| Code | 6630E | ||||||||||
| MA number | 16/0157/24-S | ||||||||||
| Product Form: | tbl flm 28x1x25 mg (blis.OPA/Al/PVC/Al - jednotk.bal.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Glenmark Pharmaceuticals s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Container: | blister OPA/Al/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 27.06.2024 |
| Validity: | 27.06.2029 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Eltrombopag Glenmark_06.2024.pdf
|
| SPC: |
SPC_Eltrombopag Glenmark_06.2024.pdf
|
| Safety feature | Yes |
| Data update: | 02.07.2024 |
