| Code | 6522B | ||||||||||
| MA number | 65/0452/15-S | ||||||||||
| Product Form: | tbl plg 90x75 mg/650 mg (blis.PVC/PVDC/papier/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
| Therapeutic Class: | 65 - ANALGETICA - ANODYNA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 06.11.2015 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Doreta SR 75 mg_650 mg tablety s predĺženým uvoľňovaním_05_2024.pdf
|
| PIL: |
PIL_Doreta SR 75 mg_650 mg tablety s predĺženým uvoľňovaním_05.2024.pdf
|
| Safety feature | Yes |
| Data update: | 12.07.2021 |
