Bitimeco

Medicinal product

(Invented) name

Bitimeco

Active substance (s)

Bimatoprostas/Timololis

Strength

0,3 mg/5 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)

S01ED51, Timolol, combinations

Marketing authorisation holder

Zakłady Farmaceutyczne POLPHARMA S.A., Lenkija

Date of authorisation

2021-10-08

Date of renewal

Documents

4827 Pakuotės lapelis 2023 12 22.docx

4827 Bitimeco RPP 2023 12 22.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

LV/H/0203/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Bimatoprostas	0,3 mg
Timololis	5 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
107355	93460	1093460	buteliukas	3 ml N1		Receptinis	LT/1/21/4827/001	Tiekiama	-	-	No	-	-	Download
107356	93461	1093461	buteliukas	3 ml N3		Receptinis	LT/1/21/4827/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-10-08	Registruotas