sec 4.5 - to include reference to concomitant administration with Meningococcal group B vaccine

Update to section 6.5 to the material of the container for the vial presentation

Section 7 – Change to name of marketing authorisation holder

Reasons for adding or updating:

·         Change to section 4.4 - Special warnings and precautions for use

·         Change to section 4.8 - Undesirable effects

·         Change to section 5.2 - Pharmacokinetic properties

·         Change to section 9 - Date of first authorisation/renewal of the authorisation

Date of revision of text on the SPC: 26-Mar-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Update of the Section 4.8 “Undesirable effects” of the SmPC:

update of the overall exposure for children aged ≥2 years who have received the vaccine in completed clinical trials.

Update of the Section 4.4 “Special warnings and precautions for use” of the SmPC + Package Leaflet: inclusion of a warning on anxiety-related reactions as per Menveo CDS v4.3.

Addition of Renewal date into sec. 9 of the SmPC

New persistency data for children 2-10.
Existing persistency data for adolescents corrected.

4.2

Section: Posology

·         term elderly removed

·         Optimal primary dosing schedule included

Section : Booster vaccination

·         updated re Imunogenicity /Long term antibody persistence data for 5 yrs included

·         Booster dosing

4.4

Section : Special warnings and precautions

·         Consideration re booster dosing

4.5

Section : Interaction with other medicinal products and other forms of interaction

·    Concomitant vaccine advice and usage updated

·    Update advice on concomitant vaccine injection sites

4.8                           

Section: Adverse reactions from clinical trials

·         Updated on the characterisation of  safety profile of Menveo in children 2-10 years

Section: Individuals 11 to 65 years of age

·         Updated trial data and increase in trial numbers, change to results

·         In list of adverse reactions from clinical trials, removal side effects  text re: immune system disorders ,  hypersensitivity, syncope, vertigo

Section: General disorders and administration site conditions

·         Editing and inclusion of text

·         Removal of spontaneous reporting text

Section: Post marketing experience ( all age groups)

·         Updated text sections and changes to read ‘not known’

Section : Reporting of suspected adverse reactions

Inclusion of text : Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to the Pharmacovigilance Section at the Irish Medicines Board at www.imb.ie.

5.1

Section: Pharmacodynamic properties

Immunogenicity

·         Amended- immunogenicity in children from 2, to 2 to 10 years of age

·         Tables and data up dated re trials- tables renumbered

·         Previous Table 4-21 month post vaccination text and data removed

·         Inclusion of text re: Persistence of immune response and booster response in adolescents, before table 5

·         Text on booster dose study results included

·         After renumbered table 8, text included re the onset of the immune response after primary vaccination

6.5

Section: Nature and contents of container

·         Removal of text re contents of components( now in 6.6)

6.6

Section: Special precautions for disposal and other handling

·         Inclusion of text re mixing vials

·         Inclusion of text (metric replaces non metric) re needle length

10

Section: Date of revision of text

·         18/06/2014

·         UK/MEN/14-0012 

Paediatric population (under 2 years of age)

Available data in children 2 to 23 months of age

Studies with Menveo have shown a waning of serum bactericidal antibody titers against serogroup A when using human complement in the assay (hSBA) (see section 5.1). The clinical relevance of the waning of hSBA serogroup A antibody titers is unknown. Currently there is limited information available on the safety of a booster dose. However, if an individual is expected to be at particular risk of exposure to Men A and received a dose of Menveo more than approximately one year previously, consideration may be given to administering a booster dose.

Section 4.8 additions from post marketing spontaneous reports