PABAL

Medicinal product

(Invented) name

PABAL

Active substance (s)

Karbetocinas

Strength

100 µg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

H01BB03, Carbetocin

Marketing authorisation holder

Ferring GmbH, Vokietija

Date of authorisation

2007-09-18

Date of renewal

2014-02-11

Documents

0794 Pakuotės lapelis 2023 10 17.docx

0794 PABAL PCS PL 2023 10 17.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DK/H/2872/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Karbetocinas	100 µg

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
62491	76900	1076900	flakonas	1 ml N5		Receptinis	LT/1/07/0794/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-02-11	Perregistruotas
2007-09-18	Registruotas