UNICLOPHEN

Medicinal product

(Invented) name

UNICLOPHEN

Active substance (s)

Diklofenako natrio druska

Strength

1 mg/ml

Pharmaceutical form

akių lašai (tirpalas)

Route (s) of administration

vartoti ant akių

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01BC03, Diclofenac

Marketing authorisation holder

UNIMED PHARMA spol. s r.o., Slovakija

Date of authorisation

2001-03-08

Date of renewal

2009-07-21

Documents

1635_1_2_UNICLOPHEN_akiu lasai_RPP_181024.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml lašų yra	1 ml
Diklofenako natrio druska	1 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
23759	26446	1026446	talpyklė su lašintuvu	5 ml N1		Receptinis	LT/1/01/1635/001	Netiekiama	-	-	No	-	-
10144	14735	1014735	talpyklė su lašintuvu	10 ml N1		Receptinis	LT/1/01/1635/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-07-21	Perregistruotas
2001-03-08	Registruotas