AUGTYRO

Medicinal product

(Invented) name

AUGTYRO

Active substance (s)

Repotrektinibas

Strength

40 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EX28, repotrectinib

Marketing authorisation holder

Bristol-Myers Squibb Pharma EEIG, Airija

Date of authorisation

2025-01-13

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

Kapsulėje yra:	1 vnt.
Repotrektinibas	40 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
116233	102335	1102335	buteliukas	N60		Receptinis	EU/1/24/1883/001	Netiekiama	-	-	No	-	-
116234	102336	1102336	buteliukas	N120		Receptinis	EU/1/24/1883/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-01-13	Registruotas