Norepinephrine Sintetica

Medicinal product

(Invented) name

Norepinephrine Sintetica

Active substance (s)

Norepinefrinas

Strength

1 mg/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)

C01CA03, Norepinephrine

Marketing authorisation holder

Sintetica GmbH, Vokietija

Date of authorisation

2019-05-17

Date of renewal

2021-12-15

Documents

4392 Norepinephrine Sintetica konc RPP 2024 12 13.docx

4392 Pakuotės lapelis 2024 12 13.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

DE/H/5453/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Norepinefrinas	1 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
101647	87751	1087751	ampulė	1 ml N10		Receptinis	LT/1/19/4392/001	Netiekiama	-	-	No	-	-
101648	87752	1087752	ampulė	4 ml N10		Receptinis	LT/1/19/4392/002	Netiekiama	-	-	No	-	-
101649	87753	1087753	ampulė	10 ml N10		Receptinis	LT/1/19/4392/003	Netiekiama	-	-	No	-	-
104884	90985	1090985	ampulė	5 ml N10		Receptinis	LT/1/19/4392/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-03-28	Išregistruotas
2021-12-15	Perregistruotas
2019-05-17	Registruotas