Tranexamic acid Kabi

Medicinal product

(Invented) name

Tranexamic acid Kabi

Active substance (s)

Traneksamo rūgštis

Strength

10 mg/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B02AA02, Tranexamic acid

Marketing authorisation holder

Fresenius Kabi Polska Sp.z.o.o., Lenkija

Date of authorisation

2024-01-19

Date of renewal

Documents

5330 Pakuotės lapelis 2024 10 31.docx

5330 Tranexamic acid Kabi PCS PL 2024 10 31.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/5640/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Traneksamo rūgštis	10 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
112591	98711	1098711	buteliukas	50 ml N10		Receptinis	LT/1/24/5330/001	Netiekiama	-	-	No	-	-
112592	98712	1098712	buteliukas	50 ml N20		Receptinis	LT/1/24/5330/002	Netiekiama	-	-	No	-	-
112593	98713	1098713	buteliukas	50 ml N40		Receptinis	LT/1/24/5330/003	Netiekiama	-	-	No	-	-
112594	98714	1098714	buteliukas	50 ml N50		Receptinis	LT/1/24/5330/004	Netiekiama	-	-	No	-	-
112595	98715	1098715	buteliukas	100 ml N10		Receptinis	LT/1/24/5330/005	Netiekiama	-	-	No	-	-	Download
112596	98716	1098716	buteliukas	100 ml N20		Receptinis	LT/1/24/5330/006	Netiekiama	-	-	No	-	-
112597	98717	1098717	buteliukas	100 ml N40		Receptinis	LT/1/24/5330/007	Netiekiama	-	-	No	-	-
112598	98718	1098718	buteliukas	100 ml N50		Receptinis	LT/1/24/5330/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-01-19	Registruotas