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Tyverb (lapatinib) – Conditions or restrictions regarding supply and use - L01XE07

Updated on site: 10-Oct-2017

Medication nameTyverb
ATC CodeL01XE07
Substancelapatinib
ManufacturerNovartis Europharm Limited

A.MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers responsible for batch release

Glaxo Operations UK Limited

Priory Street

Ware

Hertfordshire

SG12 0DG

United Kingdom

Or

Glaxo Wellcome S.A. Avenida de Extremadura 3 09400 Aranda de Duero Burgos

Spain

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley, Surrey GU16 7SR

United Kingdom

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

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 marketing authorisation holder shall submit periodic safety update reports for 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 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 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

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

Description

Due date

To present data in patients with hormone receptor-positive metastatic breast cancer,

 

not currently intended for chemotherapy, and previously treated with trastuzumab

 

from:

 

 

1.

A randomised and controlled clinical trial (EGF114299) in a patient

 

population essentially identical to that of EGF30008 except that subjects must have

 

received prior treatment with trastuzumab, with aromatase inhibitor (AI) +

 

trastuzumab included as the reference arm.

 

 

 

November

Final clinical study report

 

 

 

2.

Approximately 70 patients from study EGF114299 who have been

December

randomised to the lapatinib + AI arm with an exposure of approximately 6 months.

The clinical study report (70 patients) should include the following data:

 

Demographic and baseline characteristics, Disease characteristics, Prior anti-cancer

 

therapies, Overall Response Rate (ORR), Clinical Benefit Rate (CBR), Serious

 

Adverse Experiences (SAE)s

 

 

 

To evaluate biomarkers of drug resistance in patients with HER2+ metastatic breast

June 2018

cancer whilst on treatment with trastuzumab in combination with either lapatinib or

 

chemotherapy

 

 

 

 

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