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Bosulif (bosutinib (as monohydrate)) – Conditions or restrictions regarding supply and use - L01XE14

Updated on site: 05-Oct-2017

Medication nameBosulif
ATC CodeL01XE14
Substancebosutinib (as monohydrate)
ManufacturerPfizer Ltd

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

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

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

D-79090 Freiburg

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 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.

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.

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

To conduct a single-arm open-label, multi-centre efficacy and safety study of

Final Clinical

bosutinib in patients with Philadelphia chromosome-positive chronic

Study Report:

myelogenous leukaemia (Ph+ CML) previously treated with one or more tyrosine

 

kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not

30 September

considered appropriate treatment options.

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