Novain

Medicinal product

(Invented) name

Novain

Active substance (s)

Oksibuprokaino hidrochloridas

Strength

4 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)

S01HA02, Oxybuprocaine

Marketing authorisation holder

AGEPHA Pharma s.r.o, Slovakija

Date of authorisation

2022-12-29

Date of renewal

Documents

5085 Pakuotės lapelis 2024 10 08.docx

5085 Novain PL 2024 10 08.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

AT/H/0792/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Oksibuprokaino hidrochloridas	4 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
110032	96141	1096141	buteliukas	10 ml N1		Receptinis	LT/1/22/5085/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-29	Registruotas