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Lartruvo (olaratumab) – Conditions or restrictions regarding supply and use - L01XC27

Updated on site: 08-Oct-2017

Medication nameLartruvo
ATC CodeL01XC27
Substanceolaratumab
ManufacturerEli Lilly Nederland B.V.

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

Name and address of the manufacturer(s) of the biological active substance(s) ImClone Systems LLC

33 ImClone Drive Branchburg

New Jersey

NJ 08876 UNITED STATES

Name and address of the manufacturer(s) responsible for batch release Lilly S.A.

Avda. de la Industria 30 Alcobendas

28108 Madrid SPAIN

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.

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.

Additional risk minimisation measures

Not applicable.

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

In order to further confirm the efficacy and safety of olaratumab in the

31 January 2020

treatment of patients with advanced soft tissue sarcoma, the MAH should

 

submit the clinical study report of the phase III study JGDJ comparing

 

doxorubicin plus olaratumab versus doxorubicin in patients with

 

advanced or metastatic STS (including exploratory biomarker data).

 

In addition, the MAH will submit the second interim safety analysis of the

31 December 2016

phase III study JGDJ.

 

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