Lutathera

Medicinal product

(Invented) name

Lutathera

Active substance (s)

Liutecio (177Lu) oksodotreotidas

Strength

370 MBq/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)

V10XX04, Lutetium (177Lu) oxodotreotide

Marketing authorisation holder

Advanced Accelerator Applications, Prancūzija

Date of authorisation

2017-09-26

Date of renewal

Documents

Lutathera mokomoji medziaga pacientams.pdf

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Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for infusion	1 ml
Liutecio (177Lu) oksodotreotidas	370 MBq

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
98065	84163	1084163	flakonas	20,5 – 25 ml N1		Receptinis	EU/1/17/1226/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-09-26	Registruotas