ANDEMBRY

Medicinal product

(Invented) name

ANDEMBRY

Active substance (s)

Garadacimabas

Strength

200 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

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 švirkšte (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
116611	102710	1102710	užpildytas švirkštas	N1		Receptinis	EU/1/24/1885/001	Netiekiama	-	-	No	-	-
116612	102711	1102711	užpildytas švirkštas	N3 (3×1)		Receptinis	EU/1/24/1885/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-02-10	Registruotas