| Code | 1547E | ||||||||||
| MA number | EU/1/22/1657/001 | ||||||||||
| Product Form: | cps mdd 1x120x4 mg (fľ.HDPE) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
| Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
| ATC: |
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| Shelf life: | 48 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 15.07.2022 |
| Validity: | 24.07.2029 |
| SmPC + PL: |
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| Safety feature | Yes |
| Data update: | 04.04.2025 |