| Code | 11807 | ||||||||||
| MA number | 56/0644/11-S | ||||||||||
| Product Form: | spm rec 2x(1x14 dávok/28 mg) (nád.Al.tlak.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | National | ||||||||||
| Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | pressurised container, aluminium | ||||||||||
| Route of admin.: | Rectal use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 19.10.2011 |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Budenofalk rektalna pena_10_2020.docx
|
| SPC: |
SPC_Budenofalk rektalna pena_10_2022.pdf
|
| Safety feature | Yes |
| Data update: | 25.10.2022 |
