| Code | 9854E | ||||||||||
| MA number | EU/1/25/1918/001 | ||||||||||
| Product Form: | sus gpg 1x1 ml susp.+1x1,5 ml gél (liek.inj.COC+liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Krystal Biotech Netherlands B.V., Netherland | ||||||||||
| Therapeutic Class: | 46 - DERMATOLOGICA | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | vial | ||||||||||
| Route of admin.: | Cutaneous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 23.04.2025 |
| Validity: | 23.04.2030 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 12.05.2025 |
