Opinion/decision on a Paediatric investigation plan (PIP): (1R,2R)-2-[4-(5-methyl-1H-pyrazol-3-yl) benzoyl]-N-(4-oxo-6,7-dihydro-5H-pyrazolo [1,5-a]pyrazin-3-yl)cyclohexanecarboxamide (AZD5718), decision type: , therapeutic area: , PIP number: P/0269/2022

Human medicines European public assessment report (EPAR): Duloxetine Mylan, duloxetine, Neuralgia;Diabetic Neuropathies;Depressive Disorder, Major;Anxiety Disorders, Date of authorisation: 19/06/2015, Revision: 18, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): RSV preF protein, decision type: , therapeutic area: , PIP number: P/0350/2022

Human medicines European public assessment report (EPAR): Efmody, hydrocortisone, Adrenal Hyperplasia, Congenital, Date of authorisation: 27/05/2021, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Ecansya (previously Capecitabine Krka), capecitabine, Colonic Neoplasms;Breast Neoplasms;Colorectal Neoplasms;Stomach Neoplasms, Date of authorisation: 20/04/2012, Revision: 15, Status: Authorised

Human medicines European public assessment report (EPAR): Diacomit, stiripentol, Myoclonic Epilepsy, Juvenile, Date of authorisation: 03/01/2007, Date of refusal: 11/02/2009, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR): Aquipta, atogepant, Migraine Disorders, Date of authorisation: 11/08/2023, Status: Authorised

Apomorphine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000227/202211

Apomorphine : List of nationally authorised medicinal products - PSUSA/00000227/202211

Human medicines European public assessment report (EPAR): Regkirona, regdanvimab, COVID-19 virus infection, Date of authorisation: 12/11/2021, Revision: 8, Status: Authorised