PRODUCT DETAIL

Meropenem AptaPharma 2 000 mg prášok na infúzny roztok

Code

9493E

MA number

15/0112/25-S

Product Form:

plv ifo 6x2000 mg (liek.inj.skl.)

MA Status:

R - Valid Marketing Authorisation

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
J01DH02	Meropenem

Shelf life:

Container:

colourless glass vial (type 1), rubber stopper (type 1)

Route of admin.:

Intravenous use

Prescription Status:	Medicinal product subject to medical prescription.
Legal basis:	Article 10(3) hybrid application
MA issued:	14.04.2025
Validity:	14.04.2030
Pediatric indication:	Yes
Pediatric posology:	Yes
SPC:	SPC_Meropenem AptaPharma 2 000 mg prášok na infúzny roztok_ plv ifo_04/2025_REG.pdf
PIL:	PIL_Meropenem AptaPharma 2 000 mg prášok na infúzny roztok_ plv ifo_04/2025_REG.pdf
Safety feature	Yes
Data update:	15.04.2025