Applications for new human medicines under evaluation: December 2025
Submitted by Anonymous (not verified) on 5 December 2025 - 10:45
Applications for new human medicines under evaluation: December 2025
Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'
Submitted by Anonymous (not verified) on 5 December 2025 - 10:40
Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'
All languages - Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) - Revision 5
Submitted by Anonymous (not verified) on 5 December 2025 - 10:39
All languages - Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) - Revision 5
Opinion/decision on a Paediatric investigation plan (PIP): Cibinqo, abrocitinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Skin and subcutaneous tissue disorders, PIP number: EMA/PE/0000183059
Submitted by Anonymous (not verified) on 5 December 2025 - 10:00
Opinion/decision on a Paediatric investigation plan (PIP): Cibinqo, abrocitinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Skin and subcutaneous tissue disorders, PIP number: EMA/PE/0000183059
Opinion/decision on a Paediatric investigation plan (PIP): Eurneffy, adrenaline (epinephrine), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Surgical and medical procedures, PIP number: EMA/PE/00002210
Submitted by Anonymous (not verified) on 5 December 2025 - 9:55
Opinion/decision on a Paediatric investigation plan (PIP): Eurneffy, adrenaline (epinephrine), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Surgical and medical procedures, PIP number: EMA/PE/0000221076
EMA/PE/0000221589
Submitted by Anonymous (not verified) on 5 December 2025 - 9:39
EMA/PE/0000221589
Opinion/decision on a Paediatric investigation plan (PIP): Uplizna, inebilizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Surgical and medical procedures, PIP number: EMA/PE/0000238005
Submitted by Anonymous (not verified) on 5 December 2025 - 9:38
Opinion/decision on a Paediatric investigation plan (PIP): Uplizna, inebilizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Surgical and medical procedures, PIP number: EMA/PE/0000238005
Opinion/decision on a Paediatric investigation plan (PIP): Pyrukynd, Mitapivat, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Congenital, familial and genetic disorders, PIP number: EMA/PE/0000238074
Submitted by Anonymous (not verified) on 5 December 2025 - 9:32
Opinion/decision on a Paediatric investigation plan (PIP): Pyrukynd, Mitapivat, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Congenital, familial and genetic disorders, PIP number: EMA/PE/0000238074
Opinion/decision on a Paediatric investigation plan (PIP): Ilumetri, tildrakizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Skin and subcutaneous tissue disorders, PIP number: EMA/PE/0000182362
Submitted by Anonymous (not verified) on 5 December 2025 - 8:37
Opinion/decision on a Paediatric investigation plan (PIP): Ilumetri, tildrakizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Skin and subcutaneous tissue disorders, PIP number: EMA/PE/0000182362
EMA/PE/0000221709
Submitted by Anonymous (not verified) on 5 December 2025 - 8:29
EMA/PE/0000221709