Namuscla

Medicinal product

(Invented) name

Namuscla

Active substance (s)

Meksiletino hidrochloridas

Strength

167 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)

C01BB02, Mexiletine

Marketing authorisation holder

Lupin Europe GmbH, Vokietija

Date of authorisation

2018-12-18

Date of renewal

Documents

Namuscla paciento kortele.pdf

Namuscla mokomoji medziaga sveikatos prieziuros specialistams.pdf

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Hard capsule	1 vnt.
Meksiletino hidrochloridas	167 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
100767	86877	1086877	lizdinė plokštelė	N30		Receptinis	EU/1/18/1325/001	Netiekiama	-	-	No	-	-
100768	86878	1086878	lizdinė plokštelė	N50		Receptinis	EU/1/18/1325/002	Netiekiama	-	-	No	-	-
100769	86879	1086879	lizdinė plokštelė	N100		Receptinis	EU/1/18/1325/003	Netiekiama	-	-	No	-	-
100770	86880	1086880	lizdinė plokštelė	N200		Receptinis	EU/1/18/1325/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-12-18	Registruotas