| Code | 7565A | ||||||||||
| MA number | 46/0419/13-S | ||||||||||
| Product Form: | cps mol 100x20 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Teva B.V., Netherland | ||||||||||
| Therapeutic Class: | 46 - DERMATOLOGICA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 23.10.2013 |
| Pediatric posology: | Yes |
| PIL: |
PIL_Isotretinoin Actavis_10 mg_20 mg_03.2024.pdf
|
| SPC: |
SPC_Isotretinoin Actavis_10 mg_20 mg_03.2024.pdf
|
| Dokument: |
retinoidy_Kontrolny zoznam pre lekarnika.pdf
|
| Dokument: |
retinoidy_Karta pacienta_pacientky.pdf
|
| Dokument: |
retinoidy_Kontrolny zoznam pre lekara a potvrdzujuci formular pacientky.pdf
|
| Dokument: |
DHPC_retinoidy_07.06.2024.pdf
|
| Safety feature | Yes |
| Data update: | 21.06.2018 |
