| Code | 3227E | ||||||||||
| MA number | 86/0030/23-S | ||||||||||
| Product Form: | cps mol 100x1 µg (fľ.HDPE+uzáver PP) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Zentiva, k.s., Czechia | ||||||||||
| Therapeutic Class: | 86 - VITAMINA, VITAGENA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 10.03.2023 |
| Validity: | 10.03.2028 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| SPC: |
SPC_Medirazin 1 mikrogram mäkké kapsuly_10.2023.pdf
|
| PIL: |
PIL_Medirazin 1 mikrogram mäkké kapsuly_04.2024.pdf
|
| Safety feature | Yes |
| Data update: | 14.03.2023 |
