Medicinal Products
Irinotekan Accord 20 mg/ml koncentrat za otopinu za infuziju
| Name |
Irinotekan Accord 20 mg/ml koncentrat za otopinu za infuziju |
| Marketing Authorisation Number |
HR-H-879693802 |
| Active Substance |
irinotekanklorid trihidrat |
| Composition |
1 ml koncentrata sadrži 20 mg irinotekanklorid trihidrata, što odgovara 17,33 mg irinotekana |
| Pharmaceutical Form |
koncentrat za otopinu za infuziju |
| Manufacturer |
Accord Healthcare Polska Sp. z o.o., Pabianice, Poljska |
| Marketing Authorisation Holder |
Accord Healthcare Polska Sp. z o.o., Ul. Tasmowa 7, Mazowieckie, Varšava, Poljska |
| Marketing Authorisation Date |
11.06.2021 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/20-02/108 |
| Registration Number |
381-12-01/154-21-03 |
| 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 |
L01CE02 |
| Marketing status |
stavljeno u promet |
| Shortage status |
nema nestašice |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
Packaging
| Packaging description |
MA Number for Packaging |
Marketing status |
Shortage status |
| 1 bočica s 2 ml koncentrata, u kutiji |
HR-H-879693802-01 |
stavljeno u promet |
nema nestašice |
| 1 bočica s 5 ml koncentrata, u kutiji |
HR-H-879693802-02 |
stavljeno u promet |
nema nestašice |
| 1 bočica s 15 ml koncentrata, u kutiji |
HR-H-879693802-03 |
stavljeno u promet |
nema nestašice |
| 1 bočica s 25 ml koncentrata, u kutiji |
HR-H-879693802-04 |
stavljeno u promet |
nema nestašice |
| 1 bočica s 50 ml koncentrata, u kutiji |
HR-H-879693802-05 |
stavljeno u promet |
nema nestašice |
Direct Healthcare Professional Communication
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