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:
  • 42748
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN

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

botulinum

-toksin type A)

Læs denne indlægsseddel grundigt, inden De begynder at bruge dette lægemiddel, da

den indeholder vigtige oplysninger.

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

Spørg lægen eller apotekspersonalet, hvis der er mere, De vil vide.

Kontakt lægen eller apotekspersonalet, hvis De får bivirkninger, herunder

bivirkninger, som ikke er nævnt her. Se punkt 4.

Se den nyeste indlægsseddel på www.indlaegsseddel.dk.

Oversigt over indlægssedlen

Virkning og anvendelse

Det skal De vide, før De bliver behandlet med Azzalure

Sådan bliver De behandlet med Azzalure

Bivirkninger

Opbevaring

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.

Lægen kan give Dem Azzalure for noget andet. Spørg lægen.

2.

Det skal De vide før De bliver behandlet med Azzalure

De må ikke få en Azzalure-injektion:

hvis De er allergisk over for

Clostridium botulinum

-toksin A eller et af de øvrige

indholdsstoffer (angivet i punkt 6).

hvis De har en infektion ved det foreslåede injektionssted.

hvis De 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 De får en Azzalure-injektion:

hvis De har en neuromuskulær lidelse

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

hvis De mener, at De ofte har problemer med, at mad eller drikke kommer i den "gale

hals" (i luftrøret), hvilket får Dem til at hoste eller være ved at kvæles

hvis De har betændelse ved det foreslåede injektionssted

hvis musklerne ved det foreslåede injektionssted er svage

hvis De lider af en blødersygdom, som får Dem til at bløde længere end normalt, som

for eksempel hæmofili (arvelig blødningslidelse forårsaget af manglende

koagulationsfaktor)

hvis De er blevet opereret i ansigtet, eller hvis der er sandsynlighed for, at De inden

længe skal have foretaget en ansigtsoperation eller en anden operation

hvis De allerede har fået andre botulinumtoksin-injektioner

hvis De ikke oplevede nogen betydelig forbedring af Deres rynker efter Deres sidste

behandling med botulinumtoksin

Disse oplysninger vil hjælpe Deres læge med at træffe en beslutning på informeret grundlag

vedrørende risici og fordele ved Deres 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 De af en hvilken som helst grund skal tale med en læge, skal De sørge for at fortælle

lægen, at De 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 De bruger anden medicin eller har gjort det for nylig. Dette

gælder også medicin, som ikke er købt på recept. Azzalure kan have indflydelse på virkningen

af andre lægemidler, som De tager, eller som De 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

De kan få Azzalure-injektioner enten før eller efter, at De har spist eller drukket.

Graviditet og amning

De bør ikke få Azzalure under graviditet. Behandling med Azzalure frarådes, hvis De ammer.

Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive

gravid, skal De spørge Deres læge eller apotekspersonalet til råds, før De tager dette

lægemiddel.

Trafik- og arbejdssikkerhed

De kan få midlertidigt sløret syn eller muskelsvaghed efter behandling med Azzalure. Hvis

De føler Dem påvirket af behandlingen, må De ikke køre bil eller arbejde med værktøj eller

maskiner.

3.

Sådan bliver De 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.

Deres læge vil klargøre og indgive injektionerne. Der vil blive anvendt ét hætteglas med

Azzalure, som kun bruges til Dem 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 Deres pande i området over Deres 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 Deres læge. De bør ikke

få behandling oftere end hver 12. uge.

Hvis De har fået for meget Azzalure

Hvis De har fået mere Azzalure, end De 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 De omgående kontakte Deres læge eller sundhedspersonalet.

4.

Bivirkninger

Dette lægemiddel

kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.

Søg straks lægehjælp:

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

hvis Deres ansigt hæver, eller hvis huden bliver rød, eller hvis De får et kløende,

ujævnt udslæt. Dette kan betyde, at De har fået en overfølsomhedsreaktion over for

Azzalure

Fortæl det til Deres læge, hvis De 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

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

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

Tørre øjne

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 De forsøger at sluge;

også åndedrætsbesvær kan forekomme f.eks. lungebetændelse). Hvis disse problemer opstår,

skal De straks kontakte Deres læge.

Indberetning af bivirkninger

Hvis De oplever bivirkninger, bør De tale med Deres læge eller apoteket. Dette gælder også

mulige bivirkninger, som ikke er medtaget i denne indlægsseddel. De eller Deres pårørende

kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via de oplysninger, der

fremgår herunder.

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

Ved at indrapportere bivirkninger kan De 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. Udløbsdatoen er den sidste

dag i den nævnte måned.

Opbevares i køleskab (2 °C – 8 °C). Må ikke nedfryses.

Deres 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.

Indehaver af markedsføringstilladelsen og fremstiller

Indehaver af markedsføringstilladelsen:

Institut Produits Synthèse (IPSEN) AB

Kista Science Tower

Färögatan 33

SE-164 51

Sverige

Fremstiller:

Ipsen Biopharm Limited

Ash Road

Wrexham Industrial Estate

Wrexham

LL13 9UF

Storbritannien

Denne indlægsseddel blev senest ændret

01/2018.

Hvis De ønsker yderligere information, eller hvis De ønsker denne indlægsseddel i et andet

format, bedes De kontakte den lokale repræsentant:

Galderma Nordic AB

Seminariegatan 21

SE-752 28 Uppsala

Sverige

Tlf.: +46 (0)18 444 0330

Fax: +46 (0)18 444 0335

E-post: nordic@galderma.com.

--------------------------------------------------------------------------------------------------------------

Nedenstående oplysninger er til 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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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