Oxycodone and Naloxone

Overview

No overview information available.

No background information available.

用于治疗严重到需要每日24小时长期阿片类药物治疗的疼痛。由于阿片类药物成瘾、滥用和误用的风险，即使在推荐剂量下也存在，并且由于缓释阿片类制剂过量服用和死亡的风险更大，因此本品仅作为替代治疗方案（如非阿片类镇痛剂或速释阿片类）无效、不耐受的患者，或者不足以提供足够的疼痛管理。

No associated conditions information available.

Title	Posted	Study ID	Phase	Status	Sponsor
Oxycodone/Naloxone (OXN) Combination in Moderate to Severe Non-malignant Pain	2010/07/22	NCT01167699	Phase 3	Completed	Mundipharma Pharmaceuticals B.V.

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Oxycodone Hydrochloride and Naloxone Hydrochloride Sustained-release Tablets	NAPP PHARMACEUTICALS LIMITED	国药准字HJ20220088	化学药品	片剂	4/12/2023
Oxycodone Hydrochloride and Naloxone Hydrochloride Sustained-release Tablets	NAPP PHARMACEUTICALS LIMITED	国药准字HJ20220089	化学药品	片剂	4/12/2023
Oxycodone Hydrochloride and Naloxone Hydrochloride Sustained-release Tablets	NAPP PHARMACEUTICALS LIMITED	国药准字HJ20220087	化学药品	片剂	4/12/2023
Oxycodone Hydrochloride and Naloxone Hydrochloride Sustained-release Tablets	NAPP PHARMACEUTICALS LIMITED	国药准字HJ20220086	化学药品	片剂	4/12/2023
Oxycodone Hydrochloride and Naloxone Hydrochloride Sustained-release Tablets	山东绿叶制药有限公司	国药准字H20244209	化学药品	片剂	6/28/2024
Oxycodone Hydrochloride and Naloxone Hydrochloride Sustained-release Tablets	山东绿叶制药有限公司	国药准字H20244210	化学药品	片剂	6/28/2024

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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