Amiptifree

Medicinal product

(Invented) name

Amiptifree

Active substance (s)

Dorzolamidas/Timololis

Strength

20 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

Pharmaceutical Works POLPHARMA S.A., Lenkija

Date of authorisation

2017-07-10

Date of renewal

Documents

4092 Amiptifree PCS 2022 02 23.docx

4092 Pakuotės lapelis 2021 07 20.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

PL/H/0446/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Dorzolamidas	20 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
68715	83298	1083298	buteliukas	5 ml N1		Receptinis	LT/1/17/4092/001	Netiekiama	-	-	No	-	-	Download
68716	83299	1083299	buteliukas	5 ml N3		Receptinis	LT/1/17/4092/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-07-22	Išregistruotas
2017-07-10	Registruotas