Safety event report on non-oncological chemical synthesis drugs

Our pharmacovigilance program monitors the safety of our drugs. The purpose of this document is to compile all adverse events attributable to chemical synthesis products marketed by Advance Scientific Group, which include: CAFNEA, DEXMEDETOMIDINE, DILOZELD-UF, ENTEROCAPS, PLASMINASE and SPASTIFEN.

General Information Report

Safety event report on non-oncological chemical synthesis drugs (#19)

1. Administrative information

2. Patient information

Information of the patient who presents the adverse event.

Relevant medical history

Note: In case of ADR, indicate the start and end date of therapy.

Exclusive space for fatal adverse events

3. Medication

Concomitant drugs

4. Reaction

Note: Please indicate the type of paraclinic, its magnitude and units of measurement, which was used to identify the safety novelty.

Event Result

Check an option

Temporality criterion

In case of re-exposure, what was the outcome?

5. Additional information

Note: Feel free to enter any type of information, everything you attach will be thoroughly evaluated to deepen the information on the products immersed in the novelty.

From Advance Scientific de Colombia SAS, we appreciate the information provided that will be used to build evidence that promotes the more rational use of pharmaceutical products in the Colombian scenario.