Fosclera

Medicinal product

(Invented) name

Fosclera

Active substance (s)

Dimetilfumaratas

Strength

120 mg

Pharmaceutical form

skrandyje neirios kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AX07, Dimethyl fumarate

Marketing authorisation holder

UAB Norameda, Lietuva

Date of authorisation

2023-03-24

Date of renewal

Documents

5153_5154_pakuotes lapelis_2023-03-24.docx

5153_5154_Fosclera.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0525/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra:	1 vnt.
Dimetilfumaratas	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
110673	96784	1096784	lizdinė plokštelė	N14		Receptinis	LT/1/23/5153/001	Tiekiama	-	-	No	-	-
110674	96785	1096785	dalomoji lizdinė plokštelė	N14×1		Receptinis	LT/1/23/5153/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-03-24	Registruotas