Opinion/decision on a Paediatric investigation plan (PIP): Cenerimod, decision type: , therapeutic area: , PIP number: P/0433/2022

Opinion/decision on a Paediatric investigation plan (PIP): Efavaleukin alfa, decision type: , therapeutic area: , PIP number: P/0469/2022

Opinion/decision on a Paediatric investigation plan (PIP): Yellow fever virus, strain vYF-247, decision type: , therapeutic area: , PIP number: P/0425/2022

Human medicines European public assessment report (EPAR): Pregabalin Sandoz GmbH, pregabalin, Anxiety Disorders;Epilepsy, Date of authorisation: 19/06/2015, Revision: 16, Status: Withdrawn

Human medicines European public assessment report (EPAR): Spinraza, nusinersen, Muscular Atrophy, Spinal, Date of authorisation: 30/05/2017, Revision: 14, Status: Authorised

Human medicines European public assessment report (EPAR): Rivaroxaban Accord, rivaroxaban, Acute Coronary Syndrome;Coronary Artery Disease;Peripheral Arterial Disease;Venous Thromboembolism;Stroke;Atrial Fibrillation;Pulmonary Embolism, Date of authorisation: 16/11/2020, Revision: 5, Status: Authorised

Assessment templates and guidance

Simulect : EPAR - All Authorised presentations

Day 80 assessment report - Non-clinical template with guidance - Rev.10.23 Revamp

Day 80 assessment report - Clinical template with guidance - Rev.10.23 Revamp