AUGTYRO

Medicinal product

(Invented) name

AUGTYRO

Active substance (s)

Repotrektinibas

Strength

160 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	160 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
116231	102333	1102333	lizdinė plokštelė	N20		Receptinis	EU/1/24/1883/003	Netiekiama	-	-	No	-	-
116232	102334	1102334	lizdinė plokštelė	N60		Receptinis	EU/1/24/1883/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-01-13	Registruotas