Neotigason 10 mg tvrde kapsule
| Name | Neotigason 10 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-047281874 |
| Active Substance | acitretin |
| Composition | jedna tvrda kapsula sadrži 10 mg acitretina |
| Pharmaceutical Form | kapsula, tvrda |
| Manufacturer | Cenexi SAS, Fontenay-sous-Bois, Francuska Cenexi, Osny, Francuska |
| Marketing Authorisation Holder | Teva B.V., Swensweg 5, Haarlem, Nizozemska |
| Marketing Authorisation Date | 29.08.2023 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/16-02/109 |
| Registration Number | 381-12-01/171-23-33 |
| 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 | D05BB02 |
| 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. |
