REMUREL
20MG/ML INJ SOL ISP 90(3X30)X1ML
| SÚKL code | 0173176 |
|---|---|
| Name of the product | REMUREL |
| _MA_MEDICATION_DETAIL_INFO_MED_NAME i | REMUREL |
| Supplement | 20MG/ML INJ SOL ISP 90(3X30)X1ML |
| Strenght | 20MG/ML |
| Pharmaceutical form | Solution for injection in pre-filled syringe |
| Package | 90(3X30)X1ML |
| Route | Subcutaneous use |
| Language of the pack | Czech |
| Wrap type | Pre-filled syringe |
| Legal status | na lékařský předpis |
| Active substance | GLATIRAMER ACETATE (GLATIRAMERI ACETAS) |
| ATC group | L03AX13 |
| ATC group name | GLATIRAMER-ACETÁT |
Marketing authorisation information
| Registration Number | 59/ 222/16-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. 06. 2021 |
| MA Holder | Alvogen IPCo S.ar.l., Senningerberg |
| MA Holder country | LUCEMBURSKO |
| Actual MA holder | Zentiva, k.s., Praha |
| Actual MA holder country | ČESKÁ REPUBLIKA |
cz