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Perjeta (pertuzumab) – Conditions or restrictions regarding supply and use - L01XC13

Updated on site: 09-Oct-2017

Medication namePerjeta
ATC CodeL01XC13
Substancepertuzumab
ManufacturerRoche Registration Limited  

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

Name and address of the manufacturer of the biological active substance(s) Genentech, Inc.

1000 New Horizons Way

Vacaville, CA 95688-9431 USA

Name and address of the manufacturer responsible for batch release

Roche Pharma AG

Emil-Barell-Strasse 1

D-79639 Grenzach-Whylen

Germany

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 the first periodic safety update report for this product within 6 months following authorisation. Subsequently, 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 agreeed subsequent updates of the RMP.

An updated RMP shall be submitted annually until renewal.

When the submission of a PSUR and the update of a RMP coincide, they should be submitted at the same time.

In addition, 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 following measures:

 

 

 

Description

Due date

MO28047 (PERUSE)

September

A multicenter, open-label, single-arm study of pertuzumab in combination with

trastuzumab and a taxane in first line treatment of patients with HER2- positive

 

advanced (metastatic or locally recurrent) breast cancer

 

 

 

Post-authorisation efficacy study (PAES):

September

In order to provide long-term efficacy data in terms of DFS and OS, the MAH

should submit the results of study BO25126 (APHINITY), a randomized

 

multicenter, double-blind, placebo-controlled comparison of chemotherapy plus

 

trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab

 

as adjuvant therapy in patients with operable HER2-positive primary breast cancer

 

 

 

 

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