Florvio Drinking Water Concentrate 23 mg/mL

Main information

  • Trade name:
  • Florvio Drinking Water Concentrate 23 mg/mL
  • Pharmaceutical form:
  • Concentrate for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Florvio Drinking Water Concentrate 23 mg/mL
    Hungary
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Amphenicols
  • Therapeutic area:
  • Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0401/001
  • Authorization date:
  • 27-06-2012
  • EU code:
  • UK/V/0401/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:December2012

AN:00715/2011

Page1of7

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Florvio23mg/mlsolutionforuseindrinkingwaterforpigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Florfenicol23mg

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforuseindrinkingwater.

Clear,colourlesstoyellow,slightlyviscoussolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pig

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentandpreventionatthegrouplevelwhereclinicalsignsarepresentofswine

respiratorydiseaseassociatedwithActinobacilluspleuropneumoniaeandPasteurella

multocidasusceptibletoflorfenicol.Thepresenceofthediseaseshouldbe

establishedintheherdbeforeinitiatingtreatment.

4.3 Contraindications

Donotuseinboarsintendedforbreedingpurposes.

Donotadministerincasesofpreviousallergicreactionstoflorfenicol.

4.4 Specialwarningsforeachtargetspecies

Thetreatedpigsshouldbeplacedunderspecialobservation.Oneachofthefive

daysoftreatment,untreateddrinkingwatershouldnotbegivenuntilthefulldaily

amountofmedicateddrinkingwaterhasbeeningestedbythepigs.Ifthereisno

significantimprovementafter3treatmentdays,thediagnosisshouldbereviewed

andifnecessarythetreatmentshouldbechanged.

Issued:December2012

AN:00715/2011

Page2of7

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Theproductshouldbeusedinconjunctionwithsusceptibilitytestingandtakeinto

accountofficialandlocalantimicrobialpolicies.Inappropriateuseoftheproductmay

increasetheprevalenceofbacteriaresistanttoflorfenicolandmaydecreasethe

effectivenessoftreatmentwithflorfenicol,duetothepotentialforcross-resistance.

Treatmentshouldnotexceed5days.

Donotuseincaseofresistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Peoplewithknownhypersensitivitytopolyethyleneglycolsshouldavoidcontactwith

theveterinarymedicinalproduct.

Incaseofaccidentalspillageontoskinrinsewithwater.

Otherprecautions:

Manurefromtreatedpigsshouldbestoredfor27dayspriortospreadingand

incorporatingintoland.

4.6Adversereactions(frequencyandseriousness)

Aslightreductionofwaterconsumptionbytheanimals,darkbrownfaecesand

constipationmaybeobservedduringtreatment.

Commonlyobservedadverseeffectsarediarrhoeaand/orperi-analandrectal

erythema/oedemawhichmayaffectapproximately40%oftheanimals.Theseeffects

aretransient.Inafewoftheaffectedanimals,prolapseoftherectum,thatresolves

withouttreatment,maybeobserved.

4.7Useduringpregnancy,lactationorlay

Laboratorystudiesinpigshavenotproducedanyevidenceoffoetotoxic effects.

Thesafetyoftheveterinarymedicinalproductinsowshasnotbeenestablished

duringpregnancyandlactation.

Theuseisnotrecommendedduringpregnancyandlactation.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Nodataavailable.

4.9 Amountstobeadministeredandadministrationroute

Oralrouteindrinkingwater.

Pigs:10mgflorfenicolperkgbodyweightperdayfor5consecutivedays.Thisdose

isequivalentto0.44mloftheproductperkgbodyweightperday.

Issued:December2012

AN:00715/2011

Page3of7

TheamountoftheproductcanbecalculatedbasedontheTotalBodyWeightofherd

tobetreated(TBW)andtheTotalWaterConsumptionoftheherdin24hr(TWC)

withthefollowingformula:

Theproduct(litre)= 10xTBW(kg) per1000litreofmedicatedwaterin

23xTWC(litre) the tank

IfaproportionersetatP%isused,thentheformulais

Theproduct(litre)= 10xTBW(kg)x__1__per10litreofpre-diluted

23xTWC(litre)P(%)medicatedwaterinthe

proportioner

Dilutethecalculatedvolumeoftheproductwithwatertoatotalvolumeof10litrein

theproportioner.Donotusethisproductatanyotherproportionersetting.

Theappropriatequantityofmedicatedwaterorpre-dilutedmedicatedwatershould

bepreparedbasedonthedailywaterconsumption.

Medicateddrinkingwatershouldbereplacedevery24hours.

Checkforcompletenessofsolutionbeforeadministration.

Specificexamplesaregivenbelow:

FORBULKTANK:Totreatpigsdrinking10%oftheirbodyweight,atthedoseof10

mg/kg:addtheproducttothedrinkingwaterinthebulktank.Useonebottle(2.17

litre)ofproductforevery500litreofwaterandmixthoroughly.Thiscorrespondstoa

100mg/litredrinkingwaterconcentration.

FORPROPORTIONER(2.17litre):Twoconvenientproportionersettingsfortheuse

offlorfenicolinthedrinkingwaterare10%and1%.

A. Tenpercentsetting:

Totreat5,000kgofpigs,drinking10%oftheirbodyweight,atthedoserateof

10mg/kg:

1. Dilutethecontentofthebottleto4litrewithdrinkingwater.

2. Mixthoroughly.

3. Emptythedilutedproductintheproportioner.

4. Diluteto50litrewithdrinkingwater.

5. Mixthoroughly.

6. Settheproportioneron10%.

7. Turnontheproportioner.

B. Onepercentsetting:

Issued:December2012

AN:00715/2011

Page4of7

Totreat5,000kgofpigs,drinking8%oftheirbodyweight,atthedoserateof

10mg/kg:

1. Dilutethecontentofthebottleto4litrewithdrinkingwater.

2. Mixthoroughly.

3. Emptythedilutedproductintheproportioner.

4. Mixthoroughly.

5. Settheproportioneron1%.

6. Turnontheproportioner.

FORPROPORTIONER(0.54litre):Twoconvenientproportionersettingsfortheuse

offlorfenicolinthedrinkingwaterare10%and1%.

A. Tenpercentsetting:

Totreat1,250kgofpigs,drinking10%oftheirbodyweight,atthedoserateof

10mg/kg:

1. Dilutethecontentofthebottleto1litrewithdrinkingwater.

2. Mixthoroughly.

3. Emptythedilutedproductintheproportioner.

4. Diluteto12,5litrewithdrinkingwater.

5. Mixthoroughly.

6. Settheproportioneron10%.

7. Turnontheproportioner.

B. Onepercentsetting:

Totreat1,250kgofpigs,drinking8%oftheirbodyweight,atthedoserateof

10mg/kg:

1. Dilutethecontentofthebottleto1litrewithdrinkingwater.

2. Mixthoroughly.

3. Emptythedilutedproductintheproportioner.

4. Mixthoroughly.

5. Settheproportioneron1%.

6. Turnontheproportioner.

Solutionsshouldnotbepreparedatconcentrationsbetween1.2gand12g

florfenicolperlitre.

Theuptakeofmedicatedwaterdependsonseveralfactorsincludingtheclinicalstate

oftheanimalsandlocalconditionssuchasambienttemperatureandhumidity.In

ordertoobtainthecorrectdosagewateruptakehastobemonitoredandthe

concentrationofflorfenicolhastobeadjustedaccordingly.Ifhoweveritisnot

possibletoobtainsufficientuptakeofmedicatedwateranimalsshouldbetreated

parenterally.

Issued:December2012

AN:00715/2011

Page5of7

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Incaseofoverdosing,adecreaseinweightgain,foodandwaterconsumption,peri-

analerythemaandoedemaandmodificationofsomehaematologicaland

biochemicalparametersindicativeofdehydrationmaybeobserved.

4.11Withdrawalperiod(s)

Meatandoffal:20days

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup: Amphenicols

ATCVetCode: QJ01BA90

5.1 Pharmacodynamicproperties

Florfenicolisabroad-spectrumsyntheticantibioticinthephenicolgroupthatisactive

againstmostGram-positiveandGram-negativebacteriaisolatedfromdomestic

animals.Florfenicolactsbyinhibitionofproteinsynthesisattheribosomalleveland

isbacteriostatic.However,bactericidalactivityhasbeendemonstratedin-vitro

againstActinobacilluspleuropneumoniaeandPasteurellamultocidawhenflorfenicol

ispresentatconcentrationsabovetheMIC(µg/ml)forupto12hours.

In-vitrotestinghasshownthatflorfenicolisactiveagainstthebacterialpathogens

mostcommonlyisolatedinrespiratorydiseasesinpigs,includingActinobacillus

pleuropneumoniaeandPasteurellamultocida.

5.2 Pharmacokineticparticulars

Afteradministrationtopigsbygavageat15mg/kgunderexperimentalconditions,

absorptionofflorfenicolwasvariablebutpeakserumconcentrationsofapproximately

MIC5µg/mlwerereachedapproximately2hoursafterdosing.Theterminalhalf-life

wasbetween2and3hours.Whenpigsweregivenfreeaccess,for5days,towater

medicatedwithflorfenicolataconcentrationof100mgflorfenicolperlitreofwater,

serumconcentrationsofflorfenicolexceededMIC1µg/mlfortheentire5day

treatmentperiodexceptforacoupleofshortexcursionsbelowMIC1µg/ml.

Afterabsorptionanddistribution,florfenicolisextensivelymetabolisedbypigsand

rapidlyeliminated,primarilyinurine.

Afterparenteraldosingofflorfenicoltopigs,ithasbeenshownthatlung

concentrationsaresimilartoserumconcentrations.

Issued:December2012

AN:00715/2011

Page6of7

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Macrogol300

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2Years

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections(in-use):24hours

Donotusetheveterinarymedicinalproductformorethan5hourswithproportioners,

ifgalvanisedpipingisused.

6.4.Specialprecautionsforstorage

Donotstoreabove25

C.

6.5Natureandcompositionofimmediatepackaging

PackSizes: 1litrebottlecontaining0.54litre

4litrebottlecontaining2.17litre

Containers: HDPEbottles

Closures: PolypropyleneScrewCapswithaliner.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

NovartisAnimalHealthUKLimited

FrimleyBusinessPark

Frimley

Camberley

Surrey

GU167SR

8. MARKETINGAUTHORISATIONNUMBER

Vm12501/4182

Issued:December2012

AN:00715/2011

Page7of7

9. DATEOFFIRSTAUTHORISATION

11December2012

10. DATEOFREVISIONOFTHETEXT

December2012

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

Approved: 11/12/2012

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Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the 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 HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

Operation Pangea XI reinforces the dangers of buying unauthorized health products online

Operation Pangea XI reinforces the dangers of buying unauthorized health products online

October 23, 2018 For immediate release

Health Canada

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Abond Group Inc. recalls Tubeez Baby Bath Support

Abond Group Inc. recalls Tubeez Baby Bath Support

The bath support’s suction cups may not adhere to the bath surface, making it unstable and cause it to possibly tip over while in use. In addition, an infant can slip underneath the front support bar and become lodged under water posing a drowning hazard.

Health Canada

10-10-2018

Minister Bruins tekent Green Deal voor duurzame zorg

Minister Bruins tekent Green Deal voor duurzame zorg

Minister Bruno Bruins voor Medische Zorg en Sport heeft vandaag de Green Deal ‘Duurzame zorg voor een gezonde toekomst’ getekend. Hiermee maken 132 partijen uit de zorg, overheid en bedrijfsleven afspraken om de zorg in Nederland duurzamer te maken. Inzet is het terugdringen van CO2-uitstoot, zuiniger gebruik van grondstoffen, minder medicijnresten in het water en een gezonde leefomgeving voor patiënt, cliënt en zorgmedewerkers.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

9-10-2018

Essity Professional Hygiene North America LLC recalls Tork Foam Soap Extra Mild SKU

Essity Professional Hygiene North America LLC recalls Tork Foam Soap Extra Mild SKU

The recalled product is potentially contaminated with the bacteria Burkholderia cepacia. B. cepacia is found in soil and water and poses little medical risk to healthy people.

Health Canada

27-9-2018

Mauna Loa Macadamia Nut Corporation Voluntarily Recalls

Mauna Loa Macadamia Nut Corporation Voluntarily Recalls

Mauna Loa Macadamia Nut Corporation is voluntarily recalling all of its products produced at the Keaau facility between Sept. 6 - 21, 2018 due to a potential contamination of Escherichia coli (E. coli). The recall was initiated due to E. coli being detected in the well water and distribution system that supplies the firm's operations. No illnesses related to the water have been reported to the state.

FDA - U.S. Food and Drug Administration

20-9-2018

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Published on: Wed, 19 Sep 2018 00:00:00 +0200 The third Joint Meeting of the ECDC's Food‐ and Waterborne Disease and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network was held on 16 and 17 October 2017 in Parma. The meeting was constructed around the principle of ‘One health approach to collaborative response to foodborne disease outbreaks in EU/EEA’ and served as an opportunity for public health authorities and food safety/veterinary authorities to meet and exchange information on the...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The goal of this research is to better address the problems related to the widespread presence of pesticides in the environment. Despite the unquestionable utility of the pesticides against various pests in the agricultural field, most pesticides and the corresponding pesticide residues are toxic to the environment and hazardous to human health. The recent literature on organophosphate compounds emphasises a clear correlation between their use and the occurr...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

BioLyte Laboratories Issues Voluntary Nationwide Recall Due to the Voluntary Nationwide Recall initiated by King Bio Inc. (a Raw Material Supplier) for NeoRelief for Muscle Cramping and Restlessness Topical Gel Due to Possible Microbial Contamination

BioLyte Laboratories Issues Voluntary Nationwide Recall Due to the Voluntary Nationwide Recall initiated by King Bio Inc. (a Raw Material Supplier) for NeoRelief for Muscle Cramping and Restlessness Topical Gel Due to Possible Microbial Contamination

BioLyte Laboratories is voluntarily recalling lot numbers 1138, 1139, 1146, and 1160 of NeoRelief for Muscle Cramping and Restlessness Topical Gel to the retail and consumer level. King Bio Inc., a manufacturer of some of the active ingredients in this product, has been found to have some water contamination issues that potentially could have affected this product. King Bio has issued a recall of these active ingredients in BioLyte’s lot specific product. To date, there have been no reports of illness or...

FDA - U.S. Food and Drug Administration

12-9-2018

Natural Disaster Preparedness and Response (Drugs)

Natural Disaster Preparedness and Response (Drugs)

The FDA reminds consumers to have an emergency plan and to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves and their pets during and after severe storms (tornados, hurricanes, blizzards) and other events that can result in power outages, flooding, or road and business closures.

FDA - U.S. Food and Drug Administration

10-9-2018

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

WASHINGTON, Sept. 10, 2018 – U.S. Secretary of Agriculture Sonny Perdue, DVM and U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D. today announced a joint public meeting to be held on Oct. 23-24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry.

FDA - U.S. Food and Drug Administration

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quali...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Update of the tolerable upper intake level for vitamin D for infants

Update of the tolerable upper intake level for vitamin D for infants

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the draft Scientific Opinion on the update of the tolerable upper intake level for vitamin D for infants. This draft Scientific Opinion was prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) and endorsed by the Panel for public consultation by written procedure on 9 April 20...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

Santevia Water System Inc. recalls PureEasy Shower Filter

Santevia Water System Inc. recalls PureEasy Shower Filter

The housing can unexpectedly separate releasing the mineral contents into the eyes.

Health Canada

22-8-2018

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industr...

FDA - U.S. Food and Drug Administration

21-8-2018

Clean Republic recalls Hill Topper Electric Bike Motor Controllers

Clean Republic recalls Hill Topper Electric Bike Motor Controllers

Water can enter the controller and cause it to accelerate unexpectedly posing a crash and injury hazard to the rider.

Health Canada

18-8-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

FDA - U.S. Food and Drug Administration

23-11-2018

Orfadin (Swedish Orphan Biovitrum International AB)

Orfadin (Swedish Orphan Biovitrum International AB)

Orfadin (Active substance: Nitisinone) - PSUSA - Modification - Commission Decision (2018)7890 of Fri, 23 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2169/201802

Europe -DG Health and Food Safety

21-11-2018

Osurnia (Elanco GmbH)

Osurnia (Elanco GmbH)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7842 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/003753/T/0010

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

10-10-2018

As Hurricane #Michael nears land, take shelter & stay safe.

Follow weather updates on your phone or radio.

 In a tornado WARNING, go to an interior, windowless room.

 If water comes in, go to the highest floor that’s not flooded but do NOT enter a clos

As Hurricane #Michael nears land, take shelter & stay safe. Follow weather updates on your phone or radio. In a tornado WARNING, go to an interior, windowless room. If water comes in, go to the highest floor that’s not flooded but do NOT enter a clos

As Hurricane #Michael nears land, take shelter & stay safe. Follow weather updates on your phone or radio. In a tornado WARNING, go to an interior, windowless room. If water comes in, go to the highest floor that’s not flooded but do NOT enter a closed attic. pic.twitter.com/KD5WZ7gamP

FDA - U.S. Food and Drug Administration

2-10-2018

NexoBrid (MediWound Germany GmbH)

NexoBrid (MediWound Germany GmbH)

NexoBrid (Active substance: Concentrate of proteolytic enzymes enriched in bromelain) - PSUSA - Modification - Commission Decision (2018)6460 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10028/201712

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

19-9-2018

Fortacin (Recordati Ireland Ltd)

Fortacin (Recordati Ireland Ltd)

Fortacin (Active substance: lidocaine / prilocaine) - Centralised - Renewal - Commission Decision (2018)6103 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2693/R/23

Europe -DG Health and Food Safety

4-9-2018

Agenda:  Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda: Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda of CHMP written procedure*20-23 August 2018

Europe - EMA - European Medicines Agency

23-8-2018

 Minutes of the CAT meeting 23-25 May 2018

Minutes of the CAT meeting 23-25 May 2018

Europe - EMA - European Medicines Agency

23-8-2018

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Active substance: Human monoclonal IgG2 antibody against tissue factor pathway inhibitor) - Corrigendum - Commission Decision (2018)1246 of Thu, 23 Aug 2018

Europe -DG Health and Food Safety

23-8-2018

Public submissions on scheduling matters referred to the ACMS #23, ACCS #22 and Joint ACMS-ACCS #18 meetings held in March 2018

Public submissions on scheduling matters referred to the ACMS #23, ACCS #22 and Joint ACMS-ACCS #18 meetings held in March 2018

Public submissions on scheduling matters referred to ACMS/ACCS meetings held in March 2018

Therapeutic Goods Administration - Australia

21-8-2018

Always use contact lens solution, not water, to clean and store your lenses!  #OnePairTakeCare  https://go.usa.gov/xUs89 pic.twitter.com/Jm50z0UFVu

Always use contact lens solution, not water, to clean and store your lenses! #OnePairTakeCare https://go.usa.gov/xUs89 pic.twitter.com/Jm50z0UFVu

Always use contact lens solution, not water, to clean and store your lenses! #OnePairTakeCare https://go.usa.gov/xUs89  pic.twitter.com/Jm50z0UFVu

FDA - U.S. Food and Drug Administration