REMUREL
20MG/ML INJ SOL ISP 90(3X30)X1ML
SÚKL code | 0173176 |
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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 |
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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 |