WebOct 28, 2024 · EMA and the Heads of Medicines Agencies (HMA) are launching a pilot project to support the repurposing of medicines as a follow-up to the European Commission’s Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) discussions on a proposal for a medicines repurposing framework. WebEMA/4260/2001 Page 5/23 − on, typically but not exclusively, quality changes (e.g. , changes to manufacturing facilities) affecting multiple products or multiple indications of the same product For a broad advice and depending on the complexity of the topic, the Applicant could consider requesting a scientific advice preparatory meeting.
Paediatric investigation plans European Medicines Agency
WebMar 8, 2024 · Therapeutic indication Vimpat is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. Assessment history Changes since initial authorisation of medicine ghost of tsushima disciples
Extensions of indication in the European Union – a regulatory ... - DGRA
WebDec 21, 2024 · for a new therapeutic indication falling within a new orphan designation, i.e. an orphan designation other than the one(s) related to the already approved indication(s), the COMP will have to confirm the maintenance of the orphan designation before … This page lists questions that marketing-authorisation holders (MAHs) may have … A major change to a marketing authorisation that may have significant … Webnew or modified therapeutic indication Yes If yes, please also provide the information grey shaded in the checklist below No Do the data submitted qualify as a more than one scope (i.e.: is this a Grouping of Variations Yes If yes, please consider the specific conditions and requirement s that would apply. No Is this a WebData exclusivity European Medicines Agency Medicines Data exclusivity The period of eight years from the initial authorisation of a medicine during which the marketing-authorisation holder benefits from the exclusive rights to the results of preclinical tests and clinical trials on the medicine. ghost of tsushima director\u0027s cut upgrade ps5