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Dafiro (amlodipine / valsartan) – Conditions or restrictions regarding supply and use - C09DB01

Updated on site: 06-Oct-2017

Medication nameDafiro
ATC CodeC09DB01
Substanceamlodipine / valsartan
ManufacturerNovartis Europharm Ltd.

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 medical prescription.

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

Not applicable.

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