Tranexamic acid Baxter

Medicinal product

(Invented) name

Tranexamic acid Baxter

Active substance (s)

Traneksamo rūgštis

Strength

100 mg/ml

Pharmaceutical form

injekcinis ar 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

Baxter Holding B.V. , Nyderlandai

Date of authorisation

2020-06-11

Date of renewal

Documents

4585 Pakuotės lapelis 2025 06 23.docx

4585 Tranexamic acid Baxter PCS II PL 2025 06 23.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/6097/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Traneksamo rūgštis	100 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
104370	90472	1090472	flakonas	5 ml N5		Receptinis	LT/1/20/4585/001	Netiekiama	-	-	No	-	-
104371	90473	1090473	flakonas	5 ml N10		Receptinis	LT/1/20/4585/002	Netiekiama	-	-	No	-	-
104372	90474	1090474	flakonas	10 ml N5		Receptinis	LT/1/20/4585/003	Netiekiama	-	-	No	-	-
104373	90475	1090475	flakonas	10 ml N10		Receptinis	LT/1/20/4585/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-06-11	Registruotas