Ofost

Medicinal product

(Invented) name

Ofost

Active substance (s)

Oksitocinas

Strength

5 TV/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

H01BB02, Oxytocin

Marketing authorisation holder

AS Grindeks, Latvija

Date of authorisation

2020-09-30

Date of renewal

2022-08-23

Documents

4606_4607 Ofost PL 2024 11 04, VRA.docx

4606_4607 Pakuotės lapelis 2024 11 04, VRA.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/0961/001/E/002

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Oksitocinas	5 TV/ml

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
105036	91138	1091138	ampulė	1 ml N5		Receptinis	LT/1/20/4606/001	Netiekiama	-	-	No	-	-
105037	91139	1091139	ampulė	1 ml N10		Receptinis	LT/1/20/4606/002	Tiekiama	-	-	No	-	-
105038	91140	1091140	ampulė	1 ml N100		Receptinis	LT/1/20/4606/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-08-23	Perregistruotas
2020-09-30	Registruotas