar 13, 2025 0

EMEA-001213-PIP03-23

High-risk medical devices: consultation procedures and advice

High-risk medical devices: consultation procedures and ...

Mar 13, 2025 0

High-risk medical devices: consultation procedures and advice

List of clinical evaluation consultation procedure (CEC...

Mar 13, 2025 0

List of clinical evaluation consultation procedure (CECP) opinions issued for me...

Drug-Eluting stent (DES) - Notified Body 2265 - 10/01/2...

Mar 13, 2025 0

Drug-Eluting stent (DES) - Notified Body 2265 - 10/01/2025 - Expert decision and...

EMEA-000383-PIP04-23

EMEA-000383-PIP04-23

Mar 13, 2025 0

EMEA-000383-PIP04-23

Human medicines European public assessment report (EPAR): Entyvio, vedolizumab, Date of authorisation: 22/05/2014, Revision: 28, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 13, 2025 0

Human medicines European public assessment report (EPAR): Entyvio, vedolizumab, ...

Human medicines European public assessment report (EPAR): Imcivree, setmelanotide, Date of authorisation: 16/07/2021, Revision: 11, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 13, 2025 0

Human medicines European public assessment report (EPAR): Imcivree, setmelanotid...

Human medicines European public assessment report (EPAR): Xgeva, denosumab, Date of authorisation: 13/07/2011, Revision: 26, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 13, 2025 0

Human medicines European public assessment report (EPAR): Xgeva, denosumab, Date...

Herbal medicinal product: Polypodii rhizoma, Polypodium vulgare L., C: ongoing call for scientific data

Herbal medicinal product: Polypodii rhizoma, Polypodium...

Mar 13, 2025 0

Herbal medicinal product: Polypodii rhizoma, Polypodium vulgare L., C: ongoing c...

Agenda of the HMPC meeting 17-19 March 2025

Mar 13, 2025 0

Agenda of the HMPC meeting 17-19 March 2025

Human medicines European public assessment report (EPAR): Skojoy, aflibercept, Status: Application withdrawn

Human medicines European public assessment report (EPAR...

Mar 13, 2025 0

Human medicines European public assessment report (EPAR): Skojoy, aflibercept, S...

Opinion/decision on a Paediatric investigation plan (PIP): RoActemra, tocilizumab, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Infections and infestations, PIP number: P/0028/2024

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

Mar 12, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): RoActemra, tocilizuma...

Orphan designation: Trehalose Treatment of neuronal ceroid lipofuscinosis, 19/10/2020 Withdrawn

Orphan designation: Trehalose Treatment of neuronal cer...

Mar 12, 2025 0

Orphan designation: Trehalose Treatment of neuronal ceroid lipofuscinosis, 19/10...

Orphan designation: Humanised IgG4 monoclonal antibody against C1q Treatment of Guillain-Barré syndrome, 10/02/2025 Positive

Orphan designation: Humanised IgG4 monoclonal antibody ...

Mar 12, 2025 0

Orphan designation: Humanised IgG4 monoclonal antibody against C1q Treatment of ...

Herbal medicinal product: Lini semen, Linum usitatissimum L., C: ongoing call for scientific data

Herbal medicinal product: Lini semen, Linum usitatissim...

Mar 12, 2025 0

Herbal medicinal product: Lini semen, Linum usitatissimum L., C: ongoing call fo...

Orphan designation: Magrolimab Treatment of acute myeloid leukaemia, 11/11/2015 Withdrawn

Orphan designation: Magrolimab Treatment of acute myelo...

Mar 12, 2025 0

Orphan designation: Magrolimab Treatment of acute myeloid leukaemia, 11/11/2015 ...

Orphan designation: Seladelpar Treatment of primary biliary cholangitis, 20/02/2025 Positive

Orphan designation: Seladelpar Treatment of primary bil...

Mar 12, 2025 0

Orphan designation: Seladelpar Treatment of primary biliary cholangitis, 20/02/2...

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