| Code | 3983E | ||||||||||
| MA number | EU/1/21/1549/005 | ||||||||||
| Product Form: | cps mdd 100 (2x50)x10 mg (fľ.HDPE) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Diurnal Europe B.V., Netherland | ||||||||||
| Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
| ATC: | 
                
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| Shelf life: | 36 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Oral use | 
| Prescription Status: | Medicinal product subject to restricted medical prescription. | 
| Legal basis: | Article 10(3) hybrid application | 
| MA issued: | 27.05.2021 | 
| Validity: | 27.05.2026 | 
| SmPC + PL: | 
                                                 | 
                
| Safety feature | Yes | 
| Data update: | 06.07.2023 |