REMODULIN

Medicinal product

(Invented) name

REMODULIN

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

Ferrer Internacional, S.A., Ispanija

Date of authorisation

2007-11-12

Date of renewal

2010-10-22

Documents

0903 Remodulin 10mg_ml II PL 2024 10 30.docx

Remodulin atvejo pranesimo forma.pdf

Remodulin mokomoji medziaga sveikatos prieziuros specialistams.pdf

0903 Pakuotės lapelis 2024 10 30.docx

Remodulin paciento klausimynas.pdf

Remodulin mokomoji medziaga pacientams.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

FR/H/0278/004/MR

Marketing authorisation procedure

Savitarpio pripažinimo 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
16141	20209	1020209	buteliukas	20 ml N1		Receptinis	LT/1/07/0903/004	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2010-10-22	Perregistruotas
2007-11-12	Registruotas