Code | 0563E | ||||||||||
MA number | 16/0095/22-S | ||||||||||
Product Form: | tbl flm 60x5 mg (blis.Al/PVC/PE/PVDC) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 36 | ||||||||||
Container: | blister Al/PVC/PE/PVDC | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 21.05.2022 |
Validity: | 21.05.2027 |
SPC: | SPC Apixaban STADA 5 mg_02.2023.pdf |
PIL: | PIL Apixaban STADA 5 mg_02.2023.pdf |
Safety feature | Yes |
Data update: | 23.05.2022 |