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

Nplate (romiplostim) – Conditions or restrictions regarding supply and use - B02BX04

Updated on site: 08-Oct-2017

Medication nameNplate
ATC CodeB02BX04
Substanceromiplostim
ManufacturerAmgen Europe B.V.

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

Name and address of the manufacturers of the biological active substance

Amgen Inc

One Amgen Center Drive

Thousand Oaks, CA 91320

USA

Amgen Manufacturing Limited

State Road 31,

Km 24.6,

Juncos,

Puerto Rico 00777-4060

USA

Name and address of the manufacturers responsible for batch release

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

Amgen Technology Ireland (ADL)

Pottery Road

Dun Laoghaire

Co Dublin

Ireland

The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.

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 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 dates for 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 agree the details of the following educational tools with the National Competent Authorities and must implement such programme nationally.

Dose calculator

Physicians involved in the prescribing of romiplostim are provided with a dosing calculator to simplify the calculation of the correct dose and guide to the correct reconstitution and administration procedures.

Home Administration Training (HAT) pack

Physicians who express an interest in initiating self-administration for specific patients are provided with a HAT pack for those patients. The HAT pack includes materials for HCPs on how to select and train patients for self-administration of romiplostim; and for patients, in order to help them with the process of preparation and self-administration of the correct dose of romiplostim.

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