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Ivabradine JensonR (ivabradine hydrochloride) – Conditions or restrictions regarding supply and use - C01EB17

Updated on site: 08-Oct-2017

Medication nameIvabradine JensonR
ATC CodeC01EB17
Substanceivabradine hydrochloride
ManufacturerJensonR Limited

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

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

McDermott Laboratories Limited t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate Grange Road

Dublin 13 Ireland

Mylan Hungary Kft.

Mylan utca. 1

H-2900 Komárom

Hungary

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 medical prescription.

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 Medicine 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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