Enosat

Medicinal product

(Invented) name

Enosat

Active substance (s)

Fuzido rūgštis/Betametazonas

Strength

20 mg/1 mg/g

Pharmaceutical form

kremas

Route (s) of administration

vartoti ant odos

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D07CC01, Betamethasone and antibiotics

Marketing authorisation holder

Pharmaceutical Works POLPHARMA S.A., Lenkija

Date of authorisation

2016-09-09

Date of renewal

2021-12-13

Documents

3963 pakuotes lapelis_2021-12-13.docx

3963 Enosat_perr2021-12-13.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

LV/H/0191/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 g kremo yra	1 g
Fuzido rūgštis	20 mg
Betametazonas	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
62445	76853	1076853	tūbelė	5 g N1		Receptinis	LT/1/16/3963/001	Netiekiama	-	-	No	-	-
66408	80933	1080933	tūbelė	15 g N1		Receptinis	LT/1/16/3963/002	Tiekiama	-	-	No	-	-	Download
66409	80934	1080934	tūbelė	30 g N1		Receptinis	LT/1/16/3963/003	Netiekiama	-	-	No	-	-
66410	80935	1080935	tūbelė	60 g N1		Receptinis	LT/1/16/3963/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-12-13	Perregistruotas
2016-09-09	Registruotas