Rhesonativ

Medicinal product

(Invented) name

Rhesonativ

Active substance (s)

Žmogaus anti-D imunoglobulinas

Strength

625 TV/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J06BB01, Anti-D (rh) immunoglobulin

Marketing authorisation holder

Octapharma (IP) SPRL, Belgija

Date of authorisation

2008-04-07

Date of renewal

2012-04-27

Documents

1082 Pakuotės lapelis 2021_05_24.docx

1082 Rhesonativ inj RPP 2021_05_24.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

SE/H/0541/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Žmogaus anti-D imunoglobulinas	625 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
22913	25648	1025648	ampulė	1 ml N1		Receptinis	LT/1/08/1082/001	Netiekiama	-	-	No	-	-	Download
22914	25649	1025649	ampulė	2 ml N1		Receptinis	LT/1/08/1082/002	Tiekiama	-	-	No	-	-
29455	31947	1031947	ampulė	2 ml N10		Receptinis	LT/1/08/1082/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-04-27	Perregistruotas
2008-04-07	Registruotas