Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000150

EU PAS number

EUPAS1000000150

Study ID

1000000150

Official title and acronym

DARWIN EU® - Drug utilisation study on medicinal use of Pelargonii radix

DARWIN EU® study

Yes

Study countries

Belgium
Germany

Study description

Pelargonii radix is an herbal preparation that has received market authorisation in some European member states for 30 years. It is used for the management of common cold and acute bronchitis, however further information is needed regarding its real-world use in different age groups, especially in the younger population of children under 12 years old.

Research question
What is the real-world use of Pelargonii radix in children, adolescents, adults and elderly populations?

Study objectives
1. To characterise the cohort of patients being treated with Pelargonii radix at the time of each treatment initiation of the drug of interest in terms of demographics and indication for prescribing/dispensing. Additionally, to determine dose/strength at the treatment initiation, duration of treatment episodes and number of prescriptions of the drug of interest per treatment episode. All results will be stratified by age category (below 3; 3-5; 6-11; 12-17; 18-65, >65 years) and database.
2. To determine incidence of use of Pelargonii radix among different age categories (below 3; 3-5; 6-11; 12-17; 18-65, >65 years) by country/database, during the study period (2014-2023).

Population
Patient-level utilisation of selected medicines of interest

Study status

Ongoing
Research institution and networks

Institutions

Networks

Contact details

Dina Vojinovic

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
Study protocol
Initial protocol

DARWIN EU_D2.2.3_Protocol_P3-C1-002_DUS_Pelargonium radix_v3.1_Public.pdf

English (780.87 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable