Fentanyl Kalceks

Medicinal product

(Invented) name

Fentanyl Kalceks

Active substance (s)

Fentanilis

Strength

50 µg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N02AB03, Fentanyl

Marketing authorisation holder

UAB Niromed, Lietuva

Date of authorisation

2024-06-07

Date of renewal

Documents

2180_Fentanyl Kalceks PZ_2024-06-07.docx

2180_Fentanyl Kalceks PL_2024-06-07.docx

Stage

Registruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

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
113939	100055	1100055	ampulė	2 ml N10		Receptinis	LT/L/24/2180/001	Netiekiama	-	-	No	-	-	Download
113940	100056	1100056	ampulė	2 ml N50		Receptinis	LT/L/24/2180/002	Netiekiama	-	-	No	-	-
113941	100057	1100057	ampulė	2 ml N100		Receptinis	LT/L/24/2180/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-06-17	Registruotas
2024-06-07	Registruotas