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Kalydeco (ivacaftor) – Conditions or restrictions regarding supply and use - R07AX02

Updated on site: 08-Oct-2017

Medication nameKalydeco
ATC CodeR07AX02
Substanceivacaftor
ManufacturerVertex Pharmaceuticals (Europe) Ltd

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

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

Almac Pharma Services Ltd.

Seagoe Industrial Estate

Craigavon

Co. Armagh BT63 5UA

United Kingdom

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.

Obligation to conduct post-authorisation measures

The MAH shall complete, within the stated timeframe, the below measures:

Description

Due date

The applicant should conduct a 5-year long-term observational study with

December 2017

ivacaftor in patients with cystic fibrosis, including also microbiological and

 

clinical endpoints (e.g., exacerbations), according to a protocol agreed with the

 

CHMP. The applicant should submit yearly interim analyses and the final CSR

 

by December 2017.

 

Long-term effectiveness study to compare disease progression among children

Interim analysis

with CF who have a specified CFTR gating mutation and are aged 2 through 5

1: December

years at the time of Kalydeco treatment initiation versus disease progression

among concurrent matched cohort of children with CF who have never received

 

Kalydeco treatment.

Interim analysis

 

2: December

 

 

Interim analysis

 

3: December

 

 

Final report:

 

December 2023

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