Recoxa

Medicinal product

(Invented) name

Recoxa

Active substance (s)

Meloksikamas

Strength

10 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M01AC06, Meloxicam

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2009-05-19

Date of renewal

2014-08-01

Documents

0268 Recoxa inj PCS PL 2023 10 27.docx

0268 Pakuotės lapelis inj 2023 10 27.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H/0179/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Meloksikamas	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
29255	5161	1005161	ampulė	1,5 ml N5		Receptinis	LT/1/05/0268/011	Tiekiama	-	-	No	-	-	Download
36158	38490	1038490	ampulė	1,5 ml N10		Receptinis	LT/1/05/0268/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-08-01	Perregistruotas
2009-05-19	Registruotas