Reasons for adding or updating:

• Change to section 2 - Qualitative and quantitative composition
• 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: 24-May-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Updated to include new 1g vial size and 2 x 10g and 3 x 10g packs.

Reasons for adding or updating:

• Change to section 4.1 - Therapeutic indications
• Change to section 4.2 - Posology and method of administration
• Change to section 4.4 - Special warnings and precautions for use
• Change to section 5.1 - Pharmacodynamic properties
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 30-Oct-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

New indication - Chronic inflammatory demyelinating polyneuropathy (CIDP)$0Updated Information regarding risk factors in the development of haemolysis$0$0$0  $0$0$0$0$0

Reasons for adding or updating:

• Change to section 4.8 - Undesirable effects
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 08-May-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.8 - Update to table of adverse reactions

Reasons for adding or updating:

• Change to section 2 - Qualitative and quantitative composition
• Change to section 3 - Pharmaceutical form
• Change to section 4.1 - Therapeutic indications
• Change to section 4.2 - Posology and method of administration
• Change to section 4.4 - Special warnings and precautions for use
• Change to section 4.6 - Fertility, pregnancy and lactation
• Change to section 4.7 - Effects on ability to drive and use machines
• Change to section 4.8 - Undesirable effects
• Change to section 5.1 - Pharmacodynamic properties
• Change to section 5.2 - Pharmacokinetic properties
• Change to section 6.6 - Special precautions for disposal and other handling
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 30-Apr-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

$0Section 2: Inclusion of maximium IgAContent$0$0Inclusion of IVIG content per bottle$0$0Statement that plasma is form humandonors added$0$0Section 3: Description of pharmaceuticalform added$0$0Section 4.1: updated indications to alignwith EU Core SPC template$0$0Section 4.2: Warning that therapy shouldbe started by experienced physician added$0$0Replacement in PID minimum trough levelchanged from 4 to 5g/L$0$0Dosage section has been changed in linewith indications section$0$0Section 4.4: Warning around use ofmaltose updated in line with EU core SPC$0$0Monitoring recommendation for patientswith renal dysfunction added$0$0Hypersensitivity reaction warning added$0$0EU core SPC warnings about Asepticmeningitis syndroms, Haemolytic anaemia and interference with serologicaltesting, TRALI, falsely raised ESR, volume overload and local injection sitereactions added$0$0Updated warning re: paediatric use$0$0Section 4.6: Updated statement thatOctagam has no adverse effects on fertility added$0$0Section 4.7: Updated in line with EU coreSPC$0$0Section 4.8: Updated overview ofreactions in line with EU core SPC$0$0Addition of flu like illness added asvery rare reaction$0$0Updated Paediatric use warning and AEreporting statement$0$0Section 5.1+5.2: New data on paediatricuse added$0$0Section 6.6: Updated warnings in linewith EU core SPC$0Section10: Updated date of revision of text

Reasons for adding or updating:

• New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Legal Category:POM

Black Triangle (CHM): NO