Trepulmix

Medicinal product

(Invented) name

Trepulmix

Active substance (s)

Treprostinilis

Strength

5 mg/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B01AC21, Treprostinil

Marketing authorisation holder

SciPharm Sàrl, Liuksemburgas

Date of authorisation

2020-04-03

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for infusion	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
103736	89838	1089838	flakonas	10 ml N1		Receptinis	EU/1/19/1419/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-04-03	Registruotas