PRODUCT DETAIL

Igantibe 200 IU/ml injekčný roztok v naplnenej injekčnej striekačke

Code

2078F

MA number

59/0381/25-S

Product Form:

sol iru 1x5 ml/1000 IU (striek.inj.skl.napln.)

MA Status:

R - Valid Marketing Authorisation

Type of procedure:

National

MAH, country:

Instituto Grifols, S.A., Spain

Therapeutic Class:

59 - IMMUNOPRAEPARATA

ATC:

J	ANTIINFECTIVES FOR SYSTEMIC USE
J06	IMMUNE SERA AND IMMUNOGLOBULINS
J06B	IMMUNOGLOBULINS
J06BB	Specific immunoglobulins
J06BB04	Hepatitis B immunoglobulin

Shelf life:

Route of admin.:

Intramuscular use

Prescription Status:	Medicinal product subject to medical prescription.
Legal basis:	Article 10a well-established use application
MA issued:	18.12.2025
Validity:	18.12.2030
Pediatric indication:	Yes
Pediatric posology:	Yes
PIL:	PIL_Igantibe 200 IU_ml injekčný roztok v naplnenej injekčnej striekačke_12_2025.pdf
SPC:	SPC_Igantibe 200 IU_ml injekčný roztok v naplnenej injekčnej striekačke_12_2025.pdf
Safety feature	Yes
Data update:	19.12.2025