English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Select site language

Pandemic influenza vaccine H5N1 AstraZeneca (Pandemic influenza vaccine H5N1 Medimmune) (reassortant influenza virus (live attenuated)...) – Conditions or restrictions regarding supply and use - J07BB03

Updated on site: 09-Oct-2017

Medication namePandemic influenza vaccine H5N1 AstraZeneca (Pandemic influenza vaccine H5N1 Medimmune)
ATC CodeJ07BB03
Substancereassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain
ManufacturerAstraZeneca AB

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

Name and address of the manufacturer of the biological active substance

MedImmune UK Limited

Plot 6, Renaissance Way

Boulevard Industry Park

Speke,

Liverpool, L24 9JW

United Kingdom

Name and address of the manufacturer responsible for batch release

MedImmune UK Limited

Plot 6, Renaissance Way

Boulevard Industry Park

Speke,

Liverpool, L24 9JW

United Kingdom

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

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 requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.

The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.

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.

Additional risk minimisation measures

Not applicable

E. SPECIFIC OBLIGATION TO COMPLETE

POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION

This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:

Description

Due date

Non-interventional post-authorisation safety study (PASS) in order to further investigate

After declaration in the

the tolerability of Pandemic influenza vaccine H5N1 AstraZeneca and estimate the

EU of a pandemic and

incidence of adverse reactions of special interest in children and adolescents. The MAH

after implementation

should conduct an observational prospective cohort safety study in a large sample of

of the pandemic

children and adolescents from 12 months to less than 18 years of age during the next

vaccine

declared pandemic. The MAH should submit the final results of this study.

 

In order to further corroborate the efficacy of Pandemic influenza vaccine H5N1

After declaration in the

AstraZeneca, the MAH should conduct an observational effectiveness study in

EU of a pandemic and

community dwelling children and adolescents from 12 months to less than 18 years of

after implementation

age against laboratory confirmed influenza during the next declared pandemic. The

of the pandemic

MAH should submit the final results of this study.

vaccine

 

 

In order to further investigate the safety and reactogenicity of Pandemic influenza

After declaration in the

vaccine H5N1 AstraZeneca, the MAH should conduct an open-label single arm

EU of a pandemic and

interventional study to evaluate the safety and immunogenicity of P/LAIV in children

after implementation

and adolescents from 12 months to less than 18 years of age during the next declared

of the pandemic

pandemic. The MAH should submit the final results of this study.

vaccine

 

 

In order to define the shelf life of Pandemic influenza vaccine H5N1 AstraZeneca on a

At the time of

strain-specific basis, the MAH should generate strain-specific stability data for the actual

approval of the next

pandemic strain. The MAH should submit the final results of this study.

pandemic variation

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed