SOFTINE
0,03MG/3MG TBL FLM 2X21
| SÚKL code | 0242348 |
|---|---|
| Name of the product | SOFTINE |
| _MA_MEDICATION_DETAIL_INFO_MED_NAME i | SOFTINE |
| Supplement | 0,03MG/3MG TBL FLM 2X21 |
| Strenght | 0,03MG/3MG |
| Pharmaceutical form | Film-coated tablet |
| Package | 2X21 |
| Route | Oral use |
| Language of the pack | Czech |
| Wrap type | Blister |
| Legal status | na lékařský předpis |
| Active substance |
ETHINYLESTRADIOL (ETHINYLESTRADIOLUM) DROSPIRENONE (DROSPIRENONUM) |
| ATC group | G03AA12 |
| ATC group name | DROSPIRENON A ETHINYLESTRADIOL |
Marketing authorisation information
| Registration Number | 17/ 122/10-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 | 31. 08. 2021 |
| MA Holder | Alvogen Pharma Trading Europe EOOD, Sofia |
| MA Holder country | BULHARSKO |
| Actual MA holder | Theramex Ireland Limited, Dublin |
| Actual MA holder country | IRSKO |
cz