Azzalure

Primær information

  • Handelsnavn:
  • Azzalure pulver til injektionsvæske, opløsning
  • Lægemiddelform:
  • pulver til injektionsvæske, opløsning
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Azzalure pulver til injektionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 60092
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

Azzalure

er et registreret varemærke, der tilhører Nestlé Skin Health S.A.

Læs denne indlægsseddel grundigt, inden du begynder at bruge

dette lægemiddel, da den indeholder vigtige oplysninger.

Gem indlægssedlen. Du kan få brug for at læse den igen.

Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der

er mere, du vil vide.

Lægen har ordineret dette lægemiddel til dig personligt. Lad derfor

være med at give medicinen til andre. Det kan være skadeligt for

andre, selvom de har de samme symptomer, som du har.

Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis

du får bivirkninger, herunder bivirkninger, som ikke er nævnt her. Se

punkt 4.

Se den nyeste indlægsseddel på www.indlaegsseddel.dk.

Oversigt over indlægssedlen:

1. Virkning og anvendelse

2. Det skal du vide, før du bliver behandlet med Azzalure

3. Sådan bliver du behandlet med Azzalure

4. Bivirkninger

5. Opbevaring

6. Pakningsstørrelser og yderligere oplysninger

1. Virkning og anvendelse

Azzalure indeholder et stof, der hedder botulinumtoksin A, som får

musklerne til at slappe af. Azzalure virker ved forbindelsesstedet mellem

nerverne og musklerne ved, at det forhindrer, at et kemisk stof, der

kaldes acetylkolin, frigives fra nerveenderne. Dette forhindrer musklerne

i at trække sig sammen. Muskelafslapningen er midlertidig og forsvinder

gradvis.

Nogle mennesker bliver meget kede af det, når de får rynker i ansigtet.

Azzalure kan anvendes af voksne under 65 år til midlertidig forbedring

af moderate til svære lodrette rynker mellem øjenbrynene, der ses ved

panderynken og rynker ved den ydre øjenkrog, smilerynker, kaldet

kragetæer.

2. Det skal du vide før du bliver behandlet med Azzalure

Lægen kan have foreskrevet anden anvendelse eller dosering end angivet

i denne information. Følg altid lægens anvisning og oplysningerne på

doseringsetiketten.

Du må ikke få en Azzalure-injektion:

hvis du er allergisk over for Clostridium botulinum-toksin A eller et af

de øvrige indholdsstoffer (angivet i punkt 6).

hvis du har en infektion ved det foreslåede injektionssted.

hvis du har myasthenia gravis (en autoimmun neuromuskulær

sygdom, der forårsager varierende muskelsvaghed, specielt i ansigt,

nakke, arme og ben), Eaton-Lambert syndrom (et autoimmunt

syndrom, hvor der er en fejlkommunikation mellem nerver og

muskler. Forårsager svækkelse af hofte-og lårmuskler) eller

amyotrofisk lateral sklerose (en neurodegenerativ sygdom, der

forårsager tab af frivillig handling af muskler gennem hele kroppen).

Advarsler og forsigtighedsregler

Tal med lægen, inden du får en Azzalure-injektion:

hvis du har en neuromuskulær lidelse

hvis du ofte har svært ved at synke maden (dysfagi)

hvis du mener, at du ofte har problemer med, at mad eller drikke

kommer i den ”gale hals” (i luftrøret), hvilket får dig til at hoste eller

være ved at kvæles

hvis du har betændelse ved det foreslåede injektionssted

hvis musklerne ved det foreslåede injektionssted er svage

hvis du lider af en blødersygdom, som får dig til at bløde længere

end normalt, som for eksempel hæmofili (arvelig blødningslidelse

forårsaget af manglende koagulationsfaktor)

hvis du er blevet opereret i ansigtet, eller hvis der er sandsynlighed

for, at du inden længe skal have foretaget en ansigtsoperation eller

en anden operation

hvis du allerede har fået andre botulinumtoksin-injektioner

hvis du ikke oplevede nogen betydelig forbedring af dine rynker efter

din sidste behandling med botulinumtoksin

Disse oplysninger vil hjælpe din læge med at træffe en beslutning på

informeret grundlag vedrørende risici og fordele ved din behandling.

Særlige advarsler:

Meget sjældent kan virkningen af botulinumtoksin resultere i

muskelsvaghed andre steder end ved injektionsstedet.

Når botulinumtoksiner anvendes hyppigere end med 12 ugers mellemrum

eller ved højere doser til behandling af andre tilstande, er der i sjældne

tilfælde observeret dannelse af antistoffer. Dannelse af neutraliserende

antistoffer kan nedsætte virkningen af behandlingen.

Hvis du af en hvilken som helst grund skal tale med en læge, skal du

sørge for at fortælle lægen, at du har fået behandling med Azzalure.

Børn og unge

Azzalure er ikke beregnet til patienter under 18 år.

Brug af anden medicin sammen med Azzalure

Fortæl det altid til lægen, hvis du bruger anden medicin eller har brugt

det for nylig. Dette gælder også medicin, som ikke er købt på recept.

Azzalure kan have indflydelse på virkningen af andre lægemidler, som du

tager, eller som du har taget for nylig. Dette gælder især antibiotika for

en infektion (f.eks. aminoglykosider som for eksempel gentamicin eller

amikacin) eller andre muskelafslappende midler.

Brug af Azzalure sammen med mad og drikke

Du kan få Azzalure-injektioner enten før eller efter, at du har spist eller

drukket.

Graviditet og amning

Du bør ikke få Azzalure under graviditet. Behandling med Azzalure

frarådes, hvis du ammer. Hvis du er gravid eller ammer, har mistanke om,

at du er gravid, eller planlægger at blive gravid, skal du spørge din læge

eller apotekspersonalet til råds, før du tager dette lægemiddel.

Trafik- og arbejdssikkerhed

Du kan få midlertidigt sløret syn eller muskelsvaghed efter behandling

med Azzalure. Hvis du føler dig påvirket af behandlingen, må du ikke køre

bil eller arbejde med værktøj eller maskiner.

3. Sådan bliver du behandlet med Azzalure

Azzalure bør kun gives af en læge med passende kvalifikationer og

erfaring i denne behandling, og lægen skal råde over det nødvendige

udstyr.

Din læge vil klargøre og indgive injektionerne. Der vil blive anvendt ét

hætteglas med Azzalure, som kun bruges til dig og kun til én behandling.

Den anbefalede dosis er:

Lodrette rynker mellem øjenbrynene: 50 enheder, der indsprøjtes

som 10 enheder ved hvert af de 5 injektionssteder i din pande i

området over din næse og øjenbryn.

Rynker ved øjenkrogen, kragetæer: 60 enheder, der indsprøjtes som

10 enheder på hvert af de 6 injektionssteder i begge sider i området

med kragetæer.

De enheder, der anvendes til forskellige botulinumtoksin-produkter,

er forskellige. Azzalure Speywood-enhederne kan ikke erstattes med

enheder fra andre botulinumtoksin-produkter. Virkningen af behandlingen

bør kunne ses indenfor få dage.

Intervallet mellem behandlingerne med Azzalure vil blive bestemt af din

læge. Du bør ikke få behandling oftere end hver 12. uge.

Hvis du har fået for meget Azzalure

Hvis du har fået mere Azzalure, end du behøver, kan det ske, at muskler,

der ikke er blevet injiceret, begynder at føles svage. Dette vil måske ikke

ske lige med det samme. Hvis dette sker, skal du omgående kontakte din

læge eller sundhedspersonalet.

4. Bivirkninger

Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke

alle får bivirkninger.

Søg straks lægehjælp:

hvis du har svært ved at trække vejret, synke eller tale

hvis dit ansigt hæver, eller hvis huden bliver rød, eller hvis du får

et kløende, ujævnt udslæt. Dette kan betyde, at du har fået en

overfølsomhedsreaktion over for Azzalure

Fortæl det til din læge, hvis du bemærker en eller flere af følgende

bivirkninger:

Lodrette rynker mellem øjenbrynene

Meget almindelig (påvirker flere end 1 bruger ud af 10)

Rødmen, hævelse, irritation, udslæt, kløe, prikkende eller

snurrende fornemmelse, smerte, ubehag, svie eller blå mærker ved

injektionsstedet

Hovedpine

Almindelig (påvirker 1 til 10 brugere ud af 100)

Trætte øjne eller svagt syn, hængende øvre øjenlåg, hævede øjenlåg,

rindende øjne, tørre øjne, muskeltrækninger rundt om øjet

Forbigående lammelse i ansigtet

INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN

Azzalure

10 Speywood-enheder/0,05 ml, pulver til injektionsvæske, opløsning

(botulinum-toksin type A)

L91162A-1.0

Ikke almindelig (påvirker 1 til 10 brugere ud af 1.000)

Ændret eller sløret syn, dobbeltsyn

Svimmelhed

Kløe, udslæt

Allergiske reaktioner, se ovenfor

Forstyrrelse af øjenbevægelsen

Sjælden (påvirker 1 til 10 brugere ud af 10.000)

Kløende og ujævnt udslæt

Rynker ved den ydre øjenkrog, kragetæer

Almindelig (påvirker 1 til 10 brugere ud af 100)

Hovedpine

Hævede øjenlåg

Blå mærker, kløe og hævelse rundt om øjet

Hængende, øverste øjenlåg

Forbigående lammelse i ansigtet

Normalt optrådte disse bivirkninger inden for den første uge efter

injektionerne, og de varede ikke længe. Normalt var de milde til

moderate.

Meget sjældent er der rapporteret bivirkninger i andre muskler end den

hvor injektionen med botulinumtoksinet blev givet. Disse omfatter udtalt

muskelsvaghed og synkebesvær, på grund af hoste og kvælning (hvis

mad eller væske kommer i den gale hals, når du forsøger at sluge; også

åndedrætsbesvær kan forekomme f.eks. lungebetændelse). Hvis disse

problemer opstår, skal du straks kontakte din læge.

Indberetning af bivirkninger

Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske

eller apoteket. Dette gælder også mulige bivirkninger, som ikke er

medtaget i denne indlægsseddel. Du eller dine pårørende kan også

indberette bivirkninger direkte til Lægemiddelstyrelsen på www.

meldenbivirkning.dk, ved at kontakte Lægemiddelstyrelsen via dkma@

dkma.dk eller med almindeligt brev til Lægemiddelstyrelsen, Axel Heides

Gade 1, 2300 København S.

Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere

information om sikkerheden af dette lægemiddel.

5. Opbevaring

Opbevar Azzalure utilgængeligt for børn

Brug ikke Azzalure efter den udløbsdato, der står på pakningen efter

EXP. Udløbsdatoen er den sidste dag i den nævnte måned

Opbevares i køleskab (2 °C – 8 °C)

Må ikke nedfryses

Din læge vil opløse Azzalure i en flydende injektionsvæske.

Kemisk og fysisk stabilitet under brug er påvist i 24 timer ved

temperaturer mellem 2 °C og 8 °C. Fra et mikrobiologisk synspunkt bør

produktet anvendes omgående, medmindre rekonstitueringsmetoden

udelukker mikrobiel kontaminering. Hvis produktet ikke anvendes straks,

er brugeren ansvarlig for opbevaringstid og -forhold under anvendelsen.

6. Pakningsstørrelser og yderligere oplysninger

Azzalure indeholder

Aktivt stof: Botulinumtoksin type A*, 10 Speywood-enheder/0,05 ml

Ét hætteglas indeholder 125 Speywood-enheder

Øvrige indholdsstoffer: Humant albumin 200 g/l og

laktosemonohydrat

* Clostridium botulinum (en bakterie) toksin A hæmagglutin-kompleks.

Speywood-enhederne i Azzalure gælder specielt til dette præparat og kan

ikke erstattes med enheder fra andre lægemidler med botulinumtoksin.

Udseende og pakningsstørrelser

Azzalure er et pulver til injektionsvæske, opløsning. Det leveres i

pakningsstørrelse på 1 eller 2 hætteglas.

Azzalure er et hvidt pulver.

Indehaveren af markedsføringstilladelsen:

Abacus Medicine A/S

Vesterbrogade 149

1620 København V

Tel: +45 70 22 02 12

e-mail: kundeservice@abacusmedicine.com

Frigivet af

Abacus Medicine B.V.

Herculesstraat 25

1812 PD Alkmaar

Holland

Tel +31 6 50 57 41 87

e-mail: kundeservice@abacusmedicine.com

Denne indlægsseddel blev senest revideret 11/2017

Følgende oplysninger er tiltænkt læger og sundhedspersonale:

Dosering og indgivelsesmåde

Se venligst afsnit 3 i indlægssedlen.

Regler for destruktion og anden håndtering:

Anvisningerne vedrørende brug, håndtering og bortskaffelse skal følges

nøje.

Rekonstitution bør foretages i overensstemmelse med reglerne for god

klinisk praksis. Dette gælder i særdeleshed med hensyn til asepsis.

Azzalure skal rekonstitueres med en 0,63 ml natriumchlorid 9 mg/ml (0,9

%) injektionsvæske, opløsning.

I overensstemmelse med fortyndingstabellen nedenfor skal den

påkrævede mængde natriumchlorid 9 mg/ml (0,9 %) injektionsvæske,

opløsning, trækkes op i en injektionssprøjte for at opnå en rekonstitueret,

klar opløsning ved en koncentration på 10E pr. 0,05 ml:

Mængde af solvens

(0,9 % natriumchloridopløsning),

der skal tilsættes til et 125E

hætteglas

Resulterende dosis (enheder pr.

0,05 ml)

0,63 ml

Den nøjagtige opmåling af 0,63 ml kan foretages ved brug af 1 ml-

sprøjter gradueret i inddelinger på 0,1 ml og 0,01 ml.

ANBEFALINGER VEDRØRENDE BORTSKAFFELSE AF KONTAMINERET

MATERIALE

Umiddelbart efter brug og inden bortskaffelse skal ikke-anvendt,

rekonstitueret Azzalure (i hætteglasset eller i sprøjten) inaktiveres med 2

ml fortyndet 0,55 eller 1 % (Dakin’s solution) natriumhypokloritopløsning.

Brugte hætteglas, sprøjter og materialer bør ikke tømmes og skal lægges

i passende beholdere og bortskaffes i overensstemmelse med lokale

krav.

ANBEFALINGER I TILFÆLDE AF UHELD UNDER HÅNDTERING AF

BOTULINUMTOKSIN

Eventuelt spildt produkt skal tørres op: enten med et absorberende

materiale imprægneret med natriumhypokloritopløsning

(blegemiddel), hvis det drejer sig om spildt pulver, eller med et tørt

absorberende materiale i tilfælde af spildt, rekonstitueret opløsning.

De kontaminerede overflader skal rengøres med et absorberende

materiale imprægneret med natriumhypokloritopløsning

(blegemiddel) og derefter aftørres.

Hvis et hætteglas går i stykker, skal man følge ovenstående

anvisninger ved omhyggeligt at opsamle glasstykkerne og derefter

tørre produktet op. Man skal undgå at skære sig i huden.

Hvis produktet kommer i kontakt med huden, skal det pågældende

område vaskes med natriumhypokloritopløsning (blegemiddel) og

derefter skylles med rigelige mængder vand.

Hvis produktet kommer i kontakt med øjnene, skal øjnene skylles

grundigt med rigelige mængder vand eller med en oftalmisk

øjenskylleopløsning.

Hvis produktet kommer i kontakt med et sår, en rift eller ødelagt hud,

skal der skylles grundigt med rigelige mængder vand, og der skal

iværksættes passende lægelig behandling alt efter størrelsen af den

injicerede dosis.

Disse anvisninger vedrørende brug, håndtering og bortskaffelse skal

følges nøje.

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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

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

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

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

14-8-2018

The Uttermost Company recalls Various Types of Mirrors, Art and Wall Décor sold with Adjustable J-Hook Hanging Hardware

The Uttermost Company recalls Various Types of Mirrors, Art and Wall Décor sold with Adjustable J-Hook Hanging Hardware

The hanging hardware can break, causing mirrors and wall décor to fall from walls, posing an injury hazard to bystanders.

Health Canada

8-8-2018

FDA approves treatment for two rare types of non-Hodgkin lymphoma

FDA approves treatment for two rare types of non-Hodgkin lymphoma

FDA approves new drug for the treatment of adults with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy

FDA - U.S. Food and Drug Administration

30-7-2018

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

Under the national nutrivigilance scheme, reports of adverse effects likely to be associated with the consumption of food supplements containing melatonin have been brought to the attention of ANSES. A retrospective analysis of these reports, combined with the considerable level of consumption of this type of supplement, led ANSES to conduct an assessment of the potential health risks. In its Opinion of February 2018, the Agency highlighted the existence of populations and situations at risk, for which t...

France - Agence Nationale du Médicament Vétérinaire

25-7-2018

Kraft Heinz Voluntarily Recalls Taco Bell Salsa Con Queso Mild Cheese Dip Distributed to Retailers

Kraft Heinz Voluntarily Recalls Taco Bell Salsa Con Queso Mild Cheese Dip Distributed to Retailers

As a precaution, approximately 7,000 cases of Taco Bell Salsa Con Queso Mild Cheese Dip are being voluntarily recalled because the affected product is showing signs of product separation which can lead to a potential health hazard. This could create conditions that could allow for the growth of Clostridium botulinum (C. botulinum), a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

FDA - U.S. Food and Drug Administration

17-7-2018

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Volgend jaar worden zo’n 650.000 kinderen extra opgeroepen om zich te laten inenten tegen de zeer ernstige infectieziekte meningokokken. Het gaat om kinderen die zijn geboren na 1 januari 2001 en voor mei 2004. Dat laat staatssecretaris Paul Blokhuis (VWS) weten in een brief aan de Tweede Kamer. Reden voor deze maatregel is dat in de afgelopen jaren een stijging te zien is van het aantal mensen dat de infectie meningokokken type W oploopt. Met deze extra vaccinatieronde moet die groei worden ingedamd. He...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

6-7-2018

Radagast Pet Food, Inc. Voluntarily Recalls Three Lots of Rad Cat Raw Diet Free-Range Chicken Recipe and One Lot of Pasture-Raised Venison Recipe Because of Possible Health Risk

Radagast Pet Food, Inc. Voluntarily Recalls Three Lots of Rad Cat Raw Diet Free-Range Chicken Recipe and One Lot of Pasture-Raised Venison Recipe Because of Possible Health Risk

Radagast Pet Food, Inc. of Portland, OR is recalling three lots of Rad Cat Raw Diet Free-Range Chicken Recipe because testing results indicate they have the potential to be contaminated with Listeria monocytogenes. The Company is also recalling one lot of Rad Cat Raw Diet Pasture-Raised Venison Recipe because testing results indicate it has the potential to be contaminated with Shiga Toxin producing E. coli O121. This recall is being conducted out of an abundance of caution. Due to Radagast Pet Food’s ...

FDA - U.S. Food and Drug Administration

6-7-2018

LL’S Magnetic Clay Inc. Expands Allergy Alert On Undeclared Allergens In Prescript-Assist Dietary Supplement To All Lots

LL’S Magnetic Clay Inc. Expands Allergy Alert On Undeclared Allergens In Prescript-Assist Dietary Supplement To All Lots

LL’s Magnetic Clay, Inc. of Austin, Texas is recalling all lots of Prescript-Assist (still within expiration date), a dietary supplement it marketed until late 2017, because of its potential to contain undeclared allergens, including almonds, crustaceans, milk, casein, eggs, and peanuts. People who have an allergy or severe sensitivity to these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

5-7-2018

Recall of valsartan blood pressure medicine

Recall of valsartan blood pressure medicine

Impurities that could potentially be harmful to health have been found in variants of medicines containing the active substance valsartan. The medicine is used to treat hypertension and heart failure. Patients treated with these medicines are therefore advised to contact their doctor as soon as possible to be switched to another type of medicine.

Danish Medicines Agency

29-6-2018

LL’s Magnetic Clay Inc Issues Allergy Alert on Undeclared Allergens in Prescript-Assist Dietary Supplement

LL’s Magnetic Clay Inc Issues Allergy Alert on Undeclared Allergens in Prescript-Assist Dietary Supplement

LL’s Magnetic Clay, Inc. of Austin, Texas is recalling certain lots of Prescript-Assist, a dietary supplement it marketed until late 2017, because of its potential to contain undeclared allergens, including almonds, crustaceans, dairy, casein, eggs, and peanuts. People who have an allergy or severe sensitivity to these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

19-6-2018

Various Aortic Endovascular Graft Systems: Letter to Health Care Providers - UPDATE on Type III Endoleaks

Various Aortic Endovascular Graft Systems: Letter to Health Care Providers - UPDATE on Type III Endoleaks

Based on new information, the Endologix AFX with Strata device is at greater risk for a Type III endoleak compared to other endovascular AAA graft systems.

FDA - U.S. Food and Drug Administration

30-10-2018

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Active substance: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant) - Orphan designation - Commission Decision (2018)7281 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/18

Europe -DG Health and Food Safety

5-10-2018

Devices flag! The FDA has allowed the marketing a new type of hearing aid, a self-fitted hearing aid controlled by the user. Interested reporters should check out our press release:  https://go.usa.gov/xPkuB 

Devices flag! The FDA has allowed the marketing a new type of hearing aid, a self-fitted hearing aid controlled by the user. Interested reporters should check out our press release: https://go.usa.gov/xPkuB 

Devices flag! The FDA has allowed the marketing a new type of hearing aid, a self-fitted hearing aid controlled by the user. Interested reporters should check out our press release: https://go.usa.gov/xPkuB 

FDA - U.S. Food and Drug Administration

2-10-2018

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

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)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02

Europe -DG Health and Food Safety

24-9-2018

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Active substance: Botulinum Toxin Type B) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6221 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000301/T/0101

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2060 (Biogen Idec Limited)

EU/3/18/2060 (Biogen Idec Limited)

EU/3/18/2060 (Active substance: Adeno-associated viral vector serotype hu68 containing the human SMN1 gene) - Orphan designation - Commission Decision (2018)5732 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Active substance: Autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor) - Orphan designation - Commission Decision (2018)5739 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/049/18

Europe -DG Health and Food Safety

17-8-2018

Scientific guideline:  Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open

Scientific guideline: Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open

The present document is a third revision of the existing guideline. It should be considered as general guidance on the development of medicinal products for the treatment of epileptic disorders and should be read in conjunction with other EMA and ICH guidelines, which may apply to these conditions and patient populations. The main changes to the existing guideline include incorporation of the new classification / definitions of seizure types and epilepsies, the acceptance of add-on studies in support o...

Europe - EMA - European Medicines Agency

3-8-2018

EU/3/18/2042 (MeiraGTx UK II Limited)

EU/3/18/2042 (MeiraGTx UK II Limited)

EU/3/18/2042 (Active substance: Adenovirus associated viral vector serotype 2/8 containing the human CNGA3 gene) - Orphan designation - Commission Decision (2018)5274 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/18

Europe -DG Health and Food Safety

11-7-2018

Hiprabovis IBR Marker Live (Laboratorios Hipra, S.A.)

Hiprabovis IBR Marker Live (Laboratorios Hipra, S.A.)

Hiprabovis IBR Marker Live (Active substance: Live gE- tk- double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain CEDDEL) - Centralised - Yearly update - Commission Decision (2018)4520 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2039 (REGENXBIO EU Limited)

EU/3/18/2039 (REGENXBIO EU Limited)

EU/3/18/2039 (Active substance: Recombinant adeno-associated viral vector serotype 9 containing human iduronidase gene) - Orphan designation - Commission Decision (2018)4184 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/027/18

Europe -DG Health and Food Safety

27-6-2018

EU/3/17/1874 (Sangamo Therapeutics UK LTD)

EU/3/17/1874 (Sangamo Therapeutics UK LTD)

EU/3/17/1874 (Active substance: Recombinant adeno-associated viral vector serotype 6 encoding the B-domain-deleted human factor VIII) - Transfer of orphan designation - Commission Decision (2018)4099 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/17/T/01

Europe -DG Health and Food Safety

13-6-2018

Agenda:  Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, November 2018

Agenda: Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, November 2018

The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.

Europe - EMA - European Medicines Agency

13-6-2018

Agenda:  Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, September 2018

Agenda: Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, September 2018

The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.

Europe - EMA - European Medicines Agency

12-6-2018

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

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

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

Europe -DG Health and Food Safety

12-6-2018

EU/3/17/1955 (Sangamo Therapeutics UK LTD)

EU/3/17/1955 (Sangamo Therapeutics UK LTD)

EU/3/17/1955 (Active substance: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human alpha L-iduronidase gene) - Transfer of orphan designation - Commission Decision (2018)3810 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/167/17/T/01

Europe -DG Health and Food Safety

8-6-2018

#DYK Opioids are among the type of medication that are most commonly misused - https://go.usa.gov/xQ7Az  #FDAInnovationChallengepic.twitter.com/kQPmn4ezXD

#DYK Opioids are among the type of medication that are most commonly misused - https://go.usa.gov/xQ7Az  #FDAInnovationChallengepic.twitter.com/kQPmn4ezXD

#DYK Opioids are among the type of medication that are most commonly misused - https://go.usa.gov/xQ7Az  #FDAInnovationChallenge pic.twitter.com/kQPmn4ezXD

FDA - U.S. Food and Drug Administration

1-6-2018

#DYK #Opioids are a type of drug that includes the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OxyContin®) #FDAInnovationChallenge (1 of 2 messages)

#DYK #Opioids are a type of drug that includes the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OxyContin®) #FDAInnovationChallenge (1 of 2 messages)

#DYK #Opioids are a type of drug that includes the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OxyContin®) #FDAInnovationChallenge (1 of 2 messages)

FDA - U.S. Food and Drug Administration

1-6-2018

BTVPUR AlSap 2-4 (Merial)

BTVPUR AlSap 2-4 (Merial)

BTVPUR AlSap 2-4 (Active substance: Bluetongue Virus Serotype 2 antigen - Bluetongue Virus Serotype 4 antigen) - Withdrawal (sunset clause) - No Commission Decision

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2021 (Chemo Research S.L.)

EU/3/18/2021 (Chemo Research S.L.)

EU/3/18/2021 (Active substance: Equine immunoglobulin F(ab')2 fragments targeting Shiga toxin) - Orphan designation - Commission Decision (2018)3388 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/248/17

Europe -DG Health and Food Safety