Figure - PMC

Skip to main content

An official website of the United States government

Here's how you know

Here's how you know

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock ( ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

View full-text article in PMC

. 2022 Jan 31;36(1):33–46. doi: 10.1007/s40290-021-00414-8

Search in PMC
Search in PubMed
View in NLM Catalog
Add to search

© The Author(s) 2022

Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

PMC Copyright notice

Fig. 5 — EU-RMPs SCs with ongoing or planned aPV activities. Data were obtained from the latest HA-approved EU-RMPs as of 01 October 2020 for each of the seven studied medicinal products. a The left y-axis shows the absolute number of SCs included in the EU-RMP for per indicated medicinal product (x-axis) and the sum of the SCs (i.e., IIR, IPR, MI) for all 7 studied medicinal products. Above each column are dots (right y-axis) representing the total number of SCs per product with ongoing or planned additional (a) PV activities or (a) RM measures (red); b The percentage of the total number of EU-RMP SCs with ongoing or planned aPV activities or aRM measures (YES) versus SCs having no ongoing or planned additional PV or RM activities (NO); c The absolute number of EU-RMP SCs per risk category (i.e., IIR, IPR, MI) with ongoing or planned aPV activities. aPV additional pharmacovigilance, EU-RMP European Risk Management Plan, GVP Guidelines on Good Pharmacovigilance Practices, HA health authority, IIR important identified risk, IPR important potential risk, MI missing information, PASS Post-authorisation Safety Studies, PV pharmacovigilance, RM risk management, SCs safety concerns