Bimatoprost Accord

Medicinal product

(Invented) name

Bimatoprost Accord

Active substance (s)

Bimatoprostas

Strength

0,1 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)

S01EE03, Bimatoprost

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2015-09-30

Date of renewal

2021-12-30

Documents

3804 Pakuotės lapelis 0,1mg_ml 2022 11 17.docx

3804 Bimatoprost Accord 0,1mg_ml PCS PL 2022 11 17.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DK/H/3028/001/

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Bimatoprostas	0,1 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
59464	73692	1073692	buteliukas	3 ml N1		Receptinis	LT/1/15/3804/001	Netiekiama	-	-	No	-	-
63787	78230	1078230	buteliukas	3 ml N3		Receptinis	LT/1/15/3804/002	Netiekiama	-	-	No	-	-
63788	78231	1078231	buteliukas	3 ml N6		Receptinis	LT/1/15/3804/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-12-27	Išregistruotas
2021-12-30	Perregistruotas
2015-09-30	Registruotas