Ozurdex® (dexamethasone) Implant Risk Management Plan Injector's Guide Assessment Australia

Study identification

• EU PAS number:
  EUPAS23093
• Study ID:
  24504
• Official title and acronym:
  Ozurdex® (dexamethasone) Implant Risk Management Plan Injector's Guide Assessment Australia
• DARWIN EU® study:
  No
• Study countries:
  Australia
• Study description:
  This annex is provided in order to present a comprehensive assessment of the risk and benefits of OZURDEX® (dexamethasone) 700 μg intravitreal implant and to add Australia-specific risk assessment information to the risk management plan (RMP) v8.1
• Study status:
  Finalised

Research institutions and networks

Institutions

So What Research Pty Ltd

Study timelines

Date when funding contract was signed

Actual: 29/04/2016

Study start date

Actual: 20/12/2017

Date of interim report, if expected

Actual: 21/12/2017

Date of final study report

Actual: 29/01/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Allergan

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only