香港注册药剂制品搜寻

Detail Information

Last Updated: 25-Apr-2025

Product Name

AKEEGA TABLETS 100MG/500MG

Registration No.

HK-68296

Certificate Holder

JOHNSON & JOHNSON (HONG KONG) LTD.

Certificate Holder Address

13/F TOWER 1 GRAND CENTURY PLACE, 193 PRINCE EDWARD RD WEST, MONG KOK, KOWLOON

Legal Classification

Part 1, Schedule 1 & Schedule 3 Poison

Sale Requirement*

Prescription only Medicines

Ingredients

Active Ingredient
abiraterone acetate
niraparib (as tosilate)

Date of Registration#

09 Jul, 2024

Notes:

	There is news related to local recall of this product within six months. For more details, please click the red flag of the product. (此产品在过去六个月内有本地回收相关的消息。欲了解更多详情，请点击产品的红旗。)
♎	The product is conditionally approved with very limited safety, efficacy, and quality data for public health emergency to satisfy local unmet medical need and the registration status is subjected to be reviewed by the Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances: Certification of Clinical Trial/Medicinal Test) Committee. The product can only be supplied to institutions or registered medical practitioners. (有关产品于提供非常有限的安全性、效能及素质的数据下，获得有条件批准，以于公共卫生紧急状态下满足本地医疗需求。产品的注册状态会由药剂业及毒药(药剂制品及物质注册：临床试验及药物测试证明书)委员会审核。该产品只可供应予机构或注册医生。)
♓	The product is conditionally approved with limited safety, efficacy, and quality data for public health emergency to satisfy local unmet medical need and the registration status is subjected to be reviewed by the Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances: Certification of Clinical Trial/Medicinal Test) Committee. The product can only be supplied to institutions or registered medical practitioners. (有关产品于提供有限的安全性、效能及素质的数据下，获得有条件批准，以于公共卫生紧急状态下满足本地医疗需求。产品的注册状态会由药剂业及毒药(药剂制品及物质注册：临床试验及药物测试证明书)委员会审核。该产品只可供应予机构或注册医生。)
♇	The product can only be supplied to institutions or registered medical practitioners. (该产品只可供应予机构或注册医生。)
♐	The application for registration of the product was accepted and evaluated with special consideration in accordance with section 4.1.2 of the Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity (i.e. the "1+" mechanism). (有关产品的注册申请按《新药剂或生物元素药剂制品注册申请指南》第4.1.2段的特殊考虑条件（即「1+」机制）接纳作审批。)
♐♇	The application for registration of the product was accepted and evaluated with special consideration in accordance with section 4.1.2 of the Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity (i.e. the "1+" mechanism). The product can only be supplied to institutions or registered medical practitioners. ( 有关产品的注册申请按《新药剂或生物元素药剂制品注册申请指南》第4.1.2段的特殊考虑条件（即「1+」机制）接纳作审批。该产品只可供应予机构或注册医生。 )
Δ	The product is an advanced therapy product (ATP). (这产品是先进疗法制品。)

*	-Prescription Only Medicines are medicines which must only be purchased with a prescription in a pharmacy. (该类药物只可在药房按照医生处方才可购买。)
	-Pharmacy Only Medicines are medicines which can be purchased in a pharmacy in the presence and under the supervision of a registered pharmacist, but without the need of a prescription. (该类药物只可在有注册药剂师在场及在其监督下于药房购买，但并不需要医生处方。)
	-Over-the-Counter Medicines are in general medicines classified as Part 2 poison and 'Not a Poison'. For medicines which are classified as 'Not a Poison', they can be freely purchased from a pharmacy (Authorized Seller of Poisons), a medicine store (Listed Seller of Poisons), or any other non-licensed premises; whereas for Part 2 Poisons, they can be purchased only from a pharmacy or a medicine store. (该类药物一般归纳为第2部毒药和非毒药。非毒药可在药房(获授权毒药销售商)、药行(列载毒药销售商)或其他没有牌照的处所购买，而第2部毒药则只能在药房或药行购买。)

	- For details of legal classification of medicines and sales requirements, please refer to answers to Q5 and Q22 under the FAQs page for the Consumer. (请参考消费者常见问题网页问题5 和问题22 的答覆，以了解药物法例分类和销售管制的详细讯息。)


#	Generally, the Pharmacy and Poisons Board issues a registration certificate with a validity period of 5 years, and may be renewed for the same validity period thereafter subject to meeting conditions as stipulated in Pharmacy and Poisons Regulation (Cap 138A) reg 36(7). (一般情况下，药剂业及毒药管理局发出注册证明书有效期为5年，及后在符合《药剂业及毒药规例》(第138A章)第36(7) 条所订明的情况，证明书可给予相同有效期限的续期。)

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