Carbetocin Pharmidea

Medicinal product

(Invented) name

Carbetocin Pharmidea

Active substance (s)

Karbetocinas

Strength

100 µg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

H01BB03, Carbetocin

Marketing authorisation holder

SIA PHARMIDEA, Latvija

Date of authorisation

2017-05-29

Date of renewal

Documents

4083_1_2 Carbetocin Pharmidea PL 200515.docx

4083_1_2 Pakuotės lapelis 200515.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/3742/001/DC

Marketing authorisation procedure

Decentralizuota 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
68381	82958	1082958	flakonas	1 ml N4		Receptinis	LT/1/17/4083/001	Netiekiama	-	-	No	-	-
68382	82959	1082959	flakonas	1 ml N5		Receptinis	LT/1/17/4083/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-05-29	Išregistruotas
2017-05-29	Registruotas