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

Cabometyx (cabozantinib s-malate) – Conditions or restrictions regarding supply and use - L01XE26

Updated on site: 05-Oct-2017

Medication nameCabometyx
ATC CodeL01XE26
Substancecabozantinib s-malate
ManufacturerIpsen Pharma

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

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

Patheon France

40 Boulevard de Champaret

38300 Bourgoin-Jallieu FRANCE

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.

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.

Obligation to conduct post-authorisation measures

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

Description

Due date

Post-authorisation efficacy study (PAES): In order to address the uncertainty regarding

September

the survival advantage of cabozantinib compared with everolimus in patients with

advanced renal cancer that has progressed after VEGF TKI therapy, the MAH should

 

submit the final analysis of OS for XL184-308, a phase 3, randomized, controlled study

 

 

of cabozantinib (XL184) vs everolimus in subjects with metastatic renal cell carcinoma that has progressed after prior VEGFR tyrosine kinase inhibitor therapy.

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