Study identification

EU PAS number

EUPAS7674

Study ID

37308

Official title and acronym

Multinational database cohort study to assess RMP specified safety outcomes in association with indacaterol/glycopyrronium bromide in Europe

DARWIN EU® study

No

Study countries

Denmark
Italy
Netherlands
Spain
United Kingdom

Study description

Multinational database cohort study to assess RMP-specified safety outcomes in association with indacaterol/glycopyrronium bromide in Europe

Study status

Finalised
Research institutions and networks

Institutions

SIDIAP Jordi Gol Spain

Networks

Contact details

Clinical Disclosure Officer Novartis

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Novartis Pharma AG
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 1 (imposed as condition of marketing authorisation)