Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 139

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 139
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 that
prior to obtaining a marketing authorization in the EU, an applicant must demonstrate compliance with all measures included in an EMA-approved
Pediatric Investigation Plan (“PIP”), covering all subsets of the pediatric population, unless the EMA has granted a product-specific
waiver, class waiver or a deferral for one or more of the measures included in the PIP. The Paediatric Committee of the EMA (“PDCO”),
may grant deferrals for some medicines, allowing a company to delay development of the medicine for children until there is enough information
to demonstrate its effectiveness and safety in adults. The PDCO may also grant waivers when development of a medicine for children is
not needed or is not appropriate, such as for diseases that only affect the elderly population. An application for marketing authorization
or a variation or a variation or a line-extension which is accompanied by the pediatric clinical trials conducted in accordance with
the PIP (even where such results are negative) are eligible for a six months extension of their supplementary protection certificate.
In the case of orphan medicinal products, a two-year extension of the orphan market exclusivity may be available. This pediatric reward
is not automatically available and is subject to the EMA or the relevant national competent authorities confirming compliance with the
agreed PIP that may require an opinion to be given by the EMA’s Pediatric Committee.

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The centralized procedure provides for the
grant of a single marketing authorization by the European Commission that is valid for all EU member states, as well as the additional
member states of the EEA (Norway, Iceland and Liechtenstein). The centralized procedure is optional for products containing a new active
substance which was not authorized in the EU on May 20, 2004, or for products that constitute a significant therapeutic, scientific
or technical innovation or which are in the interest of public health in the EU. An applicant for the centralized MA must demonstrate
the quality, safety and efficacy of their products to the EMA for an opinion to be adopted regarding the approvability of the MAA. The
European Commission grants or refuses marketing authorization in light of the opinion delivered by the EMA.

Under the centralized procedure, the CHMP
established within the EMA is responsible for conducting an initial assessment of a medicinal product. The maximum timeframe for the
evaluation of an MAA is 210 days, excluding clock stops when additional information or written or oral explanation is to be provided
by the