Tresuvi

Medicinal product

(Invented) name

Tresuvi

Active substance (s)

Treprostinilis

Strength

10 mg/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B01AC21, Treprostinil

Marketing authorisation holder

OrPha-Devel Handels und Vertriebs GmbH, Austrija

Date of authorisation

2021-02-10

Date of renewal

Documents

Tresuvi atvejo pranesimo forma.pdf

Mokomoji medziaga sveikatos prieziuros specialistams.pptx

Tresuvi paciento klausimynas.pdf

Tresuvi mokomoji medziaga pacientams.pdf

4690 Tresuvi 10mg_ml RPP 2024 03 23.docx

4687_4690 Pakuotės lapelis 2024 03 23.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

AT/H/1058/004/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Treprostinilis	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
105946	92046	1092046	flakonas	10 ml N1		Receptinis	LT/1/21/4690/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2021-02-10	Registruotas