EPIRUBICIN ACTAVIS
2MG/ML INJ SOL 1X5ML I
SÚKL code | 0224648 |
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Name of the product | EPIRUBICIN ACTAVIS |
_MA_MEDICATION_DETAIL_INFO_MED_NAME i | EPIRUBICIN ACTAVIS |
Supplement | 2MG/ML INJ SOL 1X5ML I |
Strenght | 2MG/ML |
Pharmaceutical form | Solution for injection |
Package | 1X5ML I |
Route | Intravenous/intravesical use |
Language of the pack | Czech |
Wrap type | Vial |
Legal status | na lékařský předpis |
Active substance | EPIRUBICIN HYDROCHLORIDE (EPIRUBICINI HYDROCHLORIDUM) |
ATC group | L01DB03 |
ATC group name | EPIRUBICIN |
Marketing authorisation information
Registration Number | 44/ 108/08-C |
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Type of MA | A mutual recognition procedure (MRP, DCP), where CZ is Reference member state |
MA status | B - medicinal product after change, may be placed on the market for the period of 6 months (Placed on the market till) and used until expiration, not later than till the end of validity of the marketing authorisation (Valid till) |
Placed on the market till | 31. 12. 2022 |
MA Holder | Actavis Group PTC ehf., Hafnarfjördur |
MA Holder country | ISLAND |
Actual MA holder | Teva B.V., Haarlem |
Actual MA holder country | NIZOZEMSKO |