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Benepali (etanercept) – Conditions or restrictions regarding supply and use - L04AB01

Updated on site: 05-Oct-2017

Medication nameBenepali
ATC CodeL04AB01
Substanceetanercept
ManufacturerSamsung Bioepis UK Limited 5th Floor Profile West 950 Great West Road Brentford TW8 9ES United Kingdom

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

Name and address of the manufacturer of the biological active substance Biogen (Denmark) Manufacturing ApS

Biogen Allé 1

3400 Hillerød Denmark

Name and address of the manufacturer responsible for batch release Biogen (Denmark) Manufacturing ApS

Biogen Allé 1

3400 Hillerød Denmark

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

1.Prior to launch in each Member State, the MAH shall agree the final educational material with the competent authority in that Member State, consisting of information provided to all healthcare professionals expected to prescribe the product on the correct and safe use of the pre -filled pen/pre- filled syringes and to inform them that the product is not for use in children and adolescents who weigh less than 62.5 kg, and a Patient Alert Card which is to be given to patients using Benepali.

2.The healthcare professional’s educational material should contain the following key elements:

Teaching guide to facilitate training of the patients in the safe use of the pre-filled pen/prefilled syringes

A needle-free demonstration device

Material to remind healthcare professionals that Benepali is not for use in children and adolescents who weigh less than 62.5 kg

Instructional materials to share with patients.

3.The Patient Alert Card should contain the following key elements for patients treated with Benepali:

The risk of opportunistic infections and tuberculosis (TB)

The risk of Congestive Heart Failure (CHF)

Benepali is not for use in children and adolescents who weigh less than 62.5 kg.

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