Ketanov

Medicinal product

(Invented) name

Ketanov

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

Sun Pharmaceutical Industries Europe B. V., Nyderlandai

Date of authorisation

2012-01-19

Date of renewal

2017-10-16

Documents

2771 Ketanov inj tirp PCS PL 2023 08 21.docx

2771 Pakuotės lapelis 2023 08 21.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė 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
45919	59723	1059723	ampulė	1 ml N10		Receptinis	LT/1/12/2771/001	Tiekiama	-	-	No	-	-	Download
57614	71732	1071732	ampulė	1 ml N5		Receptinis	LT/1/12/2771/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-10-16	Perregistruotas
2012-01-19	Registruotas