Medicinal Products
Irinotesin 20 mg/ml koncentrat za otopinu za infuziju
| Name |
Irinotesin 20 mg/ml koncentrat za otopinu za infuziju |
| Marketing Authorisation Number |
HR-H-810518111 |
| Active Substance |
irinotekanklorid trihidrat |
| Composition |
jedan ml koncentrata sadrži 20 mg irinotekanklorid trihidrata što odgovara 17,33 mg/ml irinotekana |
| Pharmaceutical Form |
koncentrat za otopinu za infuziju |
| Manufacturer |
S.C. Sindan-Pharma S.R.L., Bukurešt, Rumunjska |
| Marketing Authorisation Holder |
Teva B.V., Swensweg 5, Haarlem, Nizozemska |
| Marketing Authorisation Date |
02.12.2020 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/14-02/248 |
| Registration Number |
381-12-01/154-20-18 |
| 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 |
L01CE02 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
Packaging
| Packaging description |
MA Number for Packaging |
Marketing status |
Shortage status |
| 1 bočica s 2 ml koncentrata za otopinu, u kutiji |
HR-H-810518111-01 |
Marketed |
No shortage |
| 1 bočica s 5 ml koncentrata za otopinu, u kutiji |
HR-H-810518111-02 |
Marketed |
Actual |
| 1 bočica s 15 ml koncentrata za otopinu, u kutiji |
HR-H-810518111-03 |
Marketed |
No shortage |
| 1 bočica s 25 ml koncentrata za otopinu, u kutiji |
HR-H-810518111-04 |
Marketed |
No shortage |
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