Status: Ongoing First registered on: 16/10/2014
Last updated on: 30/08/2021
1. Study identification
EU PAS Register NumberEUPAS7687
Official titleNon-interventional safety study on the tolerability and safety of octagam® 5%, octagam® 10% or panzyga®
Study title acronym
Study typeObservational study
Brief description of the study
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameOctapharma GmbH
Centre locationGermany
Details of (Primary) lead investigator
Title Dr
Last name Tascou
First name Semi
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?200
Countries in which this study is being conducted
National study

Germany
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/01/2014
Start date of data collection01/01/201407/03/2014
Start date of data analysis
Date of interim report, if expected
Date of final study report30/09/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesOctapharma GmbH100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Ms
Last name Asseburg
First name Carolin
Address line 1Elisabeth-Selbert-Strasse 11
Address line 2 
Address line 3 
CityLangenfeld 
Postcode40764 
CountryGermany
Phone number (incl. country code)49-2173-917226 
Alternative phone number 
Fax number (incl. country code)49-2173-917111 
Public Enquiries
Title Ms 
Last name Asseburg 
First name Carolin 
Address line 1Elisabeth-Selbert-Strasse 11 
Address line 2 
Address line 3 
CityLangenfeld 
Postcode40764 
CountryGermany 
Phone number (incl. country code)49-2173-917226 
Alternative phone number 
Fax number (incl. country code)49-2173-917111 
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