Spexotras

Medicinal product

(Invented) name

Spexotras

Active substance (s)

Trametinibas

Strength

0,05 mg/ml

Pharmaceutical form

milteliai geriamajam tirpalui

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EE01, trametinib

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2024-01-05

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

Paruošto tirpalo mililitre yra	1 ml
Trametinibas	0,05 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
112543	98663	1098663	buteliukas	4,7 mg + adapteris + geriamasis švirkštas (20 ml) N1		Receptinis	EU/1/23/1781/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-01-05	Registruotas