17 April 2020

EMA/222200/2020
Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: nifuroxazide

Procedure no.: PSUSA/00002160/201908

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands

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© European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged.
Product Name (in MRP/DCP National Authorisation Number MAH of product in the Member State where
authorisation country) Authorisation number member state product is authorised
NIFUROXAZIDE ZENTIVA not available 34009 324 163 2 5 ZENTIVA FRANCE FR
200 mg, gélule

NIFUROXAZIDE ZENTIVA not available 34009 367 469 6 1 ZENTIVA FRANCE FR

200 mg, gélule

NIFUROXAZIDE ZENTIVA not available 34009 324 164 9 3 ZENTIVA FRANCE FR

200 mg, gélule

ERCEFURYL 200 mg cps. not available 42/622/97-C TAKEDA GMBH CZ

tvrdé tobolky

Ercefuryl 200 mg capsule not available 9024/2016/01 SANOFI ROMANIA SRL RO

ERCEFURYL not available 21203/24-07-1991 SANOFI-AVENTIS AEBE GR

ERCEFURYL not available 21204/24-07-1991 SANOFI-AVENTIS AEBE GR

ERCEFURYL not available 21203/24-07-1991 SANOFI-AVENTIS AEBE GR

ERCEFURYL not available 21203/24-07-1991 SANOFI-AVENTIS AEBE GR

List of nationally authorised medicinal products

EMA/222200/2020 Page 2/3
Product Name (in MRP/DCP National Authorisation Number MAH of product in the Member State where
authorisation country) Authorisation number member state product is authorised
ERCEFURYL 4 POUR CENT, not available 34009 315 930 4 1 SANOFI-AVENTIS FRANCE FR
suspension buvable

ERCEFURYL 4 POUR CENT, not available 34009 317 825 3 7 SANOFI-AVENTIS FRANCE FR
suspension buvable

ERCEFURYL 4 POUR CENT, not available 34009 314 490 0 3 SANOFI-AVENTIS FRANCE FR
suspension buvable

ERCEFURYL 4 POUR CENT, not available 34009 314 491 7 1 SANOFI-AVENTIS FRANCE FR
suspension buvable

ERCEFURYL 200 mg, not available 34009 381 125 9 7 SANOFI-AVENTIS FRANCE FR
gélule

List of nationally authorised medicinal products

EMA/222200/2020 Page 3/3