Retsevmo

Medicinal product

(Invented) name

Retsevmo

Active substance (s)

Selperkatinibas

Strength

80 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	80 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
106028	92129	1092129	buteliukas	N60		Receptinis	EU/1/20/1527/002	Netiekiama	-	-	No	-	-
106029	92130	1092130	buteliukas	N120		Receptinis	EU/1/20/1527/003	Netiekiama	-	-	No	-	-
106864	92967	1092967	lizdinė plokštelė	N14		Receptinis	EU/1/20/1527/008	Netiekiama	-	-	No	-	-
106865	92968	1092968	lizdinė plokštelė	N28		Receptinis	EU/1/20/1527/009	Netiekiama	-	-	No	-	-
106866	92969	1092969	lizdinė plokštelė	N56		Receptinis	EU/1/20/1527/010	Netiekiama	-	-	No	-	-
106867	92970	1092970	lizdinė plokštelė	N112		Receptinis	EU/1/20/1527/011	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-02-11	Registruotas