Summary of opinion: ZILBRYSQ,Zilucoplan, 14/09/2023, Positive
Submitted by Anonymous (not verified) on 15 September 2023 - 11:00
Summary of opinion: ZILBRYSQ,Zilucoplan, 14/09/2023, Positive
Human medicines European public assessment report (EPAR): Melatonin Neurim, melatonin, Sleep Initiation and Maintenance Disorders, Date of authorisation: 07/11/2022, Revision: 1, Status: Authorised
Submitted by Anonymous (not verified) on 15 September 2023 - 10:34
Human medicines European public assessment report (EPAR): Melatonin Neurim, melatonin, Sleep Initiation and Maintenance Disorders, Date of authorisation: 07/11/2022, Revision: 1, Status: Authorised
Orphan designation: Asunercept, Treatment of myelodysplastic syndromes, 23/08/2017, Positive
Submitted by Anonymous (not verified) on 15 September 2023 - 10:31
Orphan designation: Asunercept, Treatment of myelodysplastic syndromes, 23/08/2017, Positive
Orphan designation: Recombinant fusion protein consisting of the extracellular portion of CD95 fused to the Fc part of a human IgG1 molecule, Treatment of glioma, 28/01/2010, Positive
Submitted by Anonymous (not verified) on 15 September 2023 - 10:29
Orphan designation: Recombinant fusion protein consisting of the extracellular portion of CD95 fused to the Fc part of a human IgG1 molecule, Treatment of glioma, 28/01/2010, Positive
Opinion/decision on a Paediatric investigation plan (PIP): Erdafitinib, decision type: , therapeutic area: , PIP number: P/0190/2022
Submitted by Anonymous (not verified) on 15 September 2023 - 10:02
Opinion/decision on a Paediatric investigation plan (PIP): Erdafitinib, decision type: , therapeutic area: , PIP number: P/0190/2022
Quality data requirements for applications for biological veterinary medicinal products intended for limited markets - Scientific guideline
Submitted by Anonymous (not verified) on 15 September 2023 - 10:01
Quality data requirements for applications for biological veterinary medicinal products intended for limited markets - Scientific guideline
Opinion/decision on a Paediatric investigation plan (PIP): Sotrastaurin acetate, decision type: , therapeutic area: , PIP number: P/155/2011
Submitted by Anonymous (not verified) on 15 September 2023 - 9:54
Opinion/decision on a Paediatric investigation plan (PIP): Sotrastaurin acetate, decision type: , therapeutic area: , PIP number: P/155/2011
Human medicines European public assessment report (EPAR): Gilenya, fingolimod, Multiple Sclerosis, Date of authorisation: 17/03/2011, Revision: 36, Status: Authorised
Submitted by Anonymous (not verified) on 15 September 2023 - 9:41
Human medicines European public assessment report (EPAR): Gilenya, fingolimod, Multiple Sclerosis, Date of authorisation: 17/03/2011, Revision: 36, Status: Authorised
Draft guideline on clinical investigation of medicinal products in the treatment of depression - Revision 3
Submitted by Anonymous (not verified) on 15 September 2023 - 8:35
Draft guideline on clinical investigation of medicinal products in the treatment of depression - Revision 3
EudraVigilance Expert Working Group (EV-EWG) work programme 2023-2024
Submitted by Anonymous (not verified) on 15 September 2023 - 8:32
EudraVigilance Expert Working Group (EV-EWG) work programme 2023-2024