Alcaine

Medicinal product

(Invented) name

Alcaine

Active substance (s)

Proksimetakainas

Strength

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)

S01HA04, Proxymetacaine

Marketing authorisation holder

Alcon Farmaceutika d.o.o., Kroatija

Date of authorisation

1996-10-30

Date of renewal

2012-04-23

Documents

2899 Pakuotės lapelis 2025 04 30.docx

2899 Alcaine II PL 2025 04 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
Proksimetakainas	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
4679	10023	1010023	buteliukas	15 ml su lašintuvu N1		Receptinis	LT/1/96/2899/001	Netiekiama	2024-12-09	2025-01-31	No	-	-

Stadijos

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