Roaccutane 10 mg meke kapsule
| Name | Roaccutane 10 mg meke kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-462694255 |
| Active Substance | izotretinoin |
| Composition | jedna meka kapsula sadrži 10 mg izotretinoina |
| Pharmaceutical Form | kapsula, meka |
| Manufacturer | Roche Pharma AG, Grenzach-Wyhlen, Njemačka
Catalent Germany Eberbach GmbH, Eberbach/Baden, Njemačka |
| Marketing Authorisation Holder | CHEPLAPHARM Registration GmbH, Weiler Straβe 5 E, Lörrach, Njemačka |
| Marketing Authorisation Date | 06.08.2024 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/15-02/339 |
| Registration Number | 381-12-01/171-24-85 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product subject to restricted medical prescription |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | D10BA01 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Educational materials for healthcare professionals |
Kontrolni popis i Izjava o razumijevanju rizika za liječnike, verzija 3 Kontrolni popis za ljekarnika, verzija 3 |
| Educational materials for patients / caregivers |
Kartica za bolesnika, verzija 3 |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o riziku od teratogenosti i mogućem razvoju neuropsihijatrijskih poremećaja prilikom primjene lijekova iz skupine retinoida (acitretin, adapalen, alitretinoin, beksaroten, izotretinoin, tazaroten i tretinoin) | 10.12.2018 | Belupo lijekovi i kozmetika d.d., Pliva Hrvatska d.o.o., Roche d.o.o. |
