| Code | 64786 | ||||||||||
| MA number | 56/0041/00-S | ||||||||||
| Product Form: | cps ent 50x3 mg (blis.Al/PVC/PVDC) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | National | ||||||||||
| MAH, country: | Dr. Falk Pharma GmbH, Germany | ||||||||||
| Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 03.02.2000 |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Budenofalk_3mg_01_2020.docx
|
| PIL: |
PIL_Budenofalk_3 mg_01_2020.docx
|
| Safety feature | Yes |
| Data update: | 16.04.2018 |
