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Aclasta (zoledronic acid) – Conditions or restrictions regarding supply and use - M05BA08

Updated on site: 11-Jul-2017

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

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 Marketing Authorisation Holder (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 ensure that the educational programme implemented for the authorised indications of treatment of osteoporosis in post-menopausal women and in men at increased risk of fracture, including those with a recent low-trauma hip fracture, and treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture is updated. The educational programme contains the following:

Physician educational material

Patient information pack

20
Patient reminder card on osteonecrosis of the jaw
Package leaflet
In addition, the following documents should be included in the patient information pack:

The physician educational material should contain the following key elements:

The Summary of Product Characteristics

Reminder card with the following key messages:

oNeed to calculate creatinine clearance based on actual body weight using the Cockcroft-Gault formula before each treatment with Aclasta

o Contraindication in patients with creatinine clearance < 35 ml/min

oContraindication in pregnancy and in breast-feeding women due to potential teratogenicity

oNeed to ensure appropriate hydration of the patient especially those at an advanced age and those receiving diuretic therapy

o Need to infuse Aclasta slowly over a period of no less than 15 minutes o Once-yearly dosing regime

oAdequate calcium and vitamin D intake are recommended in association with Aclasta administration

oNeed for appropriate physical activity, non-smoking and healthy diet

Patient information pack

The patient information pack should be provided and contain the following key messages:

Contraindication in patients with severe kidney problems

Contraindication in pregnancy and in breast-feeding women

Need for adequate calcium and vitamin D supplementation, appropriate physical activity, non-smoking and healthy diet

Key signs and symptoms of serious adverse reactions

When to seek attention from the health care provider

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