FULSED

Medicinal product

(Invented) name

FULSED

Active substance (s)

Midazolamas

Strength

5 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)

N05CD08, Midazolam

Marketing authorisation holder

Sun Pharmaceutical Industries Europe B. V., Nyderlandai

Date of authorisation

2001-03-08

Date of renewal

2011-04-04

Documents

2369 FULSED PCS PL 2023 10 04.docx

2369 Pakuotės lapelis 2023 10 04.docx

Stage

Perregistruotas

Controlled?

Yes

Controlled substance type

Psichotropinis

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Midazolamas	5 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
4060	9446	1009446	ampulė	1 ml N10		Receptinis	LT/1/01/2369/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-04-04	Perregistruotas
2001-03-08	Registruotas