Immix Biopharma Awarded European Union Orphan Drug Designation For NXC-201 In Multiple Myeloma
Immix Biopharma Awarded European Union Orphan Drug Designation For NXC-201 In Multiple Myeloma
Immix Biopharma 獲得 NXC-201 治療多發性骨髓瘤的歐盟孤兒藥稱號
European Orphan Drug Designation ("ODD") qualifies NXC-201 for:
歐洲孤兒藥稱號（“ODD”）使 NXC-201 有資格獲得：
- 10 years of market exclusivity once authorized in the EU
- Access to the EU centralized authorization procedure
- Reduced fees for: EU protocol assistance, marketing authorization applications, inspections before authorization, applications for changes to marketing authorizations made after approval, and reduced annual fees
- 一旦獲得歐盟授權，市場獨家經營權將持續10年
- 進入歐盟集中授權程序
- 降低了以下方面的費用：歐盟協議援助、上市許可申請、授權前的檢查、批准後提出的營銷許可變更申請以及降低的年費
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