Methylthioninium chloride Proveblue

Medicinal product

(Invented) name

Methylthioninium chloride Proveblue

Active substance (s)

Metiltioninio chloridas

Strength

5 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

V03AB17, Methylthioninium chloride

Marketing authorisation holder

Provepharm S.A.S., Prancūzija

Date of authorisation

2011-05-06

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

Solution for injection	1 ml
Metiltioninio chloridas	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
46760	60569	1060569	ampulė	10 ml N5		Receptinis	EU/1/11/682/001	Netiekiama	-	-	No	-	-
61110	75423	1075423	ampulė	2 ml N5		Receptinis	EU/1/11/682/002	Netiekiama	-	-	No	-	-
61111	75424	1075424	ampulė	2 ml N20		Receptinis	EU/1/11/682/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-05-06	Registruotas