Code | 5707E | ||||||||||
MA number | 44/0048/24-S | ||||||||||
Product Form: | cps mol 30x1x100 mg (blis.OPA/Al/PVC/Al - jednotk.bal.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | TEVA Pharmaceuticals Slovakia s.r.o., Slovakia | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 36 | ||||||||||
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: | 18.03.2024 |
Validity: | 18.03.2029 |
SPC: | SPC_Nintedanib Teva_03_2024.pdf |
PIL: | PIL_Nintedanib Teva 100 mg mäkké kapsuly_03_2024.pdf |
Safety feature | Yes |
Data update: | 25.03.2024 |