Accarb

Main information

  • Trade name:
  • Accarb 100 mg Tablet
  • Dosage:
  • 100 mg
  • Pharmaceutical form:
  • Tablet
  • Units in package:
  • Blister pack, Aluminium/Aluminium foil., 30 tablets
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Bayer AG

Documents

Localization

  • Available in:
  • Accarb 100 mg Tablet
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Indicated for the additional treatment of insulin dependent and non-insulin dependent diabetes mellitus in association with diet.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 13271
  • Authorization date:
  • 15-08-2007
  • Last update:
  • 27-09-2017

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

NEWZEALANDCONSUMER MEDICINEINFORMATION

ACCARB

AcarboseTablets50mg&100mg

Whatisinthisleaflet

Thisleafletanswerssomecommon

questionsaboutACCARB.

Itdoesnotcontainalltheavailable

information.Itdoesnottakethe

placeoftalkingtoyourdoctoror

pharmacist.

Allmedicineshaverisksand

benefits.Yourdoctorhasweighed

therisksofyoutakingACCARB

againstthebenefitstheyexpectit

willhaveforyou.

Ifyouhaveanyconcernsabout

takingthismedicine,askyour

doctororpharmacist.

Keepthisleafletwiththe

medicine.Youmayneedtoreadit

again.

WhatACCARBis

usedfor

ACCARBtabletscontaintheactive

ingredientacarbose.Theyareused

forthetreatmentofdiabetes(both

type1,insulin-dependentdiabetes

andtype2,non-insulin-dependent

diabetes)inassociationwithdiet.

ACCARBhelpstocontrolyour

bloodsugarlevelsinconjunction

withdiet,exercise,weightlossand

othermeasuresbyslowingdown

thedigestionofcarbohydrates

(complexsugars)fromyourdiet.

Thisreducestheabnormallyhigh

bloodsugarlevelsthatoccurafter

eachmeal.

Askyourdoctorifyouhaveany

questionsaboutwhythis

medicinehasbeenprescribedfor

you.

Yourdoctormayhaveprescribedit

foranotherreason.

ACCARBisnotknowntobe

Thismedicineisavailableonlywith

adoctor’sprescription.

Thereisnotenoughinformationto

recommendtheuseofthismedicine

forchildrenundertheageof18

years.

Beforeyoutake

ACCARB

Whenyoumustnottake

it

DonottakeACCARBifyouhave

anallergyto:

anymedicinecontaining

acarbose

anyoftheingredientslisted

attheendofthisleaflet.

Someofthesymptomsofan

allergicreactionmayinclude:

shortnessofbreath;wheezingor

difficultybreathing;swellingofthe

face,lips,tongueorotherpartsof

thebody;rash,itchingorhiveson

theskin.

Donottakethismedicineifyou

have:

severekidneyproblems

long-termboweldisorders

associatedwithdigestion

andabsorptionproblems

aconditionthatmaybe

worsenedbyincreasedgas

formationinthebowel

(suchasRoemheld’s

syndrome,majorhernias,

intestinalobstructionsor

intestinalulcers,ulcerative

colitisorCrohn’sdisease).

Donottakethismedicineafter

theexpirydateprintedonthe

packorifthepackagingistornor

showssignsoftampering.

Ifithasexpiredorisdamaged,

returnittoyourpharmacistfor

Ifyouarenotsurewhetheryou

shouldstarttakingthismedicine,

talktoyourdoctor.

Beforeyoustarttotake

it

Tellyourdoctorifyouhave

allergiestoanyothermedicines,

foods,preservativesordyes.

Tellyourdoctorifyouhaveor

havehadanyofthefollowing

medicalconditions:

kidneyproblems

liverproblems

bowel,digestionor

absorptionproblems.

Tellyourdoctorifyouare

pregnantorplantobecome

pregnantorarebreast-feeding.

Yourdoctorcandiscusswithyou

therisksandbenefitsinvolved.

Ifyouhavenottoldyourdoctor

aboutanyoftheabove,tell

him/herbeforeyoustarttaking

ACCARB.

Takingothermedicines

Tellyourdoctororpharmacistif

youaretakinganyother

medicines,includinganythatyou

getwithoutaprescriptionfrom

yourpharmacy,supermarketor

healthfoodshop.

SomemedicinesandACCARBmay

interferewitheachother.These

include:

digoxin,amedicinetotreat

chronicheartfailureor

irregularheartrhythms

oralneomycinantibiotic

cholestyramine,amedicine

usedtohelpreduce

cholesterol,relieveitching

duetobile,orrelievesome

causesofdiarrhoea

intestinaladsorbentssuch

ascharcoal

digestiveenzyme

preparationssuchas

ancrease™,Creon™.

Thesemedicinesmaybeaffected

byACCARBormayaffecthowwell

itworks.Youmayneeddifferent

amountsofyourmedicines,oryou

mayneedtotakedifferent

medicines.

Ifyouareusingothermedicines

fordiabetessuchasinsulin,

metforminorsulfonylureasandtend

tohavelowbloodsugarlevels,tell

yourdoctorbeforeusingACCARB.

Youshouldavoidtakingcane

sugar(sucrose)andproducts

containingsugar.

Theymaycausestomach

discomfortorevendiarrhoeaif

takenwhileyouareonACCARB

tablets.

Yourdoctorandpharmacisthave

moreinformationonmedicinesto

becarefulwithoravoidwhiletaking

thismedicine.

Howtotake

ACCARB

Followalldirectionsgiventoyou

byyourdoctororpharmacist

carefully.

Theymaydifferfromtheinformation

containedinthisleaflet.

Ifyoudonotunderstandthe

instructionsonthepack,ask

yourdoctororpharmacistfor

help.

Howmuchtotake

Togainthemaximumbenefitfrom

ACCARBitisimportantthatyou

followtheprescribeddietaswellas

takingtheexactdoseofACCARB

prescribedbyyourdoctor.Thiswill

helpcontrolyourbloodsugarlevels

andreduceside-effectsfrom

ACCARB.

WhenandHowtotakeit

Takethetabletsasprescribedby

yourdoctor.Thiswillnormallybe

oneortwotabletstakenwith

breakfast,lunchanddinner.

Whenyoufirststartyourtreatment,

youtakeyourtabletsonceortwice

aday,beforeincreasingyourdose

tothreetimesaday.

Chewthetabletswiththefirstfew

mouthfulsoffood.Ifyouprefernot

tochewthetabletsthenswallow

themwholewithalittleliquid

immediatelybeforethemeal.

Theaverageadultdoseisone

ACCARB100mgtablettakenwith

breakfast,lunchanddinner.

Takeyourmedicineataboutthe

sametimeseachday.

Takingitatthesametimeseach

daywillhavethebesteffect.Itwill

alsohelpyourememberwhento

takeit.

Howlongtotakeit

Continuetakingyourmedicine

foraslongasyourdoctortells

you.

Thismedicinehelpstocontrolyour

condition,butdoesnotcureit.Itis

importanttokeeptakingyour

medicineevenifyoufeelwell.

Ifyouforgettotakeit

IfyouforgettotakeACCARBat

thetimeyouaresupposedto,do

nottakethetabletsbetween

meals.Waituntilitistimeforyou

totakeyournextdoseandtake

ACCARBwithyourmealand

continueasbefore.

Donottakeadoubledoseto

makeupforthedosethatyou

missed.

Thismayincreasethechanceof

yougettinganunwantedsideeffect.

Ifyouarenotsurewhattodo,

askyourdoctororpharmacist.

Ifyouhavetroublerememberingto

takeyourmedicine,askyour

pharmacistforsomehints.

Ifyoutaketoomuch

(overdose)

Avoidfoodordrinkscontaining

carbohydratesandimmediately

telephoneyourdoctororthe

NationalPoisonsInformation

Centre(0800POISONor0800764

766)foradvice,orgotoAccident

andEmergencyatthenearest

anyoneelsemayhavetakentoo

muchACCARB.Dothisevenif

therearenosignsofdiscomfort

orpoisoning.Youmayneed

urgentmedicalattention.

WhenACCARBistakenwithdrinks

and/ormealscontaining

carbohydrates,overdosagecan

leadtodiarrhoeaandother

intestinalsymptomssuchas

flatulence(wind)andabdominal

cramps.

Whileyouaretaking

ACCARB

Thingsyoumustdo

Ifyouareabouttobestartedon

anynewmedicine,remindyour

doctorandpharmacistthatyou

aretakingACCARB.

Tellanyotherdoctors,dentists,

andpharmacistswhotreatyou

thatyouaretakingthismedicine.

Ifyouaregoingtohavesurgery,

tellthesurgeonoranaesthetist

thatyouaretakingthismedicine.

Itmayaffectothermedicinesused

duringsurgery.

Ifyoubecomepregnantwhile

takingthismedicine,tellyour

doctorimmediately.

Ifyouareabouttohaveany

bloodtests,tellyourdoctorthat

youaretakingthismedicine.

Itmayinterferewiththeresultsof

sometests.

Keepallofyourdoctor’s

appointmentssothatyour

progresscanbechecked.

Yourdoctormaydosometests

(suchasbloodteststocheckyour

bloodsugarlevelsandliver

function)fromtimetotimetomake

surethemedicineisworkingandto

preventunwantedsideeffects.

Thingsyoumustnotdo

DonottakeACCARBtotreatany

othercomplaintsunlessyour

doctortellsyouto.

Donotgiveyourmedicineto

anyoneelse,eveniftheyhave

thesameconditionasyou.

Donotstoptakingyourmedicine

orchangethedosagewithout

checkingwithyourdoctor.

Thingstobecarefulof

Treatinghypoglycaemia

(“hypos”orlowblood

sugar)

Youmayalsobereceivingother

medicinesforyourdiabetes.If

ACCARBisprescribedforyouin

additiontosulfonylureasor

metformintocontrolyourdiabetes,

yourdoctormayneedtoadjustthe

dosagesofyourmedicinestoavoid

theoccurrenceof“hypos”.

WhentakingACCARBtogetherwith

thesemedicines,donottreata

"hypo"withordinarysugar

(sucrose).Itwillnotworkfast

enough.Instead,youshouldtake

someGLUCOSE(alsoknownas

dextrose)orhoney.Glucoseis

availableintablets,syruporsweets,

whichshouldbeavailablefromyour

localpharmacy.

Becarefuldrivingoroperating

machineryuntilyouknowhow

ACCARBaffectsyou.

Whenusedwithsomeother

medicinesfordiabetes, “hypos”or

lowbloodsugarordizzinessmay

occurinsomepeople.Ifyouhave

anyofthesesymptoms,donot

drive,operatemachineryordo

anythingelsethatcouldbe

dangerous.

Sideeffects

Tellyourdoctororpharmacistas

soonaspossibleifyoudonot

feelwellwhileyouaretaking

ACCARB.

Thismedicinehelpsmostpeople

withdiabetes,butitmayhave

unwantedsideeffectsinsome

people.Allmedicinescanhaveside

effects.Sometimestheyare

serious,mostofthetimetheyare

not.Youmayneedmedical

attentionifyougetsomeoftheside

effects.

Donotbealarmedbythe

followinglistsofsideeffects.

Youmaynotexperienceanyof

Askyourdoctororpharmacistto

answeranyquestionsyoumay

have.

Tellyourdoctororpharmacistif

younoticeanyofthefollowing

sideeffectsandtheyworryyou:

increasedflatulence(wind)

abdominalpainor

discomfort

diarrhoea.

Theabovelistincludessomeofthe

morecommonsideeffectsofyour

medicine.Oftenthesesymptoms

willdisappearifyoucontinue

treatmentandkeeptoyour

prescribeddiet.Ifyoueatordrink

productscontainingcanesugar

(sucrose),thesesideeffectscould

getworse.

Tellyourdoctororpharmacistif

younoticeanyofthefollowing

sideeffectsandtheyworryyou:

nausea

vomiting

indigestion.

Theabovelistincludessomeofthe

lesscommonsideeffects.

Ifyouareconcerned,oranyof

yoursymptomsaresevere,talk

toyourdoctorassoonas

possible.

WhenACCARBistakentogether

withothermedicinesfordiabetes,

suchassulfonylureasormetformin,

hypoglycemia(“hypos”orlowblood

sugarlevels)canoccur.Symptoms

ofhypoglycemiamayinclude

sweating,weakness,hunger,

dizziness,trembling,headache,

flushingorpaleness,numbness,a

fast,poundingheartbeat.Letyour

doctorknowifyounoticeanyofthe

above,asyourdoctormayneedto

adjustthedosagesofyour

medicines.

Ifanyofthefollowinghappen,

tellyourdoctorimmediatelyor

gotoAccidentandEmergencyat

yournearesthospital:

jaundice(yellowingofthe

skinoreyes)

severestomachor

abdominalpain

swellingoftheface,lips,

tongueorotherpartsofthe

body

shortnessofbreath,

wheezingortroubled

breathing.

Theabovelistincludesveryserious

sideeffects.Youmayneedurgent

medicalattentionorhospitalisation.

Tellyourdoctororpharmacistif

younoticeanythingthatis

makingyoufeelunwell.

Othersideeffectsnotlistedabove

mayoccurinsomepeople.

Somesideeffectsforexample,

changesinnumbersofbloodcells,

inflammationoftheliver(hepatitis),

changesinliverenzymelevels,can

onlybefoundwhenyourdoctor

doestestsfromtimetotimeto

checkyourprogress.

AfterusingACCARB

Storage

Keepyourtabletsinthepack

untilitistimetotakethem.

Ifyoutakethetabletsoutofthe

packtheymaynotkeepwell.

Keepyourtabletsinacooldry

placewherethetemperaturestays

below25°C.

DonotstoreACCARBoranyother

medicineinthebathroomorneara

sink.Donotleaveitonawindowsill

orinthecar.

Heatanddampnesscandestroy

somemedicines.

Keepitwherechildrencannot

reachit.

Alockedcupboardatleastone-and-

ahalfmetresabovethegroundisa

goodplacetostoremedicines.

Disposal

Ifyourdoctortellsyoutostop

takingthismedicineortheexpiry

datehaspassed,askyour

pharmacistwhattodowithany

medicinethatisleftover.

Productdescription

Whatitlookslike

ACCARBtabletsareavailableina

blisterpackof90tabletsintwo

strengths.

ACCARB50mgTablets:White

roundtablet,debossedwith'AA'

breakline'50'ononesideand'G'on

thereverse,approximately7mmin

diameter.

ACCARB100mgTablets:White

roundtablet,debossedwith'AA'

breakline'100'ononesideand'G'

onthereverse,approximately9mm

indiameter.

Ingredients

ACCARB50contains50mgof

acarboseastheactiveingredient.

ACCARB100contains100mgof

acarboseastheactiveingredient.

ACCARBtabletsalsocontain:

MicrocrystallineCellulose

(PH102)

DriedMaizeStarch

ColloidalAnhydrousSilica

MagnesiumStearate.

Thismedicinedoesnotcontain

lactose,sucrose,gluten,tartrazine

oranyazodyes.

Ifyouwanttoknow

more

Shouldyouhaveanyquestions

regardingthisproduct,please

contactyourpharmacistordoctor.

Whosuppliesthis

medicine

DistributedinNewZealandby:

MylanNewZealandLtd,

POBox11183,

Ellerslie,

Auckland.

Telephone:(09)5792792

DateofInformation

1August2012

(Basedondatasheetdated

25July2012)

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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

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

14-8-2018

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful...

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

22-6-2018

Metronidazole intravenous infusion 500 mg/100 mL bag

Metronidazole intravenous infusion 500 mg/100 mL bag

Shortage and althernative supply of Metronidazole intravenous infusion 500 mg/100 mL bag

Therapeutic Goods Administration - Australia

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

12-6-2018

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Teer, nicotine en koolmonoxide gehalten in sigaretten die gemeten worden volgens de Canadian Intense (CI) methode zijn minimaal twee keer zo hoog als de gehalten gemeten met de wettelijke voorgeschreven ISO methode waarmee de EU en dus ook Nederland werkt. In sommige gevallen liggen de gehaltes zelfs tot meer dan 20 keer hoger. Dat blijkt uit onderzoek van het RIVM, dat 100 sigaretten onder de loep nam. Staatssecretaris Paul Blokhuis (VWS) heeft als opdrachtgever het onderzoek vandaag in ontvangst genome...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

3-5-2018

CVM eSubmitter Webinar 1 Agenda

CVM eSubmitter Webinar 1 Agenda

CVM will host the first of a three-part webinar series to provide information on the use of CVM’s electronic submission tool, eSubmitter, in the new animal drug application approval process. These webinars will support the use of eSubmitter as we move to 100% electronic submission.

FDA - U.S. Food and Drug Administration

28-2-2018

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim Capsules pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

8-9-2017

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector. The Agency is looking for a candidate who is willing and able to work on demanding and interesting tasks, including travels in Iceland and abroad on behalf of the Agency. The vacancy is a full post (100%).

IMA - Icelandic Medicines Agency

3-7-2017

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Agency advertises two vacancies for experts in its Quality Assessment Team. The Agency is looking for strong candidates who are willing to work on challenging and interesting tasks. Each vacancy is a full position (100%). Application deadline is up to and including 16 July 2017.

IMA - Icelandic Medicines Agency

12-12-2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

TGO 100 has been registered on the Federal Register of Legislation. It commences on 8 December 2018, repealing and replacing TGO 98

Therapeutic Goods Administration - Australia

7-12-2018


Acarbose: List of nationally authorised medicinal products - PSUSA/0000017/201803

Acarbose: List of nationally authorised medicinal products - PSUSA/0000017/201803

Acarbose: List of nationally authorised medicinal products - PSUSA/0000017/201803

Europe - EMA - European Medicines Agency

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Active substance: Propagermanium) - Orphan designation - Commission Decision (2018)7810 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/103/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: 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) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

19-9-2018

Kadcyla (Roche Registration GmbH)

Kadcyla (Roche Registration GmbH)

Kadcyla (Active substance: Trastuzumab emtansine) - Centralised - Renewal - Commission Decision (2018)6100 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2389/R/39

Europe -DG Health and Food Safety

23-8-2018

 Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Europe - EMA - European Medicines Agency

27-6-2018

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Active substance: pantoprazole) - PSUSA - Modification - Commission Decision (2018)4105 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1100/PSUSA/2285/201708

Europe -DG Health and Food Safety

6-6-2018

Agenda:  Agenda for the 100th meeting of the Management Board

Agenda: Agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

5-6-2018

Agenda:  Draft agenda for the 100th meeting of the Management Board

Agenda: Draft agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

24-5-2018

Tybost (Gilead Sciences International Limited)

Tybost (Gilead Sciences International Limited)

Tybost (Active substance: cobicistat) - PSUSA - Modification - Commission Decision (2018)3255 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10081/201708

Europe -DG Health and Food Safety

24-5-2018

Stribild (Gilead Sciences International Limited)

Stribild (Gilead Sciences International Limited)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - PSUSA - Modification - Commission Decision (2018)3277 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/PSUSA/10082/201708

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Active substance: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid) - Transfer of orphan designation - Commission Decision (2018)3149 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/14/T/01

Europe -DG Health and Food Safety