English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

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

Updated on site: 06-Oct-2017

Medication nameEnbrel
ATC CodeL04AB01
Substanceetanercept
ManufacturerPfizer Limited

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

Name and address of the manufacturers of the biological active substance

Boehringer Ingelheim Pharma KG

Birkendorfer Strasse 65

D-88397 Biberach an der Riss

Germany

Pfizer Ireland Pharmaceuticals

Grange Castle Business Park

Clondalkin

Dublin 22

Ireland

Name and address of the manufacturer responsible for batch release

Wyeth Pharmaceuticals

New Lane

Havant

Hampshire, PO9 2NG

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.

Additional risk minimisation measures

Prior to launch in each Member State, the MAH shall agree the final educational material with the competent authority in that Member State comprising of information provided to all healthcare professionals expected to prescribe the product on the correct and safe use of the pre-filled pen and a Patient Alert Card which is to be given to patients using Enbrel.

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

A needle-free demonstration device

Instructional materials to share with patients

The Patient’s Alert Card should contain the following key elements for patients treated with Enbrel:

The risk of opportunistic infections and tuberculosis (TB)

The risk of Congestive Heart Failure (CHF).

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed