Study identification

EU PAS number

EUPAS1000000762

Study ID

1000000762

Official title and acronym

Discontinuation of additional risk minimisation measure tools for centrally authorised medicinal products in the EU

DARWIN EU® study

No

Study countries

European Union

Study description

This retrospective cohort study aims to describe post-authorisation discontinuation of additional risk minimisation measure (aRMM) tools for centrally authorised medicinal products (CAPs) authorised with aRMM tools in the EU between July 2012 and December 2021. This study will be a retrospective cohort study within a medicinal product cohort. This medicinal product cohort includes CAPs authorised in the EU between 1 July 2012 and 31 December 2021. From this medicinal product cohort, we will establishe a study cohort of CAPs with aRMMs at the time of initial MA. aRMM tool discontinuations until 31 December 2024 will be identified. Our study outcome will be the time to discontinuation of the aRMM tools for CAPs authorised in the EU between July 2012 and December 2021. Furthermore, we will assess the category of aRMM tool that was discontinued, corresponding safety concern(s) of the discontinued tools, the type of regulatory procedure(s) involved in the discontinuation of the aRMM, and the rationale for discontinuation of the aRMM tool.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Marie L. De Bruin 0000-0001-9197-7068

Primary lead investigator
ORCID number:
0000-0001-9197-7068

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding

More details on funding

Medicines Evaluation Board
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable