Piasky

Medicinal product

(Invented) name

Piasky

Active substance (s)

Krovalimabas

Strength

340 mg

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AJ07, crovalimab

Marketing authorisation holder

Roche Registration GmbH, Vokietija

Date of authorisation

2024-08-22

Date of renewal

Documents

Piasky mokomoji medziaga pacientams.pdf

Piasky paciento kortele.pdf

Piasky mokomoji medziaga sveikatos prieziuros specialistams.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

Flakone (2 ml) yra:	2 ml
Krovalimabas	340 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
114712	100819	1100819	flakonas	2 ml N1		Receptinis	EU/1/24/1848/001	Tiekiama	2025-02-11	-	No	-	-

Stadijos

Data	Stadija
2024-08-22	Registruotas