EMEA-000397-PIP01-08

Key facts

Invented name
Copalia HCT
Active substance
Amlodipine besylate, valsartan, hydrochlorothiazide
Therapeutic area
Cardiovascular diseases
Decision number
P/14/2009
PIP number
EMEA-000397-PIP01-08
Pharmaceutical form(s)
Film-coated tablet
Condition(s) / indication(s)
Essential Hypertension
Route(s) of administration
Oral use
Contact for public enquiries
Applicant: Novartis Europharm Ltd.
E-mail: paediatric.enquiries@novartis.com
Country: Switzerland
Phone: +41 61 324 1111
Fax: +41 61 324 8001
Decision type
W: decision granting a waiver in all age groups for all conditions/indications

Decision

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