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Ibandronic Acid Sandoz (ibandronic acid) – Conditions or restrictions regarding supply and use - M05BA06

Updated on site: 07-Oct-2017

Medication nameIbandronic Acid Sandoz
ATC CodeM05BA06
Substanceibandronic acid
ManufacturerSandoz GmbH

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer(s) responsible for batch release

Pharmathen S.A.

6, Dervenakion

EL-15351 Pallini Attiki

Greece

Pharmathen International S.A.

Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300,

Greece

Lek S.A.

ul. Domaniewska 50 C 02-672 Warszawa Poland

Lek Pharmaceuticals d.d.

Verovškova 57, 1526 Ljubljana

Slovenia

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1, 39179 Barleben

Germany

Salutas Pharma GmbH

Dieselstrasse 5, 70839 Gerlingen

Germany

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A, RO-540472 Targu-Mures

Romania

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.

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