MultiHance 0,5 mmol/ml otopina za injekciju

Name	MultiHance 0,5 mmol/ml otopina za injekciju
Marketing Authorisation Number	HR-H-872900882
Active Substance	dimeglumingadobenat
Composition	1 ml otopine za injekciju sadrži 529 mg dimeglumingadobenata (što odgovara 334 mg (0,5 mmol/ml) gadobenatne kiseline i 195 mg meglumina)
Pharmaceutical Form	otopina za injekciju
Manufacturer	Patheon Italia S.p.A., Ferentino (FR), Italija Bracco Imaging s.p.a., Colleretto Giocosa, Torino, Italija
Marketing Authorisation Holder	Bracco Imaging s.p.a., Via Egidio Folli 50, Milano, Italija
Marketing Authorisation Date	30.01.2018
MA Period of Validity	unlimited
Classification Number	UP/I-530-09/16-02/386
Registration Number	381-12-01/30-18-05
Prescription	Medicinal product subject to medical prescription
Type of prescription	ograničeni recept
Distribution	Supply through pharmacies (community)
Advertising to general public	not allowed
ATC Code	V08CA08
Marketing status	stavljeno u promet
Shortage status	nema nestašice
SmPC	download
PL	download

Packaging

Packaging description	MA Number for Packaging	Marketing status	Shortage status
1 bočica sa 10 ml otopine, u kutiji	HR-H-872900882-01	stavljeno u promet	nema nestašice
1 bočica sa 15 ml otopine, u kutiji	HR-H-872900882-02	stavljeno u promet	nema nestašice
1 bočica sa 20 ml otopine, u kutiji	HR-H-872900882-03	stavljeno u promet	nema nestašice

Direct Healthcare Professional Communication

Name	Date	Download
Pismo zdravstvenim radnicima o najnovijim preporukama za gadolinijska kontrastna sredstva	04.12.2017	Bayer d.o.o., Bracco Imaging S.p.A., GE Healthcare d.o.o. i Pharmacol d.o.o.