[PDF] Active substance: flucloxacillin Procedure no: PSUSA

Active substance: flucloxacillin Procedure no: PSUSA

Floxapen 1000 mg pó para solução injetável ou para perfusão PT/H/0670/001 5479977 GENERIS FARMACÊUTICA, S A PT Floxapen 2000 mg pó para solução injetável ou para perfusão PT/H/0670/002 5480009 GENERIS FARMACÊUTICA, S A PT Floxapen 2000 mg pó para solução injetável ou para perfusão

FLOXAM (Flucloxacilline) - Laprophan

FLOXAM ® (Flucloxacilline) FORMES PHARMACEUTIQUES ET PRESENTATIONS Gélules dosées à 500 mg : boîtes de 16 et 24 gélules Poudre pour suspension orale dosée à 250 mg/ 5 ml

MEDICAMENTS CONTENANT DU SODIUM - HUG

Algifor sirop Irfen cpr Spedifen 400 (ibuprofène) Equivalent Floxapen Flacon-amp 1 g 49 125 4 0 20 0 50 Flacon-amp 2 g 97 247 4 0 39 1 00 Penicilline G

INFO OT - UPB-AVB

Le Staphycid® sirop est actuellement indisponible, et ce, pour une durée indéterminée Le Floxapen® sirop n’est plus commercialisé et la flucloxacilline n’existe pas en vrac Les gélules de Staphycid® et de Floxapen® sont par contre disponibles (d’après les informations dont nous disposons), mais il est déconseillé

CAPP-INFO - HUG

Floxapen flucloxacilline loin des repas Fosamax alendronate 30 min avant lepetit-déjeuner, au lever avec un grand verre d'eau Glibenese glipizide 30 min avant le repas Glucophage metformine avec le repas Hygroton chlortalidone avec le petit-déjeuner Inderal propranolol indifférent2 Isoket retard dinitrate d'isosorbide loin des repas

يــــمـــسر روــشــنـــم

306956 FLOXAPEN 500mg Gél Bt 12 5,449 5,923 8,003 A 0,080 DAR ESSAYDALI 301606 300045 DRILL Toux Sèche Ad 0 3 Sirop Fl 150ml 3,349 3,641 4,920 -

Gouttes / Sirops GES 45 23,1 g 1 boîte Ulcogant 1g sachet

Algifor junior sirop 200 ml 1 bouteille Carbomix 50 g 1 bouteille Cetallerg gttes (= Zyrtec gttes) 20 ml 1 bouteille Dafalgan sirop 3 g / 100 ml 1 bouteille Dexamethasone 50 ml 1 bouteille Flatulex 50 ml 1 bouteille GES 45 23,1 g 1 boîte Ponstan sirop 120 ml 1 bouteille Saccharose 20 3 ml 1 boite Sinecod sirop 200 ml 1 bouteille

Génériques Mepha / et spécialités

Flucloxacilline Floxapen® Floxapen® LS Fosfomycine Monuril® Fosfomycin-Mepha® LS Imipénème / cilastatine Aripiprazole Abilify® Aripiprazol-Mepha® sirop

ﻲــــﻣـــﺳر روــﺷــﻧـــﻣ

301490 VALOXINE 57 64mg/ml Sirop Fl 150ml 6,209 6,749 9,120 C 0,080 PHILADELPHIA PHARMA 301809 LEVET 500mg Comp Pell Bt 60 49,493 53,799 70,800 A 0,080 TAHA PHARMA 302375 ANTIOMAL 250 250mg Comp Pell Bt 30 14,750 16,033 21,100 A 0,080 302376 ANTIOMAL 500 500mg Comp Pell Bt 30 25,858 28,107 36,990 A 0,080 TERIAK

Appellations commerciales des médicaments et possibilités de

FLOXAPEN flucloxacilline FLUCLOXACILLINE (G) FLUIMUCIL acétylcystéine FLUIMUCIL Générique pour les EMS : ACETYLCYSTEINE FOLVITE acide folique ACIDE FOLIQUE (G) FOSAMAX alendronate ALENDRONATE (G) Générique pour les EMS : ALENDRON GARAMYCIN EPONGES gentamicine (éponge) GENTAFLEECE EPONGE (G) HEPAGEL GEL héparine (topique) LYMAN EMGEL (G)

[PDF] exercices fluctuation d'échantillonnage première bac pro

[PDF] fluctuation d'une fréquence en première bac pro

[PDF] fluctuation maths seconde

[PDF] fluctuation d'échantillonnage première s

[PDF] fluctuation d'échantillonnage paces

[PDF] fluctuation d'échantillonnage cours

[PDF] histoire d amour triste pdf

[PDF] biais d'indication

[PDF] stratification lca

[PDF] biais d'incorporation

[PDF] hypothèse du biais maximum

[PDF] biais lca

[PDF] glossaire lca anglais

[PDF] principe d'ambivalence lca

[PDF] critère de jugement censuré

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

An agency of the European Union

Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000

© European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged.

12 November 202

0

EMA/14202/2021

Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: flucloxacillin

Procedure no.:

PSUSA/00001402/202003

List of nationally authorised medicinal products

EMA/14202/2021 Page 2/26

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

Flucloxacilline Aurobindo 2 g,

poeder voor oplossing voor injectie of infusie PT/H/0670/002/DC RVG 109868 AUROBINDO PHARMA B.V. NL

Floxapen 1000 mg pó para

solução injetável ou para perfusão

PT/H/0670/001

5479969 GENERIS FARMACÊUTICA, S.A. PT

Floxapen 1000 mg pó para

solução injetável ou para perfusão

PT/H/0670/001

5479977 GENERIS FARMACÊUTICA, S.A. PT

Floxapen 2000 mg pó para

solução injetável ou para perfusão

PT/H/0670/002

5480009 GENERIS FARMACÊUTICA, S.A. PT

Floxapen 2000 mg pó para

solução injetável ou para perfusão

PT/H/0670/002

5480017 GENERIS FARMACÊUTICA, S.A. PT

Floxapen 1000 mg pó para

solução injetável ou para perfusão

PT/H/0670/0

01 5795356 GENERIS FARMACÊUTICA, S.A. PT

Floxapen 2000 mg pó para

solução injetável ou para perfusão

PT/H/0670/002

5795364 GENERIS FARMACÊUTICA, S.A. PT

Flucloxacillin 125mg/5ml Oral

Solution BP

not available PA0298/016/003 ATHLONE LABORATORIES

LIMITED

IE

List of nationally authorised medicinal products

EMA/14202/2021 Page 3/26

Flucloxacillin 125mg/5ml Oral

Solution

not available PA0298/017/003 ATHLONE LABORATORIES

LIMITED

IE

Flucloxacillin 250 mg/5ml

Granules for Oral Solution

not available PL 20416/0077 CRESCENT PHARMA LIMITED UK

Flucloxacillin 125 mg/5ml

Granules for Oral Solution

MT/H/0499/001

PL 20416/0076 CRESCENT PHARMA LIMITED UK

Flucloxacillin 125 mg/5ml

Granules for Oral Solution

MT/H/0499/001

MA1317/01201 CRESCENT PHARMA

INTERNATIONAL LIMITED

MT

Flucloxacilline Mylan 250 mg,

capsules not available RVG 10927 MYLAN B.V. NL

Flucloxacilline Mylan 500 mg,

capsules not available RVG 10928 MYLAN B.V. NL

Heracillin 500 mg filmuhúðaðar

not available 843279 (IS) MEDA AB IS

Geriflox 500 mg Capsules, Hard

not available PA0577/199/001 MYLAN IRELAND LIMITED IE

Flukloxacillin Meda 1 g

filmdragerade tabletter not available 55084 MEDA AB SE

Flukloxacillin Meda 500 mg

filmdragerade tabletter not available 21624 MEDA AB SE

Flukloxacillin Meda 750 mg

filmdragerade tabletter not available 21625 MEDA AB SE

Flucloxacillin GSB 2 g Pulver

zur Herstellung einer not available 136105 GSB PHARMA GMBH AT

List of nationally authorised medicinal products

EMA/14202/2021 Page 4/26

Floxapen® Vials for Injection not available PL 20075/0584 ACCORD HEALTHCARE LIMITED UK FLOXAPEN® Vials for Injection not available PL 20075/0587 ACCORD HEALTHCARE LIMITED UK FLOXAPEN® Vials for Injection not available PL 20075/0592 ACCORD HEALTHCARE LIMITED UK

Flucloxacilline CF, poeder voor

oplossing voor injectie 125 mg,

250 mg, 500 mg en 1 g

not available RVG 57442 CENTRAFARM B.V. NL

Flucloxacillin 125mg/5ml

powder for oral solution not available PL 21880/0063 MEDREICH PLC UK

Floxapen 1000 mg powder for

solution for injection or infusion

IE/H/0505/001

PA1380/011/007 ACTAVIS GROUP PTC EHF. IE

Floxapen 2000 mg powder for

solution for injection or infusion

IE/H/0505/002

PA 1380/11/8 ACTAVIS GROUP PTC EHF. IE

Floxapen 2 g Pulver zur

Herstellung einer Injektions-

IE/H/0505/002

1-31793 ACTAVIS GROUP PTC EHF. AT

Flucloxacilina Hikma 500 mg pó

para solução injetável not available 5623764 HIKMA FARMACÊUTICA (PORTUGAL), S.A. PT

Flucloxacilina Hikma 500 mg pó

para solução injetável not available 5623772 HIKMA FARMACÊUTICA (PORTUGAL), S.A. PT

Flucloxacilina Hikma 500 mg pó

para solução injetável not available 5623806 HIKMA FARMACÊUTICA (PORTUGAL), S.A. PT

List of nationally authorised medicinal products

EMA/14202/2021 Page 5/26

Fluclox Stragen 1g, Pulver zur

Herstellung einer Injektions-

not available 6067085.00.00 STRAGEN FRANCE DE

Fluclox Stragen 2g, Pulver zur

Herstellung einer Injektions-

not available 6067085.01.00 STRAGEN FRANCE DE Floxapen 500 mg Cápsulas not available 4666889 GENERIS FARMACÊUTICA, S.A. PT Floxapen 500 mg Cápsulas not available 8378703 GENERIS FARMACÊUTICA, S.A. PT

Flucloxacillin 125mg/5ml

Powder for Oral Solution Sugar

Free

UK/H/6073/001

PL 44278/0001 NOVELGENIX THERAPEUTICS

LIMITED

UK

Flucloxacillin 250mg/5ml

Powder for Oral Solution Sugar

Free

UK/H/6073/002

PL 44278/0002 NOVELGENIX THERAPEUTICS

LIMITED

UK

Flucloxacillin 250 mg/5ml

Powder for Oral Solution Sugar

Free

UK/H/6073/002

MA1136/00202 NOVELGENIX THERAPEUTICS

LIMITED

MT

Flucloxacillin 125mg/5ml

Powder for Oral Solution Sugar

Free

UK/H/6073/001

MA1136/00201 NOVELGENIX THERAPEUTICS

LIMITED

MT FLUCACID 1 g compresse not available 033623012 EURO-PHARMA S.R.L. IT

Flucloxacillin Sodium for

Injection 1 g

not available 24780/0015 VILLERTON INVEST S.A. UK

List of nationally authorised medicinal products

EMA/14202/2021 Page 6/26

Flucloxacillin Sodium for

Injection 500 mg

not available 24780/0014 VILLERTON INVEST S.A. UK

Flucloxacillin Sodium for

Injection 250 mg

not available 24780/0013 VILLERTON INVEST S.A. UK

Flucloxacilline Apotex 500 mg,

capsules not available RVG 18564 APOTEX EUROPE B.V. NL Flucloxacillin 500 mg Capsules UK/H/1101/002 PL 21880/0018 MEDREICH PLC UK Staphycid 500 mg, gélules not available BE080604 TRENKER BE

Staphycid 500 mg capsules

hard not available BE080604 TRENKER BE Staphycid 500 mg, gélules not available 1986060013 TRENKER LU

STAPHYCID 250 mg/ 5 ml,

poudre pour sirop not available BE154804 TRENKER BE

STAPHYCID 250 mg/5 ml,

poeder voor stroop. not available BE154804 TRENKER BE

STAPHYCID 250 mg / 5 ml,

poudre pour sirop not available 1991110826 TRENKER LU

Flucloxacilline CF, poeder voor

oplossing voor injectie 125 mg,

250 mg, 500 mg en 1 g

not available RVG 57442 CENTRAFARM B.V. NL Floxapen 500 mg Cápsulas not available 4666889 GENERIS FARMACÊUTICA, S.A. PT

List of nationally authorised medicinal products

EMA/14202/2021 Page 7/26

Floxapen 500 mg Cápsulas not available 8378703 GENERIS FARMACÊUTICA, S.A. PT

Flucloxacillin 1 g, powder for

solution for injection.

MT/H/0350/003

PL 44124/0011 PANPHARMA UK

Flucloxacillin 1 g, powder for

solution for injection.

MT/H/0350/003

PL 44124/0011 PANPHARMA UK

Flucloxacillin 1 g, powder for

solution for injection.

MT/H/0350/003

PL 44124/0011 PANPHARMA UK

Flucloxacillin 1 g, powder for

solution for injection.

MT/H/0350/003

PL 44124/0011 PANPHARMA UK

Flucloxacillin 250 mg, powder

for solution for injection.

MT/H/0350/001

PL 44124/0010 PANPHARMA UK

Flucloxacillin 250 mg, powder

for solution for injection.

MT/H/0350/001

PL 44124/0010 PANPHARMA UK

Flucloxacillin 250 mg, powder

for solution for injection.

MT/H/0350/0

01 PL 44124/0010 PANPHARMA UK

Flucloxacillin 250 mg, powder

for solution for injection.

MT/H/0350/001

PL 44124/0010 PANPHARMA UK

Flucloxacillin 500 mg, powder

for solution for injection.

MT/H/0350/002

PL 44124/0005 PANPHARMA UK

Flucloxacillin 500 mg, powder

for solution for injection.

MT/H/0350/002

PL 44124/0005 PANPHARMA UK

Flucloxacillin 500 mg, powder

for solution for injection.

MT/H/0350/002

PL 44124/0005 PANPHARMA UK

List of nationally authorised medicinal products

EMA/14202/2021 Page 8/26

Flucloxacillin 500 mg, powder

for solution for injection.

MT/H/0350/002

PL 44124/0005 PANPHARMA UK

Flucloxacillin Panpharma 500

mg, powder for solution for injection/infusion.

MT/H/0350/002

MA692/00201 PANPHARMA MT

Flucloxacillin Panpharma 500

mg, powder for solution for injection/infusion.

MT/H/0350/002

MA692/00201 PANPHARMA MT

Flucloxacillin Panpharma 500

mg, powder for solution for injection/infusion.

MT/H/0350/002

MA692/00201 PANPHARMA MT

Flucloxacillin Panpharma 500

mg, powder for solution for injection/infusion

MT/H/0350/002

MA692/00201 PANPHARMA MT

Flucloxacillin Panpharma 250

mg, powder for solution for injection/infusion.

MT/H/0350/001

MA692/00202 PANPHARMA MT

Flucloxacillin Panpharma 250

mg, powder for solution for injection/infusion.

MT/H/0350/001

MA692/00202 PANPHARMA MT

Flucloxacillin Panpharma 250

mg, powder for solution for injection/infusion.

MT/H/0350/001

MA692/00202 PANPHARMA MT

Flucloxacillin Panpharma 250

mg, powder for solution for injection/infusion.

MT/H/0350/001

MA692/00202 PANPHARMA MT

List of nationally authorised medicinal products

EMA/14202/2021 Page 9/26

Flucloxacillin Panpharma 1 g,

powder for solution for injection/infusion.

MT/H/0350/003

MA692/00203 PANPHARMA MT

Flucloxacillin Panpharma 1 g,

powder for solution for injection/infusion.

MT/H/0350/003

MA692/00203 PANPHARMA MT

Flucloxacillin Panpharma 1 g,

powder for solution for injection/infusion.

MT/H/0350/003

MA692/00203 PANPHARMA MT

Flucloxacillin Panpharma 1 g,

powder for solution for injection/infusion.

MT/H/0350/003

MA692/00203 PANPHARMA MT

LIDERCLOX 1 g compresse not available 033552011 FARMA GROUP S.R.L. IT

FLOXAPEN® Oral Suspension

125mg/5 ml

FLUCLOXACILLIN Ora

l

Suspension 125mg/5ml

not available PL 20075/0586 ACCORD HEALTHCARE LIMITED UK

FLOXAPEN® Oral Suspension

250mg/5ml

FLUCLOXACILLIN Oral

Suspension 250mg/5ml

not available PL 20075/0590 ACCORD HEALTHCARE LIMITED UK

Flucloxacillin 125mg/5ml

Sugar-Free Powder for Oral

Solution

not available PL 08215/0119 KENT PHARMACEUTICALS LTD. UK

List of nationally authorised medicinal products

EMA/14202/2021 Page 10/26

Flucloxacillin 250mg/5ml Sugar

Free Powder for Oral Solution

not available PL08215/0121 KENT PHARMACEUTICALS LTD. UK

Flucloxacilina Azevedos 500 mg

Cápsulas

not available 5585849 LABORATÓRIOS AZEVEDOS - S.A. PT

Flucloxacilina Azevedos 500 mg

Cápsulas

not available 5051156 LABORATÓRIOS AZEVEDOS - S.A. PT

Flucloxacilina Azevedos 500 mg

Cápsulas

not available 5051164 LABORATÓRIOS AZEVEDOS - S.A. PT

Flucloxacilina Azevedos 500 mg

Cápsulas

not available 5051149 LABORATÓRIOS AZEVEDOS - S.A. PT

Flucloxacillin GSB 1 g Pulver

zur Herstellung einer not available 136104 GSB PHARMA GMBH AT

Flucloxacillin Sandoz 750 mg

filmdragerade tabletter not available 25507 SANDOZ A/S SE

Flucloxacilina Generis 500 mg

Cápsulas

not available 5588843 GENERIS FARMACÊUTICA, S.A. PT

Flucloxacilina Generis 500 mg

Cápsulas

not available 5594700 GENERIS FARMACÊUTICA, S.A. PT

Flucloxacilina Generis 500 mg

Cápsulas

not available 5588850 GENERIS FARMACÊUTICA, S.A. PT

List of nationally authorised medicinal products

EMA/14202/2021 Page 11/26

Floxapen 1 g

Trockenstechampullen

not available 16914 ACTAVIS GROUP PTC EHF. AT

Flucloxacillin 125mg/5ml

Sugar-Free Powder for Oral

Solution

not available PL 08215/0120 KENT PHARMACEUTICALS LTD. UK

Flucloxacillin 250mg/5ml

Sugar-Free Powder for Oral

Solution

not available PL 08215/0122 KENT PHARMACEUTICALS LTD. UK

Staphylex® 250 mg Kapseln

Hartkapseln

not available 6007657.01.00 PUREN PHARMA GMBH & CO. KG DE

Staphylex® 500 mg Kapseln

Hartkapseln

not available 6007657.00.00 PUREN PHARMA GMBH & CO. KG DE Flucloxacillin 500mg Capsules not available PL 30464/0120 ATHLONE PHARMACEUTICALS

LIMITED

UK Flucloxacillin 250mg Capsules not available PL 30464/0119 ATHLONE PHARMACEUTICALS

LIMITED

UK Flucloxacillin 250mg Capsules not available PL 30464/0121 ATHLONE PHARMACEUTICALS

LIMITED

UK Flucloxacillin 500mg Capsules not available PL 30464/0122 ATHLONE PHARMACEUTICALS

LIMITED

UK

Flucloxacillin Sandoz 500 mg

filmdragerade tabletter not available 25506 SANDOZ A/S SE

Flucloxacillin 125mg/5ml

Sugar-Free Powder for Oral

Solution

not available PL 08215/0120 KENT PHARMACEUTICALS LTD. UK

List of nationally authorised medicinal products

EMA/14202/2021 Page 12/26

Flucloxacillin 250mg/5ml

Sugar-Free Powder for Oral

Solution

not available PL 08215/0122 KENT PHARMACEUTICALS LTD. UK

Flucloxacillin 125mg/5ml Oral

Solution

not available PL 30464/0167 ATHLONE PHARMACEUTICALS

LIMITED

UK

Flucloxacillin 250mg/5ml Oral

Solution

not available PL 30464/0168 ATHLONE PHARMACEUTICALS

LIMITED

UK

Flucloxin 125mg/5ml Oral

Solution

not available PL 30464/0167 ATHLONE PHARMACEUTICALS

LIMITED

UK

Heracillin, filmovertrukne

tabletter not available 06223 MYLAN DENMARK APS DK

Heracillin, filmovertrukne

tabletter not available 50804 MYLAN DENMARK APS DK LIDERCLOX 1 g compresse not available 033552011 FARMA GROUP S.R.L. IT FLOXAPEN® Capsules 250mg not available PL 20075/0588 ACCORD HEALTHCARE LIMITED UK Floxapen Capsules 500mg not available PL 20075/0591 ACCORD HEALTHCARE LIMITED UK

Flukloksacilin Altamedics 1 g

injiciranje/infundiranje not available H/11/01387/001 ALTAMEDICS D.O.O. SI

Flukloksacilin Altamedics 2 g

injiciranje/nfundiranje not available H/11/01387/002 ALTAMEDICS D.O.O. SI

List of nationally authorised medicinal products

EMA/14202/2021 Page 13/26

FLUCLOXACILLIN/COOPER (250

mg) not available 6520/05-03-2018 COOPER S.A.

PHARMACEUTICALS

GR

FLUCLOXACILLIN/COOPER

(500mg) not available 6521/05-03-2018 COOPER S.A.

PHARMACEUTICALS

GR

FLUCLOXACILLIN/COOPER

quotesdbs_dbs35.pdfusesText_40