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

NovoThirteen (catridecacog) – Conditions or restrictions regarding supply and use - B02BD11

Updated on site: 08-Oct-2017

Medication nameNovoThirteen
ATC CodeB02BD11
Substancecatridecacog
ManufacturerNovo Nordisk A/S

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

Name and address of the manufacturers of the biological active substance

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark

Novo Nordisk A/S

Hagedornsvej 1

DK-2820 Gentofte

Denmark

Name and address of the manufacturer responsible for batch release

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

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.

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 within 60 days as a result of an important (pharmacovigilance or risk minimisation) milestone being reached.

Additional risk minimisation measures

The Marketing Authorisation Holder (MAH) shall ensure that, at launch, a letter is sent to all expected and actual prescribers of NovoThirteen with an Educational Pack containing the following:

1.Physician brochure

2.Patient brochure

Both documents are to be used as part of an educational plan aiming to minimise risks of medication errors, risk of thromboembolic events due to increased levels of non-proteolytically activated rFXIII in connection with incorrect storage, and risk of off-label use for treatment of breakthrough bleeding. The MAH should ensure harmonisation between terminology used in the brochures and the product information.

The physician brochure should contain the following key elements and item:

Indication of the product

The risks of off-label use within FXIII congenital deficiency

Appropriate diagnostic procedures to confirm FXIII A-subunit deficiency

Warning of the difference of both posology and concentration between NovoThirteen and other FXIII containing products (the recommended dose of NovoThirteen is 35 IU/kg body weight (bw) once monthly, administered as an intravenous bolus injection. The dose volume in millilitres should be calculated based on body weight for each patient using the following formula: Dose volume in ml = 0.042 x subject bw (kg) if bw > 24 kg or dose volume in

ml = 0.117 x bw (kg) if bw < 24 kg).

Correct handling and the risks associated with mishandling

Embolic and thrombotic events including the increased risk of vessel occlusion in patients at risk of thrombosis

What to do in the event of incorrect storage, thrombosis or embolism

Contraindication of hypersensitivity

Warning and precautions regarding anaphylaxis

The importance of collecting safety data and how to enrol patients in the PASS and other registries

Distribution and use of the patient brochure and the need to ensure that the patient has read and understood the brochure

Summary of Product Characteristics.

The patient brochure, to be distributed to patients by the prescribers, should contain the following key elements and item:

Indication of the product

The risks of off-label use within FXIII congenital deficiency

How to safely store, handle, reconstitute and administer the product

The risks associated with incorrect storage and mishandling

How to recognise the potential side effects (thrombosis and embolism)

What to do in the event of incorrect storage, thrombosis or embolism

Package Leaflet.

The Marketing Authorisation Holder must implement this educational plan nationally, prior to marketing. The final content, format and distribution modalities of both documents should be agreed with the national competent authority in each Member State.

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