Ketorolac Baxter

Medicinal product

(Invented) name

Ketorolac Baxter

Active substance (s)

Ketorolako trometamolis

Strength

30 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 Pakuotės lapelis 2024 09 09.docx

3655 Ketorolac Baxter PCS PL 2024 09 09.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PT/H/2379/002

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Ampulėje (1 ml) yra	1 ml
Ketorolako trometamolis	30 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
56305	70402	1070402	ampulė	1 ml N5		Receptinis	LT/1/14/3655/004	Netiekiama	-	-	No	-	-
60614	74901	1074901	ampulė	1 ml N10		Receptinis	LT/1/14/3655/005	Netiekiama	-	-	No	-	-
60615	74902	1074902	ampulė	1 ml N25		Receptinis	LT/1/14/3655/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-11-22	Perregistruotas
2014-11-10	Registruotas