A.MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer responsible for batch release
Novartis Pharma GmbH
- Copalia hct - amlodipine / valsartan / hydrochlorothiazide
Prescription drugs listed. Substance: "Amlodipine / valsartan / hydrochlorothiazide"
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
The MAH must ensure that the system of pharmacovigi ance, presented in Module 1.8.1. of the
Marketing Authorisation, is in place and functioning beforelongerand whilst the product is on the market.