CEVAXEL ceftiofur 50 mg/ml

Main information

  • Trade name:
  • CEVAXEL ceftiofur 50 mg/ml
  • Pharmaceutical form:
  • Powder and solvent for solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CEVAXEL ceftiofur 50 mg/ml
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Ceftiofur
  • Therapeutic area:
  • Cattle, Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0177/001
  • Authorization date:
  • 13-02-2012
  • EU code:
  • FR/V/0177/001
  • Last update:
  • 09-08-2016

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

1/19 C577-cevaxel-labelling-varIA-day0

A.LABELLING

2/19 C577-cevaxel-labelling-varIA-day0

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Boxcontaining1vialofCEVAXEL50mg/ml,1g

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CEVAXEL50mg/ml,powderandsolventforsolutionforinjectionforcattleandpigs.

Ceftiofur(assodium)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Ceftiofur(assodium) 1g

3. PHARMACEUTICALFORM

Powderandsolventforsolutionforinjection

4. PACKAGESIZE

1g

5. TARGETSPECIES

Cattleandpigs.

6. INDICATION(S)

7. METHODANDROUTE(S)OFADMINISTRATION

Methodandrouteofadministration:readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Meatandoffal:

-Cattle:2days

-Pigs:2days.

Milk:zerodays.

9. SPECIALWARNING(S),IFNECESSARY

Penicillinsandcephalosporinsmayoccasionallycausesevereallergicreactions.Seepackageleaflet

foruserwarnings.

3/19 C577-cevaxel-labelling-varIA-day0

10. EXPIRYDATE

EXP:

“Oncereconstituted,useby------(7days,storedinarefrigerator,12hours,storedbelow25°C)

Oncebroached,useby

11. SPECIALSTORAGECONDITIONS

Storedinarefrigerator(2°C-8°C)

Keepthevialintheoutercartoninordertoprotectfromlight

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Disposal:readpackageleaflet.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly

Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Lot:

4/19 C577-cevaxel-labelling-varIA-day0

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Boxcontaining1vialof20mlsolvent.

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CEVAXEL ,50mg/mlpowderandsolventforsolutionforinjectionforcattleandpigs.

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Waterforinjections20ml

3. PHARMACEUTICALFORM

Powderandsolventforsolutionforinjection

4. PACKAGESIZE

20ml

5. TARGETSPECIES

Cattleandpigs.

6. INDICATION(S)

7. METHODANDROUTE(S)OFADMINISTRATION

Methodandrouteofadministration:readthepackageleafletinthe1gpowderpackbeforeuse.

TobeusedwithCEVAXEL50mg/ml,1gonly.

8. WITHDRAWALPERIOD

9. SPECIALWARNING(S),IFNECESSARY

Specialwarnings:readthepackageleafletinthe1gpowderpackbeforeuse.

5/19 C577-cevaxel-labelling-varIA-day0

10. EXPIRYDATE

EXP:

11. SPECIALSTORAGECONDITIONS

Nospecialprecautionsforstorage.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Disposal:readpackageleafletinthe1gpowderpack.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly

Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Lot:

6/19 C577-cevaxel-labelling-varIA-day0

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Boxcontaining1vialofCEVAXEL50mg/ml,4g

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CEVAXEL50mg/ml,powderandsolventforsolutionforinjectionforcattleandpigs.

Ceftiofur(assodium)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Ceftiofur(assodium) 4g

3. PHARMACEUTICALFORM

Powderandsolventforsolutionforinjection

4. PACKAGESIZE

4g

5. TARGETSPECIES

Cattleandpigs.

6. INDICATION(S)

7. METHODANDROUTE(S)OFADMINISTRATION

Methodandrouteofadministration:readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Meatandoffal:

-Cattle:2days

-Pigs:2days.

Milk:zerodays.

9. SPECIALWARNING(S),IFNECESSARY

Penicillinsandcephalosporinsmayoccasionallycausesevereallergicreactions.Seepackageleaflet

foruserwarnings.

7/19 C577-cevaxel-labelling-varIA-day0

10. EXPIRYDATE

EXP:

“Oncereconstituted,useby------(7days,storedinarefrigerator,12hours,storedbelow25°C).

Oncebroached,useby

11. SPECIALSTORAGECONDITIONS

Storedinarefrigerator(2°C-8°C).

Keepthevialintheoutercartoninordertoprotectfromlight.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Disposal:readpackageleaflet.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly

Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Lot:

8/19 C577-cevaxel-labelling-varIA-day0

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Boxcontaining1vialof80mlsolvent.

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CEVAXEL50mg/ml,powderandsolventforsolutionforinjectionforcattleandpigs.

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Waterforinjections 80ml

3. PHARMACEUTICALFORM

Powderandsolventforsolutionforinjection.

4. PACKAGESIZE

1vialof80mlsolvent.

5. TARGETSPECIES

Cattleandpigs.

6. INDICATION(S)

7. METHODANDROUTE(S)OFADMINISTRATION

Methodandrouteofadministration:readthepackageleafletinthe4gpowderpackbeforeuse.

TobeusedwithCEVAXEL50mg/ml,4gonly.

8. WITHDRAWALPERIOD

9. SPECIALWARNING(S),IFNECESSARY

Specialwarnings:readthepackageleafletinthe4gpowderpackbeforeuse.

9/19 C577-cevaxel-labelling-varIA-day0

10. EXPIRYDATE

EXP:

11. SPECIALSTORAGECONDITIONS

Nospecialprecautionsforstorage.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Disposal:readpackageleafletinthe4gpowderpack.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly

Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Lot:

10/19 C577-cevaxel-labelling-varIA-day0

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

Label:1gpowder

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CEVAXEL50mg/ml,powderandsolventforsolutionforinjectionforcattleandpigs.

Ceftiofur(assodium)1g.

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

1g.

4. ROUTE(S)OFADMINISTRATION

Intramuscularuse.

Tobeusedwith20mlwaterforinjection.

5. WITHDRAWALPERIOD

Meatandoffal:

-Cattle:2days.

-Pigs:2days.

Milk:zerodays.

6. BATCHNUMBER

Lot:{number}

7. EXPIRYDATE

EXP:{month/year}

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

11/19 C577-cevaxel-labelling-varIA-day0

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

Label:20mlsolvent

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CEVAXEL50mg/ml,powderandsolventforsolutionforinjectionforcattleandpigs.

Waterforinjections

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

20ml.

4. ROUTE(S)OFADMINISTRATION

Intramuscularuse.

TobeusedwithCEVAXEL50mg/ml,1gonly.

5. WITHDRAWALPERIOD

6. BATCHNUMBER

Lot:{number}

7. EXPIRYDATE

EXP:{month/year}

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

12/19 C577-cevaxel-labelling-varIA-day0

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

Label:4gpowder

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CEVAXEL50mg/ml,powderandsolventforsolutionforinjectionforcattleandpigs.

Ceftiofur(assodium)4g

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

4g.

4. ROUTE(S)OFADMINISTRATION

Intramuscularuse.

Tobeusedwith80mlwaterforinjection.

5. WITHDRAWALPERIOD

Meatandoffal:

-Cattle:2days.

-Pigs:2days.

Milk:zerodays.

6. BATCHNUMBER

Lot:{number}

7. EXPIRYDATE

EXP:{month/year}

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

13/19 C577-cevaxel-labelling-varIA-day0

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

Label:80mlsolvent

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CEVAXEL50mg/ml,powderandsolventforsolutionforinjectionforcattleandpigs.

Waterforinjections

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

80ml.

4. ROUTE(S)OFADMINISTRATION

Intramuscularuse.

TobeusedwithCEVAXEL50mg/ml,4gonly.

5. WITHDRAWALPERIOD

6. BATCHNUMBER

Lot:{number}

7. EXPIRYDATE

EXP:{month/year}

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

14/19 C577-cevaxel-labelling-varIA-day0

B.PACKAGELEAFLET

15/19 C577-cevaxel-labelling-varIA-day0

PACKAGELEAFLET

CEVAXEL50mg/ml,powderandsolventforsolutionforinjectionforcattleandpigs.

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

Marketingauthorisationholder:

Manufacturerforthebatchrelease:

CEVASANTEANIMALE–Z.I.LaBallastière–33500LIBOURNE-France

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CEVAXEL50mg/ml,powderandsolventforsolutionforinjectionforcattleandpigs.

Ceftiofur(assodium)

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Powdervials:

1gofceftiofur(assodium)

4gofceftiofur(assodium)

Solvent:

Waterforinjections

Reconstitutedsolution:

Ceftiofur(assodium)50mg/ml

4. INDICATION(S)

Cattle:

-ForthetreatmentofbacterialrespiratorydiseaseassociatedwithPasteurellamultocidaand

Mannheimiahaemolyticaandsensitivetoceftiofur.

-Forthetreatmentofcattlewithinterdigitalnecrobacillosis(footrot)inwhichFusobacterium

necrophorumandBacteroidesmelaninogenicus(Porphyromonasasaccharolytica)sensitiveto

ceftiofurareinvolved.

Pigs:

-ForthetreatmentofbacterialrespiratorydiseaseinwhichPasteurellamultocida,Actinobacillus

pleuropneumoniaandStreptococcussuissensitivetoceftiofurareinvolved.

5. CONTRAINDICATIONS

Donotuseinanimalspreviouslyfoundtobehypersensitivetoceftiofurorotherbeta-lactamines.

Donotuseinpoultry(includingeggs)duetoriskofspreadofantimicrobialresistancetohumans.

16/19 C577-cevaxel-labelling-varIA-day0

6. ADVERSEREACTIONS

Inlocaltolerancestudiesconductedincattleandswinemildandtransientswellingwereobservedat

theinjectionsiteinafewanimalssixhoursafterinjection

Nogeneralsymptomshavebeenobserved.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Cattleandpigs.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Intramuscularuse.

Thesolutionforinjectionistobereconstitutedwith20mlofwaterforinjectionsforthe1g

presentationandwith80mlofwaterforinjectionsforthe4gpresentation.

Rapidadditionofsolventwillgivebestresults.

Cattle:

-Forrespiratorydisease

1mgceftiofur(assodium)perkgbodyweightperdayfor3to5days,i.e.1mlofreconstituted

solutionper50kgbodyweightperdayfor3to5days.

-Forinterdigitalnecrobacillosis(foulinthefootrot)

1mgceftiofur(assodium)perkgbodyweightperdayfor3days,i.e.1mlofreconstitutedsolution

per50kgbodyweightperdayfor3days.

Pigs:

3mgceftiofur(assodium)perkgbodyweightperdayfor3days,i.e.1mlofreconstitutedsolution

per16kgbodyweightperdayfor3days.

Thedoseshouldbegivenoncedailyat24hourintervals.

Donotadministermorethan10mlperinjectionsite.

9. ADVICEONCORRECTADMINISTRATION

10. WITHDRAWALPERIOD

Meatandoffal:

-Cattle:2days.

-Pigs:2days.

Milk:zerodays.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Storedinarefrigerator(2°C–8°C)

Keepthevialintheoutercartoninordertoprotectfromlight

-Shelflifeoftheproductafterreconstitutionaccordingtodirections:

17/19 C577-cevaxel-labelling-varIA-day0

7days,storedinarefrigerator(2°C–8°C)

12hours,storedbelow25°

Donotuseaftertheexpirydatewhichisstatedonthecartonafter:{DDmonthYYYY}

12. SPECIALWARNING(S)

Specialprecautionsforuseinanimals

Incaseofrepeatedadministrations,precautionsmustbetaken,suchasinjectionsonbothsidesofthe

neck.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproduct

toanimals

Penicillinsandcephalosporinsmaycausehypersensitivityfollowinginjection,inhalation,ingestion

orskincontact.Hypersensitivitytopenicillinsmayleadtocrosssensitivitytocephalosporinsand

viceversa.Allergicreactionstothesesubstancesmayoccasionallybeserious.

Peoplewithknownhypersensitivityshouldavoidcontactwiththeveterinarymedicinalproduct.

Incaseofdevelopmentofaskinrashfollowingexposure,seekmedicaladvice.

Swellingoftheface,lipsoreyesordifficultyinbreathingaremoreserioussymptomsandrequire

urgentmedicalattention.

Washhandsafteruse.

Pregnancyandlactation

Ceftiofurshowednoreproductiveordevelopmentaltoxicityattherapeuticdosesinrats.Thesafetyof

theproducthasnotbeenassessedinpregnantandlactatingcowsandsows.Useonlyaccordingtothe

benefit/riskassessmentbytheresponsibleveterinarian.

Interactionwithothermedicinalproductsandotherformsofinteraction

Theuseofceftiofurwithotherß-lactamantibioticsorcephalosporinsmayinduceinrareoccasiona

potentialimmunologicalcross-reaction.

Overdose

Incattle,nosignsofsystemictoxicityareobservedafterimportantoverdosebyparenteral

administrations.

Inpigs,thelowesttoxicityofceftiofurwasdemonstratedat8timesthetherapeuticdosefor15days

byintramuscularuse.

UseofCevaxelmayconstitutearisktopublichealthduetospreadofantimicrobialresistance.

Cevaxelshouldbereservedforthetreatmentofclinicalconditionswhichhaverespondedpoorly,or

areexpectedtorespondpoorlytofirstlinetreatment.Official,nationalandregionalantimicrobial

policiesshouldbetakenintoaccountwhentheproductisused.Increaseduse,includinguseofthe

productdeviatingfromtheinstructionsgiven,mayincreasetheprevalenceofresistance.Whenever

possible,Cevaxelshouldonlybeusedbasedonsusceptibilitytesting.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIAL,IFANY

Disposeofanyunusedproductandemptycontainersinaccordancewithguidancefromyourlocalwaste

regulationauthority.

18/19 C577-cevaxel-labelling-varIA-day0

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Pharmacodynamicproperties

Ceftiofurisacephalosporin,resistanttobeta-lactamase.CeftiofurisactiveagainstGram-positiveand

Gram-negativebacteria.

Ceftiofurhasbactericidalproperties,actingbyinhibitionofthebacteriacellwallsynthesis.

Cellwallsynthesisisdependentonenzymesthatarecalledpenicillin-bindingproteins(PBP's).

Bacteriadevelopresistancetocephalosporinsbyfourbasicmechanisms:1)alteringoracquiring

penicillinbindingproteinsinsensitivetoanotherwiseeffectiveb-lactam;2)alteringthepermeability

ofthecelltob-lactams;3)producingb-lactamasesthatcleavetheb-lactamringofthemolecule,or4)

activeefflux.

Ceftiofurisactiveagainstthefollowingpathogenicbacteria:

Mannheimiahaemolytica,Pasteurellamultocida,Actinobacillussomnusresponsiblefor

bovinerespiratorydiseases

Fusobacterium necrophorum and Bacteroides melaninogenicus(Porphyromonas

asaccharolytica)responsibleforbovineinterdigitalnecrobacillosis

Pasteurellamultocida,StreptococcussuisandActinobacilluspleuropneumoniaresponsible

forporcinerespiratorydiseases

ThefollowingMinimumInhibitoryConcentrations(MIC)havebeendeterminedforceftiofurin

Europeanisolates(France,UnitedKingdom,Netherlands,Denmark,Germany,Belgium,Italy,Czech

Republic,Ireland,PolandandSpain)collectedfromdiseasedanimalsbetween2000to2007:

Bacteriaspecies Origin Year Nbof

strains CMIofceftiofur(µg/mL)

Range CMI

50 CMI

90

Pasteurellamultocida Cattle 2004to2006 82 0.0019–0.0625 ≤

0.003 ≤

0.005

Pigs 2004to2006 66 0.0019–0.0156 ≤

0.003 ≤

0.006

Mannheimiahaemolytica Cattle 2004to2006 72 0.0019–0.0156 ≤

0.005 ≤

0.008

Haemophilussomnus Cattle 2005to2007 62 0.0019–0.125 ≤

0.004 ≤

0.02

Actinobacillus

pleuropneumoniae Pigs 2003/2004 58 0.0039–0.0312 ≤

0.006 ≤

0.02

Streptococcussuis Pigs 2004to2006 44 0.0312–0.5 ≤

0.2 ≤

0.3

Fusobacteriumnecrophorum Cattle 2000to2006 27 0.015–16 0.1 0.2

Thefollowingceftiofurbreakpointsareused: ≤

2µg/mL(Susceptible),4µg/mL(Intermediate)and ≥

8

µg/mL(Resistant).

Pharmacokineticparticulars

Afteradministrationbyintramuscularroute,biodisponibilityofceftiofuristotalincattleandinpigs.

Ceftiofurisquicklymetabolisedintodesfuroylceftiofurforwhichthemaximalconcentrationis

reachedin2.5hoursincattleandinlessthanonehourinpigs.Half-lifeofdesfuroylceftiofurisof

11.2hoursincattleandof15.2hoursinpigs.

Repeatedadministrationsinducenoaccumulationincattleandpigs.

19/19 C577-cevaxel-labelling-varIA-day0

Packagesizes:

Boxcontaining1vialofCEVAXEL50mg/ml,1gandboxcontainingavialof20mlsolvent.

Boxcontaining1vialofCEVAXEL50mg/ml,4gandboxcontainingavialof80mlsolvent.

Notallpacksizesmaybemarketed.

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Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

France - Agence Nationale du Médicament Vétérinaire

2-11-2018

Frito-Lay Issues Allergy Alert on Undeclared Milk In Select Smartfood Delight Sea Salt Flavored Popcorn

Frito-Lay Issues Allergy Alert on Undeclared Milk In Select Smartfood Delight Sea Salt Flavored Popcorn

Frito-Lay announced a voluntary recall of select 1/2 oz. bags of Smartfood Delight Sea Salt Flavored popcorn because they were inadvertently filled with cheese flavored tortilla chips that contain undeclared milk ingredients. The recalled bags were sold only in the two variety packs listed below.

FDA - U.S. Food and Drug Administration

2-11-2018

Barcelona Nut Company Recalls Roasted and Salted in Shell Pistachios Because of Possible Health Risk

Barcelona Nut Company Recalls Roasted and Salted in Shell Pistachios Because of Possible Health Risk

Barcelona Nut Company of Baltimore, Maryland is recalling 239 cases of roasted and salted in shell pistachios, because it has the potential to be contaminated with Salmonella, an organism that can cause serious and sometimes-fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

FDA - U.S. Food and Drug Administration

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

29-10-2018

Maribel’s Sweets Inc. Allergy Alert on Undeclared Milk Allergens in Chocolate Bars

Maribel’s Sweets Inc. Allergy Alert on Undeclared Milk Allergens in Chocolate Bars

Maribel’s Sweets Inc. of Brooklyn, NY is recalling its 2.82oz MarieBelle Japanese Matcha Japanese Green Tea and White Chocolate Bar, container code 101619, Cacao Market by MarieBelle Rosemary Truffle Salt 60% Dark Chocolate Bar, all container codes, and the Cacao Market by MarieBelle Orange Peels 60% Dark Chocolate Bar, all container codes, because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if...

FDA - U.S. Food and Drug Administration

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

BazziniI LLC of Allentown, PA out of an abundance of caution, is recalling 4,000 pounds of Roasted and Salted Colossal Natural, Super Colossal Natural and Rams Head Natural in Shell Pistachios received from one of its suppliers because it has the potential to be contaminated with Salmonella. NO OTHER BAZZINI PISTACHIOS OR BAZZINI PRODUCTS ARE IMPACTED OR PART OF THIS RECALL. The recall is being initiated voluntarily and no illnesses have been reported to date.

FDA - U.S. Food and Drug Administration

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

8-9-2018

Steve’s Real Food Voluntarily Recalls One Lot of Turducken Recipe, One Lot of Quest Emu, and One Lot of Quest Beef Due to Possible Salmonella and L. Mono Contamination

Steve’s Real Food Voluntarily Recalls One Lot of Turducken Recipe, One Lot of Quest Emu, and One Lot of Quest Beef Due to Possible Salmonella and L. Mono Contamination

Steve’s Real Food of Salt Lake City, Utah is voluntarily recalling one lot of 5lb Turducken Recipe, one lot of 2lb Quest Emu Diet, and one lot of 2lb Quest Beef Diet, due to their possible Salmonella and/or L. mono contamination.

FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

31-8-2018

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles

FDA - U.S. Food and Drug Administration

29-8-2018

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

Requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.

FDA - U.S. Food and Drug Administration

15-8-2018

Salt & Straw Voluntarily Recalls Certain Lots of Chocolate Gooey Brownie Ice Cream Pints Due to Possible Undeclared Peanuts

Salt & Straw Voluntarily Recalls Certain Lots of Chocolate Gooey Brownie Ice Cream Pints Due to Possible Undeclared Peanuts

Salt & Straw Ice Cream is voluntarily recalling a limited number of its Chocolate Gooey Brownie pints because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of a serious or life threatening allergic reaction if they consume this product. The product is safe to consume unless you have a peanut allergy or sensitivity. No illnesses have been reported to date in connection with this problem.

FDA - U.S. Food and Drug Administration

3-8-2018

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

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

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

31-7-2018

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was fo...

FDA - U.S. Food and Drug Administration

25-7-2018

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., is recalling dry whey powder packaged in 50-pound and 25-kg bags that were produced at the cooperative’s Blair, Wis., dry whey plant from May 1-5, 2018; May 24-29, 2018; June 2-5, 2018; and June 7-14, 2018 due to the potential to be contaminated with Salmonella. This is a precautionary recall. All products shipped to the marketplace tested negative for Salmonella.

FDA - U.S. Food and Drug Administration

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

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

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

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

FDA - U.S. Food and Drug Administration

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

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

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

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

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Active substance: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt) - Orphan designation - Commission Decision (2018)5729 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/18

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

3-8-2018

Sodium oxybate

Sodium oxybate

Sodium oxybate (Active substance: Sodium oxybate) - Centralised - Art 28 - (PSUR - Commission Decision (2018)5381 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10612/201710

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

Europe -DG Health and Food Safety

11-7-2018

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Active substance: Alendronate Sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4518 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/619/T/42

Europe -DG Health and Food Safety

10-7-2018

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Active substance: Alendronate sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4477 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/759/T/39

Europe -DG Health and Food Safety

10-7-2018

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Active substance: Sodium phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)4483 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Withdrawn application:  Prohippur, sodium benzoate, Initial authorisation

Withdrawn application: Prohippur, sodium benzoate, Initial authorisation

Europe - EMA - European Medicines Agency

19-6-2018

Xyrem (UCB Pharma S.A.)

Xyrem (UCB Pharma S.A.)

Xyrem (Active substance: Sodium oxybate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3912 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/593/T/74

Europe -DG Health and Food Safety

12-6-2018

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate salt) - Transfer of orphan designation - Commission Decision (2018)3797 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/244/16/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl] acetate salt) - Transfer of orphan designation - Commission Decision (2018)3798 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/166/12/T/01

Europe -DG Health and Food Safety