ACLASTA

5/100 Micromol Solution for Infusion

Novartis Europharm LimitedEU/1/05/308/001

Main Information

Trade NameACLASTA
Active SubstancesZOLEDRONIC ACID
Strength5/100 Micromol
Dosage FormSolution for Infusion
Licence HolderNovartis Europharm Limited
Licence NumberEU/1/05/308/001

Group Information

ATC CodeM05BA08 zoledronic acid

Status

Authorised/WithdrawnAuthorised
Licence Issued15/04/2005
Supply StatusSupply through pharmacies only
Dispensing StatusProduct subject to prescription which may not be renewed (A)
Marketing Status--Unknown--
Promotion StatusPromotion to Healthcare Professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website

Educational Materials - HCP

Educational Materials - Patient

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