ANDEMBRY

Medicinal product

(Invented) name

ANDEMBRY

Active substance (s)

Garadacimabas

Strength

200 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B06AC07, garadacimab

Marketing authorisation holder

CSL Behring GmbH, Vokietija

Date of authorisation

2025-02-10

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

Užpildytame švirkštiklyje (1,2 ml) yra	1.2 ml
Garadacimabas	200 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
116613	102712	1102712	užpildytas švirkštiklis	N1		Receptinis	EU/1/24/1885/003	Netiekiama	-	-	No	-	-
116614	102713	1102713	užpildytas švirkštiklis	N3 (3×1)		Receptinis	EU/1/24/1885/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-02-10	Registruotas