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Nimenrix (Neisseria meningitidis serogroup A polysaccharide...) – Conditions or restrictions regarding supply and use - J07AH08

Updated on site: 08-Oct-2017

Medication nameNimenrix
ATC CodeJ07AH08
SubstanceNeisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid /Neisseria meningitidis serogroup W-135 polysaccharide conjugated to tetanus toxoid / Neisseria
ManufacturerPfizer Limited

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

Name and address of the manufacturers of the biological active substance GlaxoSmithKline Biologicals S.A.

89, rue de l'Institut B-1330 Rixensart Belgium

GlaxoSmithKine Biologicals Kft. Homoki Nagy István utca 1. 2100 Gödöllö

Hungary

GlaxoSmithKline Biologicals S.A. Parc de la Noire Epine

20, rue Fleming B-1300 Wavre Belgium

Name and address of the manufacturer(s) responsible for batch release

Pfizer Manufacturing Belgium N.V.

Rijksweg 12

B-2870 Puurs

Belgium

The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.

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.

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 in the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.

Obligation to conduct post-authorisation measures

The MAH shall complete, within the stated timeframe, the below measures:

Description

Due date

Study to evaluate immediate and longer term antibody titres elicited by

 

one or two doses of Nimenrix administered in children aged 12-23 months.

1 year CSR Q1 2017

The safety and antibody persistence data up to year 5 and the data on

3 year CSR Q1 2019

co-administration of MenACWY-TT with Prevenar 13 will be provided in

5 year CSR Q1 2021

sequential study reports at 1, 3 and 5 years after vaccination.

 

 

 

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