25 April 2018 EMA/263468/2018 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: permethrin

Procedure no.: PSUSA/00002355/201707

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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

InfectoMite® 5 % Creme

not available

67447.00.00

INFECTOPHARM

DE

ARZNEIMITTEL UND CONSILIUM GMBH InfectoPedicul® +

not available

70310.00.00

INFECTOPHARM

Nissenkamm Lösung 430

ARZNEIMITTEL UND

mg/100 ml

CONSILIUM GMBH

NIX Crème Rinse, 10

not available

NR 1995060146

mg/g Lotion NIX Crème Rinse, 10

LU

NV not available

NR 1995060146

mg/g lotion Loxazol 10 mg/g

OMEGA PHARMA BELGIUM

DE

OMEGA PHARMA BELGIUM

LU

NV not available

RVG 13969

crèmespoeling, oplossing

OMEGA PHARMA NEDERLAND

NL

B.V.

voor cutaan gebruik LYCLEAR Creme Rinse

not available

PL 02855/0013

OMEGA PHARMA LTD

UK

Lyclear Creme Rinse 1%

not available

PA1186/003/001

CHEFARO IRELAND LIMITED

IE

Nix 1 % schampo

not available

10928

ACO HUD NORDIC AB

FI

Nix, 1%, schampo

not available

11499

ACO HUD NORDIC AB

SE

Nix, shampoo

not available

13403

ACO HUD NORDIC AB

DK

Nix 1 % shampoo

not available

10928

ACO HUD NORDIC AB

FI

Nix 1% sjampo

not available

7779

ACO HUD NORDIC AB

NO

NIX 10 mg/g creme

not available

2244986

OMEGA PHARMA

PT

w/w Cutaneous solution

PORTUGUESA LDA Nix 5 % emulsiovoide

not available

List of nationally authorised medicinal products EMA/263468/2018

10929

ACO HUD NORDIC AB

FI

Page 2/4

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Nix 5 % kräm

not available

10929

ACO HUD NORDIC AB

FI

Nix 5% krem

not available

7776

ACO HUD NORDIC AB

NO

Nix, creme

not available

13605

ACO HUD NORDIC AB

DK

NIX Crème Rinse, 10

not available

BE 162057

OMEGA PHARMA BELGIUM

BE

not available

BE 162057

not available

BE 162057

mg/g lotion NIX Crème Rinse, 10

NV

mg/g lotion NIX Creme Spülung, 10

OMEGA PHARMA BELGIUM

BE

NV

mg/g Lotion

OMEGA PHARMA BELGIUM

BE

NV

Nix 1% hársápa

not available

940194

ACO HUD NORDIC AB

IS

ΝΙΧ

not available

21525/19-5-2014

OMEGA PHARMA HELLAS S.A.

GR

NIX® 10 mg/g emulsione

not available

028017022

CHEFARO PHARMA ITALIA

IT

cutanea BiomoPedicul® 0,5 %

SRL not available

74315.00.00

BIOMO PHARMA GMBH

DE

not available

74928.00.00

BIOMO PHARMA GMBH

DE

not available

74927.00.00

BIOMO PHARMA GMBH

DE

Lösung Lösung mit 430 mg Permethrin 25/75 (cis/trans) pro 100 ml Lösung permethrin-biomo Lösung 0,5 % permethrin-biomo® Creme 5 % Creme mit 50 mg Permethrin pro 1g Creme

List of nationally authorised medicinal products EMA/263468/2018

Page 3/4

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

InfectoMite® 5 % Creme

not available

67447.00.00

INFECTOPHARM

DE

ARZNEIMITTEL UND CONSILIUM GMBH InfectoPedicul® +

not available

70310.00.00

INFECTOPHARM

Nissenkamm Lösung 430

ARZNEIMITTEL UND

mg/100 ml

CONSILIUM GMBH

DE

Sarcop

not available

62971

UNIPHARMA S.A.

ES

SCABIANIL 5% crema

not available

036289015

SOFAR S.P.A.

IT

SCABIANIL 5% crema

not available

036289039

SOFAR S.P.A.

IT

gepescab 5 % Creme

not available

74314.00.00

GEPEPHARM GMBH

DE

ZALVOR 5 % Crème

not available

BE 161402

GLAXOSMITHKLINE

BE

Zalvor 5 % Creme

not available

BE 161402

ZALVOR 5 % Crème

not available

BE 161402

PHARMACEUTICALS SA GLAXOSMITHKLINE

BE

PHARMACEUTICALS SA GLAXOSMITHKLINE

BE

PHARMACEUTICALS SA Loxazol 5%, 50 mg/g

not available

RVG 14487

GLAXOSMITHKLINE B.V.

NL

not available

PL 44673/0052

GLAXOSMITHKLINE

UK

hydrofiele crème. Permethrin Lotion 5% w/w

CONSUMER HEALTHCARE (UK) TRADING LIMITED

Permethrin Crème Rinse

not available

1% w/w

PL 44673/0053

GLAXOSMITHKLINE

UK

CONSUMER HEALTHCARE (UK) TRADING LIMITED

List of nationally authorised medicinal products EMA/263468/2018

Page 4/4