Harmonix Leaf Active

Primær information

  • Handelsnavn:
  • Harmonix Leaf Active Flydende middel
  • Lægemiddelform:
  • Flydende middel
  • Sammensætning:
  • 240 g/l eddikesyre
  • Brugt til:
  • Planter
  • Medicin typen:
  • agrokemiske

Dokumenter

  • for sundhedspersonale:
  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.


    Anmode informationsbrochure for sundhedspersonale.

Lokation

  • Fås i:
  • Harmonix Leaf Active Flydende middel
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • SEGES Landbrug & Fødevarer
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • Må ikke anvendes nærmere end 2 meter fra vandmiljøet (vandløb, søer m.v.) for at beskytte organismer, der lever i vand.
  • Sidste ændring:
  • 22-07-2018

Indlægsseddel

15 L

DKXXXXXXXXA - ARTICLE XXXXXXXX

Bredtvirkende - aktivt mod de fleste planter

Hurtigtvirkende mod ukrudt og mos

Genplantning kan foretages så snart ukrudtet er visnet

Må kun anvendes til ukrudtsbekæmpelse på

parkeringsarealer, veje, indkørsler, fortove, havegange,

terrasser og udyrkede arealer.

Dette plantebeskyttelsesmiddel må kun købes af

professionelle og anvendes erhvervsmæssigt og kræver

gyldig autorisation.

UKRUDTSMIDDEL

Dossier : HARMONIX LEAF ACTIVE • Contenu : 15 L • Pays : DK • Réf. : DKXXXXXXXXA • ARTICLE. : XXXXXXXXX • Dim. : L 155 mm x H 190 mm

Bayer Environmental Science • AGCI • Date : 19/10/17 • Auteur : Ch.

Colors : CYAN MAGENTA YELLOW BLACK

LABSC_5011_A_PacTec

DKXXXXXXXXA - ARTICLE XXXXXXXX

ADVARSEL

Bayer A/S

Arne Jacobsens Allé 13

DK-2300 København S

Danmark

Tlf. +45 45 23 50 00

www.environmentalscience.bayer.dk

#:AAAAAA=UUUUUU:

Brugsanvisningen skal følges for ikke at bringe menneskers sundhed og miljøet i fare (EUH401).

Forårsager hudirritation (H315).

Forårsager alvorlig øjenirritation (H319).

Kan forårsage irritation af luftvejene (H335).

Undgå indånding af tåge (P261).

Bær beskyttelseshandsker/øjenbeskyttelse/ansigtsbeskyttelse (P280).

Vær opmærksom på, at Arbejdstilsynet har regler for arbejde med og udsættelse for plantebeskyttelsesmidler.

Læs nærmere i det eventuelt lovpligtige sikkerhedsdatablad.

Overtrædelse af nedenstående særligt fremhævede forskrifter kan medføre straf:

Må kun anvendes til ukrudtsbekæmpelse på parkeringsarealer, veje, indkørsler, fortove, havegange,

terrasser og udyrkede arealer.

Brugsanvisningens doseringsangivelser må ikke overskrides.

Må ikke anvendes nærmere end 2 meter fra vandmiljøet (vandløb, søer mv.) for at beskytte organismer,

der lever i vand (SPe3).

Undgå forurening af vandmiljøet med produktet eller med beholdere, der har indeholdt produktet. Rens

ikke sprøjteudstyr nær overfladevand/Undgå forurening via dræn fra gårdspladser og veje (SP1).

Opbevares under lås og utilgængeligt for børn (P405+P102).

Må ikke opbevares sammen med fødevarer, drikkevarer og foderstoffer.

FØRSTEHJÆLP

Hvis der er brug for lægehjælp, medbring da beholderen eller etiketten (P101).

VED KONTAKT MED HUDEN: Vask med rigeligt vand (P302+P352). Alt tilsmudset tøj tages af og vaskes inden genanvendelse (P362+P364).

VED INDÅNDING: Flyt personen til et sted med frisk luft og sørg for, at vejrtrækningen lettes. Ring til en GIFTINFORMATION eller læge i tilfælde af ubehag

(P304+P340+P312).

VED KONTAKT MED ØJNENE: Skyl forsigtigt med vand i flere minutter. Fjern eventuelle kontaktlinser, hvis dette kan gøres let. Fortsæt skylning (P305+P351+P338).

Ved vedvarende øjenirritation: Søg lægehjælp (P337+P313).

Opbevares på et godt ventileret sted. Hold beholderen tæt lukket (P403+P233).

DEKLARATION

Ukrudtsmiddel nr. 18-630

Omfattet af Miljøministeriets bekendtgørelse om bekæmpelsesmidler og plantebeskyttelsesmiddelforordningen 1107/2009.

Indeholder:

Eddikesyre, 240 g/l (22,54% w/w) ved 20°C

Nettoindhold: 15 Liter

Midlet er et vandopløseligt koncentrat.

Produktionsnummer er påtrykt emballagen.

Produktet er ved korrekt opbevaring holdbart i mindst 3 år efter

produktionsdato.

Batchnummer er påtrykt emballagen.

LABMC_5039_E_PacTec

Bayer Environmental Science • AGCI • Date : 24/10/17 • Auteur : Ant

Dossier : HARMONIX LEAF ACTIVE • Contenu : 15 L • Pays : DK • Réf. : DKXXXXXXXA • ARTICLE : XXXXXXX • Dim. : L 135 mm x H 190 mm

Colors : CYAN MAGENTA YELLOW BLACK

FRONT PAGE

BRUGSANVISNING

Harmonix Leaf Active er et ikke-selektivt kontaktvirkende bekæmpelsesmiddel til ukrudt og mos, som er aktiv mod de

fleste bløde plantedele. Ukrudt og mos bekæmpes ved at dække bladene helt og jævnt med sprøjtevæsken. Kort tid

efter behandlingen begynder bladene på ukrudt og mos at visne og dø. Planternes rødder dræbes ikke og ny vækst

kan forekomme, særligt fra rødderne på flerårigt ukrudt. Etårigt ukrudt og mos kan bekæmpes, men genbehandling

vil typisk være nødvendig, særligt for at holde flerårigt ukrudt nede.

De bedste resultater opnås på spinkelt, småt ukrudt, der er mindre end 10 cm højt. For at opnå den bedste effekt

behandles der i foråret og behandlingerne gentages i løbet af vækstsæsonen om nødvendigt.

Undgå afdrift fra sprøjteområdet.

Anvendelsesområde

Harmonix Leaf Active kan anvendes til bekæmpelse af ukrudt og mos på parkeringsarealer, veje, indkørsler, fortove,

havegange, terrasser og udyrkede arealer. Undgå at sprøjte på grøntsager, blomster, buske og græsplæner. Alle

planter, der rammes af sprøjtevæsken, vil blive skadet.

Dosering og sprøjteteknik

Bland 1 del Harmonix Leaf Active med 3 dele rent vand.

Eksempel: i en 16-liters rygsprøjte blandes 4 liter Harmonix Leaf Active med 12 liter vand.

1. Fyld tanken halvt med vand.

2. Tilsæt den nødvendige mængde Harmonix Leaf Active.

3. Fyld tanken med mere rent vand indtil det korrekte niveau.

4. Ryst grundigt før brug.

Harmonix Leaf Active udsprøjtes med low-drift dyse således at mosset eller ukrudtets blade og stængler er helt

dækket. Der genbehandles efter behov.

Harmonix Leaf Active bør udsprøjtes på tørre planter. Behandlingen er regnfast efter 6 timer.

Maksimal dosis: 25 ml produkt pr. m

Maksimalt antal behandlinger pr. år: 6.

Der skal minimum være et interval på 7 dage mellem behandlingerne

Hold mennesker og dyr væk fra områder der er behandlet indtil det behandlede område er tørt, oftest kun

15-20 minutter. Harmonix Leaf Active kan gøre nogle overflader glatte i kort tid efter behandlingen.

For at beskytte bier og insekter, der samler pollen, må der ikke sprøjtes på blomstrende planter. Blomstrende ukrudt

behandles udenfor biernes flyvetid.

Efterfølgende plantning

Der er ingen resteffekt af Harmonix Leaf Active i jorden. Såning eller plantning kan foretages så snart mosset eller

ukrudtet er visnet.

RESISTENSHÅNDTERING

Harmonix Leaf Active har en uspecifik virkemekanisme. Risikoen for at ukrudtsarter udvikler resistens overfor midlet

anses for at være lav.

RENGØRING

Skyl sprøjteudstyret rent efter brug.

OPBEVARING

Opbevares i original beholder på et godt ventileret og sikkert sted. Hold beholderen tæt lukket (P403+P233).

BORTSKAFFELSE

Indholdet/beholderen bortskaffes i overensstemmelse med kommunale regler for affaldshåndtering (P501).

Rester skal afleveres til den kommunale affaldsordning for farligt affald. Tomme beholdere kan bortskaffes med

dagrenovationen. Den tomme beholder bør skylles inden bortskaffelse. Skyllevandet hældes op i sprøjtevæsken.

Emballagen må ikke genbruges.

LABMC_5039_E_PacTec

Bayer Environmental Science • AGCI • Date : 24/10/17 • Auteur : Ant

Dossier : HARMONIX LEAF ACTIVE • Contenu : 15 L • Pays : DK • Réf. : DKXXXXXXXA • ARTICLE : XXXXXXX • Dim. : L 131 mm x H 190 mm

Colors : CYAN MAGENTA YELLOW BLACK

PAGE 1

DKXXXXXXXXA - ARTICLE XXXXXXXX

Bayer A/S

Arne Jacobsens Allé 13

DK-2300 København S

Danmark

Tlf. +45 45 23 50 00

www.environmentalscience.bayer.dk

#:AAAAAA=UUUUUU:

Produktionsnummer er påtrykt emballagen.

Produktet er ved korrekt opbevaring holdbart i mindst 3 år efter

produktionsdato.

Batchnummer er påtrykt emballagen.

ADVARSEL

Brugsanvisningen skal følges for ikke at bringe menneskers sundhed og miljøet i fare (EUH401).

Forårsager hudirritation (H315).

Forårsager alvorlig øjenirritation (H319).

Kan forårsage irritation af luftvejene (H335).

Undgå indånding af tåge (P261).

Bær beskyttelseshandsker/øjenbeskyttelse/ansigtsbeskyttelse (P280).

Vær opmærksom på, at Arbejdstilsynet har regler for arbejde med og udsættelse for plantebeskyttelsesmidler.

Læs nærmere i det eventuelt lovpligtige sikkerhedsdatablad.

Overtrædelse af nedenstående særligt fremhævede forskrifter kan medføre straf:

Må kun anvendes til ukrudtsbekæmpelse på parkeringsarealer, veje, indkørsler, fortove, havegange,

terrasser og udyrkede arealer.

Brugsanvisningens doseringsangivelser må ikke overskrides.

Må ikke anvendes nærmere end 2 meter fra vandmiljøet (vandløb, søer mv.) for at beskytte organismer,

der lever i vand (SPe3).

Undgå forurening af vandmiljøet med produktet eller med beholdere, der har indeholdt produktet. Rens

ikke sprøjteudstyr nær overfladevand/Undgå forurening via dræn fra gårdspladser og veje (SP1).

Opbevares under lås og utilgængeligt for børn (P405+P102).

Må ikke opbevares sammen med fødevarer, drikkevarer og foderstoffer.

FØRSTEHJÆLP

Hvis der er brug for lægehjælp, medbring da beholderen eller etiketten (P101).

VED KONTAKT MED HUDEN: Vask med rigeligt vand (P302+P352). Alt tilsmudset tøj tages af og vaskes inden genanvendelse (P362+P364).

VED INDÅNDING: Flyt personen til et sted med frisk luft og sørg for, at vejrtrækningen lettes. Ring til en GIFTINFORMATION eller læge i tilfælde af ubehag

(P304+P340+P312).

VED KONTAKT MED ØJNENE: Skyl forsigtigt med vand i flere minutter. Fjern eventuelle kontaktlinser, hvis dette kan gøres let. Fortsæt skylning (P305+P351+P338).

Ved vedvarende øjenirritation: Søg lægehjælp (P337+P313).

Opbevares på et godt ventileret sted. Hold beholderen tæt lukket (P403+P233).

DEKLARATION

Ukrudtsmiddel nr. 18-630

Omfattet af Miljøministeriets bekendtgørelse om bekæmpelsesmidler og plantebeskyttelsesmiddelforordningen 1107/2009.

Indeholder:

Eddikesyre, 240 g/l (22,54% w/w) ved 20°C

Nettoindhold: 15 Liter

Midlet er et vandopløseligt koncentrat.

LABMC_5039_E_PacTec

Bayer Environmental Science • AGCI • Date : 24/10/17 • Auteur : Ant

Dossier : HARMONIX LEAF ACTIVE • Contenu : 15 L • Pays : DK • Réf. : DKXXXXXXXA • ARTICLE : XXXXXXX • Dim. : L 131 mm x H 190 mm

Colors : CYAN MAGENTA YELLOW BLACK

REPEATER PAGE

ARTICLE XXXXXXX

Bayer A/S

Arne Jacobsens Allé 13

DK-2300 København S

Danmark

Tlf. +45 45 23 50 00

www.environmentalscience.bayer.dk

1 x 15 L

Bredtvirkende - aktivt mod de fleste planter

Hurtigtvirkende mod ukrudt og mos

Genplantning kan foretages så snart ukrudtet er visnet

Må kun anvendes til ukrudtsbekæmpelse på parkeringsarealer,

veje, indkørsler, fortove, havegange, terrasser og udyrkede

arealer.

Dette plantebeskyttelsesmiddel må kun købes af professionelle

og anvendes erhvervsmæssigt og kræver gyldig autorisation.

UKRUDTSMIDDEL

1 x 15 L

ADVARSEL

straf:

Må kun anvendes til ukrudtsbekæmpelse på parkeringsarealer, veje, indkørsler, fortove, havegange, terrasser og

udyrkede arealer.

Brugsanvisningens doseringsangivelser må ikke overskrides.

Må ikke anvendes nærmere end 2 meter fra vandmiljøet (vandløb, søer mv.) for at beskytte organismer, der lever i

vand (SPe3).

Undgå forurening af vandmiljøet med produktet eller med beholdere, der har indeholdt produktet. Rens ikke

sprøjteudstyr nær overfladevand/Undgå forurening via dræn fra gårdspladser og veje (SP1).

Opbevares under lås og utilgængeligt for børn (P405+P102).

Må ikke opbevares sammen med fødevarer, drikkevarer og foderstoffer.

FØRSTEHJÆLP

Hvis der er brug for lægehjælp, medbring da beholderen eller etiketten (P101).

VED KONTAKT MED HUDEN: Vask med rigeligt vand (P302+P352). Alt tilsmudset tøj tages af og vaskes inden genanvendelse

(P362+P364).

VED INDÅNDING: Flyt personen til et sted med frisk luft og sørg for, at vejrtrækningen lettes. Ring til en GIFTINFORMATION

eller læge i tilfælde af ubehag (P304+P340+P312).

VED KONTAKT MED ØJNENE: Skyl forsigtigt med vand i flere minutter. Fjern eventuelle kontaktlinser, hvis dette kan gøres let.

Fortsæt skylning (P305+P351+P338). Ved vedvarende øjenirritation: Søg lægehjælp (P337+P313).

Opbevares på et godt ventileret sted. Hold beholderen tæt lukket (P403+P233).

DEKLARATION

Ukrudtsmiddel nr. 18-630

Omfattet af Miljøministeriets bekendtgørelse om bekæmpelsesmidler og plantebeskyttelsesmiddelforordningen 1107/2009.

Indeholder:

Eddikesyre, 240 g/l (22,54% w/w) ved 20°C

Nettoindhold: 15 Liter

Midlet er et vandopløseligt koncentrat.

#:AAAAAA=UUUUUU:

Produktionsnummer er påtrykt emballagen.

Produktet er ved korrekt opbevaring holdbart i mindst 3 år efter

produktionsdato.

Batchnummer er påtrykt emballagen.

Brugsanvisningen skal følges for ikke at bringe menneskers sundhed

og miljøet i fare (EUH401).

Forårsager hudirritation (H315).

Forårsager alvorlig øjenirritation (H319).

Kan forårsage irritation af luftvejene (H335).

Undgå indånding af tåge (P261).

Bær beskyttelseshandsker/øjenbeskyttelse/ansigtsbeskyttelse (P280).

Vær opmærksom på, at Arbejdstilsynet har regler for arbejde med og

udsættelse for plantebeskyttelsesmidler. Læs nærmere i det eventuelt

lovpligtige sikkerhedsdatablad.

Overtrædelse af nedenstående særligt fremhævede forskrifter kan medføre

DKXXXXXXXXA - ARTICLE XXXXXXXX

Bredtvirkende - aktivt mod de fleste planter

Hurtigtvirkende mod ukrudt og mos

Genplantning kan foretages så snart ukrudtet er visnet

Må kun anvendes til ukrudtsbekæmpelse på parkeringsarealer,

veje, indkørsler, fortove, havegange, terrasser og udyrkede

arealer.

Dette plantebeskyttelsesmiddel må kun købes af professionelle

og anvendes erhvervsmæssigt og kræver gyldig autorisation.

UKRUDTSMIDDEL

Bayer Environmental Science • AGCI • Date : 19/10/17 • Auteur : Ch.

Dossier : HARMONIX LEAF ACTIVE • Contenu : 1 x 15 L • Pays : DK • Réf. : DKXXXXXXXXA • Article : XXXXXXXX • Dim. : L 403 mm x H 175 mm

Colors : CYAN MAGENTA YELLOW BLACK

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30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

30-10-2018

Food Recall of Fit & Active Southwest Veggie Stuffed Sandwiches Due to Possible Listeria monocytogenes and Salmonella Contamination in Vegetables

Food Recall of Fit & Active Southwest Veggie Stuffed Sandwiches Due to Possible Listeria monocytogenes and Salmonella Contamination in Vegetables

J&J Snack Foods Handheld Corp. of Holly Ridge, NC is voluntarily recalling two lots of Fit & Active Southwest Veggie Stuffed Sandwiches due to potential contamination with Listeria monocytogenes and Salmonella. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

FDA - U.S. Food and Drug Administration

29-10-2018

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

FDA - U.S. Food and Drug Administration

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Active substance: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains) - Transfer of orphan designation - Commission Decision (2018)7574 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/270/16/02

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

12-11-2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Active substance: efavirenz / emtricitabine / tenofovir disoproxil) - Centralised - Yearly update - Commission Decision (2018)7547 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

6-11-2018

Symkevi (Vertex Pharmaceuticals (Europe) Limited)

Symkevi (Vertex Pharmaceuticals (Europe) Limited)

Symkevi (Active substance: tezacaftor/ivacaftor) - Centralised - Authorisation - Commission Decision (2018)7415 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4682

Europe -DG Health and Food Safety

6-11-2018

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

Trelegy Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7416 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4363/WS/1369

Europe -DG Health and Food Safety

6-11-2018

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7417 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4781/WS/1369

Europe -DG Health and Food Safety

6-11-2018

Neulasta (Amgen Europe B.V.)

Neulasta (Amgen Europe B.V.)

Neulasta (Active substance: Pegfilgrastim) - Centralised - Yearly update - Commission Decision (2018)7420 of Tue, 06 Nov 2018

Europe -DG Health and Food Safety

5-11-2018

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Active substance: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid) - Orphan designation - Commission Decision (2018)7271 of Mon, 05 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/114/18

Europe -DG Health and Food Safety

5-11-2018

Improvac (Zoetis Belgium S.A.)

Improvac (Zoetis Belgium S.A.)

Improvac (Active substance: Not available) - Centralised - Yearly update - Commission Decision (2018)7381 of Mon, 05 Nov 2018

Europe -DG Health and Food Safety

1-11-2018

Zolvix (Elanco GmbH)

Zolvix (Elanco GmbH)

Zolvix (Active substance: monepantel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7383 of Thu, 01 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/000154/T/0024

Europe -DG Health and Food Safety

1-11-2018

Protopic (Leo Pharma A/S)

Protopic (Leo Pharma A/S)

Protopic (Active substance: Tacrolimus) - Centralised - Yearly update - Commission Decision (2018)7343 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

1-11-2018

Taxespira (Hospira UK Limited)

Taxespira (Hospira UK Limited)

Taxespira (Active substance: docetaxel) - Centralised - Withdrawal - Commission Decision (2018)7368 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (Active substance: Eptifibatide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7340 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/230/T/79

Europe -DG Health and Food Safety

31-10-2018

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (Active substance: Ambrisentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7339 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/839/T/56

Europe -DG Health and Food Safety

31-10-2018

AMGEVITA (Amgen Europe B.V.)

AMGEVITA (Amgen Europe B.V.)

AMGEVITA (Active substance: adalimumab) - Centralised - Yearly update - Commission Decision (2018)7341 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

30-10-2018

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Active substance: Phosphorothioate oligonucleotide targeted to transthyretin) - Transfer of orphan designation - Commission Decision (2018)7282 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/13/T/01

Europe -DG Health and Food Safety

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

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Active substance: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG) - Orphan designation - Commission Decision (2018)7279 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/091/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Active substance: Melatonin) - Orphan designation - Commission Decision (2018)7278 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/077/18

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

30-10-2018

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Active substance: Gefitinib) - Orphan designation - Commission Decision (2018)7276 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (Active substance: Avapritinib) - Orphan designation - Commission Decision (2018)7275 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/079/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Active substance: Autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA) - Orphan designation - Commission Decision (2018)7274 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/113/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Active substance: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile) - Orphan designation - Commission Decision (2018)7272 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

Europe -DG Health and Food Safety

29-10-2018

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7249 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1144/WS1433/0051

Europe -DG Health and Food Safety

29-10-2018

Replagal (Shire Human Genetic Therapies AB)

Replagal (Shire Human Genetic Therapies AB)

Replagal (Active substance: Agalsidase alfa) - Centralised - Yearly update - Commission Decision (2018)7250 of Mon, 29 Oct 2018

Europe -DG Health and Food Safety

25-10-2018

Canigen L4 (Intervet International B.V.)

Canigen L4 (Intervet International B.V.)

Canigen L4 (Active substance: Leptospira interrogans serogroup Canicola serovar Portland-vere/Leptospira interrogans serogroup Icterohaemorrhagiae serovar Copenhageni/Leptospira interrogans serogroup Australis serovar Bratislava/Leptospira kirschneri serogroup Grippotyphosa serovar Dadas) - Centralised - Yearly update - Commission Decision (2018)7138 of Thu, 25 Oct 2018

Europe -DG Health and Food Safety

25-10-2018

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Active substance: enzalutamide) - Centralised - 2-Monthly update - Commission Decision (2018)7132 of Thu, 25 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2639/II/39G

Europe -DG Health and Food Safety

25-10-2018

Micardis (Boehringer Ingelheim International GmbH)

Micardis (Boehringer Ingelheim International GmbH)

Micardis (Active substance: telmisartan) - Centralised - Yearly update - Commission Decision (2018)7136 of Thu, 25 Oct 2018

Europe -DG Health and Food Safety

23-10-2018

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

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

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

Europe -DG Health and Food Safety

22-10-2018

NEXGARD SPECTRA (Merial)

NEXGARD SPECTRA (Merial)

NEXGARD SPECTRA (Active substance: Afoxolaner / milbemycin oxime) - Centralised - 2-Monthly update - Commission Decision (2018)6977 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/003842/WS1338/0015/G

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Active substance: 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate) - Transfer of orphan designation - Commission Decision (2018)6989 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/253/15/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1689 (Alan Boyd Consultants Ltd)

EU/3/16/1689 (Alan Boyd Consultants Ltd)

EU/3/16/1689 (Active substance: Teriparatide) - Transfer of orphan designation - Commission Decision (2018)6987 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/031/16/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/01/075 (Eisai GmbH)

EU/3/01/075 (Eisai GmbH)

EU/3/01/075 (Active substance: Denileukin diftitox) - Transfer of orphan designation - Commission Decision (2018)6991 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/038/01/T/02

Europe -DG Health and Food Safety

22-10-2018

Pemetrexed Hospira (Pfizer Europe MA EEIG)

Pemetrexed Hospira (Pfizer Europe MA EEIG)

Pemetrexed Hospira (Active substance: pemetrexed) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6971 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3970/T/14

Europe -DG Health and Food Safety

22-10-2018

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Active substance: mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) - Centralised - Yearly update - Commission Decision (2018)6972 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/05/264 (Roche Registration GmbH)

EU/3/05/264 (Roche Registration GmbH)

EU/3/05/264 (Active substance: Cholest-4-en-3-one, oxime) - Transfer of orphan designation - Commission Decision (2018)6995 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/081/04/T/02

Europe -DG Health and Food Safety

22-10-2018

EU/3/11/901 (Merck Sharp and Dohme B.V.)

EU/3/11/901 (Merck Sharp and Dohme B.V.)

EU/3/11/901 (Active substance: Dinaciclib) - Transfer of orphan designation - Commission Decision (2018)6990 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/052/11/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2018)6992 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/007/15/T/02

Europe -DG Health and Food Safety

22-10-2018

Evoltra (Genzyme Europe B.V.)

Evoltra (Genzyme Europe B.V.)

Evoltra (Active substance: clofarabine) - Centralised - Yearly update - Commission Decision (2018)6973 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

Irbesartan / Hydrochlorothiazide Teva (Teva B.V.)

Irbesartan / Hydrochlorothiazide Teva (Teva B.V.)

Irbesartan / Hydrochlorothiazide Teva (Active substance: irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018) 6974 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

Forsteo (Eli Lilly Nederland B.V.)

Forsteo (Eli Lilly Nederland B.V.)

Forsteo (Active substance: Teriparatide) - Centralised - Yearly update - Commission Decision (2018) 6975 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety