Soolantra

Medicinal product

(Invented) name

Soolantra

Active substance (s)

Ivermektinas

Strength

10 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)

D11AX22, Ivermectin

Marketing authorisation holder

Galderma International, Prancūzija

Date of authorisation

2015-05-13

Date of renewal

2021-05-17

Documents

3726 Pakuotės lapelis 2021 05 17, VRA_19765.docx

3726 Soolantra krem PL 2021 05 17, VRA_19765.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

SE/H/1428/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Viename grame kremo yra	1 g
Ivermektinas	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
58936	73154	1073154	tūbelė	2 g N1		Receptinis	LT/1/15/3726/001	Netiekiama	-	-	No	-	-
62229	76602	1076602	tūbelė	15 g N1		Receptinis	LT/1/15/3726/002	Netiekiama	-	-	No	-	-
62230	76603	1076603	tūbelė	30 g N1		Receptinis	LT/1/15/3726/003	Tiekiama	-	-	No	-	-	Download
62231	76604	1076604	tūbelė	45 g N1		Receptinis	LT/1/15/3726/004	Netiekiama	-	-	No	-	-
62232	76605	1076605	tūbelė	60 g N1		Receptinis	LT/1/15/3726/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-05-17	Perregistruotas
2015-05-13	Registruotas