REMODULIN

Medicinal product

(Invented) name

REMODULIN

Active substance (s)

Treprostinilis

Strength

5 mg/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti į odą

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

Remodulin atvejo pranesimo forma.pdf

Remodulin mokomoji medziaga sveikatos prieziuros specialistams.pdf

Remodulin mokomoji medziaga pacientams.pdf

Remodulin paciento klausimynas.pdf

0903 Remodulin 5mg_ml II PL 2024 10 30.docx

0903 Pakuotės lapelis 2024 10 30.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

FR/H/0278/003/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Treprostinilis	5 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
16140	20208	1020208	buteliukas	20 ml N1		Receptinis	LT/1/07/0903/003	Tiekiama	-	-	No	-	-	Download

Stadijos

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