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NeuroBloc (botulinum toxin type B) – Conditions or restrictions regarding supply and use - M03AX01

Updated on site: 08-Oct-2017

Medication nameNeuroBloc
ATC CodeM03AX01
Substancebotulinum toxin type B
ManufacturerEisai Ltd.

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

Name and address of the manufacturer of the biological active substance

Solstice Neurosciences LLC

701 Gateway Blvd, South San Francisco

California 94080

USA

Name and address of the manufacturer responsible for batch release

Eisai Manufacturing Limited

European Knowledge Centre

Mosquito Way

Hatfield

Hertfordshire

AL10 9SN

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 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

Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational material with the National Competent Authority.

The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where NeuroBloc is marketed, at launch and after launch all physicians who are expected to use NeuroBloc are provided with updated physician information pack containing the following elements:

Physician information

Patient information

The physician information should contain the following key elements:

The Summary of Product Characteristics

Appropriate injection technique

Appropriate dose selection and dosing interval

Awareness that toxin dosages are NOT interchangeable between botulinum toxin containing products.

The need for continued observation for patients with risk factors for toxin spread from the site of injection to other parts of the body and identification of these patients so caution can be exercised.

Plan for thorough discussion between physician and patient regarding risk/benefit.

The safety of NeuroBloc outside the approved indication has not been established and the risks (including dysphagia and respiratory difficulties) may outweigh the benefits.

Awareness of educational material for patients.

The patient information should contain the following key elements:

The need for early recognition of symptoms that could indicate spread of toxin e.g. swallowing, speech or respiratory difficulties.

The need to seek immediate medical attention especially in event of swallowing, speech and respiratory difficulties.

The safety of NeuroBloc outside the approved indication has not been established and the risks (including dysphagia and respiratory difficulties) may outweigh the benefits.

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