Month: July 2023

ROVI informs on the evaluation process to obtain marketing authorisation for Risvan® (Risperidone ISM®) in the United States and reports that the United States Food and Drug Administration (FDA) has issued a Complete Response Letter. In this letter, the FDA informs ROVI that it considers the responses to the evaluation of the Risvan® dossier to be complete and makes no additional observations.

Likewise, the letter states that ROVI must close the observations made by the FDA during its inspection in May 2023. ROVI will submit a response to reinitiate the procedure providing details of the responses that have already been filed. ROVI will then await a further notification from the FDA with the estimated User Fee Goal Date for the closure of the procedure, which is expected to be in February 2024.

Furthermore, there are no observations that have not yet been resolved by ROVI’s suppliers.

Therefore, ROVI will continue to report on the milestones deemed significant in the process to obtain authorisation of Risvan® from the FDA.

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ROVI has renewed its ‘Excellent’ rating in the Profarma 2021-2022 Programme for Promoting Competitiveness in the pharmaceutical industry, awarded by the Ministry of Industry, Trade and Tourism.

This programme classifies and rates companies in a series of groups and categories (Excellent, Very Good, Good and Acceptable) according to their excellence in different industrial, economic and research, development and innovation aspects.

The aim is to favour the competitiveness of the sector by boosting activities that provide greater added value, such as investment in new plants and new production technologies, promoting R&D&I.

ROVI receives the award for “Best Shareholder Service by a Listed Company” at Rankia’s 20th anniversary. The event was held at the Círculo de Bellas Artes in Madrid and recognised the most outstanding entities and personalities in the financial world.

With this award, ROVI ratifies its commitment to assertive, direct and transparent communication with its shareholders. The award was collected by Marta Campos Martínez and Beatriz de Zavala, head and member of the Investor Relations department, who congratulated the other winning companies and the Rankia management team for their 20 years working for financial communication.