Fentanyl Kalceks

Medicinal product

(Invented) name

Fentanyl Kalceks

Active substance (s)

Fentanilis

Strength

0,05 mg/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 Rx pharma, Lietuva

Date of authorisation

2024-09-11

Date of renewal

Documents

2217_Fentanyl Kalceks_PZ_2024-09-11.docx

2217_Fentanyl Kalceks_Pl_2024-09-11.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	0,05 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
114926	101033	1101033	ampulė	2 ml N50	ASPĮ	Receptinis	LT/L/24/2217/001	Netiekiama	-	-	No	-	-	Download
114927	101034	1101034	ampulė	10 ml N50	ASPĮ	Receptinis	LT/L/24/2217/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2024-09-11	Registruotas