| Code | 4167E | ||||||||||
| MA number | 86/0176/23-S | ||||||||||
| Product Form: | cps mol 100x1x1 µg (blis.Al/PVC/PVDC-jednotliv.dáv.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
| Therapeutic Class: | 86 - VITAMINA, VITAGENA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister Al/PVC/PVDC | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 15.08.2023 |
| Validity: | 15.08.2028 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Alfacalcidol STADA 1 µg mäkké kapsuly_07 2023.pdf
|
| SPC: |
SPC_Alfacalcidol STADA 1 µg mäkké kapsuly_07 2023.pdf
|
| Safety feature | Yes |
| Data update: | 16.08.2023 |
