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Drug-related conditions are as follows: First, CY150112 film clinical trial notice main content Drug name: CY150112 tablets acceptance number: CXHL2000134; CXHL2000135; CXHL2000136 dose type: tablet registration classification: chemical drugs Class 1 specification: 0.5mg, 2mg, 5mg Application Matters: Domestic Drug Registration Applicant: Jiangsu Enhua Pharmaceutical Co., Ltd. Approval Conclusion: According to the Drug Administration Law of the People's Republic of China and the relevant provisions, after examination, the CY150112 tablets accepted on March 24, 2020 meet the relevant requirements of drug registration, agreed to carry out clinical trials of schizophrenia.
II, TRV-130 Injection Clinical Trial Notice Main Content Drug Name: Oliceridine Fumatate Injection, Code TRV-130 Acceptance Number: CXHL2000125; 2mg:2ml Application Matters: Domestic Drug Registration Applicant: Jiangsu Enhua Pharmaceutical Co., Ltd. Approval Conclusion: According to the Drug Administration Law of the People's Republic of China and the relevant provisions, after examination, the Oliceridine Fuma acid injection received on March 24, 2020 meets the requirements of drug registration, and agrees to conduct clinical trials of moderate to severe acute pain in adults who need to use intravenous opioids.
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