What's new

What's new

Questions and answers for biological medicinal products

Questions and answers for biological medicinal products

25 September 2026

PSUSA/00000167/202601

PSUSA/00000167/202601

25 September 2026

PSUSA/00010430/202511

PSUSA/00010430/202511

25 September 2026

PSUSA/00000091/202601

PSUSA/00000091/202601

25 September 2026

Human medicines European public assessment report (EPAR): Tyruko, natalizumab, Date of authorisation: 22/09/2023, Revision: 4, Status: Authorised

Human medicines European public assessment report (EPAR): Tyruko, natalizumab, Date of authorisation: 22/09/2023, Revision: 4, Status: Authorised

25 September 2026

Human medicines European public assessment report (EPAR): Celldemic, zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures), Date of authorisation: 19/04/2024, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Celldemic, zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures), Date of authorisation: 19/04/2024, Revision: 1, Status: Authorised

25 September 2026

Human medicines European public assessment report (EPAR): Incellipan, pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures), Date of authorisation: 19/04/2024, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR): Incellipan, pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures), Date of authorisation: 19/04/2024, Revision: 2, Status: Authorised

25 September 2026

Human medicines European public assessment report (EPAR): Gobivaz, golimumab, Date of authorisation: 17/11/2025, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Gobivaz, golimumab, Date of authorisation: 17/11/2025, Revision: 1, Status: Authorised

25 September 2026

Human medicines European public assessment report (EPAR): Suboxone, buprenorphine,naloxone, Date of authorisation: 26/09/2006, Revision: 24, Status: Withdrawn

Human medicines European public assessment report (EPAR): Suboxone, buprenorphine,naloxone, Date of authorisation: 26/09/2006, Revision: 24, Status: Withdrawn

25 September 2026

Human medicines European public assessment report (EPAR): Tolvaptan Accord, tolvaptan, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR): Tolvaptan Accord, tolvaptan, Revision: 2, Status: Authorised

25 September 2026