Medicinal Products
Dotagraf 0,5 mmol/ml otopina za injekciju
| Name |
Dotagraf 0,5 mmol/ml otopina za injekciju |
| Marketing Authorisation Number |
HR-H-834184821 |
| Active Substance |
meglumingadoterat |
| Composition |
1 ml otopine za injekciju sadrži 279,32 mg gadoteratne kiseline (u obliku megluminske soli), što odgovara 0,5 mmol |
| Pharmaceutical Form |
otopina za injekciju |
| Manufacturer |
Sanochemia Pharmazeutika GmbH, Neufeld An Der Leitha, Austrija |
| Marketing Authorisation Holder |
Bayer d.o.o., Radnička cesta 80, Zagreb, Hrvatska |
| Marketing Authorisation Date |
27.11.2019 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/19-02/183 |
| Registration Number |
381-12-01/30-19-03 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product subject to restricted medical prescription
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
V08CA02 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
Packaging
| Packaging description |
MA Number for Packaging |
Marketing status |
Shortage status |
| 1 bočica s 10 ml otopine, u kutiji |
HR-H-834184821-01 |
Marketed |
No shortage |
| 1 bočica s 15 ml otopine, u kutiji |
HR-H-834184821-02 |
Marketed |
No shortage |
| 1 bočica s 20 ml otopine, u kutiji |
HR-H-834184821-03 |
Marketed |
No shortage |
| 10 bočica s 10 ml otopine, u kutiji |
HR-H-834184821-04 |
Never marketed |
- |
| 10 bočica s 15 ml otopine, u kutiji |
HR-H-834184821-05 |
Never marketed |
- |
| 10 bočica s 20 ml otopine, u kutiji |
HR-H-834184821-06 |
Never marketed |
- |
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