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Mysimba (bupropion hydrochloride / naltrexone...) – Conditions or restrictions regarding supply and use - A08AA

Updated on site: 08-Oct-2017

Medication nameMysimba
ATC CodeA08AA
Substancebupropion hydrochloride / naltrexone hydrochloride
ManufacturerOrexigen Therapeutics Ireland Limited

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

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

Central Pharma Contract Packaging Ltd.

Caxton Road, Bedford, Bedfordshire, MK41 0XZ

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 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 shall ensure that in each Member State where Mysimba is marketed, all healthcare professionals who are expected to prescribe Mysimba are provided with a prescriber guide. Prior to launch of Mysimba in each Member State the Marketing Authorisation Holder (MAH) must agree the content and format of the prescriber guide with the National Competent Authority.

The prescriber guide shall contain the following key elements:

-a reminder of the indication and the need to discontinue treatment if there are concerns with the safety or tolerability of ongoing treatment, or if after 16 weeks patients have lost less than 5% of their initial body weight;

-a reminder of the contraindications, warnings and precautions as well as patient characteristics that place patients at higher risk of adverse reactions to Mysimba, to help ensure appropriate patient selection.

Obligation to conduct post-authorisation measures

 

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

 

 

 

Description

Due date

Post Authorisation Safety Study :

Submission of

 

 

The MAH should conduct and submit results of a multicentre, randomised, double-

final study

blind, placebo-controlled, phase 4 study to assess the effect of naltrexone extended

report by 31

release (ER) /bupropion ER on the occurrence of major adverse cardiovascular

March 2022

events (MACE) in overweight and obese subjects. The study is to be monitored

 

regularly by a Data Monitoring Committee (DMC). The study protocol, including

Submission of

key aspects of the DMC charter, has to be agreed before initiation of the study.

the protocol

 

 

by 31 March

 

 

 

 

 

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