THE ASSESSMENT OF SAFETY PROFILE AND TOLERANCE OF ZOLEDRONIC ACID ACTAVIS® FORMULATION IN POLISH PATIENTS POPULATION

Study identification

• EU PAS number:
  EUPAS9727
• Study ID:
  18996
• Official title and acronym:
  THE ASSESSMENT OF SAFETY PROFILE AND TOLERANCE OF ZOLEDRONIC ACID ACTAVIS® FORMULATION IN POLISH PATIENTS POPULATION
• DARWIN EU® study:
  No
• Study countries:
  Poland
• Study description:
  Post Authorization Safety Study has been initiated on the company´s own initiative with no obligation requested by any Health Authorities. Nor there are any additional activities requested beyond routine PhV activities in RMP. Product is registered since April 20th, 2012, there are 13 brands on the Polish market containing the same active substance and what should be emphasized, product safety was and will continue to be evaluated through routine PhV activity. Recommendations being the outcome of list of signals discussed at PRAC since September 2012 i.e. Osteonecrosis of the external auditory canal, have been implemented in product information. Therefore believing that product safety is adequately monitored with routine activities and appropriate actions are taken when necessary, voluntary PASS project will not be further pursued.
• Study status:
  Planned

Research institutions and networks

Institutions

Europharma

Study timelines

Date when funding contract was signed

Planned: 12/05/2015

Study start date

Planned: 15/05/2015

Date of final study report

Planned: 31/12/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ACTAVIS

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable