en

PRODUCT DETAIL

Sevelamer Carbonate Mylan 800 mg

Code 7215B
MA number 87/0502/15-S
Product Form: tbl flm 420(2x210)x800 mg (fľ.HDPE)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Mutual recognition procedure
MAH, country: Mylan Ireland Limited, Ireland
Therapeutic Class: 87 - VARIA I
ATC:
V VARIOUS
V03 ALL OTHER THERAPEUTIC PRODUCTS
V03A ALL OTHER THERAPEUTIC PRODUCTS
V03AE Drugs for treatment of hyperkalemia and hyperphosphatemia
V03AE02 Sevelamer
Shelf life: 36
Container: bottle HDPE
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(3) hybrid application
MA issued: 21.12.2015
SPC: SPC_Sevelamer Carbonate Mylan_12.2019.docx  
PIL: PIL_Sevelamer Carbonate Mylan_08.2023.pdf  
Safety feature Yes
Data update: 18.10.2019
eu-flag.png sk-flag.png