ELAHERE

Medicinal product

(Invented) name

ELAHERE

Active substance (s)

Mirvetuksimabas soravtansinas

Strength

5 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01FX26, mirvetuximab soravtansine

Marketing authorisation holder

AbbVie Deutschland GmbH & Co. KG , Vokietija

Date of authorisation

2024-11-14

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 koncentrato infuziniam tirpalui yra	1 ml
Mirvetuksimabas soravtansinas	5 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
115647	101750	1101750	flakonas	20 ml N1		Receptinis	EU/1/24/1866/001	Netiekiama	-	2027-06-30	No	-	-

Stadijos

Data	Stadija
2024-11-14	Registruotas