Allersoothe

Main information

  • Trade name:
  • Allersoothe 10 mg Film coated tablet
  • Dosage:
  • 10 mg
  • Pharmaceutical form:
  • Film coated tablet
  • Units in package:
  • Blister pack, Al-Amber PVC/PVDC blister in a cardboard carton, 20 tablets
  • Class:
  • Restricted
  • Prescription type:
  • Restricted
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Harika Drugs Pvt Ltd

Documents

Localization

  • Available in:
  • Allersoothe 10 mg Film coated tablet
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • 1. Treatment of allergic conditions including some allergic reactions to drugs, urticaria and allergic contact dermatitis, and allergic reactions to insect bites and stings 2. Relief of excessive secretion in the upper respiratory tract as a result of hayfever and allergic rhinitis 3. Anti-emetic for vomiting from various causes including post-operative vomiting, irradiation sickness, drug induced nausea and motion sickness 4. Sedation - for short term use under the advice of a doctor or pharmacist, Do not use for more than 7-10 consecutive days 5. Promethazine has sedative effects and can be used in the symptomatic management of measles and chickenpox. 6. Promethazine can be used as a pre-anaesthetic medication for the prevention and control of post-operative vomiting.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 12120
  • Authorization date:
  • 15-06-2005
  • Last update:
  • 27-09-2017

Summary of Product characteristics: dosage,interactions,side effects

Data Sheet

Allersoothe

Promethazinehydrochloride10mg and25mg tablets

Promethazinehydrochloride5mg/5mLElixir

Presentation

Allersoothe 10mg tabletsarelightblue,round,biconvex,film-coatedtablets.Theycontain

10 mg promethazine hydrochloride.

Allersoothe 25mg tabletsarelightblue,round,biconvex,film-coatedtablets.Theycontain

25 mg promethazine hydrochloride.

Allersoothe Elixirisa clear,orange,syrupyliquidwithbanana andvanillaflavour.Each 5mL

ofthe elixircontains5mg ofpromethazine hydrochloride.

Uses

Actions

Promethazine,a phenothiazine derivative,isa long actingantihistaminewith mild atropine-

like anticholinergiceffectsand someanti-serotonin effects.Because ofitsmarkedeffecton

the centralnervoussystem(CNS),itactsasananti-emetic,hypnotic,tranquiliseranda

potentiatorofanaesthetics,hypnotics,sedativesand analgesics.The antihistamine action

hasbeenreportedto lastforbetween 4 and 12hours.

Pharmacokinetics

Promethazine iswellabsorbed afteroraldosingwith peakplasmaconcentrationsbeing

reached 2-3 hoursafteradministration.Duetohighfirstpassmetabolismin the liverthere is

lowsystemicbioavailabilityafteroraladministration.Itiswidelydistributed in thebody,

enteringthe brain andcrossing theplacenta.Itishighlybound toplasmaproteins(76-93%).

Promethazine undergoesextensive metabolismand isslowlyexcreted via urine andbile,

mainlyasmetabolites.Elimination half-livesof5-14 hourshave beenreported.

Phenothiazinespassintobreastmilkatlowconcentrations.

Indications

1.Treatmentofallergicconditionsincludingsomeallergicreactionsto drugs,urticaria and

allergiccontactdermatitis,andallergicreactionsto insectbitesand stings

2.Reliefofexcessivesecretion in theupperrespiratorytractasaresultofhayfeverand

allergicrhinitis

3.Anti-emeticforvomitingfromvariouscausesincludingpost-operative vomiting,irradiation

sickness,drug induced nausea andmotion sickness

4.Sedation-forshorttermuse undertheadvice ofa doctororpharmacist,Do notusefor

morethan7-10consecutive days

5.Promethazine hassedative effectsandcanbe usedin thesymptomaticmanagementof

measlesandchickenpox.

6.Promethazine can be used asapre-anaestheticmedicationfortheprevention and

controlofpost-operative vomiting.

DosageandAdministration

Allersoothe should notbe used inchildren lessthan two yearsofage.

Thedosage variesaccordingtothecondition being treatedandthe patient'sresponse.

Allergic disorders

Children 2-5 yearsofage:5-15 mg(5-15 mL)asasingle doseatnightor5mg(5 mL)2-3

timesdaily.

Children 6-12 yearsofage:10-25 mg(10-25mL)asasingle doseatnightor10mg(10mL)

2-3 timesdaily

Children over12 yearsand adults: 25-75mgasasingledose atnightor10-20 mg2-3 times

daily.

Sedation

Give asa single dose atnight.

Children 2-5 years:5-15 mg(5-15 mL)

Children 6-12 yearsofage:10-25 mg(10-25mL)

Children over12 yearsand adults:25-75 mg

Travelsickness

Tobetakenthe nightbeforetraveland repeatedafter6-8 hoursonthefollowingdayif

required.

Children 2-5 yearsofage:5mg (5mL)

Children 6-12 yearsofage:10mg (10mL)

Children over12 yearsand adults:25mg

Nausea andvomiting

Children 2-5 yearsofage:5 mg(5 mL)very4-6hoursto amaximumdailydose of15mg(15

mL).

Children 6-12 yearsofage:10mg (10mL)every4-6hourstoamaximumdailydose of20

mg(20mL)

Children over12 yearsand adults:25mg every4-6 hoursto amaximumdailydose of100

mg.

Contraindications

Patientswith hypersensitivityto promethazine,substanceswith a similarchemical

structureortoanyoftheexcipients.

Patientswho areallergictosodiumbenzoate.

Newborn and prematureinfants

Children under2yearsofage

Womenwho are breastfeeding

Patientswho have received highdosesofotherCNSdepressantsand/orare

comatose

Allersoothe should notbegiven forjaundiceinduced byotherphenothiazine

derivatives..

Allersoothe should beavoided in patientswho have been takingmonoamine oxidase

inhibitorswithin the previous14 days.

WarningsandPrecautions

Caution isadvised in patientswith:

Cardiovasculardisease

Impairedhepaticfunction

Impairedrenalfunction orrenalfailure

Acute orchronicrespiratoryimpairment

Epilepsy-epilepticpatientsmayexperience increased severityofconvulsions

Hypertensive crisis

Narrow-angle glaucoma

Stenosing pepticulcer

Symptomaticprostatichypertrophy

Bladderneckobstruction

Pyloroduodenalobstruction

Promethazine maycause drowsinessandmayincreasethe effectsofalcohol.Drowsiness

maycontinuethefollowing day.Thoseaffectedshould notdrive oroperate machinery.

Alcoholshould be avoided.

Solardermatitishasbeen reportedfollowingoraldosesofpromethazine in patientswith

eczema oratendencytorheumatism.

QTintervalprolongationhasbeenreported with phenothiazines.

Useduring Pregnancyand Lactation

CategoryC

Promethazine hascaused ormaybesuspected ofcausing,harmfuleffectsonthe human

foetusorneonatewithoutcausing malformations.Theseeffectsmaybereversible.When

promethazine hasbeengiven in highdosesduring late pregnancy,ithascaused prolonged

neurologicaldisturbancesin theinfant.Promethazine should onlybe used duringpregnancy

ifthepotentialbenefitstothepatientouweigh thepotentialriskstothefoetus.

Available evidence suggeststhatthe amountexcretedin breastmilkisverylow.However,

therearerisksofneonatalirritabilityand excitement.Itshouldnotbe used unlessthe

physician considersitessential.

Children

Children mayexperience paradoxicalexcitation.

Use ofpromethazine in children and adolescentswith signandsymptomssuggestive of

Reye'ssyndrome should be avoided.

Promethazine should notbe usedin childrenunder2yearsofagedie tothe potentialfor

fatalrespiratorydepression.

Caution should beexercised when administeringpromethazine to childrenduetothe

potentialforcentralandobstructive apnoea andreduced arousal.Excessive dosagesmay

resultinhalluconations,convulsionsand suddendeath.

Elderlypatients

Theelderlymayexperience paradoxicalexcitation.

Theelderlyaremorelikelyto have CNSdepressive side effectsincludingconfusion andare

moresusceptible totheanti-muscariniceffectsof anti-histaminesincluding hypotension.

Effects onability todriveandusemachines

PatientsreceivingAllersootheforthefirsttimeshould notbeincontrolofvehiclesor

machineryforthefirstfewdaysuntilitisestablished thattheyare notreacting tothe central

nervouseffectsofthemedicine and do notsufferfromdisorientation,confusion ordizziness.

AdverseEffects

CNSEffects

CNSdepressive effectsofpromethazine include sedation andimpaired performance

(impaired driving,poorworkperformance,incoordination,reducedmotorskillsand impaired

information processing).Performancemaybeimpaired in theabsenceofsedation andmay

persistthemorning aftera night-timedose.

Thestimulatoryeffectsofpromethazine mayincludeanxiety,hallucinations,appetite

stimulation,muscle dyskenesiasand activation ofepileptogenicfoci.

Highdosesofpromethazine maycause nervousness,tremor,insomnia,agitation and

irritability.

Anti-cholinergicEffects

Side effectsofpromethazine associated with cholinergicblockade includedrynessofthe

eyes,nose andmouth,blurred vision,urinaryhesitancyand retention,constipation and

tachycardia.

Common Reactions

Gastrointestinal:Drymouth,epigastricdistress,lossofappetite,nausea,vomiting,

constipation,diarrhoea

Nervous system:Sedation,restlessness,dizziness,lassitude,incoordination,fatigue

Ocular:Blurred vision

LessCommon Reactions

Cardiovascular:Tachcardia,bradycardia,faintness

Dermatological:Contactdermatitis(topical),photosensitisation,urticaria,angioneurotic

oedema,pruritus

Haematological:Leucopenia,agranulocytosis,aplasticanemia,thrombocytopenicpurpura

Hepatic:Jaundice

Musculoskeletal:Extrapyramidalsymptoms

Nervous system:Tinnitus,euphoria,nervousness,insomnia,convulsive seizures,oculogyric

crises,excitation,catatonic-like states,hysteria,extrapyramidalsymptoms,tardive

dyskenesia

Respiratory:Marked irregularrespiration

Severe orLife-threateningReactions

Agranulocytosis,anaphylaxis.

Allersoothe Elixercontainssodiumbenzoate which hasbeenreportedtocause

hypersensitivityreactions.

Interactions

Promethazine maycause drowsinessandmayenhance thesedative effectsofCNS

depressantse.g.alcohol,barbiturates,hypnotics,opiod analgesics,anxiolyticsedativesand

neurolepticsandhave additive anti-muscarinicactionswith otheranti-muscarinicdrugse.g.

atropine andtricyclicantidepressants.Interactionsbetween promethazine andmonoamine

oxidase inhibitors(MAOI)andtricyclicantidepressantsmayprolongand intensifytheanti-

cholinergicandCNSdepressive effects.

Overdosage

Themainsignofacute poisonongfromoverdosageisunconsciousnesswhich iscommonly

delayed.Convulsions,hallucinations,delirium,acuteanxiety,psychoticreactions,extreme

hyperaesthesia and hyperalgesiawith extensorplantarresponsesmayalso occur.Anti-

cholinergicactionsmaycause tachycardia,flushed skin,drymouthand sometimesmydriasis

and urinaryretention.

In adultsCNSismorecommonwith drowsiness,coma,convulsions,progressing to

respiratoryfailureorcardiovascularcollapse.

In infantsand children,CNSstimulationpredominatesoverCNSdepression causingataxia,

excitement,tremors,psychoses,hallucinations,convulsionsand possible hyperpyrexiawhich

maybefollowed bydeepeningcomaand cardiorespiratorycollapse.

Aswith otherphenothiazinessymptomatic,supportive therapyisindicated.Maintenance of

adequate ventilation should be instituted ifnecessary.

PharmaceuticalPrecautions

Store below30°C.Protectfromlight.

Medicines Classification

PharmacistOnlyMedicine

Package Quantities

10 mg tablets:OTCblisterpacksof20and 50tablets,dispensing blisterpackof50tablets

25 mg tablets:OTCblisterpacksof20and 50tablets,dispensing blisterpackof50tablets

Elixir:Bottlesof100mL

FurtherInformation

AllersootheTabletscontain lactose andcolour.

Allersoothe Elixircontainssodiumbenzoate asapreservative.Italsocontainscolourand

flavours.

NameandAddress

AFTPharmaceuticalsLtd

POBox33-0232

Takapuna

Auckland

Tel:(09)4880232

Email:customer.service@aftpharm.com

Date ofPreparation

25 March 2013

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11-1-2019


Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment

Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment

Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment of maple syrup urine disease, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

4-1-2019


Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Recommendations on eligibility to PRIME scheme -  Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Europe - EMA - European Medicines Agency

14-12-2018


Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Europe - EMA - European Medicines Agency

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

13-12-2018


Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

11-12-2018


Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Europe - EMA - European Medicines Agency

10-12-2018

Exondys (AVI BioPharma International Ltd)

Exondys (AVI BioPharma International Ltd)

Exondys (Active substance: eteplirsen) - Centralised - Refusal of marketing authorisation - Commission Decision (2018)8620 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4355

Europe -DG Health and Food Safety

10-12-2018

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (Active substance: ivabradine) - Centralised - Withdrawal - Commission Decision (2018)8623 of Mon, 10 Dec 2018

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (Active substance: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate) - Transfer of orphan designation - Commission Decision (2018)8626 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/011/16/T/01

Europe -DG Health and Food Safety

10-12-2018

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (Active substance: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein) - Transfer of orphan designation - Commission Decision (2018)8634 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002509

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)8630 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002507

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (Active substance: Recombinant adeno-associated viral vector serotype 9 carrying the gene for the human E6-AP ubiquitin protein ligase) - Transfer of orphan designation - Commission Decision (2018)8632 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002508

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1802 (FGK Representative Service GmbH)

EU/3/16/1802 (FGK Representative Service GmbH)

EU/3/16/1802 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)8627 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002422

Europe -DG Health and Food Safety

10-12-2018

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (Active substance: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt) - Transfer of orphan designation - Commission Decision (2018)8636 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002385

Europe -DG Health and Food Safety

10-12-2018

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (Active substance: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1?3)-beta-D-galactopyranoside) - Transfer of orphan designation - Commission Decision (2018)8628 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/17/T/01

Europe -DG Health and Food Safety

10-12-2018

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Active substance: Mercaptopurine (oral suspension)) - Transfer of orphan designation - Commission Decision (2018)8629 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002301

Europe -DG Health and Food Safety

10-12-2018

EU/3/11/933 (Les Laboratoires Servier)

EU/3/11/933 (Les Laboratoires Servier)

EU/3/11/933 (Active substance: Nanoliposomal irinotecan) - Transfer of orphan designation - Commission Decision (2018)8625 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/11/T/02

Europe -DG Health and Food Safety

7-12-2018


Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Europe - EMA - European Medicines Agency

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-guanidino-1-hexanone hexahydrochloride, decision type: , therapeutic area: , PIP number: P/0134/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Europe - EMA - European Medicines Agency

26-11-2018

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware of those technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

22-11-2018

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Active substance: emtricitabine / tenofovir disoproxil) - Centralised - 2-Monthly update - Commission Decision (2018)7884 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4215/IB/10G

Europe -DG Health and Food Safety

22-11-2018


Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety