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Adcetris (brentuximab vedotin) – Conditions or restrictions regarding supply and use - L01XC12

Updated on site: 05-Oct-2017

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

Name and address of the manufacturers of the biological active substance

Piramal Healthcare UK Ltd.

Earls Road, Grangemouth

Stirlingshire, Scotland FK3 8XG

United Kingdom

Lonza AG

Lonzastrasse

3930 Visp

Switzerland

Name and address of the manufacturers responsible for batch release

Takeda Austria GmbH

St. Peter-Straβe 25

A-4020 Linz

Austria

Delpharm Novara S.r.l.

Via Crosa, 86

28065 Cerano (NO)

Italy

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 restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).

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 Risk Management Plan 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

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

Provision of the results of the ongoing

Second Interim analysis: within the annual

Non-Interventional Post-Authorization Safety Study

renewal 2017.

(PASS) conducted in HL and sALCL patient

 

populations (Study MA25101).

Final study report: 31/12/2020

 

To perform a single-arm study in a similar patient

 

population as the sALCL population investigating

Final Study Report by: Q1 2021

response rate, duration of response, rate of (second)

 

ASCT and data in subpopulations (including but not

 

necessarily restricted to ALK status and age) based on

 

a CHMP agreed protocol (Study C25006).

 

 

 

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