Study identification

EU PAS number

EUPAS1000000790

Study ID

1000000790

Official title and acronym

DARWIN EU® – Drug Utilisation Study of terbinafine-containing products

DARWIN EU® study

Yes

Study countries

Croatia
Denmark
Finland
Germany
Spain
United Kingdom

Study description

Terbinafine is an antifungal agent indicated for the treatment of superficial mycoses, with widespread use across Europe in both oral and topical formulations. Monitoring its utilisation is essential to informing regulatory decision-making, particularly in relation to emerging safety concerns, such as antifungal resistance. This study aims to characterise the incidence and patterns of terbinafine use, describe the clinical profiles of treated patients, and examine treatment pathways.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Ellen Gerritsen

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable