[PDF] flucloxacillin: List of nationally authorised medicinal products





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FLOXAPEN - Flucloxacilline

FLOXAPEN gélules : gélule noire et caramel contenant 500 mg de Flucloxacilline sous forme Préparation du sirop: Avant l'administration de ce médicament ...



Floxapen Syrup 125 mg/5 ml Powder for Oral Suspension

1 What Floxapen Syrup is and what it is used for. Floxapen is an antibiotic used to treat infections by killing the bacteria that can cause them. It belongs.



FLOXAPEN

FLOXAPEN Gélules : Gélules noires et caramélisées contenant 500 mg de flucloxacilline sous forme de flucloxacilline sodique Ph. Eur.



FLOXAPEN

FLOXAPEN solution injectable 250 mg et 500 mg : FLOXAPEN est indiqué pour le traitement des infections dues à des organismes Gram-positifs y.



NOTICE : INFORMATION DE LUTILISATEUR FLOXAPEN 500 mg

FLOXAPEN est indiqué dans le traitement des infections : • de la peau et des tissus sous-cutanés (impétigo érysipèle



Pharmacovigilance

17 sept. 2020 Flucloxacilline (BE : FLOXAPEN® et STAPHYCID®) : plaintes ... BAUME PULMONAIRE 10mg/15ml ; 100mg/15ml sirop ; NOSCAFLEX EXPECTORANS.



INFO OT

1 janv. 2019 Floxapen® sirop n'est plus commercialisé et la flucloxacilline n'existe pas en vrac. Les gélules de Staphycid® et.



Algifor junior sirop 200 ml 1 bouteille Carbomix 50 g 1 bouteille

Dafalgan sirop. 3 g / 100 ml Floxapen. 500 mg. 1 boîte. Imodium lingual ... Floxapen. 1 g. 3 ampoules. Garamycine. 20 mg. 3 ampoules. Garamycine.



flucloxacillin: List of nationally authorised medicinal products

12 nov. 2020 Floxapen 1000 mg pó para solução injetável ou para ... Floxapen® Vials for Injection not available ... poudre pour sirop not available.



PHEL Infos No56.pub

Floxapen® capsules 500 mg quates



[PDF] FLOXAPEN - Flucloxacilline

Aucune information n'est disponible pour cette page · Découvrir pourquoi



FLOXAPEN 250 mg Poudre pour sirop - Pharmapresse

Adultes et enfants à partir de 12 ans : 500 mg trois fois par jour • Enfants âgés de 6 à 12 ans : 250 mg trois fois par jour Contres indications : Si vous 



FLOXAPEN 125 mg Poudre pour sirop - Pharmapresse

Voie orale: 500 mg 3 à 4 fois par jour · Injection (i m / i v ): 1 g 3 fois par jour · Perfusion: 2 à 8 g par jour en 3 ou 4 perfusions rapides (20 à 30 minutes) 



FLOXAPEN 125 mg Poudre pour sirop au Maroc MAJ 2023 - Medtn

FLOXAPEN 125 mg Poudre pour sirop · Voie orale: 500 mg 3 à 4 fois par jour · Injection (i m / i v ): 1 g 3 fois par jour · Perfusion: 2 à 8 g par jour en 3 ou 4 



FLOXAPEN 250 mg Poudre pour sirop - Medtn

FLOXAPEN 250 mg Poudre pour sirop · infections de la peau (furonculose anthrax abcès impétigo) des tissus mous et sous-cutanés (phlegmons cellulites 



[PDF] Floxapen Syrup 125 mg/5 ml Powder for Oral Suspension - HPRA

It belongs to a group of antibiotics called “penicillins” Floxapen syrup may be used to treat: • chest infections • throat or nose infections • ear 



FLOXAPEN® 125 mg/5 ml Poudre pour suspension buvable

Indications Ce médicament est indiqué particulièrement dans les:- Infections de la peau et des tissus mous: furoncle; abcès; folliculites; cellulites; 



ANSM - Résumé des Caractéristiques du Produit

20 sept 2016 · La posologie quotidienne doit être fractionnée en 2 à 3 prises pour les angines voire en 3 ou 4 prises pour les autres indications · Chez l' 



Flucloxacilline - CBIP

Flucloxacilline Posologie per os: - adulte: impétigo: 1 à 2 g p j en 3 à 4 



Floxapen 125 MG 5ml OS IPI 12 PDF Insuffisance rénale - Scribd

FLOXAPEN Gélules : Gélules noires et caramélisées contenant 500 mg de flucloxacilline Le reflux gastro-oesophagien pdf Ventoline Sirop Ipi 05 Guinee

  • Comment prendre le Floxapen ?

    FLOXAPEN peut être administré par injection intraveineuse ou intramusculaire et par perfusion. Votre médecin décidera de la posologie et de la durée du traitement. Celles-ci dépendront de la sévérité et du type d'infection dont vous souffrez.

  • Pourquoi prendre Floxapen ?

    Médicament pour le traitement des infections causées par des bactéries.

  • Comment prendre la Flucloxacilline ?

    La dose quotidienne usuelle est de 25 à 50 mg de flucloxacilline par kg de poids corporel et par jour, répartis en trois ou quatre doses égales, par injection intraveineuse ou intramusculaire. En cas d'infections graves, vous pourrez recevoir jusqu'à 100 mg/kg par jour en trois ou quatre doses.
  • Prescrite pour plusieurs raisons, la ciprofloxacine peut être utilisée pour protéger les gens qui ont côtoyé une personne atteinte d'une méningite, d'une infection bactérienne de la membrane cérébrale ou d'une infection bactérienne du sang.
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
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