| Code | 7361C | ||||||||||
| MA number | 46/0102/18-S | ||||||||||
| Product Form: | ung 1x30 g (tuba Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | BAUSCH HEALTH IRELAND LIMITED, Ireland | ||||||||||
| Therapeutic Class: | 46 - DERMATOLOGICA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | tube Al | ||||||||||
| Route of admin.: | Cutaneous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 19.03.2018 |
| Validity: | 19.03.2023 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_DERMITOPIC 1 mg-g_01.2024.pdf
|
| SPC: |
SPC_DERMITOPIC 1 mg-g_01.2024.pdf
|
| Safety feature | Yes |
| Data update: | 16.01.2024 |
