PRODUCT DETAIL

Ertapenem AptaPharma 1 g prášok na koncentrát na infúzny roztok

Code

9611D

MA number

15/0028/22-S

Product Form:

plc ifc 10x1g (liek.inj.skl.)

MA Status:

D - Marketing Authorisation valid for an unlimited period

Type of procedure:

Mutual recognition procedure

MAH, country:

Apta Medica Internacional d.o.o., Slovenia

Therapeutic Class:

15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM)

ATC:

J	ANTIINFECTIVES FOR SYSTEMIC USE
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01DH	Carbapenems
J01DH03	Ertapenem

Shelf life:

Container:

glass vial

Route of admin.:

Intravenous use

Prescription Status:	Medicinal product subject to medical prescription.
Legal basis:	Article 10(1) generic application
MA issued:	17.03.2022
Pediatric indication:	Yes
Pediatric posology:	Yes
Pediatric warnings:	Yes
PIL:	PIL_Ertapenem_AptaPharma_1_g_prasok_na_koncentrat_na_infuzny_roztok_03.2025.pdf
SPC:	SPC_Ertapenem AptaPharma 1 g prášok na koncentrát na infúzny roztok_03.2025.pdf
Safety feature	Yes
Data update:	08.11.2022