EMEA-000057-PIP01-07-M07

Key facts

Invented name
Aclasta
Active substance
zoledronic acid
Therapeutic area
Endocrinology, -gynacology-fertility-metabolism
Decision number
P/0028/2020
PIP number
EMEA-000057-PIP01-07-M07
Pharmaceutical form(s)
Solution for infusion
Condition(s) / indication(s)
  • Treatment of osteoporosis
  • Treatment of Paget’s disease of the bone
Route(s) of administration
Intravenous use
Contact for public enquiries
Novartis Europharm Limited

E-mail: paediatric.enquiries@novartis.com
Tel. +41 61 324 1111

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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