| Code | 8213E | ||||||||||
| MA number | 86/0332/24-S | ||||||||||
| Product Form: | cps mol 60x0,5 µg (blis.PVC/PVDC//Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Medreg s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 86 - VITAMINA, VITAGENA | ||||||||||
| ATC: |
|
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| Shelf life: | 48 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 21.12.2024 |
| Validity: | 21.12.2029 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_Alfacalcidol Medreg_12_2024.pdf
|
| SPC: |
SPC_Alfacalcidol Medreg_12_2024.pdf
|
| Safety feature | Yes |
| Data update: | 27.12.2024 |
