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Adasuve (loxapine) – Conditions or restrictions regarding supply and use - N05AH01

Updated on site: 05-Oct-2017

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

FERRER INTERNACIONAL, S.A.

Joan Buscalla, 1-9, 08173 Sant Cugat del Vallès, Barcelona, Spain

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 the first periodic safety update report for this product within 6 months following authorisation. Subsequently, 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 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 shall be submitted annually until renewal.

When the submission of a PSUR and the update of a RMP coincide, they should be submitted at the same time.

In addition, 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) mileston being reached.

Addtional risk minimisation measures

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

The MAH shall ensure that, following discussion and agreement with the National Competent Authorities in each Member State where ADASUVE is marketed, at launch and after launch, all healthcare professionals who are expected to use ADASUVE are provided with an information pack containing the following items:

Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling

Educational material for the healthcare professionals

Key elements to be included in the educational materials:

General:

Introductory statement on the purpose of the educational material

Statement on acute setting of indication

Risk of bronchospasm:

Mention of contra-indications and related warnings

A clear recommendation not to start ADASUVE treatment in patients with a respiratory medical history

Treatment with ADASUVE to be limited to a hospital setting

Availabilty of rescue medicatins (short acting beta agonist bronchodilator) during treatment

Observation of patients for 1 hour after each dose of ADASUVE

Risk of QT prolongation:

Administration of a maximum of 2 doses

Caution to be exercised when ADASUVE is administered in patients with known cardiovascular disease or a family history of QT prolongation, and in cases of concomitant use with other medicial products known to prolong the QT interval

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