NEUTRAL SULFA 50

Main information

  • Trade name:
  • NEUTRAL SULFA 50 SOLUTION
  • Dosage:
  • 45MG; 45MG; 20MG
  • Pharmaceutical form:
  • SOLUTION
  • Composition:
  • SULFAMETHAZINE 45MG; SULFATHIAZOLE 45MG; SULFAPYRIDINE 20MG
  • Administration route:
  • ORAL
  • Units in package:
  • 500ML/1 US GALLON
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NEUTRAL SULFA 50 SOLUTION
    Canada
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • CATTLE
  • Product summary:
  • Active ingredient group (AIG) number: 0310688001

Other information

Status

  • Source:
  • Health Canada
  • Authorization status:
  • MARKETED
  • Authorization number:
  • 00346632
  • Authorization date:
  • 31-12-1968
  • Last update:
  • 11-03-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

LABEL

X: 500 cc., 128 fl. oz. (1 U.S. Gallon) – Version 2 NOV 2017

ACTIVE INGREDIENTS: Each mL contains: sulfamethazine

45 mg; sulfathiazole 45 mg; and sulfapyridine 20 mg; methyl

and propyl paraben as a preservative 0.26 percent.

The total sulfonamide content is equivalent to a solution

containing 12.5 percent of Sodium Sulfonamides

(approximately 50 grains per fl. ounce).

INDICATIONS: Indicated for the treatment of infections in

cattle for which the causative organisms are susceptible to

sulfonamides.

DIRECTIONS FOR USE:

To reduce the development of antimicrobial resistance and

maintain effectiveness, use this antibiotic prudently.

For foot rot, shipping fever complex, hemorrhagic septicemia,

bacterial enteritis, upper respiratory infections of bacterial

origin, acute mastitis, bacterial calf diphtheria, pyosepticemia,

(naval ill), and secondary infections associated with bacterial

scours.

Initial Dose is 75 mL per 100 pounds of body weight for the first

day. Subsequent Dose is 25 mL per 100 pounds of body

weight every twelve hours for 2 to 4 additional days.

Medication may be administered in the drinking water provided

that it is the sole source of water. Add 75 mL (2 ½ ounces) of

Neutral Sulfa 50 to each imperial gallon of water (160 fl.

ounces).

CAUTIONS: This preparation, like all sulfonamides, may cause

toxic reactions. It should be administered under adequate

supervision. Provide ample drinking water at all times. If

prolonged depression, blood-tinged urine or cloudy urine is

noted, discontinue the drug and force liquids orally or

intravenously to hasten elimination of the drug. Do not

administer Neutral Sulfa 50 for more than 5 days.

Note: This preparation may darken on standing, but the

potency remains unaffected.

WARNINGS: Milk taken from treated animals during treatment

and within 96 hours after the latest treatment must not be used

DIN 00346632

Pr

NEUTRAL SULFA 50

Triple Sulfonamide Solution

Solution triple de sulfamides

Veterinary use only

Usage vétérinaire seulement

Antibiotic / Antibiotique

Warnings: Keep out of reach of children.

For complete warnings see side panel.

Mises en garde: Garder hors de la portée des enfants.

Voir le panneau latéral pour les mises en garde complètes.

CONTENTS / CONTENU : X

Professional Veterinary Laboratories

1199 Sanford Street

Winnipeg, Manitoba R3E 3A1

1-800-465-7122 - www.domvet.com

INGRÉDIENTS ACTIFS :

Chaque mL contient : sulfaméthazine 45 mg, sulfathiazole 45

mg et sulfapyridine 20 mg; méthyl et propyl-paraben comme

agent de conservation 0,26 pour cent.

La teneur totale en sulfamides est équivalente à une solution

contenant 12,5 pour cent de sulfamides sodiques (environ 50

grains par once liq.).

INDICATIONS : Indiqué chez les bovins pour le traitement des

infections dont les organismes étiologiques sont sensibles aux

sulfamides.

MODE D'EMPLOI :

Pour réduire le développement de résistance aux

antimicrobiens et maintenir l'efficacité de cet antibiotique,

l'utiliser avec prudence.

Pour le traitement du piétin, du complexe respiratoire bovin, de

la septicémie hémorragique, de l'entérite bactérienne, des

infections des voies respiratoires supérieures d'origine

bactérienne, de la mammite aiguë, de la diphtérie du veau, de

la pyosepticémie (omphalite) et des infections secondaires

associées à la diarrhée bactérienne.

La dose initiale est de 75 mL. par 100 livres (45,4 kg) de poids

corporel la première journée. Les doses subséquentes sont de

25 mL par 100 livres de poids corporel toutes les 12 heures

pendant les 2 à 4 prochains jours. Le médicament peut être

administré dans l'eau de boisson à condition que ce soit la

seule source d'eau. Ajouter 75 mL (2 ½ onces) de Neutral

Sulfa 50 dans chaque gallon impérial d'eau (4,55 L).

PRÉCAUTIONS : Cette préparation, comme c'est le cas pour

tous les sulfamides, peut avoir des effets toxiques. Il devrait

être administré sous surveillance étroite. Fournir en tout temps

de l'eau en quantité suffisante. En cas d'abattement prolongé

ou si une urine sanguinolente ou trouble est observée,

interrompre l'usage du médicament et administrer du liquide

par voie orale ou intraveineuse, afin d'accélérer l'élimination du

médicament. Ne pas administrer Neutral Sulfa 50 pendant plus

LABEL

X: 500 cc., 128 fl. oz. (1 U.S. Gallon) – Version 2 NOV 2017

in food. Treated cattle must not be slaughtered for use in food

for at least 10 days after the latest treatment with this drug.

Sulfonamides can cause allergic reactions in sensitized

individuals. When handling the product, avoid inhalation, oral

exposure and direct contact with skin or eyes. Keep out of

reach of children.

STORAGE:

Store at room temperature (15-30°C).

de 5jours.

Remarque : Cette préparation peut s'obscurcir après un temps

de repos, mais son activité n'est pas réduite.

MISES EN GARDE : Le lait provenant des animaux traités qui

est extrait pendant le traitement et dans les 96 heures après

administration de la dernière dose ne doit pas être utilisé

comme aliment. Les bovins traités avec ce médicament ne

doivent pas être abattus à des fins alimentaires dans un délai

d’au moins 10 jours après la dernière administration du

médicament. Les sulfamidés peuvent causer des réactions

allergiques chez les individus sensibilisés. Lors de la

manipulation du produit, éviter l’inhalation, l’exposition orale et

le contact direct avec la peau ou les yeux. Garder hors de la

portée des enfants.

ENTREPOSAGE :

Entreposer à température ambiante (15-30°C).

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Earth City, MO, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

15-3-2019

Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter

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FDA - U.S. Food and Drug Administration

5-3-2019

Morphine Sulfate Injection BP 30 mg in 1 mL ampoule

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Safety advisory – Section 19A product not for epidural or intrathecal use

Therapeutic Goods Administration - Australia

1-3-2019

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

1-2-2019

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30-1-2019

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FDA - U.S. Food and Drug Administration

3-1-2019

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21-12-2018

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FDA - U.S. Food and Drug Administration

6-12-2018

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FDA - U.S. Food and Drug Administration

29-11-2018

ANSES Newsletter in English - N°50 - November 2018

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France - Agence Nationale du Médicament Vétérinaire

22-11-2018

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Europe - EFSA - European Food Safety Authority Publications

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17-10-2018

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Europe - EFSA - European Food Safety Authority Publications

7-9-2018

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3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

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25-7-2018

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FDA - U.S. Food and Drug Administration

17-7-2018

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

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FDA - U.S. Food and Drug Administration

2-7-2018

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FDA - U.S. Food and Drug Administration

31-5-2018

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FDA - U.S. Food and Drug Administration

18-3-2019


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18-3-2019


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Europe -DG Health and Food Safety

25-2-2019

EU/3/14/1259 (Insmed Netherlands B.V.)

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EU/3/14/1259 (Active substance: Amikacin sulfate) - Transfer of orphan designation - Commission Decision (2019)1625 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003885

Europe -DG Health and Food Safety

25-2-2019

EU/3/06/387 (Insmed Netherlands B.V.)

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EU/3/06/387 (Active substance: Amikacin sulfate (liposomal)) - Transfer of orphan designation - Commission Decision (2019)1624 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003770

Europe -DG Health and Food Safety

18-2-2019

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Europe -DG Health and Food Safety

4-2-2019

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Europe -DG Health and Food Safety

1-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): (Z)-N-(3-bromo-4- fluorophenyl)-N-hydroxy-4-(2-(sulfamoylamino)ethylamino)-1,2,5-oxadiazole-3-carboximidamide, decision type: , therapeutic area: , PIP number: P/0246/2018

Opinion/decision on a Paediatric investigation plan (PIP): (Z)-N-(3-bromo-4- fluorophenyl)-N-hydroxy-4-(2-(sulfamoylamino)ethylamino)-1,2,5-oxadiazole-3-carboximidamide, decision type: , therapeutic area: , PIP number: P/0246/2018

Opinion/decision on a Paediatric investigation plan (PIP): (Z)-N-(3-bromo-4- fluorophenyl)-N-hydroxy-4-(2-(sulfamoylamino)ethylamino)-1,2,5-oxadiazole-3-carboximidamide, decision type: , therapeutic area: , PIP number: P/0246/2018

Europe - EMA - European Medicines Agency

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Europe - EMA - European Medicines Agency

29-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Cresemba,Isavuconazonium (sulfate), decision type: , therapeutic area: , PIP number: P/0314/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cresemba,Isavuconazonium (sulfate), decision type: , therapeutic area: , PIP number: P/0314/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cresemba,Isavuconazonium (sulfate), decision type: , therapeutic area: , PIP number: P/0314/2018

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Amikacin (sulfate), decision type: , therapeutic area: , PIP number: P/0346/2018

Opinion/decision on a Paediatric investigation plan (PIP): Amikacin (sulfate), decision type: , therapeutic area: , PIP number: P/0346/2018

Opinion/decision on a Paediatric investigation plan (PIP): Amikacin (sulfate), decision type: , therapeutic area: , PIP number: P/0346/2018

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Trecondi,treosulfan,  13/12/2018,  Positive

Summary of opinion: Trecondi,treosulfan, 13/12/2018, Positive

Summary of opinion: Trecondi,treosulfan, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated viral vector capsid containing the human iduronate-2-sulfatase (hIDS) expression cassette

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated viral vector capsid containing the human iduronate-2-sulfatase (hIDS) expression cassette

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated viral vector capsid containing the human iduronate-2-sulfatase (hIDS) expression cassette

Europe - EMA - European Medicines Agency

11-12-2018

Ziagen (ViiV Healthcare BV)

Ziagen (ViiV Healthcare BV)

Ziagen (Active substance: abacavir sulfate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8685 of Tue, 11 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/252/T/104

Europe -DG Health and Food Safety

3-12-2018


Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type: , therapeutic area: , PIP number: P/0223/2018

Europe - EMA - European Medicines Agency

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

Europe -DG Health and Food Safety

19-9-2018

Targretin (Eisai GmbH)

Targretin (Eisai GmbH)

Targretin (Active substance: bexarotene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6098 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/326/T/50

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Active substance: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate) - Transfer of orphan designation - Commission Decision (2018)4094 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/15/T/02

Europe -DG Health and Food Safety

12-6-2018

EU/3/17/1956 (Sangamo Therapeutics UK LTD)

EU/3/17/1956 (Sangamo Therapeutics UK LTD)

EU/3/17/1956 (Active substance: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human iduronate 2-sulfatase gene) - Transfer of orphan designation - Commission Decision (2018)3811 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/168/17/T/01

Europe -DG Health and Food Safety

4-6-2018

Eliquis (Bristol-Myers Squibb/Pfizer EEIG)

Eliquis (Bristol-Myers Squibb/Pfizer EEIG)

Eliquis (Active substance: apixaban) - Centralised - 2-Monthly update - Commission Decision (2018)3616 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2148/II/50

Europe -DG Health and Food Safety

18-5-2018

EU/3/13/1220 (IQVIA RDS Ireland Limited)

EU/3/13/1220 (IQVIA RDS Ireland Limited)

EU/3/13/1220 (Active substance: Poly[2-[(4-{[1-carboxy-2-(hexadecylcarbamoyl)ethyl]sulfanyl}-2,3-bis({2-[((2S)-2-(2-{[(2R)-2-carbamoyl-(2-{[(2S)-1-ethoxy-3-(3-hydroxy-4oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}ethyl]sulfanyl}-3-{[(2S)-1-ethoxy-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}propanamido)-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)propanoyl Ethyl ester) )-methoxy]acetyl}oxy)butyl)sulfanyl]-3-(hexadecylcarbamoyl)propanoic acid]-poly(ethylene glycol)-este...

Europe -DG Health and Food Safety

14-5-2018

Girolan and its associated name Apralan

Girolan and its associated name Apralan

Girolan and its associated name Apralan (Active substance: Apramycin sulfate) - Community Referrals - Art 34 - Commission Decision (2018)2989 of Mon, 14 May 2018 European Medicines Agency (EMA) procedure number: EMEA/V/A/122

Europe -DG Health and Food Safety