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PRODUCT DETAIL

BELORETIN 10 mg

Code 9792C
MA number 46/0390/18-S
Product Form: cps mol 30(2x15)x10 mg (blis.PVC/PVDC/Al)
MA Status: R - Valid Marketing Authorisation
Type of procedure: National
Therapeutic Class: 46 - DERMATOLOGICA
ATC:
D DERMATOLOGICALS
D10 ANTI-ACNE PREPARATIONS
D10B ANTI-ACNE PREPARATIONS FOR SYSTEMIC USE
D10BA Retinoids for treatment of acne, for systematic use
D10BA01 Isotretinoin
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: 07.12.2018
Validity: 07.12.2023
MA renewed: Renewal application submitted
Pediatric posology: Yes
PIL: PIL_BELORETIN_10 mg_20 mg_05.2022.pdf  
SPC: SPC_BELORETIN_10 mg_20 mg_05.2022.pdf  
Safety feature Yes
Data update: 13.12.2018
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