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PRODUCT DETAIL

Fludrocortisone acetate Hualan 0,1 mg tablety

Code 8002E
MA number 56/0253/24-S
Product Form: tbl 30x0,1 mg (blis.PVC/PE/PVDC-Al)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
MAH, country: Hualan Pharmaceuticals Limited, Ireland
Therapeutic Class: 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU)
ATC:
H SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02AA Mineralocorticoids
H02AA02 Fludrocortisone
Shelf life: 36
Container: blister PVC/PE/PVDC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10a well-established use application
MA issued: 31.12.2024
Validity: 31.12.2029
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
SPC: SPC_Fludrocortisone acetate Hualan_12 2024.pdf  
PIL: PIL_Fludrocortisone acetate Hualan_12 2024.pdf  
Safety feature Yes
Data update: 10.01.2025
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