natgillin/translations-raw huggingface dataset:
Danmark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Denmark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Danmark Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
Denmark Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
Storbritannien Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
ICN Polfa Rzeszow, ul.
Lithuania ICN Polfa Rzeszow, ul.
Danmark Generics (UK) Ltd., Station Close, Potters Bar, UK-EN61TL
Denmark Generics (UK) Ltd., Station Close, Potters Bar, UK-EN61TL
Danmark Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Denmark Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Danmark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Denmark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Storbritannien Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Danmark Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Denmark Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Storbritannien Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Danmark Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Denmark Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Storbritannien Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Netherlands KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Slovenien Eli Lilly Holdings Limited, Kingsclere Road, Basinstoke, Hampshire RG21
Lithuania Eli Lilly Holdings Limited, Kingsclere Road, Basing Stoke, Hampshire, RG21
Danmark Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Denmark Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Grœkenland UNI-PHARMA AEBE, 14 Km National Road Athinon-Lamias, 14564 K.kifissia, Greece
UNI-PHARMA AEBE, 14 Km National Road Athinon-Lamias, 14564 K.kifissia, Greece
Danmark Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Denmark Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Netherlands Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
20 mg/0,5 ml Koncentrat til infusionsvœske, opløsning
20 mg/0,5 ml Concentrate for solution for infusion
Koncentrat til injektionsvœske til opløsning
Concentrate for solution for injection
- Med hensyn til atomoxetin, som kun er indiceret til behandling af ADHD, konkluderede udvalget, at der i produktresumeet og de relevante dele af indlægssedlen for lægemidler indeholdende atomoxetin skulle indføjes dels en advarsel om, at fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) og emotionel labilitet blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med atomoxetin i forhold til gruppen behandlet med placebo, dels en advarsel om manglende virkning ved behandling af depression har CHMP anbefalet, at markedsføringstilladelserne for lægemidlerne nævnt i bilag I opretholdes, for hvilke ændringerne af de relevante dele af produktresuméer og indlægssedler er gengivet i henholdsvis bilag III og IV.
- For atomoxetine, which is only indicated in the treatment of ADHD, the Committee concluded that a warning to reflect that hostility (predominantly aggression, oppositional behaviour and anger), and emotional lability were more frequently observed in clinical trials among children and adolescents treated with atomoxetine compared to those treated with placebo and a warning indicating the lack of efficacy in depression should be included in the Summaries of Product Characteristics and relevant section of the Package Leaflets of atomoxetine containing medicinal products.
Storbritannien Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
Storbritannien KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
Storbritannien Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Grœkenland FARMASERV LILLY, 15 Km National Road, Athinon-Lamias, 14564 Kifissia, Greece
FARMASERV LILLY, 15 Km National Road, Athinon-Lamias, 14564 Kifissia, Greece
2, navnlig hvad angår disses brug i den pædiatriske patientgruppe: fluoxetin, fluvoxamin, sertralin, paroxetin, citalopram, escitalopram, atomoxetin, duloxetin, venlafaxin, mianserin, milnacipran, reboxetin og mirtazapin.
1/SNRIs products particularly as regards their use in the paediatric population: fluoxetine, fluvoxamine, sertraline, paroxetine, citalopram, escitalopram, atomoxetine, duloxetine, venlafaxine, mianserine, milnacipran, reboxetine, and mirtazapine.
IV.I ÆNDRINGER I DE RELEVANTE DELE AF INDLÆGSSEDLEN FOR FLUOXETIN, FLUVOXAMIN, SERTRALIN, PAROXETIN, CITALOPRAM, ESCITALOPRAM, VENLAFAXIN, MIANSERIN, MILNACIPRAN, REBOXETIN OG MIRTAZAPIN
IV.I AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE PACKAGE LEAFLET FOR FLUOXETINE, FLUVOXAMINE, SERTRALINE, PAROXETINE, CITALOPRAM, ESCITALOPRAM, VENLAFAXINE, MIANSERINE, MILNACIPRAN, REBOXETINE AND MIRTAZAPINE
Danmark Combino Pharm S.L., C/Fructuos Gelabert 6-8, ES-08970 Sant Joan, Despi, Barc, Spain
Denmark Combino Pharm S.L., C/Fructuos Gelabert 6-8, ES-08970 Sant Joan, Despi, Barc, Spain
Tyskland Neosan Filchnerstr.
Filchnerstr.
Storbritannien Sandoz Limited, 37 Woolmer Way, Bordon, Hants GU35 9QE; UK
Sandoz Limited, 37 Woolmer Way, Bordon, Hants GU35 9QE; UK
Storbritannien Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Storbritannien John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
Grœkenland PHARMABRAND AEBE, 15 Km National Road Athinon-Lamias, 14510 Kifissia, Greece
PHARMABRAND AEBE, 15 Km National Road Athinon-Lamias, 14510 Kifissia, Greece
Orale dråber, opløsning Oral anvendelse
Oral Drops, solution Oral use
Tyskland Lundbeck GmbH Postfach 900662
Lundbeck GmbH Postfach 900662 D-21046 Hamburg
Storbritannien Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, UK
Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, UK
Storbritannien Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
Alfred Tiefenbacher (GmbH & Co.
Netherlands Alfred Tiefenbacher (GmbH & Co. KG)
Danmark Sandoz GmbH, Biochemiestrasse 10, A-6250 Austria
Denmark Sandoz GmbH, Biochemiestrasse 10, A-6250 Austria
Dispergible tablet
Dispersable tablet
Tyskland F. Joh. Kwizda GesmbH Dr. Karl-Lueger-Ring 6
F. Joh. Kwizda GesmbH Dr. Karl-Lueger-Ring 6 A-1010 Wien
Storbritannien Pharmascope Limited, Unit 107, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Pharmascope Limited, Unit 107, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
D-53773 Hennef paroxetin-biomo 20mg 20 mg
Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef paroxetin-biomo 20mg 20 mg
Orale dråber, opløsning
Oral drops, solution
Danmark Solvay Pharmaceuticals B.V., C. J. Houtenlaan 36, NL-1381 CP Weesp, Netherland
Denmark Solvay Pharmaceuticals B.V., C. J. Houtenlaan 36, NL-1381 CP Weesp, Netherland
Tyskland ct-Arzneimittel GmbH Lengeder Str. 42a
Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
Centrafarm Services B.V.
Netherlands Centrafarm Services B.V. Postbus 289
Grœkenland CHRISPA ALFA, PHARMACUTICALS, 16Km Marathonos Av., 15344 Pallini Attikis, GREECE
PHARMACUTICALS, 16Km Marathonos Av., 15344 Pallini Attikis, GREECE
Tyskland Pfizer Pharma GmbH Pfizerstr.
Pfizer Pharma GmbH Pfizerstr.
D-13407 Berlin paroxetin von ct 20 mg Filmtabletten
Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin paroxetin von ct 20 mg Filmtabletten
Storbritannien Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
Danmark Ranbaxy (UK) Limited, 95 Park Lane, Mayfair, UK-W1K7TE, London, GB
Denmark Ranbaxy (UK) Limited, 95 Park Lane, Mayfair, UK-W1K7TE, London, GB
Danmark Synthon BV, Microweg 22, NL-6545 CM, Nijmegen, Netherland
Denmark Synthon BV, Microweg 22, NL-6545 CM, Nijmegen, Netherland
Storbritannien Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks; London E16 2QJ; UK
Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks; London E16 2QJ; UK
Storbritannien Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park;
Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park; Caldecotte; Milton Keynes; Bucks; MK7 8LF; UK
Slovenien KRKA, tovarna zdravil, d.d., Novo mesto, Šmarješka cesta 6, SI-8501
KRKA, tovarna zdravil, d.d., Novo mesto, Šmarješka cesta 6, SI-8501 Novo mesto, Slovenia
Danmark Stada Arzneimittel AG, Staclastrasse 2-18, D-61118 Bad Vibel, Germany
Denmark Stada Arzneimittel AG, Staclastrasse 2-18, D-61118 Bad Vibel, Germany
Danmark Genthon BV, Microweg 22, NL-6545 CM Nijmegen, Netherland
Denmark Genthon BV, Microweg 22, NL-6545 CM Nijmegen, Netherland
Danmark Durascan Medical Products A/S, C. F. TietgensBoulevard 40, DK-5220
Denmark Durascan Medical Products A/S, C. F. TietgensBoulevard 40, DK-5220
Danmark Arrow Generics Limited, Unit 2, Eastman Way, SG14SZ Hertfordshire, GB
Denmark Arrow Generics Limited, Unit 2, Eastman Way, SG14SZ Hertfordshire, GB
Danmark Arrow Generics Limited, Unit 2, Eastman Way, UK-SG1 4SZ, Hertz, GB
Denmark Arrow Generics Limited, Unit 2, Eastman Way, UK-SG1 4SZ, Hertz, GB
Danmark Durascan Medical Products A/S, C. F. Tietgens Boulevard 40, DK-5220
Denmark Durascan Medical Products A/S, C. F. Tietgens Boulevard 40, DK-5220
Sverige ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Tyskland (DEU)
Sweden ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Tyskland (DEU)
Danmark Durascan Medical Products A/S, C. F. Tietgen Boulevard 40, DK-5220
Denmark Durascan Medical Products A/S, C. F. Tietgen Boulevard 40, DK-5220
Storbritannien Pinewood Laboratories, Ballymacabry, Clonmel, Co. Tipperary, Ireland
Pinewood Laboratories, Ballymacabry, Clonmel, Co. Tipperary, Ireland
Slovenien LEK farmacevtska družba d.d., Verovškova 57, SI-1526 Ljubljana, Slovenia
LEK farmacevtska družba d.d., Verovškova 57, SI-1526 Ljubljana, Slovenia
Eli Lilly Holdings Limited, Kingsclere Road, Basing Stoke, Hampshire, RG21 6XA, United Kingdom
Eli Lilly Holdings Limited, Kingsclere Road, Basinstoke, Hampshire RG21 6XA, Great Britain
Storbritannien Apotex Europe Limited, Rowan House, 41 London Street, Reading, Berks RG1 4PS; UK
Apotex Europe Limited, Rowan House, 41 London Street, Reading, Berks RG1 4PS; UK
D-53773 Hennef mirtazepin-biomo 30 mg Filmtabletten
Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef mirtazepin-biomo 30 mg Filmtabletten
Lœgemiddelform Indgivelsesvej
Pharmaceutical form Route of administration
CHMP konkluderede derfor, at der i produktresumeet og de relevante dele af indlægssedlen for lægemidler indeholdende atomoxetin skulle indføjes dels en advarsel om, at fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) og emotionel labilitet blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med atomoxetin i forhold til gruppen behandlet med placebo, dels en advarsel om manglende virkning ved behandling af depression.
Therefore the CHMP concluded that a warning to reflect that hostility (predominantly aggression, oppositional behaviour and anger) and emotional lability were more frequently observed in clinical trials among children and adolescents treated with atomoxetine compared to those treated with placebo and a warning indicating the lack of efficacy in depression should be included in the Summaries of Product Characteristics and the relevant section of the Package Leaflets of atomoxetine containing medicinal products.
Danmark Laboratoires IREX, 22 Avenue Galilée, 92350 Le Plessis Robinson, France
Denmark Laboratoires IREX, 22 Avenue Galilée, 92350 Le Plessis Robinson, France
Dispergible tablets
Dispersible tablets
Danmark HEXAL A/S, Kanalholmen 8-12, DK2650 Hvidovre
Denmark HEXAL A/S, Kanalholmen 8-12, DK2650 Hvidovre
Pinewood Laboratories Ltd., Ballymacarbry, IE-Clonmel, Co. Tipperary
Netherlands Pinewood Laboratories Ltd., Ballymacarbry, IE-Clonmel, Co. Tipperary
D-53773 Hennef mirtazapin-biomo 45 mg Filmtabletten
Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef mirtazapin-biomo 45 mg Filmtabletten
CHMP konkluderede, at der i produktresumeet og de relevante dele af indlægssedlen for lægemidler indeholdende citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin og venlafaxin skulle indføjes en advarsel om, at selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med antidepressive midler i forhold til gruppen behandlet med placebo.
The CHMP concluded that a warning to reflect that suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo, should be included in the Summaries of Product Characteristics and relevant section of the Package Leaflets of citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine containing medicinal products.
VENLAFAXIN indeholder medicinsk product med markeføringstilladelse i den Europœiske Union Medlems land Indehaver af markedsføringstilladelsen
VENLAFAXINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Storbritannien H Lundbeck A/S; Ottliliavej 9; DK 2500 Valby; Copenhagen; Denmark
H Lundbeck A/S; Ottliliavej 9; DK 2500 Valby; Copenhagen; Denmark
Danmark Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vibel, Germany
Denmark Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vibel, Germany
Danmark N.V.
Denmark N.V. Organon, P.O.
Oral vœske
Oral soulution
D-53773 Hennef mirtazapin-biomo 15 mg Filmtabletten
Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef mirtazapin-biomo 15 mg Filmtabletten
I.C.C.
Netherlands I.C.C.
D-53773 Hennef fluoxetin-biomo 20mg Kapseln
Germany biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef fluoxetin-biomo 20mg Kapseln
Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel
Netherlands Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel
Oral use
Oropharyngeal use
MIRTAZAPIN indeholder medicinsk product med markeføringstilladelse i den Europœiske Union Medlems land Indeholder af markedsforings tilladelsen
MIRTAZAPINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
- CHMP konkluderede derfor, at der i produktresumeet og de relevante dele af indlægssedlen for lægemidler indeholdende citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin og venlafaxin skulle indføjes en advarsel om, at selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med antidepressive midler i forhold til gruppen behandlet med placebo.
- The Committee, as a consequence, concluded that a warning to reflect that suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo, should be included in the Summaries of Product Characteristics and relevant section of the Package Leaflets of citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine containing medicinal products.
CITALOPRAM indeholder medicinsk product med markeføringstilladelse i den Europœiske Union Medlems land Indehaver af markedsføringstilladelsen
CITALOPRAM containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
MILNACIPRAN indeholder medicinsk product med markeføringstilladelse i den Europœiske Union Medlems land Indeholder af markedsføringstilladelsen
MILNACIPRAN containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Danmark H. Lundbeck A/S, Ottiliavej 7-9, DK2500 Valby, Denmark
Denmark H. Lundbeck A/S, Ottiliavej 7-9, DK2500 Valby, Denmark
Niche Generics Ltd.
Generics (UK) Ltd.
D-53773 Hennef fluoxetin-biomo 20mg Tabletten
Germany biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef fluoxetin-biomo 20mg Tabletten
Danmark Copyfarm A/S, Energivej 15, DK-5260 Odense S, Denmark
Denmark Copyfarm A/S, Energivej 15, DK-5260 Odense s, Denmark
D-13407 Berlin mirtazapin-ct 45 mg Filmtabletten
Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 45 mg Filmtabletten
Tyskland biomo pharma GmbH Josef-Dietzgen-Str. 3
Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef
Danmark Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria
Denmark Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria
Katwijk Farma B.V.
Netherlands Katwijk Farma B.V. Postbus 408
FLUOXETIN indeholder medicinsk product med markeføringstilladelse i den Europœiske Union Medlems land Indeholder af markedsføringstilladelsen
FLUOXETINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Oral opløsning
Oral suspension
ESCITALOPRAM indeholder medicinsk product med markeføringstilladelse i den Europœiske Union Medlems land Indehaver af markedføringstilladelsen
ESCITALOPRAM containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Overtrukket tablets
Coated tablets
ATOMOXETIN indeholder medicinsk product med markeføringstilladelse i den Europœiske Union Medlemsland Indehaver af markedføringstilladelsen
ATOMOXETINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
D-13407 Berlin mirtazapin-ct 30 mg Filmtabletten
Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 30 mg Filmtabletten
FLUVOXAMIN indeholder medicinsk product med markeføringstilladelse i den Europœiske Union Medlems land Indeholder af markedsføringstilladelsen
FLUVOXAMINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
B-1080 Bruxelles
1050 Bruxelles, Belgium
Danmark HEXAL A/S, Kanalholmen 8-12, DK2650 Hvidovre, Denmark
Denmark HEXAL A/S, Kanalholmen 8-12, DK2650 Hvidovre, Denmark
Storbritannien Ranbaxy (UK) Limited; CP House, 97107 Uxbridge Road, Ealing, London W5 5TL, UK
Ranbaxy (UK) Limited; CP House, 97107 Uxbridge Road, Ealing, London W5 5TL, UK
Danmark Actavis Nordic A/S, Hammervej 7, DK-2970 Hørsholm, Denmark
Denmark Actavis Nordic A/S, Hammervej 7, DK-2970 Hørsholm, Denmark
H. Lundbeck A/S, Ottiliavej 9, DK2500 Valby
Netherlands H. Lundbeck A/S, Ottiliavej 9, DK2500 Valby
Storbritannien Ranbaxy (UK) Limited; CP House, 97107 Uxbridge Road, Ealing, London W5 5TL, U.K.
Ranbaxy (UK) Limited; CP House, 97107 Uxbridge Road, Ealing, London W5 5TL, U.K.
Grœkenland H. LUNDBECK A/S DENMARK, Ottiliave 9, DK-2500, VALBY COPENHAGEN, DENMARK
H. LUNDBECK A/S DENMARK, Ottiliave 9, DK-2500, VALBY COPENHAGEN, DENMARK
D-13407 Berlin mirtazapin-ct 15 mg Filmtabletten
Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 15 mg Filmtabletten
Storbritannien Arrow Generics limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, U.K.
Arrow Generics limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, U.K.
Medlemsland Indehaver af markedsføringstilladelsen
Member State Marketing Authorisation Holder Invented Name
Danmark Ratiopharm GmbH, Grat-Arco-Strasse 3, D-89079 Ulm, Germany
Denmark Ratiopharm GmbH, Grat-Arco-Strasse 3, D-89079 Ulm, Germany
Danmark Actavis Nordic A/S, Hammervej 7, DK- 2970 Hørsholm, Denmark
Denmark Actavis Nordic A/S, Hammervej 7, DK- 2970 Hørsholm, Denmark
Grœkenland SANDOZ AUSTRIA Biochemiestrasse 10, A-6250 Kundl, Austria
SANDOZ AUSTRIA Biochemiestrasse 10, A-6250 Kundl, Austria
Storbritannien Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel, Germany
Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel, Germany
Slovenien Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria
Lithuania Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria
Cipralex 5mg-Filmtabletten 5mg
Cipralex 5mg-Filmtabletten
Storbritannien Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, UK
Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, UK
D-51377 Leverkusen
Basics GmbH Hemmelrather Weg 201 D-51377 Leverkusen
Danmark Ratiopharm GmbH, Graft-Arco-Strasse 3, D-89079 Ulm, Germany
Denmark Ratiopharm GmbH, Graft-Arco-Strasse 3, D-89079 Ulm, Germany
Storbritannien Hexal A/S, Kanalholmen 8-12, Hvidovre, DK-2650, Denmark
Hexal A/S, Kanalholmen 8-12, Hvidovre, DK-2650, Denmark
Danmark Ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm, Germany
Denmark Ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm, Germany
Opløselig tablet
Orodispersible tablets
Grœkenland SANDOZ AUSTRIA, Biochemiestrasse 10, A-6250 Kundl, Austria
SANDOZ AUSTRIA, Biochemiestrasse 10, A-6250 Kundl, Austria
Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl
Netherlands Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl
Koncentrat til oral opløsning Intravenøs anvendelse
Prolonged release capsule Oral use
Kapsel med modificeret udløsning
Modified Release Capsule, hard
Ljubljana, Slovenia
Limassol, Cyprus
GlaxoSmithKline B.V.
Netherlands GlaxoSmithKline B.V. Postbus 780
SERTRALIN indeholder medicinsk product med markeføringstilladelse i den Europœiske Union
SERTRALINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Koncentrat til infusionsvœske, opløsning
Concentrate for Solution for Infusion
1 hætteglas Slagtning: kvæg: 22 dage
Meat and offal: cattle: 22 days.
Subkutan anvendelse Hætteglas 500 ml
Subcutaneous use Vial (glass) 500 ml
Dette sammendrag blev sidst ajourført den 14/03/2011.
This summary was last updated on 14/03/2011.
Den er udbredt i landene omkring Middelhavet.
It is widespread in countries bordering the Mediterranean Sea.
Disse reaktioner forsvinder spontant inden for en periode på fra to dage til to uger.
These reactions resolve spontaneously within two days to two weeks.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for CaniLeish til Virbac S.A. den 14/03/2011.
The European Commission granted a marketing authorisation valid throughout the European Union, for CaniLeish to Virbac S.A. on 14/03/2011.