Bimifree

Medicinal product

(Invented) name

Bimifree

Active substance (s)

Bimatoprostas

Strength

0,3 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)

S01EE03, Bimatoprost

Marketing authorisation holder

Pharmaceutical Works POLPHARMA S.A., Lenkija

Date of authorisation

2017-05-10

Date of renewal

2022-04-11

Documents

4075 Bimifree RPP 2023 11 24.docx

4075 Pakuotės lapelis 2023 11 24.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

PL/H/0425/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename ml tirpalo yra	1 ml
Bimatoprostas	0,3 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
68192	82758	1082758	buteliukas	3 ml N1		Receptinis	LT/1/17/4075/001	Netiekiama	-	-	No	-	-	Download
68193	82759	1082759	buteliukas	3 ml N3		Receptinis	LT/1/17/4075/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-04-11	Perregistruotas
2017-05-10	Registruotas