Study identification

EU PAS number

EUPAS9574

Study ID

28105

Official title and acronym

Drug utilisation safety study (DUS)

DARWIN EU® study

No

Study countries

Czechia
Slovakia

Study description

To characterise prescribing practices for Vreya during clinical use in representative groups of prescribers and to assess main reasons for prescription and determine the conditions for prescribing. This study should also discover if the new rules for prescribing will be followed.22nd July 2015Object: Early termination of study: Post-authorisation safety study (PASS) a Drug utilisation study (DUS) for medical product VREYA (cyproterone acetat/ ethinylestradiol)PASS: ENCEPP/SDPP/9569DUS: ENCEPP/SDPP/9574The 25th July 2013 were decided by European Commission, that there was a need of DUS and PASS studies concerning all products containing combination CPA/EE.The company BAYER is the originator of medical product containing a combination of cyprterone acetat/ ethinylestradiol DIANE-35 and therefore it is charged to be an organiser of joint PASS/DUS.The company HEATON k.s has MA for a medical product containig this combination called VREYA authorised by MRP procedure (NL/H/0623/001/DCP).Based on this procedure HEATON k.s. is obliged by CMDh to joint the BAYER consortium and stop all activities concerning the own studies.

Study status

Finalised
Research institutions and networks

Institutions

HEATON k.s.

Contact details

Jaromír Frič

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

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

More details on funding

HEATON k.s.
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)