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Obizur (susoctocog alfa) – Conditions or restrictions regarding supply and use - B02

Updated on site: 08-Oct-2017

Medication nameObizur
ATC CodeB02
Substancesusoctocog alfa
ManufacturerBaxalta Innovations GmbH

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

Name and address of the manufacturer of the biological active substance

Baxalta US, Inc

27 Maple Street

Milford

MA 01757

UNITED STATES

Name and address of the manufacturer responsible for batch release

Baxter AG

Industriestrasse 67

A-1221 Vienna

AUSTRIA

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.

Additional risk minimisation measures

Prior to launch of Obizur in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.

The educational programme is aimed to minimize the risk of dose dispensing errors.

The MAH shall ensure that in each Member State where Obizur is marketed, all healthcare professionals who are expected to prescribe and dispense Obizur have access to/are provided with the following educational package:

Physician educational material

The physician educational material should contain:

The Summary of Product Characteristics

The healthcare professionals training material

The healthcare professionals training material shall contain the following key elements:

Health care professional brochure including a detailed calculation of number of vials for a patient weighing for example 70 kg

An on-line video to further elaborate on the required calculation and administration of the drug

E. SPECIFIC OBLIGATION TO COMPLETE

POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES

This being a marketing authorisation under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:

Description

Due date

To collect and analyse immediate and long-term data on clinical efficacy and safety of

Annually

all patients with acquired haemophilia and who are treated with Obizur, the MAH must

within the

conduct a surveillance programme/ registry according to an agreed protocol and for an

annual

indefinite time.

reassessment

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