SONTILEN

Medicinal product

(Invented) name

SONTILEN

Active substance (s)

Sufentanilis

Strength

50 µg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti į epidurinę ertmę

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N01AH03, Sufentanil

Marketing authorisation holder

Medochemie Ltd., Kipras

Date of authorisation

2018-12-28

Date of renewal

2024-10-16

Documents

4321-22 pakuotes lapelis_2024-10-16.docx

4321-22 Sontilen_perr2024-10-16.docx

Stage

Išregistruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

10(1)

Procedure number

DK/H/2799/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Sufentanilis	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
100752	86862	1086862	ampulė	5 ml N5		Receptinis	LT/1/18/4322/001	Tiekiama	-	-	No	-	-	Download
100753	86863	1086863	ampulė	5 ml N10		Receptinis	LT/1/18/4322/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-12-31	Išregistruotas
2024-10-16	Perregistruotas
2018-12-28	Registruotas