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Other Disclosures4534Mochida Pharmaceutical Co.,Ltd.Pharmaceuticals

Notice of Application for Partial Change Approval to Add Pediatric Dosage and Administration for YULIS Tablets, a Treatment for Gout and Hyperuricemia

Mochida Pharmaceutical Co., Ltd. filed an application for partial change approval to add a dosage and administration regimen for pediatric use of “ユリス Tablets,” a treatment for gout and hyperuricemia. The application is currently in the approval process, and pediatric use has not yet been approved.

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Announced details

ユリス Tablets (generic name: dotinurad; development code: FYU-981)
Applicable field (uses covered by this announcement)

Gout and hyperuricemia; pediatric hyperuricemia

Launch dateLaunched in May 2020 (actual results)
Relationship between the counterparty and the company
Mochida Pharmaceutical Co.,Ltd.4534
Relationship with the Company

The manufacturing and marketing approval for ユリス Tablets, originated by 株式会社富士薬品, changed from 株式会社富士薬品 to Mochida Pharmaceutical Co., Ltd. on 30 June 2026.

CounterpartyFuji Yakuhin Co., Ltd.

The company that originated ユリス Tablets. Other information, including its location, representative, business activities, capital, and year of establishment, is Not disclosed.

In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.

Announced details
ItemDetails
Names of Products / Services Coveredユリス Tablets (generic name: dotinurad; development code: FYU-981)
CounterpartyFuji Yakuhin Co., Ltd.
Counterparty overviewThe company that originated ユリス Tablets. Other information, including its location, representative, business activities, capital, and year of establishment, is Not disclosed.
Relationship with the CompanyThe manufacturing and marketing approval for ユリス Tablets, originated by 株式会社富士薬品, changed from 株式会社富士薬品 to Mochida Pharmaceutical Co., Ltd. on 30 June 2026.
Launch dateLaunched in May 2020 (actual results)
Applicable areaGout and hyperuricemia; pediatric hyperuricemia
Items this document does not state (12)
Contract ValueOffering priceContract DateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocationLocation scaleQuantitative EffectsUsage historyImpact on Business PerformanceSource

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

Hyperuricemia in children is often associated with an underlying disease, and drug treatment may be considered when the condition does not improve with lifestyle guidance or when the effects of such guidance are insufficient. Mochida Pharmaceutical aims to obtain approval so that it can contribute to improving the quality of life of pediatric patients.

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Notice of Application for Partial Change Approval to Add Pediatric Dosage and Administration for YULIS Tablets, a Treatment for Gout and Hyperuricemia | Mochida Pharmaceutical Co.,Ltd. (4534) timely disclosure | Komori