Fentanyl Kalceks

Medicinal product

(Invented) name

Fentanyl Kalceks

Active substance (s)

Fentanilis

Strength

0,05 mg/ml

Pharmaceutical form

injekcinis 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 Ideal Trade Links, Lietuva

Date of authorisation

2024-02-27

Date of renewal

Documents

2088_Fentanyl Kalceks_PŽPL_2024-02-27.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
112993	99111	1099111	ampulė	2 ml N10		Receptinis	LT/L/24/2088/001	Netiekiama	-	-	No	-	-	Download
112994	99112	1099112	ampulė	2 ml N20		Receptinis	LT/L/24/2088/002	Netiekiama	-	-	No	-	-
112995	99113	1099113	ampulė	2 ml N50		Receptinis	LT/L/24/2088/003	Tiekiama	-	-	No	-	-
112996	99114	1099114	ampulė	10 ml N10		Receptinis	LT/L/24/2088/004	Netiekiama	-	-	No	-	-
112997	99115	1099115	ampulė	10 ml N50		Receptinis	LT/L/24/2088/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-02-27	Registruotas