| Code | 6291E | ||||||||||
| MA number | 30/0107/24-S | ||||||||||
| Product Form: | tbl flm 90x50 mg (blis.PVC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Medreg s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 30 - ANTIDEPRESSIVA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 48 | ||||||||||
| Container: | blister PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 11.06.2024 |
| Validity: | 11.06.2029 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Sertraline Medreg_05 2024.pdf
|
| PIL: |
PIL_Sertraline Medreg_05 2024.pdf
|
| Dokument: |
VHS_SK_H_0297_001-002_DC_Sertraline Medreg_PAR.pdf
|
| Dokument: |
VHS_SK_H_0297_001-002_DC_Sertraline Medreg_summary PAR.pdf
|
| Safety feature | Yes |
| Data update: | 28.06.2024 |
