Pharmacovigilance Polaris Beta

Is a query-able archive of therapeutic indications and adverse reactions reported on Summary of Product Characteristics (SmPCs) encoded as MedDRA Lowest Level Terms (LLTs).

Use cases

Safety report analysis

Check if a reaction is known for a drug. Detect an off-label use of a drug. Sort drug-reaction pairs in signal detection.

SmPCs harmonization

Harmonize SmPCs among medicinal products with the same pharmaceutical composition.

Drug deprescription

Automatically spot medical conditions treated by a drug that could be adverse reactions of another one.


It is currently based on AIFA and EMA SmPC archives, and it could be extended, upon request, to other datasources.

It is automatically built through web-scraping and text auto-coding procedures.

It can be validated manually, upon request, through a dedicated graphic user interface.

It is query-able online, and it can provide aggregated information about similar drugs and at different levels of MedDRA terminology.

Sample dataset

Data source Medicinal Product SmPC data
AIFA 022252062 - Zymaflour Download
EMA EMEA/H/C/004411 - Verkazia Download
EMA EMEA/H/C/005852 - Amvuttra Download
Pharmacovigilance Polaris Pharmacovigilance Polaris

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