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 Edupharma, Lietuva

Date of authorisation

2022-05-10

Date of renewal

Documents

1688-001_Ugurol 500mg-5ml_inj_inf_tirp_PZPL_2022-05-10.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
108574	94678	1094678	ampulė	5 ml N6	ASPĮ	Receptinis	LT/L/22/1688/001	Netiekiama	2026-01-01	2026-03-31	No	-	-	Download

Stadijos

Data	Stadija
2022-05-10	Registruotas