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Bexsero (recombinant Neisseria meningitidis group-B...) – Conditions or restrictions regarding supply and use - J07AH09

Updated on site: 05-Oct-2017

Medication nameBexsero
ATC CodeJ07AH09
Substancerecombinant Neisseria meningitidis group-B NHBA fusion protein /recombinant Neisseria meningitidis group-B NadA protein /recombinant Neisseria meningitidis group B fHbp fusion protein /outer membrane vesiclesfrom Neisseria meningitidis group-B strain NZ98
ManufacturerGSK Vaccines S.r.l.

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

Name and address of the manufacturers of the biological active substances (NHBA, NadA, fHbp):

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

Name and address of the manufacturers of the biological active substance (OMV):

GSK Vaccines S.r.l.

Bellaria-Rosia

IT-53018 Sovicille-Siena

Italy

GSK Vaccines S.r.l.

Via Fiorentina, 1

IT-53100 Siena

Italy

Name and address of the manufacturer responsible for batch release:

GSK Vaccines S.r.l.

Bellaria-Rosia

IT-53018 Sovicille-Siena

Italy

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

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