Ugurol

Medicinal product

(Invented) name

Ugurol

Active substance (s)

Traneksamo rūgštis

Strength

500 mg/5 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

UAB Niromed, Lietuva

Date of authorisation

2025-02-14

Date of renewal

Documents

2378_Ugurol_500mg5ml_inj_N6_PIL.docx

2378_Ugurol_500mg5ml_inj_N6_PZ.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

1 ml tirpalo yra:	5 ml
Traneksamo rūgštis	500 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
116693	102794	1102794	ampulė	5 ml N6		Receptinis	LT/L/25/2378/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2025-02-14	Registruotas