| Code | 80316 | ||||||||
| MA number | 17/0328/09-S | ||||||||
| Product Form: | tbl flm 3x21 (blis. PVC/PVDC/Al) | ||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||
| Type of procedure: | Decentralised | ||||||||
| MAH, country: | Exeltis Slovakia s.r.o., Slovakia | ||||||||
| Therapeutic Class: | 17 - ANTICONCIPIENTIA | ||||||||
| ATC: |
|
||||||||
| Shelf life: | 36 | ||||||||
| Container: | blister PVC/PVDC/Al | ||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 23.09.2009 |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Dienorette filmom obalené tablety_01.2023.pdf
|
| PIL: |
PIL_Dienorette filmom obalené tablety_11.2024.pdf
|
| Safety feature | Yes |
| Data update: | 09.05.2018 |
