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

AS Kalceks, Latvija

Date of authorisation

2015-04-30

Date of renewal

2019-12-19

Documents

FentanylBB_AR.pdf

3715 Pakuotės lapelis 2024 10 01.docx

3715 Fentanyl Kalceks PL 2024 10 01, VRA rastas 17041.docx

Stage

Perregistruotas

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
59479	73708	1073708	ampulė	2 ml N10		Receptinis	LT/1/15/3715/001	Tiekiama	-	-	No	-	-	Download
61983	76355	1076355	ampulė	2 ml N100	ASPĮ	Receptinis	LT/1/15/3715/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-12-19	Perregistruotas
2015-04-30	Registruotas