Agilus

Medicinal product

(Invented) name

Agilus

Active substance (s)

Dantroleno natrio druska hemiheptahidratas

Strength

120 mg

Pharmaceutical form

milteliai injekciniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M03CA01, Dantrolene

Marketing authorisation holder

Norgine B.V., Nyderlandai

Date of authorisation

2024-05-29

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Kiekviename flakone yra	1 vnt.
Dantroleno natrio druska hemiheptahidratas	120 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
113788	99905	1099905	flakonas	N6		Receptinis	EU/1/24/1805/001	Netiekiama	-	-	No	-	-
113789	99906	1099906	flakonas	N10		Receptinis	EU/1/24/1805/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-05-29	Registruotas