Information on the state control over vaccine used for influenza prevention as of 16.10.2020

Опубліковано 16.10.2020 о 14:51

In accordance with the data base of the State Service of Ukraine on Medicines and Drugs Control and according to the Order for control over compliance of immunological product with the state and international standards requirements approved by the Order of the Ministry of Health of Ukraine as of 01.10.2014 № 698 (hereinafter Order) the following vaccines used for influenza prevention underwent the state quality control and got positive conclusions on compliance of medical immunological product with the state and international standards requirements (hereinafter – Conclusion).

1.VAXIGRIP TETRA, influenza virus vaccine, split virion, quadrivalent (inactivated), suspension for injection in a pre-filled syringe of 0,5 ml; one pre-filled syringe with a needle in a carton box, UA/16141/01/01, manufacturer – Sanofi Pasteur, France; importer – Sanofi Aventis Llc.
Total doses amount is 222 069.

Series №

Number of Doses

Cocnclusion №

Date of Cocnclusion

U3J641M

137200

№ 53225/20/10П

15.10.2020

U3J641M

  84 869

№ 52912/20/10

15.10.2020

 

2. GC FLU vaccine for prophyaxis of influenza, suspension for injection in a pre-filled syringe of 0,5 ml with a needle; one syringe per one original package; 10 syringes in a carton, UA/16223/01/01, manufacturer Green Gross Corporation, Republic of Korea, imported by “Biolabs”.
Total amount of doses is 100 000.

Series №

Number of Doses

Conclusion №

Date of Conclusion

V60220008

40 000

№ 54702/20/26П

13.10.2020

V60220008

29 640

№ 51803/20/26П

01.10.2020

V60220008

30 360

№ 51752/20/26

01.10.2020

 

3. GC FLU QUADRIVALENT vaccine for prophiyaxis of influenza, suspension for injection in a pre-filled syringe of 0,5 ml with a needle; one syringe in one blister; 10 blisters in a carton, UA/18246/01/01, manufactured by Green Gross Corporation, Republic of Korea, imported by “Biolabs”.
Total amount of doses is 20 000.

Series №

Number of Doses

Conclusion №

Date of Conclusion

Q60220042

19 700

№ 54883/20/26П

15.10.2020

Q60220042

  3 000

№ 54882/20/26

15.10.2020

 

4. INFLUVAC® vaccine for prophyaxis of influenza, surface antigen, suspension for injection in pre-filled syringe 0,5 ml; 1 syringe in a carton, UA/13027/01/01, manufactured by Abbott Biologicals B.V. the Netherlands, imported by LLC “Vanta LTD”, JV OPTIMA-PHARM LTD TOV.
Total amount of doses is 44 930.

Series №

Number of Doses

Conclusion №

Date of Conclusion

X23

  8 210

№ 51549/20/04

13.10.2020

X23

36 720

№ 51220/20/10

13.10.2020

 

Additionally

As per information provided by”Sanofi Aventis LLC” (importer of the medicine VAXIGRIP® TETRA), 280 678 doses of vaccine are expected to be imported to Ukraine.

The helpline provides information on VAXIGRIP® TETRA, influenza virus vaccine, split virion, quadrivalent (inactivated), manufactured by Sanofi Pasteur, France.

The helpline is accessible by the following phone number +380 44 354-20-00. It’s also possible to submit a request on the company web site https://www.sanofi.ua/uk/contacts/medical.

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Working group on mainstreaming of the Register of individuals responsible for introduction into circulation medicinal products, active implantable medical devices, in vitro diagnostic medical devices

Наступна

The State Service of Ukraine on Medicines and Drugs Control keeps working in quarantine conditions till 31 December 2020