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Ablavar (Vasovist) (gadofosveset trisodium) – Conditions or restrictions regarding supply and use - V08CA

Updated on site: 11-Jul-2017

Medication nameAblavar (Vasovist)
ATC CodeV08CA
Substancegadofosveset trisodium
ManufacturerTMC Pharma Services Ltd.
Medicinal product no longer authorised

A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Bayer Schering Pharma AG

D – 13342 Berlin

Germany

B. CONDITIONS OF THE MARKETING AUTHORISATION

 

CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON

 

THE MARKETING AUTHORISATION HOLDER

 

 

CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND

 

EFFECTIVE USE OF THE MEDICINAL PRODUCT

authorised

 

OTHER CONDITIONS

 

 

 

 

 

 

 

Risk Management Plan

 

 

 

 

The MAH commits to performing the studies and additi

al pharmacovigilance activities

detailed in the Pharmacovigilance Plan, as agreed in versi

2.0 of the Risk Management Plan

(RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates

of the RMP agreed by the CHMP.

longer

 

As per the CHMP Guideline on Risk ManagementnoSystems for medicinal products for human use, any

updated RMP should be submitted at the same time as the following Periodic Safety Update Report

(PSUR).

 

 

 

 

In addition, an updated RMP sh

uld be submitted:

 

 

 

 

When new information is

eceived that may impact on the current Safety Specification,

 

Pharmacovigilance P an or risk minimisation activities

 

 

Within 60 ys of nproductimportant (pharmacovigilance or risk minimisation) milestone being

 

reached

 

 

 

 

At the request of the European Medicines Agency

 

 

Medicinal

 

 

 

 

PSURs

The MAH will continue to submit yearly PSURs unless otherwise specified by the CHMP.

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