MON 0818

Primær information

  • Handelsnavn:
  • MON 0818 Flydende middel
  • Lægemiddelform:
  • Flydende middel
  • Sammensætning:
  • 1000 g/l sprede-klæbemiddel
  • Brugt til:
  • Planter
  • Medicin typen:
  • agrokemiske

Dokumenter

  • for den brede offentlighed:
  • 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 offentligheden.

  • 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:
  • MON 0818 Flydende middel
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • SEGES Landbrug & Fødevarer
  • Autorisation status:
  • Udgået
  • Sidste ændring:
  • 08-02-2018
  • 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 offentligheden.

Der er ingen sikkerhedsadvarsler relateret til dette produkt.

23-4-2018

Volibris (Glaxo Group Ltd)

Volibris (Glaxo Group Ltd)

Volibris (Active substance: Ambrisentan) - Centralised - Yearly update - Commission Decision (2018)2514 of Mon, 23 Apr 2018

Europe -DG Health and Food Safety

23-4-2018

Sutent (Pfizer Limited)

Sutent (Pfizer Limited)

Sutent (Active substance: sunitinib) - Centralised - Yearly update - Commission Decision (2018)2512 of Mon, 23 Apr 2018

Europe -DG Health and Food Safety

23-4-2018

Deltyba (Otsuka Novel Products GmbH)

Deltyba (Otsuka Novel Products GmbH)

Deltyba (Active substance: delamanid) - Centralised - Annual renewal - Commission Decision (2018)2492 of Mon, 23 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2552/R/27

Europe -DG Health and Food Safety

23-4-2018

Xadago (Zambon S.p.A.)

Xadago (Zambon S.p.A.)

Xadago (Active substance: safinamide) - Centralised - Yearly update - Commission Decision (2018)2513 of Mon, 23 Apr 2018

Europe -DG Health and Food Safety

16-4-2018

Kinzalkomb (Bayer AG)

Kinzalkomb (Bayer AG)

Kinzalkomb (Active substance: Telmisartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2294 of Mon, 16 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/415/T/105

Europe -DG Health and Food Safety

16-4-2018

Lumigan (Allergan Pharmaceuticals Ireland)

Lumigan (Allergan Pharmaceuticals Ireland)

Lumigan (Active substance: Bimatoprost) - Centralised - Yearly update - Commission Decision (2018)2300 of Mon, 16 Apr 2018

Europe -DG Health and Food Safety

16-4-2018

Ravicti (Horizon Pharma Ireland Limited)

Ravicti (Horizon Pharma Ireland Limited)

Ravicti (Active substance: Glycerol phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)2302 of Mon, 16 Apr 2018

Europe -DG Health and Food Safety

16-4-2018

Actrapid (Novo Nordisk A/S)

Actrapid (Novo Nordisk A/S)

Actrapid (Active substance: Insulin human (rDNA)) - Centralised - Yearly update - Commission Decision (2018)2301 of Mon, 16 Apr 2018

Europe -DG Health and Food Safety

16-4-2018

Vidaza (Celgene Europe Limited)

Vidaza (Celgene Europe Limited)

Vidaza (Active substance: Azacitidine) - Centralised - Yearly update - Commission Decision (2018)2305 of Mon, 16 Apr 2018

Europe -DG Health and Food Safety

16-4-2018

Signifor (Novartis Europharm Limited)

Signifor (Novartis Europharm Limited)

Signifor (Active substance: pasireotide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2304 of Mon, 16 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2052/T/37

Europe -DG Health and Food Safety

16-4-2018

Sebivo (Novartis Europharm Limited)

Sebivo (Novartis Europharm Limited)

Sebivo (Active substance: telbivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2317 of Mon, 16 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/713/T/50

Europe -DG Health and Food Safety

16-4-2018

Farydak (Novartis Europharm Limited)

Farydak (Novartis Europharm Limited)

Farydak (Active substance: panobinostat) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2322 of Mon, 16 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3725/T/11

Europe -DG Health and Food Safety

16-4-2018

Extavia (Novartis Europharm Limited)

Extavia (Novartis Europharm Limited)

Extavia (Active substance: Interferon beta-1b) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2321 of Mon, 16 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/933/T/90

Europe -DG Health and Food Safety

16-4-2018

Galafold (Amicus Therapeutics UK Ltd)

Galafold (Amicus Therapeutics UK Ltd)

Galafold (Active substance: migalastat) - Centralised - Yearly update - Commission Decision (2018)2318 of Mon, 16 Apr 2018

Europe -DG Health and Food Safety

16-4-2018

Actraphane (Novo Nordisk A/S)

Actraphane (Novo Nordisk A/S)

Actraphane (Active substance: Insulin human (rDNA)) - Centralised - Yearly update - Commission Decision (2018)2312 of Mon, 16 Apr 2018

Europe -DG Health and Food Safety

16-4-2018

Pemetrexed Lilly (Eli Lilly Nederland B.V.)

Pemetrexed Lilly (Eli Lilly Nederland B.V.)

Pemetrexed Lilly (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)2308 of Mon, 16 Apr 2018

Europe -DG Health and Food Safety

16-4-2018

Sylvant (Janssen-Cilag International NV)

Sylvant (Janssen-Cilag International NV)

Sylvant (Active substance: siltuximab) - Centralised - Yearly update - Commission Decision (2018)2311 of Mon, 16 Apr 2018

Europe -DG Health and Food Safety

16-4-2018

Fiasp (Novo Nordisk A/S)

Fiasp (Novo Nordisk A/S)

Fiasp (Active substance: insulin aspart) - Centralised - 2-Monthly update - Commission Decision (2018)2309 of Mon, 16 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4046/II/3/G

Europe -DG Health and Food Safety

26-3-2018

Lokelma (AstraZeneca AB)

Lokelma (AstraZeneca AB)

Lokelma (Active substance: sodium zirconium cyclosilicate) - Centralised - Authorisation - Commission Decision (2018)1912 of Mon, 26 Mar 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4029

Europe -DG Health and Food Safety

26-3-2018

Panacur AquaSol (Intervet International B.V.)

Panacur AquaSol (Intervet International B.V.)

Panacur AquaSol (Active substance: Fenbendazole) - Corrigendum - Commission Decision (2018)1849 of Mon, 26 Mar 2018

Europe -DG Health and Food Safety

26-3-2018

EU/3/18/1990 (PharmaBio Consulting)

EU/3/18/1990 (PharmaBio Consulting)

EU/3/18/1990 (Active substance: Dimethyl fumarate) - Orphan designation - Commission Decision (2018)1879 of Mon, 26 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/219/17

Europe -DG Health and Food Safety

26-3-2018

Suvaxyn PCV (Zoetis Belgium S.A.)

Suvaxyn PCV (Zoetis Belgium S.A.)

Suvaxyn PCV (Active substance: Porcine circovirus recombinant virus (cpcv) 1-2, inactivated) - Centralised - Yearly update - Commission Decision (2018)1927 of Mon, 26 Mar 2018

Europe -DG Health and Food Safety

26-3-2018

Palladia (Zoetis Belgium S.A.)

Palladia (Zoetis Belgium S.A.)

Palladia (Active substance: Toceranib) - Centralised - Yearly update - Commission Decision (2018)1926 of Mon, 26 Mar 2018

Europe -DG Health and Food Safety

26-3-2018

Suvaxyn CSF Marker (Zoetis Belgium S.A.)

Suvaxyn CSF Marker (Zoetis Belgium S.A.)

Suvaxyn CSF Marker (Active substance: Live Recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 (CP7_E2alf)) - Centralised - Yearly update - Commission Decision (2018)1928 of Mon, 26 Mar 2018

Europe -DG Health and Food Safety

26-3-2018

Draxxin (Zoetis Belgium S.A.)

Draxxin (Zoetis Belgium S.A.)

Draxxin (Active substance: Tulathromycin) - Centralised - Yearly update - Commission Decision (2018)1925 of Mon, 26 Mar 2018

Europe -DG Health and Food Safety

26-3-2018

ERAVAC (Laboratorios Hipra, S.A.)

ERAVAC (Laboratorios Hipra, S.A.)

ERAVAC (Active substance: rabbit haemorrhagic disease vaccine (inactivated)) - Centralised - 2-Monthly update - Commission Decision (2018)1924 of Mon, 26 Mar 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4239/II/3/G

Europe -DG Health and Food Safety

19-3-2018

Erivedge (Roche Registration GmbH)

Erivedge (Roche Registration GmbH)

Erivedge (Active substance: vismodegib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)1691 of Mon, 19 Mar 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2602/T/37

Europe -DG Health and Food Safety

19-3-2018

NeoRecormon (Roche Registration GmbH)

NeoRecormon (Roche Registration GmbH)

NeoRecormon (Active substance: Epoetin beta) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)1693 of Mon, 19 Mar 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/116/T/98

Europe -DG Health and Food Safety

19-3-2018

Pegasys (Roche Registration GmbH)

Pegasys (Roche Registration GmbH)

Pegasys (Active substance: peginterferon alfa-2a) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)1692 of Mon, 19 Mar 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/395/T/100

Europe -DG Health and Food Safety

19-3-2018

Vaxelis (MCM Vaccine B.V.)

Vaxelis (MCM Vaccine B.V.)

Vaxelis (Active substance: Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed)) - Centralised - Yearly update - Commission Decision (2018)1695 of Mon, 19 Mar 2018

Europe -DG Health and Food Safety

19-3-2018

Alecensa (Roche Registration GmbH)

Alecensa (Roche Registration GmbH)

Alecensa (Active substance: alectinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)1694 of Mon, 19 Mar 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4164/T/13

Europe -DG Health and Food Safety

19-3-2018

Humira (AbbVie Deutschland GmbH and Co. KG)

Humira (AbbVie Deutschland GmbH and Co. KG)

Humira (Active substance: Adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)1696 of Mon, 19 Mar 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/481/T/176

Europe -DG Health and Food Safety

5-3-2018

IDELVION (CSL Behring GmbH)

IDELVION (CSL Behring GmbH)

IDELVION (Active substance: albutrepenonacog alfa) - Centralised - Yearly update - Commission Decision (2018)1417 of Mon, 05 Mar 2018

Europe -DG Health and Food Safety

5-3-2018

Insulatard (Novo Nordisk A/S)

Insulatard (Novo Nordisk A/S)

Insulatard (Active substance: Insulin human (rDNA)) - Centralised - Yearly update - Commission Decision (2018)1412 of Mon, 05 Mar 2018

Europe -DG Health and Food Safety

5-3-2018

Protaphane (Novo Nordisk A/S)

Protaphane (Novo Nordisk A/S)

Protaphane (Active substance: Insulin human (rDNA)) - Centralised - Yearly update - Commission Decision (2018)1413 of Mon, 05 Mar 2018

Europe -DG Health and Food Safety

5-3-2018

Mixtard (Novo Nordisk A/S)

Mixtard (Novo Nordisk A/S)

Mixtard (Active substance: Insulin human (rDNA)) - Centralised - Yearly update - Commission Decision (2018)1415 of Mon, 05 Mar 2018

Europe -DG Health and Food Safety

5-3-2018

Jalra (Novartis Europharm Limited)

Jalra (Novartis Europharm Limited)

Jalra (Active substance: vildagliptin) - Centralised - Yearly update - Commission Decision (2018)1421 of Mon, 05 Mar 2018

Europe -DG Health and Food Safety

5-3-2018

GONAL-f (Merck Serono Europe Limited)

GONAL-f (Merck Serono Europe Limited)

GONAL-f (Active substance: Follitropin alfa) - Centralised - Yearly update - Commission Decision (2018)1411 of Mon, 05 Mar 2018

Europe -DG Health and Food Safety

5-3-2018

BiResp Spiromax (Teva Pharma B.V.)

BiResp Spiromax (Teva Pharma B.V.)

BiResp Spiromax (Active substance: budesonide / formoterol) - Centralised - Yearly update - Commission Decision (2018)1410 of Mon, 05 Mar 2018

Europe -DG Health and Food Safety

5-3-2018

Galvus (Novartis Europharm Limited)

Galvus (Novartis Europharm Limited)

Galvus (Active substance: vildagliptin) - Centralised - Yearly update - Commission Decision (2018)1420 of Mon, 05 Mar 2018

Europe -DG Health and Food Safety

5-3-2018

Ameluz (Biofrontera Bioscience GmbH)

Ameluz (Biofrontera Bioscience GmbH)

Ameluz (Active substance: 5-Aminolaevulinic acid) - Centralised - 2-Monthly update - Commission Decision (2018)1424 of Mon, 05 Mar 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2204/II/27G

Europe -DG Health and Food Safety

5-3-2018

Xiliarx (Novartis Europharm Limited)

Xiliarx (Novartis Europharm Limited)

Xiliarx (Active substance: vildagliptin) - Centralised - Yearly update - Commission Decision (2018)1423 of Mon, 05 Mar 2018

Europe -DG Health and Food Safety

5-3-2018

EU/3/16/1789 (La Jolla Pharmaceutical II BV)

EU/3/16/1789 (La Jolla Pharmaceutical II BV)

EU/3/16/1789 (Active substance: Synthetic human hepcidin) - Transfer of orphan designation - Commission Decision (2018)1427 of Mon, 05 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/144/16/T/02

Europe -DG Health and Food Safety

5-3-2018

EU/3/15/1555 (La Jolla Pharmaceutical II BV)

EU/3/15/1555 (La Jolla Pharmaceutical II BV)

EU/3/15/1555 (Active substance: Synthetic hepcidin) - Transfer of orphan designation - Commission Decision (2018)1426 of Mon, 05 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/15/T/02

Europe -DG Health and Food Safety

5-3-2018

EU/3/12/975 (Voisin Consulting S.A.R.L.)

EU/3/12/975 (Voisin Consulting S.A.R.L.)

EU/3/12/975 (Active substance: Carbetocin) - Transfer of orphan designation - Commission Decision (2018)1425 of Mon, 05 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/119/11/T/01

Europe -DG Health and Food Safety

26-2-2018

Dynastat (Pfizer Limited)

Dynastat (Pfizer Limited)

Dynastat (Active substance: Parecoxib ) - Centralised - Yearly update - Commission Decision (2018)1234 of Mon, 26 Feb 2018

Europe -DG Health and Food Safety

26-2-2018

Eucreas (Novartis Europharm Limited)

Eucreas (Novartis Europharm Limited)

Eucreas (Active substance: vildagliptin / metformin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)1235 of Mon, 26 Feb 2018

Europe -DG Health and Food Safety

26-2-2018

Zurampic (GrUnenthal GmbH)

Zurampic (GrUnenthal GmbH)

Zurampic (Active substance: lesinurad) - Centralised - Yearly update - Commission Decision (2018)1233 of Mon, 26 Feb 2018

Europe -DG Health and Food Safety

26-2-2018

Trulicity (Eli Lilly Nederland B.V.)

Trulicity (Eli Lilly Nederland B.V.)

Trulicity (Active substance: dulaglutide) - Centralised - 2-Monthly update - Commission Decision (2018)1236 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2825/II/22

Europe -DG Health and Food Safety

26-2-2018

EU/3/18/1988 (Chiesi Farmaceutici S.p.A.)

EU/3/18/1988 (Chiesi Farmaceutici S.p.A.)

EU/3/18/1988 (Active substance: (R)-2-(5-cyano-2-(6-(methoxycarbonyl)-7-methyl-3-oxo-8-(3-(trifluoromethyl)phenyl)-2,3,5,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrimidine-5-yl)phenyl)-N,N,N-trimethylethanaminium methanesulfonate dehydrate) - Orphan designation - Commission Decision (2018)1255 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/203/17

Europe -DG Health and Food Safety

26-2-2018

EU/3/18/1987 (Richardson Associates Regulatory Affairs Ltd)

EU/3/18/1987 (Richardson Associates Regulatory Affairs Ltd)

EU/3/18/1987 (Active substance: Vocimagene amiretrorepvec) - Orphan designation - Commission Decision (2018)1254 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/185/17

Europe -DG Health and Food Safety

26-2-2018

EU/3/18/1986 (UCB Biopharma SPRL)

EU/3/18/1986 (UCB Biopharma SPRL)

EU/3/18/1986 (Active substance: Seletalisib) - Orphan designation - Commission Decision (2018)1253 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/205/17

Europe -DG Health and Food Safety

26-2-2018

EU/3/18/1985 (Raremoon Consulting Ltd)

EU/3/18/1985 (Raremoon Consulting Ltd)

EU/3/18/1985 (Active substance: Rusalatide acetate) - Orphan designation - Commission Decision (2018)1252 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/221/17

Europe -DG Health and Food Safety

26-2-2018

EU/3/18/1984 (Omeros London Limited)

EU/3/18/1984 (Omeros London Limited)

EU/3/18/1984 (Active substance: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2) - Orphan designation - Commission Decision (2018)1251 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/200/17

Europe -DG Health and Food Safety

26-2-2018

EU/3/18/1983 (Medicure Pharma Europe Limited)

EU/3/18/1983 (Medicure Pharma Europe Limited)

EU/3/18/1983 (Active substance: Pyridoxal 5'-phosphate) - Orphan designation - Commission Decision (2018)1250 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/201/17

Europe -DG Health and Food Safety

26-2-2018

EU/3/18/1982 (ATXA Therapeutics Limited)

EU/3/18/1982 (ATXA Therapeutics Limited)

EU/3/18/1982 (Active substance: N-(tert-butylcarbamoyl)-5-cyano-2-((4'-(difluoromethoxy)-[1,1'-biphenyl]-3-yl)oxy)benzenesulfonamide) - Orphan designation - Commission Decision (2018)1249 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/199/17

Europe -DG Health and Food Safety

26-2-2018

EU/3/18/1981 (Midatech Pharma Plc)

EU/3/18/1981 (Midatech Pharma Plc)

EU/3/18/1981 (Active substance: Mertansine functionalised gold nanoconjugate) - Orphan designation - Commission Decision (2018)1248 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/312/16

Europe -DG Health and Food Safety

26-2-2018

EU/3/18/1980 (Orion Corporation)

EU/3/18/1980 (Orion Corporation)

EU/3/18/1980 (Active substance: Levosimendan) - Orphan designation - Commission Decision (2018)1247 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/174/17

Europe -DG Health and Food Safety

26-2-2018

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Active substance: Human monoclonal IgG2 antibody against tissue factor pathway inhibitor) - Orphan designation - Commission Decision (2018)1246 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/189/17

Europe -DG Health and Food Safety

26-2-2018

EU/3/18/1978 (Richardson Associates Regulatory Affairs Ltd)

EU/3/18/1978 (Richardson Associates Regulatory Affairs Ltd)

EU/3/18/1978 (Active substance: Flucytosine) - Orphan designation - Commission Decision (2018)1245 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/198/17

Europe -DG Health and Food Safety

26-2-2018

EU/3/18/1977 (GW Research Ltd)

EU/3/18/1977 (GW Research Ltd)

EU/3/18/1977 (Active substance: Cannabidivarin) - Orphan designation - Commission Decision (2018)1244 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/215/17

Europe -DG Health and Food Safety

26-2-2018

EU/3/18/1976 (UniversitAtsmedizin der Johannes Gutenberg-UniversitAt Mainz)

EU/3/18/1976 (UniversitAtsmedizin der Johannes Gutenberg-UniversitAt Mainz)

EU/3/18/1976 (Active substance: Allogeneic CD4+ and CD25+ T lymphocytes ex vivo incubated with GP120) - Orphan designation - Commission Decision (2018)1243 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/150/17

Europe -DG Health and Food Safety

26-2-2018

EU/3/18/1975 (Nightstar Therapeutics plc)

EU/3/18/1975 (Nightstar Therapeutics plc)

EU/3/18/1975 (Active substance: Adenovirus-associated viral vector serotype 8 containing the human RPGR gene) - Orphan designation - Commission Decision (2018)1242 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/220/17

Europe -DG Health and Food Safety

26-2-2018

EU/3/18/1974 (Takeda Pharma A/S)

EU/3/18/1974 (Takeda Pharma A/S)

EU/3/18/1974 (Active substance: 6-{[(1R,2S)-2-aminocyclohexyl]amino}-7-fluoro-4-(1-methyl-1H-pyrazol-4-yl)-1,2-dihydro-3H-pyrrolo[3,4-c]pyridin-3-one monocitrate) - Orphan designation - Commission Decision (2018)1257 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/193/17

Europe -DG Health and Food Safety