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Deltyba (delamanid) – Conditions or restrictions regarding supply and use - J04AK06

Updated on site: 06-Oct-2017

Medication nameDeltyba
ATC CodeJ04AK06
Substancedelamanid
ManufacturerOtsuka Novel Products GmbH

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Otsuka Novel Products GmbH

Erika-Mann-Straße 21

80636 München

Germany

AndersonBrecon (UK) Ltd.

Wye Valley Business Park

Brecon Road

Hay-on-Wye

Hereford

HR3 5PG

United Kingdom

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

Additional risk minimisation measures

The MAH should agree the educational material with the Member States, prior to launch.

In each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority and implement it prior to launch.

The MAH shall ensure that all healthcare professionals involved in the prescribing, dispensing, handling or administration of Deltyba are provided with educational material.

1.The Educational material for Healthcare Providers (HCPs) shall address the following key elements:

SmPC

Drug- resistance

Risk of QT interval prolongation

Drug use during pregnancy

Drug use during breast feeding.

2. The educational material for Patients

to be provided via the HCPs to reinforce and supplement the information provided in the patient information leaflet. It shall address the following key elements:

Drug use during pregnancy

Drug use during breast feeding.

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 complete a confirmatory trial examining delamanid added to optimal background

Submission of

regimen in licensed indication: Phase 3 trial comparing delamanid 100 mg BID for 2

final report:

months + 200 mg QD for 4 months plus OBR for 18-24 months versus OBR for 18-24

By 2Q2017

months with placebo for the first 6 months.

 

 

 

To resolve the uncertainties around exposure and antimicobacterial activity, by

Submission of

conducting a further study exploring the relationship between different doses with

final report:

respect to 2 months SCC and longer term outcome : to perform a controlled study of the

By 4Q2021

efficacy, safety and pharmacokinetics of delamanid 100 mg twice daily for 2 months

 

followed by delamanid 200 mg in a single daily dose for 4 months or delamanid 400 mg

 

single daily dose for 6 months in adult patients with pulmonary multidrug-resistant

 

tuberculosis, based on a CHMP-agreed protocol.

 

 

 

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