Observational prospective cohort study to evaluate the incidence of adverse events (AE), risk factors, and drug utilization patterns related to treatment with BUSCAPINA COMPOSITUM N from March to December 2016 in patients from Metropolitan Lima (PASS PERU)

First published 31/08/2016

Last updated 19/10/2026

EU PAS number:

EUPAS15008

Study

Finalised

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Documents

Study protocol

Initial protocol

Pharmacovigilance Plan Buscapina Compositum N - Submitted document 2015DEC28

English (224.79 KB - PDF) View document

Study results

0218-0705_Synopsis.pdf

English (134.32 KB - PDF) View document

Study report

No information provided.

ENCePP Seal

The use of the ENCePP Seal has been discontinued since February 2025. The ENCePP Seal fields are retained in the display mode for transparency but are no longer maintained.

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Observational prospective cohort study to evaluate the incidence of adverse events (AE), risk factors, and drug utilization patterns related to treatment with BUSCAPINA COMPOSITUM N from March to December 2016 in patients from Metropolitan Lima (PASS PERU)

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