PHARMACY & POISONS BOARD OF HONG KONG | 香港藥劑業及毒藥管理局

Detail Information

Last Updated: 23-Apr-2025

Product Name

PROPECIA TAB 1MG

Registration No.

HK-44266

Certificate Holder

ORGANON HONG KONG LIMITED

Certificate Holder Address

UNIT 48-136, 48/F, LEE GARDEN ONE, 33 HYSAN AVENUE, CAUSEWAY BAY, HONG KONG

Legal Classification

Part 1, Schedule 1 & Schedule 3 Poison

Sale Requirement*

Prescription only Medicines

Ingredients

Active Ingredient
finasteride

Date of Registration#

03 Feb, 1999

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. (此產品在過去六個月內有本地回收相關的消息。欲了解更多詳情，請點擊產品的紅旗。)
♎	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. (有關產品於提供非常有限的安全性、效能及素質的數據下，獲得有條件批准，以於公共衞生緊急狀態下滿足本地醫療需求。產品的註冊狀態會由藥劑業及毒藥(藥劑製品及物質註冊：臨牀試驗及藥物測試證明書)委員會審核。該產品只可供應予機構或註冊醫生。)
♓	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. (有關產品於提供有限的安全性、效能及素質的數據下，獲得有條件批准，以於公共衞生緊急狀態下滿足本地醫療需求。產品的註冊狀態會由藥劑業及毒藥(藥劑製品及物質註冊：臨牀試驗及藥物測試證明書)委員會審核。該產品只可供應予機構或註冊醫生。)
♇	The product can only be supplied to institutions or registered medical practitioners. (該產品只可供應予機構或註冊醫生。)
♐	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). (有關產品的註冊申請按《新藥劑或生物元素藥劑製品註冊申請指南》第4.1.2段的特殊考慮條件（即「1+」機制）接納作審批。)
♐♇	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. ( 有關產品的註冊申請按《新藥劑或生物元素藥劑製品註冊申請指南》第4.1.2段的特殊考慮條件（即「1+」機制）接納作審批。該產品只可供應予機構或註冊醫生。 )
Δ	The product is an advanced therapy product (ATP). (這產品是先進療法製品。)

*	-Prescription Only Medicines are medicines which must only be purchased with a prescription in a pharmacy. (該類藥物只可在藥房按照醫生處方才可購買。)
	-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. (該類藥物只可在有註冊藥劑師在場及在其監督下於藥房購買，但並不需要醫生處方。)
	-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. (該類藥物一般歸納為第2部毒藥和非毒藥。非毒藥可在藥房(獲授權毒藥銷售商)、藥行(列載毒藥銷售商)或其他沒有牌照的處所購買，而第2部毒藥則只能在藥房或藥行購買。)

	- 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. (請參考消費者常見問題網頁問題5 和問題22 的答覆，以了解藥物法例分類和銷售管制的詳細訊息。)


#	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). (一般情況下，藥劑業及毒藥管理局發出註冊證明書有效期為5年，及後在符合《藥劑業及毒藥規例》(第138A章)第36(7) 條所訂明的情況，證明書可給予相同有效期限的續期。)

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