EMEA-000300-PIP01-08-M04

Key facts

Invented name
Alipza and associated names
Active substance
Pitavastatin (calcium)
Therapeutic area
Endocrinology, -gynacology-fertility-metabolism
Decision number
P/0096/2016
PIP number
EMEA-000300-PIP01-08-M04
Pharmaceutical form(s)
Film-coated tablet
Condition(s) / indication(s)
Treatment of disorders of lipoprotein metabolism and other lipidaemias
Route(s) of administration
Oral use
Contact for public enquiries
Kowa Pharmaceutical Europe Company Ltd
United Kingdom
Tel. +44 (0)1189229000
E-mail: regulatory@kowa.co.uk
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000300-PIP01-08-M04
Compliance opinion date
19/08/2016
Compliance outcome
positive

Decision

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