Empesin

Medicinal product

(Invented) name

Empesin

Active substance (s)

Argipresinas

Strength

40 TV/2 ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

H01BA01, Vasopressin (argipressin)

Marketing authorisation holder

OrPha-Devel Handels und Vertriebs GmbH, Austrija

Date of authorisation

2018-03-23

Date of renewal

2022-10-17

Documents

4205 Pakuotės lapelis 2023 11 23.docx

4205 Empesin PCS PL 2023 11 23.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

DE/H/4530/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Ampulėje (2 ml) koncentrato infuziniam tirpalui yra:	2 ml
Argipresinas	40 TV/2 ml

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
99151	85257	1085257	ampulė	2 ml N5		Receptinis	LT/1/18/4205/001	Netiekiama	-	-	No	-	-
99152	85258	1085258	ampulė	2 ml N10		Receptinis	LT/1/18/4205/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-10-17	Perregistruotas
2018-03-23	Registruotas