Enjaymo

Medicinal product

(Invented) name

Enjaymo

Active substance (s)

Sutimlimabas

Strength

50 mg/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AJ04, sutimlimab

Marketing authorisation holder

Recordati Rare Diseases, Prancūzija

Date of authorisation

2022-11-15

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

1 ml infuzinio tirpalo yra:	1 ml
Sutimlimabas	50 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
109865	95972	1095972	flakonas	22 ml N1		Receptinis	EU/1/22/1687/001	Netiekiama	-	-	No	-	-
109866	95973	1095973	flakonas	22 ml N6 (6×1)		Receptinis	EU/1/22/1687/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-11-15	Registruotas