PRODUCT DETAIL

Entecavir FMK 0,5 mg

Code

0349D

MA number

42/0025/19-S

Product Form:

tbl flm 30x0,5 mg (fľ.HDPE)

MA Status:

D - Marketing Authorisation valid for an unlimited period

Type of procedure:

Decentralised

Therapeutic Class:

42 - CHEMOTHERAPEUTICA (VRATANE TUBERKULOSTATIK)

ATC:

J	ANTIINFECTIVES FOR SYSTEMIC USE
J05	ANTIVIRALS FOR SYSTEMIC USE
J05A	DIRECT ACTING ANTIVIRALS
J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05AF10	Entecavir

Shelf life:

Route of admin.:

Oral use

Prescription Status:	Medicinal product subject to restricted medical prescription.
Legal basis:	Article 10(1) generic application
MA issued:	30.01.2019
Pediatric indication:	Yes
Pediatric posology:	Yes
Pediatric warnings:	Yes
PIL:	PIL_Entecavir FMK_tbl flm_10.2023.pdf
SPC:	SPC_Entecavir FMK_tbl flm_10.2023.pdf
Safety feature	Yes
Data update:	16.10.2023