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

BIKTARVY TABLETS

Registration No.

HK-65914

Certificate Holder

GILEAD SCIENCES HONG KONG LIMITED

Certificate Holder Address

FLAT/RM 2603, 26/F, HYSAN PLACE, 500 HENNESSY ROAD, CAUSEWAY BAY, HONG KONG

Legal Classification

Part 1, Schedule 1 & Schedule 3 Poison

Sale Requirement*

Prescription only Medicines

Ingredients

Active Ingredient
bictegravir (as sodium)
emtricitabine
tenofovir alafenamide (as fumarate)

Date of Registration#

26 Sep, 2018

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.
♎	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.
♓	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.
♇	The product can only be supplied to institutions or registered medical practitioners.
♐	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 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.
Δ	The product is an advanced therapy product (ATP).

*	-Prescription Only Medicines are medicines which must only be purchased with a prescription in a pharmacy.
	-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.
	-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.

	- 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.


#	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).

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