FENTANYL WZF Polfa

Medicinal product

(Invented) name

FENTANYL WZF Polfa

Active substance (s)

Fentanilis

Strength

50 µg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N01AH01, Fentanyl

Marketing authorisation holder

Warszawskie Zakłady Farmaceutyczne Polfa S.A., Lenkija

Date of authorisation

1996-02-15

Date of renewal

2010-11-10

Documents

2221_1_Pakuotės lapelis_190527.docx

2221_1_FENTANYL WZF Polfa_inj_tirp_RPP_190527.doc

Stage

Išregistruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Fentanilis	50 µg

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
2544	8141	1008141	ampulė	2 ml N10		Receptinis	LT/1/96/2221/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2021-10-28	Išregistruotas
2010-11-10	Perregistruotas
1996-02-15	Registruotas