Nylosed

Medicinal product

(Invented) name

Nylosed

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

Warszawskie Zakłady Farmaceutyczne Polfa S.A., Lenkija

Date of authorisation

2012-10-30

Date of renewal

Documents

3114_1_2 Nylosed inj_inf RPP 160530.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename 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
43775	57552	1057552	flakonas	20 ml N5		Receptinis	LT/1/12/3114/001	Netiekiama	-	-	No	-	-
54163	68152	1068152	flakonas	20 ml N10		Receptinis	LT/1/12/3114/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-07-04	Išregistruotas
2012-10-30	Registruotas