Nuedexta

Medicinal product

(Invented) name

Nuedexta

Active substance (s)

Dekstrometorfanas/Chinidinas

Strength

15 mg/9 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N07XX, Other nervous system drugs

Marketing authorisation holder

Jenson Pharmaceutical Services Ltd., Jungtinė Karalystė

Date of authorisation

2013-06-24

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Hard capsule	1 vnt.
Dekstrometorfanas	15 mg
Chinidinas	9 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
56652	70755	1070755	buteliukas	N60		Receptinis	EU/1/13/833/001	Netiekiama	-	-	No	-	-
56653	70756	1070756	lizdinė plokštelė	N13		Receptinis	EU/1/13/833/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2013-06-24	Registruotas