List of nationally authorised medicinal products - PSUSA/00002102 ...

25 January 2017 EMA/150639/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: nadifloxacin

Procedure no.: PSUSA/00002102/201605

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Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

FERRER INTERNACIONAL,

DE

number Nadixa ® 10 mg/g

DE/H/0253/001

44621.00.00

Creme Nadixa 1% Creme

S.A. DE/H/0253/001

1-24350

FERRER INTERNACIONAL,

AT

S.A. Nadixa 1% crema

DE/H/0253/001

64.291

FERRER INTERNACIONAL,

ES

S.A. NADIXA 1% κρέμα

DE/H/0253/001

38896/05/9-10-2006

FERRER INTERNACIONAL,

GR

S.A. Nadixa crème 1%

DE/H/0253/001

1379/02/02/0035

FERRER INTERNACIONAL,

LU

S.A. Nadixa 1% crema

DE/H/0253/001

034885020/M

FERRER INTERNACIONAL,

IT

S.A. Nadixa 1% crema

DE/H/0253/001

034885032/M

FERRER INTERNACIONAL,

IT

S.A. Nadixa 1% crema

DE/H/0253/001

034885044/M

FERRER INTERNACIONAL,

IT

S.A. Nadixa 1% crema

DE/H/0253/001

034885057/M

FERRER INTERNACIONAL,

IT

S.A. Nadixa 10 mg/g creme

DE/H/0253/001

3699485

FERRER INTERNACIONAL,

PT

S.A. Nadixa 10 mg/g creme

DE/H/0253/001

3699584

FERRER INTERNACIONAL,

PT

S.A.

List of nationally authorised medicinal products EMA/150639/2017

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Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

FERRER INTERNACIONAL,

PT

number Nadixa 10 mg/g creme

DE/H/0253/001

3699683

S.A. Nadixa 10 mg/g creme

DE/H/0253/001

3699782

FERRER INTERNACIONAL,

PT

S.A. Nadixa 10 mg/g creme

DE/H/0253/001

3699881

FERRER INTERNACIONAL,

PT

S.A. Надикса 1% крем

not available

II-13749/07.07.2006

FERRER INTERNACIONAL,

BG

S.A.

List of nationally authorised medicinal products EMA/150639/2017

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