Dobutamine Baxter

Medicinal product

(Invented) name

Dobutamine Baxter

Active substance (s)

Dobutaminas

Strength

12,5 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)

C01CA07, Dobutamine

Marketing authorisation holder

Baxter Holding B.V. , Nyderlandai

Date of authorisation

2012-01-27

Date of renewal

2018-06-25

Documents

2785_1_2 Pakuotės lapelis 200818.docx

2785_1_2 Dobutamine Baxter konc PCS PL 200818.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IE/H/0867/001/

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Ampulėje yra	1 ml
Dobutaminas	12,5 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
39426	53125	1053125	ampulė	20 ml N1		Receptinis	LT/1/12/2785/001	Netiekiama	-	-	No	-	-
50896	64786	1064786	ampulė	20 ml N5		Receptinis	LT/1/12/2785/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-04-29	Išregistruotas
2018-06-25	Perregistruotas
2012-01-27	Registruotas