Medicinal Products

Melarth 4 mg granule

Name Melarth 4 mg granule
Marketing Authorisation Number HR-H-264846897
Active Substance montelukastnatrij
Composition jedna vrećica granula sadrži 4 mg montelukasta (u obliku montelukastnatrija)
Pharmaceutical Form granule
Manufacturer Pliva Hrvatska d.o.o., Zagreb, Hrvatska
Teva Operations Poland Sp. z o.o., Krakow, Poljska
Marketing Authorisation Holder Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska
Marketing Authorisation Date 21.11.2016
MA Period of Validity unlimited
Classification Number UP/I-530-09/15-02/388
Registration Number 381-12-01/70-16-04
Prescription Medicinal product subject to medical prescription
Type of prescription Medicinal product on medical prescription for renewable delivery
Distribution Supply through pharmacies (community)
Advertising to general public not allowed
ATC Code R03DC03
Marketing status Marketed
Shortage status No shortage
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