TOPOTECAN ACCORD
1MG/ML INF CNC SOL 1X4ML
| SÚKL code | 0178630 |
|---|---|
| Name of the product | TOPOTECAN ACCORD |
| _MA_MEDICATION_DETAIL_INFO_MED_NAME i | TOPOTECAN ACCORD |
| Supplement | 1MG/ML INF CNC SOL 1X4ML |
| Strenght | 1MG/ML |
| Pharmaceutical form | Concentrate for solution for infusion |
| Package | 1X4ML |
| Route | Intravenous use |
| Language of the pack | Czech |
| Wrap type | Vial |
| Legal status | na lékařský předpis |
| Active substance | TOPOTECAN HYDROCHLORIDE (TOPOTECANI HYDROCHLORIDUM) |
| ATC group | L01CE01 |
| ATC group name | TOPOTEKAN |
Marketing authorisation information
| Registration Number | 44/ 322/12-C |
|---|---|
| Type of MA | A mutual recognition procedure (MRP, DCP), where CZ is Concerned 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 | 30. 09. 2019 |
| MA Holder | Accord Healthcare Limited, North Harrow |
| MA Holder country | VELKÁ BRITÁNIE |
| Actual MA holder | ACCORD HEALTHCARE POLSKA Sp. z o.o., Varšava |
| Actual MA holder country | POLSKO |
cz