Ketorolac Baxter

Medicinal product

(Invented) name

Ketorolac Baxter

Active substance (s)

Ketorolako trometamolis

Strength

10 mg/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)

M01AB15, Ketorolac

Marketing authorisation holder

Baxter Holding B.V. , Nyderlandai

Date of authorisation

2014-11-10

Date of renewal

2019-11-22

Documents

3655 Ketorolac Baxter inj II PL 2021 08 31.docx

3655 Pakuotės lapelis 2021 08 31.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PT/H/2379/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Ampulėje (1 ml) yra	1 ml
Ketorolako trometamolis	10 mg

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
56304	70401	1070401	ampulė	1 ml N5		Receptinis	LT/1/14/3655/001	Netiekiama	-	-	No	-	-
60612	74899	1074899	ampulė	1 ml N10		Receptinis	LT/1/14/3655/002	Netiekiama	-	-	No	-	-
60613	74900	1074900	ampulė	1 ml N25		Receptinis	LT/1/14/3655/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-29	Išregistruotas
2019-11-22	Perregistruotas
2014-11-10	Registruotas