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Adjupanrix (Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals) (split influenza virus, inactivated,...) – Conditions or restrictions regarding supply and use - J07BB02

Updated on site: 11-Jul-2017

Medication nameAdjupanrix (Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals)
ATC CodeJ07BB02
Substancesplit influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
ManufacturerGlaxoSmithKline Biologicals S.A.

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substance

Sächsisches Serumwerk Dresden

Branch of GlaxoSmithKline Biologicals

Zirkustraße 40, D-01069 Dresden

Germany

Name and address of the manufacturer responsible for batch release

GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut

B-1330 Rixensart Belgium

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

Adjupanrix can only be marketed when there is an official WHO/EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Adjupanrix takes due account of the officially declared pandemic strain.

Official batch release

In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic Safety Update Reports

The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.

Outside of the pandemic period, the normal PSUR periodicity and format will be maintained, with a specific review of AESI and possible adverse events related to adjuvants. This should include data from ongoing studies, or actual use if applicable, of the ‘mock-up’ strains and any safety data relevant to the adjuvant system.

During a pandemic situation, the resources must be concentrated on a timely and effective monitoring of the safety profile of the influenza vaccines used during the pandemic. Moreover, a 6-monthly cycle may be too long to allow assessment of the safety of a vaccine for which high levels of exposure are expected within a short period of time. Therefore, 6-monthly or annual PSURs falling within the pandemic period will be replaced by monthly “simplified PSURs” (S-PSUR) accompanied by a summary of vaccine distribution.

Frequency of submission

-The clock should start from the first Monday after shipment of the first batch of vaccine.

-First data-lock point is 30 days later.

-S-PSUR submission to the Rapporteur and CHMP members on Day 45.

-Rapporteur’s assessment report is circulated to CHMP members on Day 50.

-CHMP report is circulated to the vaccine manufacturer on Day 55.

-Reporting to be monthly for the first 6 months.

-Periodicity should be reviewed by the MAH and the (Co-)Rapporteur at 6 monthly intervals.

When it has been agreed by the CHMP that the S-PSUR is no longer necessary, a full PSUR covering the period since the data lock point of the last routine PSUR will be submitted within a time frame to be agreed with the Rapporteur.

Format of the simplified PSUR

Only spontaneously reported data should be included in the PSUR. The report should include the following Tables of aggregate data (using the pre-defined templates attached in Annex 2).

1.An overview for all spontaneous cases per country, stratified according to type of report (medically confirmed or non-medically confirmed) and seriousness, for the period covered by the report and cumulatively.

2.An overview for all spontaneous adverse reactions by SOC, High Level Term (HLT) and Preferred Term (PT), stratified according to type of report (medically confirmed or non- medically confirmed) and including the number of fatal reports, for the period covered by the report and cumulatively.

3.Adverse Events of Special Interest stratified according to type of report (medically confirmed or non-medically confirmed). AESIs will be defined as follows:

-

Neuritis:

PT “Neuritis”

-

Convulsion:

narrow SMQ “Convulsions”

-

Anaphylaxis:

narrow SMQ “Anaphylactic reaction” and narrow SMQ

 

 

“Angioedema”

-

Encephalitis:

narrow SMQ “Non-infectious encephalitis”

-

Vasculitis:

narrow SMQ “Vasculitis”

-Guillain-Barré syndrome: narrow SMQ “Guillain-Barré syndrome”

-

Demyelination:

narrow SMQ “Demyelination” (as GBS is also included in

 

 

this SMQ, there will be an overlap in the number of cases for

 

 

these two categories).

-

Bell’s palsy:

PT “Bell’s palsy”

-

Vaccination failure:

PT “Vaccination failure”.

4.Serious unlisted adverse reactions (SOC, HLT, PTs) stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.

5.All spontaneous adverse reactions by age group, per SOC, HLT and PT, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively. The following age groups will be used: < 2 years, 2-8 years, > 9 years.

6.All spontaneous adverse reactions (SOC, HLT, PT) occurring in pregnant women, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.

The following principles should be followed when compiling the data:

-Except for Table 1, all tables will be based on number of reactions (presented on PT level, sorted by System Organ Class [SOC] and High Level Term [HLT]) and not number of cases.

-All tables will be based on generic and not product-specific data1. Product-specific data can be evaluated during signal work-up.

-“Cumulatively” means since the use of the vaccine; events not reported during the period of interest should not be presented in the tables.

-All non-medically confirmed events are those that have been entered into the database by the data-lock point. Those which have not yet been entered should be reported in the following S- PSUR.

-A line listing of fatal cases will be provided in an Annex.

A short summary should be provided in which validated signals and areas of concern are highlighted, taking into account information arising from the prospective cohort study described in 4.5. In the event of multiple signals, signal work-up may be prioritised and appropriate timelines for submission of a full signal evaluation report should be provided.

Vaccine distribution report

To put the safety report into context, a summary of vaccine distribution should be included and should provide details of the number of doses of vaccine distributed in

i)EU member states for the reporting period by batch number,

ii)EU member states cumulatively and

iii)the rest of the world.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:

At the request of the European Medicines Agency;

Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.

If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.

E. SPECIFIC OBLIGATION TO COMPLETE

POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES

This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:

,

Description

Due date

During the pandemic, the applicant will collect clinical safety

Depending on and after

and effectiveness data of the pandemic vaccine and submit

implementation of vaccine when

this information to the CHMP for evaluation.

first pandemic will take place.

1 Based on the assumption that product name will not be provided in a significant proportion of cases.

During the pandemic, the applicant will conduct a

Depending on and after

prospective cohort study as identified in the

implementation of vaccine when

Pharmacovigilance plan.

first pandemic will take place.

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