Dexamethasone PPH [DEXAMETHASONE WZF POLFA]

Medicinal product

(Invented) name

Dexamethasone PPH [DEXAMETHASONE WZF POLFA]

Active substance (s)

Deksametazonas

Strength

1 mg/ml

Pharmaceutical form

akių lašai (suspensija)

Route (s) of administration

vartoti į akis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01BA01, Dexamethasone

Marketing authorisation holder

Zakłady Farmaceutyczne POLPHARMA S.A., Lenkija

Date of authorisation

1994-11-11

Date of renewal

2009-05-13

Documents

1568 Dexamethasone PPH RPP 2024 03 01.docx

1568 Pakuotės lapelis 2024 03 01.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml suspensijos yra	1 ml
Deksametazonas	1 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
18030	4660	1004660	buteliukas	5 ml N1		Receptinis	LT/1/94/1568/001	Tiekiama	-	-	No	-	-	Download
524	6460	1006460	buteliukas	10 ml N1		Receptinis	LT/1/94/1568/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-05-13	Perregistruotas
1994-11-11	Registruotas