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

Fabrazyme (agalsidase beta) – Conditions or restrictions regarding supply and use - A16AB04

Updated on site: 06-Oct-2017

Medication nameFabrazyme
ATC CodeA16AB04
Substanceagalsidase beta
ManufacturerGenzyme Europe B.V.

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

Name and address of the manufacturer of the biological active substance

Genzyme Corp.

45, 51, 68, 74, 76 and 80 New York Avenue

Framingham

MA 01701-9322

USA

Name and address of the manufacturer responsible for batch release

Genzyme Ltd.

37 Hollands Road

Haverhill

Suffolk CB9 8PU

United Kingdom

Genzyme Ireland Ltd.

IDA Industrial Park

Old Kilmeaden Road

Waterford

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 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.

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 Marketing Authorisation Holder (MAH) shall agree the details of the educational programme for Fabrazyme home infusion with the National Competent Authorities prior to implementing the programme nationally.

The MAH shall ensure that all Healthcare Professional who are expected to prescribe/use Fabrazyme are provided with an educational pack aiming to facilitate the training of the patients/caregivers and also to guide prescribers regarding patient evaluation and selection and organisational requirements for home infusion.

The educational pack should contain the following:

Home infusion manual for healthcare professionals

Home infusion manuals for patients

Summary of Product Characteristics and Package Leaflet

The educational material for healthcare professionals should include information on the following key elements:

-Guidance regarding patient evaluation and selection and organisational requirements for home infusion.

-That it is the responsibility of the prescribing physician to determine which patients may be suitable for home or self-administration of Fabrazyme.

-That it is the responsibility of the prescribing physician to provide appropriate training to the non-healthcare professional, such as the patient for self-administration or a caregiver who will administer the treatment at home, if the treating physician decides that this is appropriate.

-Regular review of the administration by the patient and/or caregiver needs to be performed to ensure maintenance of optimal practice.

-The training to be provided to the patient and /or caregiver should address the following elements:

-That it is essential to follow strictly the prescribed dose and infusion rate

-Method of preparation and administration of Fabrazyme

-Instructions in handling possible adverse events

-Instruction to seek emergency treatment by healthcare professionals in the event of any adverse reactions during an infusion

-The need to seek urgent treatment in the event of failure to gain venous access or if there is a lack of efficacy

-The need to keep a diary to document each treatment received at home and to bring it at each visit

-It is the responsibility of the prescribing physician to verify that all necessary skills have been acquired by the non-healthcare professional and that Fabrazyme may be safely and effectively administered at home.

The educational material for patients should include information on the following key elements:

-The prescribing physician may decide that Fabrazyme may be administered at home. The level of support required for home infusion will be discussed and agreed by the patient and/or caregiver with the prescribing physician.

-The treating physician will be responsible for determining which patients may be suitable for home or self-administration of Fabrazyme and for arranging for treatment at home and training the patient and/or caregiver in the appropriate skills necessary for this.

-Necessary skills have to be acquired by non-healthcare professionals before Fabrazyme may be safely and effectively administered at home.

-Their prescribing physician will provide training on the following elements:

-That it is essential to follow strictly the prescribed dose and infusion rate

-Method of preparation and administration of Fabrazyme

-Instructions in handling possible adverse events

-Instruction to seek emergency treatment by healthcare professionals in the event of any adverse reactions during an infusion

-The need to seek urgent treatment in the event of failure to gain venous access or if there is a lack of efficacy

-The need to keep a diary to document each treatment received at home and to bring it at each visit

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