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Unituxin (dinutuximab) – Conditions or restrictions regarding supply and use - L01XC

Updated on site: 10-Oct-2017

Medication nameUnituxin
ATC CodeL01XC
Substancedinutuximab
ManufacturerUnited Therapeutics Europe Ltd

Article Contents

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

Name and address of the manufacturer of the biological active substance

United Therapeutics Corporation

1040 Spring Street

Silver Spring, Maryland 20910

USA

Name and address of the manufacturer responsible for batch release

Penn Pharmaceutical Services Limited

23-24 Tafarbaubach Industrial Estate, Tredegar, Gwent

NP22 3AA

United Kingdom

 

 

 

authorised

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).

 

longer

 

 

 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic safety update reports

no

 

 

product

 

 

 

 

 

The marketing authorisation holder shall submit the first periodic safety update report for this product

within six months following authorisation. Subsequently, the marketing authorisation holder shall submit periodic safety update reports f this product in accordance with the requirements set out in

the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on theMedicinalEuropean 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.

If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.

Obligation to conduct post-authorisation measures

Description

Due date

Non-interventional post authorisation safety study (PASS): In order to evaluate the long-term safety outcomes of dinutuximab in high-risk neuroblastoma patients (including central and peripheral nervous system, prevalence of organ dysfunction, long-term effects on growth and endocrine development, hearing loss, cardiac toxicity and survival data) the applicant should conduct and submit the results of a safety registry.

The study protocol should be submitted within 3 months of the EC decision.

 

The clinical study report should be submitted by

 

 

 

06/2029

 

 

 

 

 

PASS: In order to better characterise the safety and immunogenicity of Unituxin and its

 

impact on drug exposure, the applicant should conduct and submit the results of

 

safety study.

 

 

 

authorised

 

The clinical study report should be submitted by

 

 

12/2018

 

 

no

longer

 

 

 

 

 

 

product

 

 

 

Medicinal

 

 

 

 

 

 

 

 

 

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