Reasons for adding or updating:

• Change to section 4.2 - Posology and method of administration
• Change to section 4.8 - Undesirable effects
• Change to section 5.1 - Pharmacodynamic properties

Date of revision of text on the SPC: 01-Aug-2016

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

·         Treat and extend year 2 wording implemented into wAMD and DME posology sections (Section 4.2)

·         The ‘Antiplatelet Trialists’ Collaboration (APTC)’ text has been condensed (Section 4.8)

·         Information on Protocol T data has been added to Section 5.1 of the SmPC

·         Section 5.1 of the SmPC has been shortened by rewording the text.

·         Text has been brought in line with the QRD template version 9.1

·         The heading of ADR ‘Table 1’ now includes ‘or during post-marketing surveillance’ and the footnote on ‘allergic reactions’ has been changed to ‘During the post-marketing period, reports of hypersensitivity included rash, pruritus, urticaria, and isolated cases of severe anaphylactic/anaphylactoid reactions.’ (Section 4.8)

Reasons for adding or updating:

• Change to section 4.8 - Undesirable effects
• 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: 19-Nov-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 4.8 Undesirable effects

·        The updated patient numbers and results have been added to the ‘Summary of the safety profile’ and ‘Description of selected adverse reactions’.

·        In the ADR table ‘Cataract cortical’ has moved from the frequency ‘uncommon’ to ‘common’. ‘Uveitis’ has been moved from frequency ‘rare’ to ‘uncommon’ and ‘Cornel oedema’ has moved to a lower position in the ‘Uncommon’ frequency column.

Section 5.1 Pharmacodynamic properties

·        The ‘Diabetic macular oedema’ sections have been updated with the 2 year results.

Reasons for adding or updating:

• Change to section 4.1 - Therapeutic indications
• Change to section 5.1 - Pharmacodynamic 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: 28-Oct-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 4.1 Therapeutic indications

The following bullet point has been added

• visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).

 Section 4.2 Posology and method of administration

Under the posology section a new section on Myopic choroidal neovascularization has been added

Section 4.4 Special warnings and precautions for use

Under ‘Populations with limited data’ a new paragraph on myopic CNV has been added.

Section 4.8 Undesirable effects

In the ‘Summary of the safety profile’ the number of patients and studies has been updated.

In the ADR table under ‘Eye disorders’:

·        ‘Eye pain’ has moved from frequency ‘common’ to ‘very common’

·        ‘Cataract cortical’ and ‘corneal oedema’ have moved from frequency ‘common’ to ‘uncommon’

·        ‘Blindness’ and ‘Uvetitis’ have moved from frequency ‘uncommon’ to ‘Rare’

Section 5.1 Pharmacodynamic properties

The sections on Macular odema secondary to CRVO and BRVO and Diabetic macular oedema have been amended to shorten the text.

New sections on Myopic choroidal neovascularization have been added

Section 6.6 Special precautions fort disposal and other handling

Under ‘Instructions for use of vial’ the previous point 8 regarding the plastic needle shield has been deleted and some of the pictures have been updated.

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 4.8 - Undesirable effects
• Change to section 5.1 - Pharmacodynamic properties
• Change to section 5.2 - Pharmacokinetic properties
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 25-Feb-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

The key changes are:

·        Section 4.1 ‘Therapeutic indications’

The CRVO bullet point has been changed to ‘visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1),’

·        Section 4.2 ‘Posology and method of administration’

Part of the posology for wet AMD and DME has changed to ‘After the first 12 months of treatment with Eylea, the treatment interval may be extended based on visual and/or anatomic outcomes……’.

Under the section ‘Macular Oedema secondary to CRVO’ it has been changed to ‘Macular Oedema secondary to RVO (branch RVO or central RVO)’ and the section has been significantly rewritten.

·     Section 4.4 ‘Special warnings and precautions for use’

The section ‘Endophthalmitis’ has been changed to ‘Intravitreal injection-related reactions’ and the section has been reworded.

In the section on ‘Systemic effects’ a statement on concomitant use of other anti-VEGF has been added.

·     Section 4.8 ‘Undesirable effects’

The number of patients and number of trials has been updated and the phase III BRVO study information added.

Blindness, cataracts traumatic and vitreous haemorrhage have been added to the list of serious adverse reactions. 

In the ADR table ‘eye pain’ has been moved from ‘very common’ to ‘common’ and ‘cataract traumatic’ has been added to ‘rare’.

·     Section 5.1 Pharmacodynamic properties

Under ‘Pharmacodynamic effects’ BRVO has been added to the section ‘Macular Oedema secondary to CRVO’, which is now called ‘Macular Oedema secondary to CRVO and BRVO’ and information on the Copernicus, Galileo and Vibrant study has been added as text. 

The previous Table 2 on Pharmacodynamic parameters has been removed.

Under ‘Clinical efficacy and safety’ a new section on ‘Macular Oedema secondary to BRVO’ has been added.

·     Section 5.2 Pharmacokinetic properties

Under Absorption/Distribution’ the statement on pharmacokinetic sub-studies has been amended to include information on BRVO.

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: 26-Aug-2014

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

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 4.8 - Undesirable effects
• Change to section 5.1 - Pharmacodynamic properties
• Change to section 5.2 - Pharmacokinetic properties
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 01-Aug-2014

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

The key changes are;

·        Additional indication for the  treatment of patients with visual impairment due to diabetic macular oedema (DMO). 

Reasons for adding or updating:

• Change to section 4.1 - Therapeutic indications

Date of revision of text on the SPC: 26-Aug-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Reasons for adding or updating:

• 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 4.8 - Undesirable effects
• Change to section 5.1 - Pharmacodynamic properties
• Change to section 5.2 - Pharmacokinetic properties
• Change to section 5.3 - Preclinical safety data
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 26-Aug-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

The key changes are:

• New indication: treatment of visual impairment due to macular oedema following CRVO. 
• The new SmPC includes new information related specifically to the new indication, additional warning and precautions (including use in pregnancy and women of childbearing potential), changes to the frequency of some adverse reactions and new text is included related to the additional monitoring (required by new legislation).

Reasons for adding or updating:

• New SPC for new product

Legal Category:POM

Black Triangle (CHM): YES