Elmetacin Spray

Medicinal product

(Invented) name

Elmetacin Spray

Active substance (s)

Indometacinas

Strength

8 mg/ml

Pharmaceutical form

odos purškalas (tirpalas)

Route (s) of administration

vartoti ant odos

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M02AA23, Indometacin

Marketing authorisation holder

UAB STADA Baltics, Lietuva

Date of authorisation

1996-12-06

Date of renewal

2013-07-31

Documents

3347_1 Pakuotės lapelis 210127.docx

3347_1 Elmetacin spray RPP 210127.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml (0,8 g) tirpalo yra	1 ml
Indometacinas	8 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
5536	10779	1010779	buteliukas	50 ml su purškalo pompa N1		Nereceptinis	LT/1/96/3347/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-03-31	Išregistruotas
2013-07-31	Perregistruotas
1996-12-06	Registruotas