Mydriacyl

Medicinal product

(Invented) name

Mydriacyl

Active substance (s)

Tropikamidas

Strength

10 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)

S01FA06, Tropicamide

Marketing authorisation holder

Alcon Farmaceutika d.o.o., Kroatija

Date of authorisation

1996-10-30

Date of renewal

2012-04-23

Documents

0005 Pakuotės lapelis 2024 09 30.docx

0005 Mydriacyl II PL 2024 09 30.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Tropikamidas	10 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
4677	10021	1010021	buteliukas	15 ml su lašintuvu N1		Receptinis	LT/1/92/0005/002	Netiekiama	2025-03-26	2025-07-31	No	-	-

Stadijos

Data	Stadija
2012-04-23	Perregistruotas
1996-10-30	Registruotas