| Code | 24939 | ||||||||
| MA number | 80/0611/95-S | ||||||||
| Product Form: | cps dur 250x300 mg (blis.Al/PVC) | ||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||
| Type of procedure: | National | ||||||||
| MAH, country: | Opella Healthcare Slovakia s.r.o., Slovakia | ||||||||
| Therapeutic Class: | 80 - HEPATICA | ||||||||
| ATC: |
|
||||||||
| Shelf life: | 24 | ||||||||
| Container: | blister Al/PVC | ||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 23.10.1995 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_Essentiale 300mg_cps dur_04_2023.pdf
|
| SPC: |
SPC_Essentiale 300mg_cps dur_04_2023.pdf
|
| SPC: |
SPC_Essentiale 300mg_cps dur_09_2023.pdf
|
| PIL: |
PIL_Essentiale 300 mg_cps dur_04_2024.pdf
|
| Safety feature | No |
| Data update: | 23.07.2019 |
