ONDANSETRON ACCORD
2MG/ML INJ/INF SOL 5X2ML
| SÚKL code | 0162578 |
|---|---|
| Name of the product | ONDANSETRON ACCORD |
| _MA_MEDICATION_DETAIL_INFO_MED_NAME i | ONDANSETRON ACCORD |
| Supplement | 2MG/ML INJ/INF SOL 5X2ML |
| Strenght | 2MG/ML |
| Pharmaceutical form | Solution for injection/infusion |
| Package | 5X2ML |
| Route | Intramuscular/intravenous use |
| Language of the pack | Czech |
| Wrap type | Ampoule |
| Legal status | na lékařský předpis |
| Active substance | ONDANSETRON HYDROCHLORIDE DIHYDRATE (ONDANSETRONI HYDROCHLORIDUM DIHYDRICUM) |
| ATC group | A04AA01 |
| ATC group name | ONDANSETRON |
Marketing authorisation information
| Registration Number | 20/ 176/10-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