Leaflet / SmPC consistency
Identify possible divergences between indications, posology, contraindications, warnings, interactions or adverse effects.
Patient leaflet & SmPC
Patient leaflet review and SmPC check for medicinal product documents
EryonOne helps compare a patient leaflet and an SmPC, both ways, when the documents are provided as main document and reference.
Leaflet / SmPC comparison
Sensitive sections
PDF only for now
French and English
Benefits
What the tool helps check
Patient readability
Spot complex, ambiguous or overly technical wording to prepare a rewrite by the relevant teams.
Versions and missing information
Highlight duplicates, contradictions, dosage gaps, incomplete cross-references or sections to review.
Use cases
When to use it
- Before a submission, a variation or a documentary update.
- After modifying an SmPC to prepare the patient leaflet review.
- During a multi-product, multi-dosage or multilingual harmonisation.
Limits
EryonOne does not validate a leaflet or an SmPC
The tool helps analyse, compare, flag and structure. Final validation remains the responsibility of authorised experts and applicable regulatory processes.
Frequently asked questions
FAQ
Can a patient leaflet be compared with an SmPC?
Yes. EryonOne can help spot discrepancies between a patient leaflet and an SmPC when both documents are provided.
Which types of discrepancies can be flagged?
Terminology, posology, contraindications, precautions, adverse effects, storage or missing information.
Does EryonOne validate a leaflet compliance?
No. The tool prepares the documentary review, but regulatory validation stays human.
Can it be used before a variation or an update?
Yes. It is a useful preparatory usage to structure the points to check before internal validation.
Next step
Test a leaflet / SmPC consistency check
Create an account to start a first project or contact us to frame the use case.