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Detail Information  

Last Updated: 18-Jun-2021
 
Product Name : ALPROLIX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 1000IU
Registration No. : HK-67045
Certificate Holder : SANOFI HONG KONG LIMITED
Certificate Holder Address : 1/F & SECTION 212 ON 2/F, AXA SOUTHSIDE, 38, WONG CHUK HANG ROAD, WONG CHUK HANG, HONG KONG
Legal Classification : Part 1, Schedule 1 & Schedule 3 Poison
Sale Requirement* : Prescription only Medicines
Ingredients :
Component Active Ingredient
drug powder vial eftrenonacog alfa
diluent pre-filled syringe sodium chloride
Date of Registration# : 14 Apr, 2021
 
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 designated institutions.
  
*-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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