Ojemda

Medicinal product

(Invented) name

Ojemda

Active substance (s)

Tovorafenibas

Strength

25 mg/ml

Pharmaceutical form

suspensija geriamajai suspensijai

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EC04, tovorafenib

Marketing authorisation holder

Ipsen Pharma, Prancūzija

Date of authorisation

2026-04-20

Date of renewal

Documents

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

Paruošus vaistą, 1 ml suspensijos yra:	1 ml
Tovorafenibas	25 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
120604	106708	1106708	buteliukas	N1 (+buteliuko adapteris, dozavimo švirkštas)		Receptinis	EU/1/26/2025/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-04-20	Registruotas