natgillin/translations-raw huggingface dataset:
Storbritannien Pliva Pharma Ltd; Vision House; Bedford Road; Petersfield, Hampshire GU32 3QB; UK
Pliva Pharma Ltd; Vision House; Bedford Road; Petersfield, Hampshire GU32 3QB; UK
Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
Netherlands Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
Storbritannien Dr Reddy's Laboratories (UK) Limited; 208-214 York Road, London SW11 3SD; UK
Dr Reddy's Laboratories (UK) Limited; 208-214 York Road, London SW11 3SD; UK
BILAG 1 LISTE OVER LÆGEMIDLERNES SÆRNAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJ OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danmark Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark
Denmark Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark
Grœkenland KLEVA, 189 Parnithos, 13671 Aharne Attikis, Greece
KLEVA, 189 Parnithos, 13671 Aharne Attikis, Greece
SNRI påvirker noradrenalin- og serotonin-neurotransmittere
SNRIs work on the norepinephrine and serotonin neurotransmitters
Merck Generics BV Dieselweg 25
Netherlands Merck Generics BV Dieselweg 25
Storbritannien Wessex Fine Chemicals Limited, Thornhill Works, Coolham, West Sussex RH13 8QN; UK
Wessex Fine Chemicals Limited, Thornhill Works, Coolham, West Sussex RH13 8QN; UK
Storbritannien Waymade PLC, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR; UK
Waymade PLC, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR; UK
CHMP var enige om, at der forelå potentielle tegn på øget selvmordsadfærd, herunder selvmordsforsøg og selvmordstanker og/eller relateret adfærd som f.eks. selvbeskadigelse, fjendtlighed og humørlabilitet hos børn og unge, der behandles med SSRI og SNRI.
The CHMP agreed that there was a potential signal of an increase in suicidal behaviour, including suicide attempts and suicidal ideation and/or related behaviour like self-harm, hostility and mood lability in children and adolescents treated with SSRIs and SNRIs.
Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
Netherlands Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
Tyskland Merz Pharmaceuticals GmbH Eckenheimer Landstr.
Merz Pharmaceuticals GmbH Eckenheimer Landstr.
Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
Netherlands Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
Tyskland 1 A Pharma GmbH Keltenring 1 + 3
1 A Pharma GmbH Keltenring 1 + 3
Desuden gøres opmærksom på, at patienter under 18 år har øget risiko for bivirkninger som f.eks. selvmordsforsøg, selvmordstanker og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede), når de behandles med denne klasse af lægemidler.
Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.
Grœkenland FAMAR ABE, P.Marinopopulou 7, P.O Box 3327 17456 Kalamaki, Greece
FAMAR ABE, P.Marinopopulou 7, P.O Box 3327 17456 Kalamaki, Greece
2 SNRI står for ‘Serotonin-Norepinephrine Reuptake Inhibitor' (serotonin-noradrenalin-genoptagelseshæmmer).
2 SNRI stands for ‘Serotonin-Norepinephrine Reuptake Inhibitor'.
Danmark Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
Denmark Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
Netherlands Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
Tyskland SIEMENS & CO Postfach 1262
SIEMENS & CO Postfach 1262
Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
Netherlands Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
Grœkenland FARMEDIA AE, 2 B Aigaiou Pelagous, 15343 Agia Paraskevi, Greece
FARMEDIA AE, 2 B Aigaiou Pelagous, 15343 Agia Paraskevi, Greece
Tyskland AAI Deutschland GmbH & Co.KG Wegenerstr.
AAI Deutschland GmbH & Co.KG Wegenerstr.
Tyskland PharmaSelect GmbH Am Saegewerk 13
PharmaSelect GmbH Am Saegewerk 13
Slovenien Merck, Proizvodnja in prodaja farmacevtskih in kemijskih proizvodov, d.o.o., Dunajska 156, SI1000 Ljubljana, Slovenia
Merck, Proizvodnja in prodaja farmacevtskih in kemijskih proizvodov, d.o.o., Dunajska 156, SI1000 Ljubljana, Slovenia
Grœkenland HELP, 4 Valaoritou, 14452 Metamorfosi Attikis, Greece
HELP, 4 Valaoritou, 14452 Metamorfosi Attikis, Greece
IV.2 ÆNDRINGER I DE RELEVANTE DELE AF INDLÆGSSEDLEN FOR ATOMOXETIN
IV.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE PL FOR ATOMOXETINE
Storbritannien Teva Pharmaceuticals Limited, Barclays House, 1 Gatehouse Way, Aylesbury, Bucks HP19 8DB; UK
Teva Pharmaceuticals Limited, Barclays House, 1 Gatehouse Way, Aylesbury, Bucks HP19 8DB; UK
Storbritannien CP Pharmaceuticals Limited, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK
CP Pharmaceuticals Limited, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK
Storbritannien Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Republic of Ireland
Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Republic of Ireland
Tyskland Holsten Pharma GmbH Im Buergerstock 7
Holsten Pharma GmbH Im Buergerstock 7
Slovenien SALUS Ljubljana, d.d., Mašera Spasićeva ulica 10, SI-1000 Ljubljana, Slovenia
SALUS Ljubljana, d.d., Mašera Spasićeva ulica 10, SI-1000 Ljubljana, Slovenia
Tyskland Winthrop Arzneimittel GmbH Industriestr.
Winthrop Arzneimittel GmbH Industriestr.
Grœkenland ALLERTEC HELLAS AE, 20 Phaethonos, 55132 N.Krini Thessaloniki, Greece
ALLERTEC HELLAS AE, 20 Phaethonos, 55132 N.Krini Thessaloniki, Greece
Danmark Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
Denmark Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
Tyskland HEXAL AG Postfach 1263
HEXAL AG Postfach 1263
Tyskland TEVA Generics GmbH Kandelstr.
TEVA Generics GmbH Kandelstr.
Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts
Netherlands Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts
- Udvalget konkluderede på baggrund af de tilgængelige data fra kliniske undersøgelser, at der er signaler på selvmordsadfærd, herunder selvmordsforsøg og selvmordstanker og/eller relateret adfærd, f.eks. selvbeskadigelse, fjendtlighed og humørlabilitet hos børn og unge, der behandles med selektive serotonin-genoptagelseshæmmere og serotonin-noradrenalingenoptagelseshæmmere, såsom de ovennævnte lægemidler.
- The Committee, in view of available data from clinical trials, concluded that there is a signal of suicidal behaviour, including suicide attempts and suicidal ideation and/or related behaviour like self-harm, hostility and mood lability in children and adolescents treated with Selective Serotonin Reuptake Inhibitors and Serotonin-Norepinephrine Reuptake Inhibitors, such as the medicinal products mentioned above;
Grœkenland LUNDBECK HELLAS, 64a Kifissias Aven, 15125 Maroussi, Greece
LUNDBECK HELLAS, 64a Kifissias Aven, 15125 Maroussi, Greece
GenRx B.V., Postbus 75, NL-6920 AB Duiven
Netherlands GenRx B.V., Postbus 75, NL-6920 AB Duiven
Storbritannien SmithKline Beecham Phamraceuticals Limited, Stockley Park West, Uxbridge, Middx UB11 1BT, UK
SmithKline Beecham Phamraceuticals Limited, Stockley Park West, Uxbridge, Middx UB11 1BT, UK
Grœkenland REMEDINA, 25 Gounari & Areos, 13451 Kamatero Attikis, Greece
REMEDINA, 25 Gounari & Areos, 13451 Kamatero Attikis, Greece
Storbritannien Ratiopharm UK Limited, 5 Jackson Close, Grove Road, Cosham, Portsmouth, Hants PO6 1UP; UK
Ratiopharm UK Limited, 5 Jackson Close, Grove Road, Cosham, Portsmouth, Hants PO6 1UP; UK
Holland ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
Netherlands ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
Tyskland Desitin Arzneimittel GmbH Postfach 630164
Desitin Arzneimittel GmbH Postfach 630164
AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
Netherlands AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
Grœkenland RAFARM AEBEE, Kapodistriou & Korinthou 12, 15451 N.Psyhiko, Greece
RAFARM AEBEE, Kapodistriou & Korinthou 12, 15451 N.Psyhiko, Greece
Slovenien Wyeth Whitehall, Podružnica v Sloveniji, Topniška 4a, SI-1000
Wyeth Whitehall, Podružnica v Sloveniji, Topniška 4a, SI-1000 Ljubljana, Slovenia
Storbritannien Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
Danmark Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
Denmark Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
Danmark Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
Denmark Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
Netherlands Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
Der gøres opmærksom på, at sjældne, alvorlige psykiatriske bivirkninger ligesom ved anvendelse af andre psykotrope lægemidler ikke kan udelukkes.
Also you should know that as with other psychotropic medication, the possibility of rare, serious psychiatric adverse effects cannot be excluded.
Storbritannien Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX; UK
Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX; UK
Slovenien GlaxoSmithKline d.o.o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, SI-1000 Ljubljana, Slovenia
GlaxoSmithKline d.o.o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, SI-1000 Ljubljana, Slovenia
Grœkenland ANTOR EPE, 4 Omirou Street, Maroussi Attikis 15126, Greece
ANTOR EPE, 4 Omirou Street, Maroussi Attikis 15126, Greece
Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Netherlands Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Grœkenland BIOMEDICA-CHEMICA AE, 25 G.LYRA 14564 K.Kifissia, Greece
BIOMEDICA-CHEMICA AE, 25 G.LYRA 14564 K.Kifissia, Greece
Grœkenland SOLVAY PHARMA, 63 Agiou Dimitriou 17456 Alimos, Greece
SOLVAY PHARMA, 63 Agiou Dimitriou 17456 Alimos, Greece
Danmark 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
Denmark 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
Zoloft 25 mg + 50 mg 25 mg + 50 mg Filmovertrukket tablet
Zoloft 25 mg + 50 mg 25 mg + 50 mg Film-coated tablet
Grœkenland ELPEN AE, 21Km Leoforos Marathonos, 19009 Pikermi Attikis, Greece
ELPEN AE, 21Km Leoforos Marathonos, 19009 Pikermi Attikis, Greece
Danmark Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
Denmark Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Netherlands Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Danmark PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
Denmark PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
Cipralex Orale dråber
Cipralex Oral Drops
Grœkenland ORGANON HELLAS Vouliagmenis Avenue 122 P.O Box 73893, 16777
ORGANON HELLAS Vouliagmenis Avenue 122 P.O Box 73893, 16777 Elliniko, Greece
Grœkenland PHARMACYPRIA HELLAS, 6 Paster, 11521 Ampelokipi Athens, Greece
PHARMACYPRIA HELLAS, 6 Paster, 11521 Ampelokipi Athens, Greece
Grœkenland VERISFIELD LTD UK, 41 Chalton Street, London, NW1 1JD, U.K.
VERISFIELD LTD UK, 41 Chalton Street, London, NW1 1JD, U.K.
Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Netherlands Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
III.2 ÆNDRINGER I DE RELEVANTE DELE AF PRODUKTRESUMEET FOR ATOMOXETIN
III.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE SPC FOR ATOMOXETINE
Tyskland Neuraxpharm Arzneimittel GmbH & Co.KG
Neuraxpharm Arzneimittel GmbH & Co.KG
BILAG IV ÆNDRINGER I INDLÆGSSEDLEN
ANNEX IV AMENDMENTS TO THE PACKAGE LEAFLET
Storbritannien Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
Tyskland Esparma GmbH Postfach 1461
Esparma GmbH Postfach 1461
Slovenien Torrex Pharma, d.o.o., Trdinova 4, SI1000 Ljubljana, Slovenia
Torrex Pharma, d.o.o., Trdinova 4, SI1000 Ljubljana, Slovenia
Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Netherlands Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Netherlands Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Tyskland Krewel Meuselbach GmbH Postfach 1263
Krewel Meuselbach GmbH Postfach 1263
BILAG III ÆNDRINGER I PRODUKTRESUMEET
ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS
Tyskland Hormosan-Kwizda GmbH Postfach 600340
Hormosan-Kwizda GmbH Postfach 600340
Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Netherlands Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Grœkenland GLAXOSMITHKLINE AEBE, 266 Kifissias Av 15232 Halandri, Greece
GLAXOSMITHKLINE AEBE, 266 Kifissias Av 15232 Halandri, Greece
Danmark Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
Denmark Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
Grœkenland WYETH HELLAS, Kyprou 126& 25 Martiou, 164 52 Argyroupoli, Greece
WYETH HELLAS, Kyprou 126& 25 Martiou, 164 52 Argyroupoli, Greece
Grœkenland GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli Greece
GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli Greece
Tyskland Merck dura GmbH Postfach 100635
Merck dura GmbH Postfach 100635
Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Netherlands Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Grœkenland ALLEN FARMAKEUTIKI AE, 34 Filellinon Street, 15232 Halandri, Greece
ALLEN FARMAKEUTIKI AE, 34 Filellinon Street, 15232 Halandri, Greece
Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Netherlands Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Danmark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Denmark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Pharmaceutical Works Polpharma S.A., ul.
Lithuania Pharmaceutical Works Polpharma S.A., ul.
Danmark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Denmark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Tyskland Solvay Arzneimittel GmbH Postfach 220
Solvay Arzneimittel GmbH Postfach 220
Danmark Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Denmark Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Tyskland Sandoz Pharmaceuticals GmbH Dieselstr.
Sandoz Pharmaceuticals GmbH Dieselstr.
Danmark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Denmark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Tyskland Juta Pharma GmbH Gutenbergstr.
Juta Pharma GmbH Gutenbergstr.
Tyskland IIP-Institut fuer industrielle Pharmazie Benzstr.
IIP-Institut fuer industrielle Pharmazie Benzstr.
Storbritannien Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
Grœkenland GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli, Greece
GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli, Greece
Danmark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Denmark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Storbritannien Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
Danmark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Denmark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Netherlands Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Netherlands Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Oral opløsning, enkelt dosis Oral anvendelse
Oral solution, single dose Oral use
Tyskland Pharmacia GmbH Pfizerstr.
Pharmacia GmbH Pfizerstr.
Storbritannien Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Storbritannien Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20
Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20 8RB, UK
Tyskland Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
Koncentrat til oral opløsning Oral anvendelse
Concentrate for oral solution Oral use
Danmark Merck NM AB, Ynglingagatan 14, 11347, P.Box 22033, S-10435
Denmark Merck NM AB, Ynglingagatan 14, 11347, P.Box 22033, S-10435
Danmark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Denmark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Tyskland Heumann Pharma GmbH & Co. Generica KG
Heumann Pharma GmbH & Co. Generica KG
Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Netherlands Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Tyskland BC Biochemie Pharma GmbH Dieselstr.
BC Biochemie Pharma GmbH Dieselstr.
Danmark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Denmark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Tyskland Boehringer Ingelheim Pharma GmbH & Co.KG
Boehringer Ingelheim Pharma GmbH & Co.KG
Tyskland Wyeth Pharma GmbH Postfach 8806
Wyeth Pharma GmbH Postfach 8806
1 The Cam Centre Wilbury Way
Wilbury Way
Depotkapsel, blød
Capsule, soft
Tyskland Generics (UK) Ltd. Frankfurter Str. 129a D-64293 Darmstadt
Frankfurter Str. 129a D-64293 Darmstadt
KG) Van-der-Smissen-Str. 1
Van-der-Smissen-Strasse 1
Fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) og emotionel labilitet blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med [særnavn] sammenholdt med gruppen behandlet med placebo.
Hostility (predominantly aggression, oppositional behaviour and anger) and emotional lability were more frequently observed in clinical trials among children and adolescents treated with [Invented Name] compared to those treated with placebo.
Tyskland STADA GmbH Stadastr.
STADA GmbH Stadastr.
Slovenien Medis, Podjetje za proizvodnjo in trženje d.o.o., Brnčičeva 1, SI-1001
Medis, Podjetje za proizvodnjo in trženje d.o.o., Brnčičeva 1, SI-1001 Ljubljana, Slovenia
Storbritannien Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Storbritannien Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Storbritannien Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Netherlands Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Netherlands Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Grœkenland NOVEXAL HELLAS, Agiou Dimitriou 25 17455 Kalamaki Greece
NOVEXAL HELLAS, Agiou Dimitriou 25 17455 Kalamaki Greece
Grœkenland PHARMATEN, 6 Dervenakion, 15351 Pallini Attikis, Greece
PHARMATEN, 6 Dervenakion, 15351 Pallini Attikis, Greece
Tyskland Synthon B.V.
Synthon B.V.
Hexal AG, Postfach 1263, D-83602 Holzkirchen
Netherlands Hexal AG, Postfach 1263, D-83602 Holzkirchen
Grœkenland NOVARTIS HELLAS, 12 Km National Road Athinon-Lamias, 14410 Metamorfosi, Greece
NOVARTIS HELLAS, 12 Km National Road Athinon-Lamias, 14410 Metamorfosi, Greece
Storbritannien Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Tyskland Hennig Arzneimittel GmbH & Co.KG Postfach 1240
Hennig Arzneimittel GmbH & Co.KG Postfach 1240
Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Netherlands Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Grœkenland FARAN, Ahaias & trizinias, 14564 N.Kifissia, Greece
FARAN, Ahaias & trizinias, 14564 N.Kifissia, Greece
Grœkenland ANFARM HELLAS AE K.Paleologou& Perikleous 27 15232 Halandri, Greece
ANFARM HELLAS AE K.Paleologou& Perikleous 27 15232 Halandri, Greece
Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739 Langefeld
Netherlands Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
Storbritannien Tillomed Laboratories Limited; 3 Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Netherlands Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Grœkenland NOVEXAL HELLAS, Agiou Dimitriou 25, 17455 Kalamaki, Greece
NOVEXAL HELLAS, Agiou Dimitriou 25, 17455 Kalamaki, Greece
Estland Estland ALPHARMA Whiddon ValleyBarnstaple, North Devon EX 32 8NS, England
ALPHARMA Whiddon ValleyBarnstaple, North Devon EX 32 8NS, England
BEXAL S.A. Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
Belgium BEXAL S.A. Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Netherlands Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Laboratoires S.M.B.
S.A. Laboratoires S.M.B.
Grœkenland GENEPHARM AEBE, 18 Km Marathonos Av., 15351 Palini Attikis, Greece
GENEPHARM AEBE, 18 Km Marathonos Av., 15351 Palini Attikis, Greece
Grœkenland BROS, Avgis &Galinis 15, 14564 N.kifissia, Greece
BROS, Avgis &Galinis 15, 14564 N.kifissia, Greece
Grœkenland PFIZER HELLAS, 5 Alketou, 116 33 Athens, Greece
PFIZER HELLAS, 5 Alketou, 116 33 Athens, Greece
Storbritannien Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Grœkenland ALVIA AE, 18Km Leoforos Marathonos, 15344 Pallini Attikis, Greece
ALVIA AE, 18Km Leoforos Marathonos, 15344 Pallini Attikis, Greece
Danmark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Denmark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Entact Orale dråber
Entact Oral Drops
Danmark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Denmark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
- Udvalget behandlede sagen, der var indbragt i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer, vedrørende lægemidler indeholdende atomoxetin, citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin og venlafaxin.
Whereas - The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing atomoxetine, citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine;
CITALOPRAM, ESCITALOPRAM, ATOMOXETIN, VENLAFAXIN, MIANSERIN, MILNACIPRAN, REBOXETIN OG MIRTAZAPIN (se bilag I)
CITALOPRAM, ESCITALOPRAM, VENLAFAXINE, MIANSERINE, MILNACIPRAN, REBOXETINE AND MIRTAZAPINE
Tyskland Aliud Pharma GmbH & Co.KG Postfach 1380
Aliud Pharma GmbH & Co.KG Postfach 1380
Tyskland Temmler Pharma GmbH & Co.KG Postfach 2269
Temmler Pharma GmbH & Co.KG Postfach 2269
Danmark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Denmark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Danmark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Denmark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Tyskland Rodleben Pharma GmbH Postfach 205
Rodleben Pharma GmbH Postfach 205
Storbritannien Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22
Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG; UK
Tyskland TAD Pharma GmbH Postfach 720
TAD Pharma GmbH Postfach 720
Filmovertrukket tablets
Film-coated tablets
Rue-de-la-Pastorale 26-28
Rue-de-la-Pastorale 26-28 B-1080 Bruxelles