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Ocaliva (obeticholic acid) – Conditions or restrictions regarding supply and use - A05AA04

Updated on site: 08-Oct-2017

Medication nameOcaliva
ATC CodeA05AA04
Substanceobeticholic acid
ManufacturerIntercept Pharma Ltd

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

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

Almac Pharma Services

Seagoe Industrial Estate

Portadown

Craigavon

BT63 5UA

United Kingdom

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

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.

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

 

 

Interventional study 747-302:

Final report: 2023

Description: In order to confirm the efficacy and safety of OCALIVA, the MAH

 

should conduct and submit the results of study 747-302, a confirmatory double-

 

blind, randomised, placebo-controlled multicentre study investigating the clinical

 

benefit associated with OCALIVA treatment in patients with PBC who are either

 

unresponsive or intolerant to UDCA treatment based on clinical endpoints.

 

Rationale: to investigate the effect of obeticholic acid on clinical outcomes in

 

subjects with PBC

 

 

 

Interventional study 747-401:

Final report: 2020

Description: In order to confirm the efficacy and safety of OCALIVA, the MAH

 

should conduct and submit the results of study 747-401, a double-blind, randomised,

 

placebo-controlled study evaluating the efficacy, safety and pharmacokinetics of

 

OCALIVA in patients with PBC and moderate to severe hepatic impairment.

 

Rationale: to investigate the uncertainties related to the lack of data in a population

 

with more advanced liver disease

 

 

 

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