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Agenda of the COMP meeting 21-23 January 2025
Substances considered as not falling within the scope of Regulation (EC) No. 470...
Heading and text to be inserted in Section 5.1 of the SmPC
Minimum inhibitory concentration (MIC) breakpoints
Training on human variations web-based electronic application form (eAF) functio...
Demonstration of efficacy for veterinary medicinal products containing antimicro...
Agenda – Executive Steering Group on Shortages and Safety of Medicinal Products ...
Conduct of efficacy studies for intramammary products for use in cattle - Scient...
Human medicines European public assessment report (EPAR): Omvoh, mirikizumab, Da...
Human medicines European public assessment report (EPAR): Lenvima, lenvatinib, D...
Human medicines European public assessment report (EPAR): Fabhalta, Iptacopan, D...
Human medicines European public assessment report (EPAR): Victoza, liraglutide, ...
Development of the Clinical Trials Information System
Minutes of the CVMP meeting 14-15 January 2025
Orphan designation: Rilzabrutinib Treatment of autoimmune haemolytic anaemia, 16...
Orphan designation: Clofutriben Treatment of Cushing's syndrome of endogenous or...
Orphan designation: zopapogene imadenovec Treatment of recurrent respiratory pap...
Orphan designation: N-(2-Methoxyethyl)-6-methyl-N-[(3-methyl-2-thienyl)methyl]-2...
Human medicines European public assessment report (EPAR): Tuznue, trastuzumab, D...
Orphan designation: Adeno-associated viral vector serotype 9 containing the huma...
Orphan designation: Autologous CD34+ cells transduced with a lentiviral vector c...
Orphan designation: Autologous CD34+ cells transfected with lentiviral vector co...