Amiptic

Medicinal product

(Invented) name

Amiptic

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

2013-02-28

Date of renewal

2018-12-14

Documents

3222_1_3 Pakuotės lapelis 200316.docx

3222_1_3 Amiptic RPP 200316.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

PL/H/0616/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Kiekviename ml 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
53821	67805	1067805	buteliukas	5 ml N1		Receptinis	LT/1/13/3222/001	Netiekiama	-	-	No	-	-	Download
55312	69360	1069360	buteliukas	5 ml N3		Receptinis	LT/1/13/3222/002	Netiekiama	-	-	No	-	-
55313	69361	1069361	buteliukas	5 ml N6		Receptinis	LT/1/13/3222/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-12-29	Išregistruotas
2018-12-14	Perregistruotas
2013-02-28	Registruotas