Summary of opinion: Columvi, 27/02/2025 Positive
Submitted by Anonymous (not verified) on 28 February 2025 - 11:00
Summary of opinion: Columvi, 27/02/2025 Positive
Human medicines European public assessment report (EPAR): Kizfizo, temozolomide, Status: Opinion
Submitted by Anonymous (not verified) on 28 February 2025 - 11:00
Human medicines European public assessment report (EPAR): Kizfizo, temozolomide, Status: Opinion
Summary of opinion: Keytruda, 27/02/2025 Positive
Submitted by Anonymous (not verified) on 28 February 2025 - 11:00
Summary of opinion: Keytruda, 27/02/2025 Positive
Summary of opinion: Kalydeco, 27/02/2025 Positive
Submitted by Anonymous (not verified) on 28 February 2025 - 11:00
Summary of opinion: Kalydeco, 27/02/2025 Positive
List of centrally authorised products with safety-related changes to the product information
Submitted by Anonymous (not verified) on 28 February 2025 - 9:56
List of centrally authorised products with safety-related changes to the product information
Procedural advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment principles, objective criteria and methodology in accordance with Article 62 (1) of Regulation (EC) No 726/2004
Submitted by Anonymous (not verified) on 28 February 2025 - 9:53
Procedural advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment principles, objective criteria and methodology in accordance with Article 62 (1) of Regulation (EC) No 726/2004
Draft guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Revision 2
Submitted by Anonymous (not verified) on 28 February 2025 - 7:00
Draft guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Revision 2
Clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Scientific guideline
Submitted by Anonymous (not verified) on 28 February 2025 - 7:00
Clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Scientific guideline
Minutes of the CAT meeting 22-24 January 2025
Submitted by Anonymous (not verified) on 27 February 2025 - 16:41
Minutes of the CAT meeting 22-24 January 2025
Human medicines European public assessment report (EPAR): Advagraf, tacrolimus, Date of authorisation: 23/04/2007, Revision: 29, Status: Authorised
Submitted by Anonymous (not verified) on 27 February 2025 - 13:19
Human medicines European public assessment report (EPAR): Advagraf, tacrolimus, Date of authorisation: 23/04/2007, Revision: 29, Status: Authorised