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PRODUCT DETAIL

DERMITOPIC 1 mg/g masť

Code 7360C
MA number 46/0102/18-S
Product Form: ung 1x10 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:
D DERMATOLOGICALS
D11 OTHER DERMATOLOGICAL PREPARATIONS
D11A OTHER DERMATOLOGICAL PREPARATIONS
D11AH Agents for dermatitis, excluding corticosteroids
D11AH01 Tacrolimus
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
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