Retsevmo

Medicinal product

(Invented) name

Retsevmo

Active substance (s)

Selperkatinibas

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)

L01EX22, selpercatinib

Marketing authorisation holder

Eli Lilly Nederland B.V., Nyderlandai

Date of authorisation

2021-02-11

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

Capsule, hard	1 vnt.
Selperkatinibas	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
106027	92128	1092128	buteliukas	N60		Receptinis	EU/1/20/1527/001	Netiekiama	-	-	No	-	-
106860	92963	1092963	lizdinė plokštelė	N14		Receptinis	EU/1/20/1527/004	Netiekiama	-	-	No	-	-
106861	92964	1092964	lizdinė plokštelė	N42		Receptinis	EU/1/20/1527/005	Netiekiama	-	-	No	-	-
106862	92965	1092965	lizdinė plokštelė	N56		Receptinis	EU/1/20/1527/006	Netiekiama	-	-	No	-	-
106863	92966	1092966	lizdinė plokštelė	N168		Receptinis	EU/1/20/1527/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-02-11	Registruotas