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An Open-Label, One-Sequence Study to Evaluate the Steady-State Comparative Bioavailability of Intramuscular Risperidone ISM and Oral Risperidone
An Open-Label, One-Sequence Study to Evaluate the Steady-State Comparative Bioavailability of Intramuscular Risperidone ISM and Oral Risperidone
Status:Completed
Phase of Trial:
Phase I
Latest Information Update:31 Jan 2020
Price :
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At a glance
Drugs
Risperidone (Primary)
;
Risperidone
Indications
Schizophrenia
Focus
Pharmacokinetics; Registrational
Acronyms
BORIS
Sponsors
Rovi
Most Recent Events
31 Jan 2020
According to an Rovi Media release, after the conclusion of the validation phase, the European health authorities have commenced the assessment process to grant marketing authorisation for Doria in the European Union (EU).
31 Jan 2020
According to an Rovi Media release, the company has filed its application for marketing authorisation for Doria with the European health authorities, the European Medicines Agency (EMA), through the Centralised Procedure on 27 December, 2019. After passing the validation phase satisfactorily, the dossier was admitted for evaluation on 30 January, 2020.
30 Jul 2019
According to an Rovi Media release, the company will include long-term safety data on more than 100 patients exposed to at least one year of treatment with Doria in the registration dossier, as recommended in the International Conference on Harmonization (ICH) Guideline E1.
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