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Imprida HCT (amlodipine / valsartan / hydrochlorothiazide) – Conditions or restrictions regarding supply and use - C09DB03

Updated on site: 08-Oct-2017

Medication nameImprida HCT
ATC CodeC09DB03
Substanceamlodipine / valsartan / hydrochlorothiazide
ManufacturerNovartis Europharm Ltd.
OTHER CONDITIONS

A.MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

B.CONDITIONS OF THE MARKETING AUTHORISATION

CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER

Medicinal product subject to medical prescription.

CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Not applicable.

authorised

Pharmacovigilance system

The MAH must ensure that the system of pharmacovigi ance, presented in Module 1.8.1. of the

 

 

no

Marketing Authorisation, is in place and functioning beforelongerand whilst the product is on the market.

Medicinal

product

 

 

 

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