Cohiber

Medicinal product

(Invented) name

Cohiber

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

Farmaprojects S.A.U., Ispanija

Date of authorisation

2023-07-18

Date of renewal

Documents

5202-3 pakuotes lapelis_2023-07-18.docx

5202-5203 Cohiber.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/1131/001/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
111277	97390	1097390	lizdinė plokštelė	N14		Receptinis	LT/1/23/5202/001	Netiekiama	-	-	No	-	-
111278	97391	1097391	lizdinė plokštelė	N56		Receptinis	LT/1/23/5202/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-07-18	Registruotas