| Code | 5135E | ||||||||||
| MA number | 59/0221/23-S | ||||||||||
| Product Form: | tbl flm 30x14 mg (blis.OPA/Al/PVC//papier-Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | HCS BV, Belgium | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 07.12.2023 |
| Validity: | 07.12.2028 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Aregalu 14 mg filmom obalené tablety_11/2024.pdf
|
| PIL: |
PIL_Aregalu 14 mg filmom obalené tablety_11/2024.pdf
|
| Dokument: |
Teriflunomid_Pokyny pre zdravotníckych pracovníkov.pdf
|
| Dokument: |
VHS_Teriflunomide HCS_SK_H_0272_0274_0275_0291_DC.doc
|
| Dokument: |
VHS_Teriflunomide HCS_SK_H_0272_0274_0275_0291_DC_sumár.doc
|
| PIL: |
PIL_Teriflunomide HCS 14 mg filmom obalené tablety_11/2024.pdf
|
| SPC: |
SPC_Teriflunomide HCS 14 mg filmom obalené tablety_11/2024.pdf
|
| Safety feature | Yes |
| Data update: | 15.05.2024 |
