Results of the fifth batch of pharmaceutical and chemical combination products of Food and Drug Administration defined
Medical Network March 28th News To guide the applicant to make a reasonable declaration, the results of the fifth batch of drug combination product properties are now announced.
Special announcement.
Attachment: Results of defining the properties of the fifth batch of medical and chemical combination products
No.
Application deadline
Application unit
product name
Define the conclusion
1
January 30, 2018
Zhaoke Pharmaceutical (Hefei) Co., Ltd.
Lidocaine Hydrochloride Powder-free Percutaneous Injection System (Product Name: Zingo)
Drugs that do not belong to combination products, should be reported as drugs
2
February 9, 2018
Zhaoke Pharmaceutical (Hefei) Co., Ltd.
Loxapine inhalation aerosol single dose delivery system (Product name: ADASUVE)
Drugs that do not belong to combination products, should be reported as drugs
3
February 11, 2018
Sanofi (China) Investment Co., Ltd.
Alirocumab Injection (Automatic Injector)
Drugs that do not belong to combination products, should be reported as drugs
4
February 11, 2018
Sanofi (China) Investment Co., Ltd.
Alirocumab Injection (Prefilled Syringe)
Drugs that do not belong to combination products, should be reported as drugs
5
February 12, 2018
Beijing Novartis Pharmaceutical Co., Ltd.
Canatinumab injection
Drugs that do not belong to combination products, should be reported as drugs
6
February 12, 2018
Zhejiang Haichuang Medical Instrument Co., Ltd.
Drug-carrying catheter
Medical device-based combination products
7
March 1, 2018
Sanofi (China) Investment Co., Ltd.
Efpeglenatide Injection (Prefilled Syringe)
Drugs that do not belong to combination products, should be reported as drugs
8
March 1, 2018
Sanofi (China) Investment Co., Ltd.
Efpeglenatide Injection (Automatic Injector)
Drugs that do not belong to combination products, should be reported as drugs
State Food and Drug Administration Administrative Reception Service Hall
