Gammanorm
Last Updated on eMC 22-Jun-2017 View document | Octapharma Limited Contact details
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 22-Jun-2017 and displayed until Current
Reasons for adding or updating:
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Date of revision of text on the SPC: 19-Jun-2017
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 6.4: Update of RT shelf life now for up to 6 months (within overall shelf life). Previously 2 months.Updated on 19-Mar-2015 and displayed until 22-Jun-2017
Reasons for adding or updating:
- Correction of spelling/typing errors
Date of revision of text on the SPC: 18-Dec-2014
Legal Category:POM
Black Triangle (CHM): NO
Updated on 16-Mar-2015 and displayed until 19-Mar-2015
Reasons for adding or updating:
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.8 - Undesirable effects
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 31-Dec-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
$0Section 2: New vial Sizes AddedUpdated on 05-Nov-2013 and displayed until 16-Mar-2015
Reasons for adding or updating:
- Removal of black triangle
Date of revision of text on the SPC: 24-Feb-2012
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Black Triangle Status Removed. No further changesUpdated on 16-Mar-2012 and displayed until 05-Nov-2013
Reasons for adding or updating:
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of Excipients
Date of revision of text on the SPC: 24-Feb-2012
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
· CC2010-266: Addition of Polysorbate 80 to Gammanorm after UF
· CC2011-184: Lower limit of Polysorbate 80 in FPS: 20 µg/ml
· Corrections in section 3 “Purification process columns”
Updated on 10-Aug-2010 and displayed until 16-Mar-2012
Reasons for adding or updating:
- New SPC for new product
Legal Category:POM
Black Triangle (CHM): YES
Octapharma Limited
The Zenith Building, 26 Spring Gardens, Manchester, Lancashire, M2 1AB
+44 (0)161 837 3799
+44 (0)161 837 3770
0845 1300 522
+44 (0)161 837 3799
Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Active ingredients
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