Bonadix

Medicinal product

(Invented) name

Bonadix

Active substance (s)

Ciprofloksacinas/Fluocinolono acetonidas

Strength

3 mg/0,25 mg/ml

Pharmaceutical form

ausų lašai (tirpalas vienadozėje talpyklėje)

Route (s) of administration

vartoti į ausis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S02CA05, Fluocinolone acetonide and antiinfectives

Marketing authorisation holder

UAB Orivas, Lietuva

Date of authorisation

2022-11-29

Date of renewal

Documents

5076_pakuotes lapelis_2022-11-29.docx

5076_Bonadix.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

ES/H/0166/002/E/002

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Ciprofloksacinas	3 mg
Fluocinolono acetonidas	0,25 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
109894	96001	1096001	vienadozė talpyklė	0,25 ml N15		Receptinis	LT/1/22/5076/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-11-29	Registruotas