Atenativ

Medicinal product

(Invented) name

Atenativ

Active substance (s)

Žmogaus antitrombinas III

Strength

50 TV/ml

Pharmaceutical form

milteliai ir tirpiklis infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B01AB02, Antithrombin III

Marketing authorisation holder

Octapharma (IP) SPRL, Belgija

Date of authorisation

2020-01-24

Date of renewal

2024-08-05

Documents

4501 Atenativ RPP 2025 04 23.docx

4501 Pakuotės lapelis 2025 04 23.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DK/H/1016/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Ištirpinus tirpiklyje, 1 ml tirpalo yra	1 ml
Žmogaus antitrombinas III	50 TV

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
103121	89222	1089222	flakonas	milteliai (500 TV) ir flakonas tirpiklio (10 ml) N1		Receptinis	LT/1/20/4501/001	Netiekiama	-	-	No	-	-
103122	89223	1089223	flakonas	milteliai (1000 TV) ir flakonas tirpiklio (20 ml) N1		Receptinis	LT/1/20/4501/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-08-05	Perregistruotas
2020-01-24	Registruotas