Trobalt

Medicinal product

(Invented) name

Trobalt

Active substance (s)

Retigabinas

Strength

400 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

N03AX21, Retigabine

Marketing authorisation holder

Glaxo Group Ltd., Jungtinė Karalystė

Date of authorisation

2011-03-28

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

Film-coated tablet	1 vnt.
Retigabinas	400 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
46079	59885	1059885	lizdinė plokštelė	N84		Receptinis	EU/1/11/681/011	Netiekiama	-	-	No	-	-
46080	59886	1059886	lizdinė plokštelė	N168 (2x84) (sudėtinė)		Receptinis	EU/1/11/681/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-07-23	Išregistruotas
2011-03-28	Registruotas