WebFeb 22, 2024 · Trodelvy is given by infusion (drip) into a vein on day 1 and day 8 of a repeating 3-week cycle. The dose depends on the patient’s weight. Treatment may be continued for as long as it remains effective. All patients are monitored for any reactions during the infusion and for at least 30 minutes afterwards. WebNovember 2005 and authorisation of new indication within 8 years + 1 year data exclusivity for a new therapeutic indication for a well - established substance, provided that significant pre-clinical or clinical studies were carried out in relation to the new indication (Art. 10(5) Dir. 2001/83/EC) (=+1 WEU)
Repurposing of authorised medicines: pilot to support not-for …
WebThe European Medicines Agency (EMA) assesses applications from companies to market generic medicines in the European Union (EU). To help applicants, EMA has published questions and answers (Q&As) on its position on issues applicants preparing to request marketing authorisation for generic or hybrid medicines typically raise. WebAccording to Article 10(5) of Directive 2001/83/EC as amended, 'where an application is made for a new indication for a well established substance, a non-cumulative period of one year of data exclusivity shall be granted, provided that significant preclinical or clinical studies were carried out in relation to the new indication.' bohle professional glass cleaner sds
European Medicines Agency - Wikipedia
WebMay 1, 2024 · As for line extensions (Fig. 1), RWD applications included 3 cases in a new indication (blinatumomab, paliperidone palmitate, TAVR device); 3 cases in which the data were used to complete the labeling, such as tolerability and outcomes of use during pregnancy (fosamprenavir), data on tolerability (etravirine, EMA approval), and on … WebApr 4, 2024 · EMA Recommends Extension of Therapeutic Indications for Lisocabtagene Maraleucel. New indication concerns treatment of adult patients with DLBCL, HGBCL, PMBCL and FL3B, who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. Date: 04 Apr 2024. Topics: Cancer Immunology and … 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 bohle premium glass cleaner