COVID 19 Vaccine AstraZeneca

Disclaimer: The information on this page is intended for Healthcare Professionals only.

The Agency for Medicines and Medical Devices of Serbia (ALIMS) is on March 5, 2021 issued a conditional permit for the COVID-19 Vaccine AstraZeneca vaccine.
This medicine is under additional monitoring. This allows new security information to be discovered quickly. Healthcare professionals should report any suspected adverse reactions to this drug.

For how to report adverse reactions, see section 4.8. Summary of Product Characteristics, the ALIMS website or the text below this page.


 

Report an Adverse Event

Healthcare professionals should report any suspected adverse reactions to vaccines:

Doctors - through the national system of surveillance of adverse events after immunization (in accordance with the Ordinance on the reporting of infectious diseases and special conditions and according to the Instructions for surveillance of events after immunization). The doctor who determines the existence or suspicion of an adverse event after immunization, reports the individual case to the epidemiological service of the competent institute / institute of public health (IPH / PHI) and at the same time submits the Report of adverse event after immunization on Form no. 14 - NDNI application. The health institution, whose doctor determined the existence of an adverse event, submits the report to the Agency for Medicines and Medical Devices of Serbia (www.alims.gov.rs).

All healthcare professionals - through the national system for reporting adverse reactions: Agency for Drugs and Medical Devices of Serbia (ALIMS), data and reporting forms, including direct online reporting, available on the ALIMS website: www.alims.gov.rs. It is important to indicate the protected name and batch number (batch / Lot) of the administered vaccine in the suspected suspected reaction.

Additionally, you can report any suspected adverse reactions to the holder of the marketing authorization for COVID-19 Vaccine AstraZeneca in Serbia using the link below:

 

AstraZeneca Reporting

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