Fosclera

Medicinal product

(Invented) name

Fosclera

Active substance (s)

Dimetilfumaratas

Strength

240 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_Fosclera.docx

5153_5154_pakuotes lapelis_2023-03-24.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0525/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra:	1 val.
Dimetilfumaratas	240 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
110675	96786	1096786	lizdinė plokštelė	N56		Receptinis	LT/1/23/5154/001	Tiekiama	-	-	No	-	-
110676	96787	1096787	dalomoji lizdinė plokštelė	N56×1		Receptinis	LT/1/23/5154/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-03-24	Registruotas