| Code | 9121E | ||||||||||
| MA number | EU/1/24/1897/001 | ||||||||||
| Product Form: | tbl dsp 60x350 µg (blis.PVC/Al) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Rare Thyroid Therapeutics International AB, Sweden | ||||||||||
| Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
| ATC: |
|
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| Shelf life: | 18 | ||||||||||
| Container: | blister Al/PVC | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 12.02.2025 |
| Validity: | 12.02.2030 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 02.07.2025 |
