Propofol Baxter

Medicinal product

(Invented) name

Propofol Baxter

Active substance (s)

Propofolis

Strength

10 mg/ml

Pharmaceutical form

injekcinė ar infuzinė emulsija

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N01AX10, Propofol

Marketing authorisation holder

Baxter Holding B.V. , Nyderlandai

Date of authorisation

2009-05-19

Date of renewal

2019-03-04

Documents

1589 Pakuotės lapelis 10mg_ml 2022 01 10.docx

1589 Propofol Baxter 10mg_ml II PL 2022 01 10.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/1268/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 ml emulsijos yra	1 ml
Propofolis	10 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
30484	32945	1032945	flakonas	10 ml N1		Receptinis	LT/1/09/1589/001	Netiekiama	-	-	No	-	-
30485	32946	1032946	flakonas	20 ml N1		Receptinis	LT/1/09/1589/002	Netiekiama	-	-	No	-	-	Download
35710	38042	1038042	flakonas	50 ml N1		Receptinis	LT/1/09/1589/003	Netiekiama	-	-	No	-	-
35711	38043	1038043	flakonas	100 ml N1		Receptinis	LT/1/09/1589/004	Netiekiama	-	-	No	-	-
60268	74543	1074543	flakonas	20 ml N5		Receptinis	LT/1/09/1589/006	Netiekiama	-	-	No	-	-
60269	74544	1074544	flakonas	20 ml N10		Receptinis	LT/1/09/1589/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-01-31	Išregistruotas
2019-03-04	Perregistruotas
2009-05-19	Registruotas