Name |
Genotropin 12 mg prašak i otapalo za otopinu za injekciju u ulošku |
Marketing Authorisation Number |
HR-H-358647692 |
Active Substance |
somatropin |
Composition |
jedan dvodijelni uložak sadrži 12 mg somatropina i 1 ml otapala
nakon rekonstitucije, koncentracija somatropina je12 mg/ml |
Pharmaceutical Form |
prašak i otapalo za otopinu za injekciju u ulošku |
Manufacturer |
Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgija |
Marketing Authorisation Holder |
Pfizer Croatia d.o.o., Slavonska avenija 6, Zagreb, Hrvatska |
Marketing Authorisation Date |
21.02.2018 |
MA Period of Validity |
unlimited |
Classification Number |
UP/I-530-09/16-02/493 |
Registration Number |
381-12-01/30-18-04 |
Prescription |
na recept |
Type of prescription |
ograničeni recept
|
Distribution |
u ljekarni |
Advertising to general public |
zabranjeno |
ATC Code |
H01AC01 |
Medicinal product marketed in the Croatia |
Da |
SmPC |
download |
PL |
download |