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Besponsa (inotuzumab ozogamicin) – Conditions or restrictions regarding supply and use - L01XC

Updated on site: 05-Oct-2017

Medication nameBesponsa
ATC CodeL01XC
Substanceinotuzumab ozogamicin
ManufacturerPfizer Limited

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

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

Wyeth Pharmaceutical Division, of Wyeth Holdings Corporation, A subsidiary of Pfizer Inc.

401 North Middletown Road, Pearl River, New York 10965 United States

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

Pfizer Ireland Pharmaceuticals

Grange Castle Business Park

Clondalkin

Dublin 22

Ireland

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.

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