FrancophonIA/ELRC3.0 huggingface dataset:
English: Only some of these products are authorised for the treatment of children and adolescents with obsessive-compulsive disorder and only one of them for the treatment of Attention Deficit/Hyperactivity Disorder.
Swedish: Bara vissa av dessa produkter är godkända för behandling av barn och ungdomar med tvångssyndrom och bara en av dem för behandling av ADHD.
English: 1 SSRI stands for ‘Serotonin-Selective Reuptake Inhibitor'.
Swedish: 1 SSRI står för Serotonin-Selective Reuptake Inhibitor (selektiv serotoninåterupptagshämmare).
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
Swedish: BILAGA II EMEA:S VETENSKAPLIGA SLUTSATSER OCH SKÄLEN TILL ÄNDRING AV PRODUKTRESUMÉERNA OCH BIPACKSEDLARNA
English: 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
Swedish: BILAGA I FÖRTECKNING ÖVER FANTASINAMN, LÄKEMEDELSFORMER, LÄKEMEDELSSTYRKOR, ADMINISTRERINGSSÄTT OCH INNEHAVARE AV GODKÄNNANDE FÖR FÖRSÄLJNING I MEDLEMSSTATERNA
English: Solvay Pharma 42 rue Rouget de lisle BP 22
Swedish: Frankrike Solvay Pharma 42 rue Rouget de lisle BP 22
English: The Committee also concluded that a different warning was more appropriate for atomoxetine, which is only indicated in the treatment of ADHD.
Swedish: Kommittén fastslog även att det för atomoxetin, som endast indikeras för ADHD, bör ges en annorlunda varning.
English: [Invented Name] is not indicated for the treatment of major depressive episodes and/or anxiety as the results of clinical trials that were conducted in adults did not show any effect compare to placebo, and therefore were negative.
Swedish: [Fantasinamn] är inte indicerat för behandling av egentlig depression och/eller ångesttillstånd, eftersom resultaten från kliniska prövningar med vuxna patienter inte visade några effekter jämfört med placebo och således var negativa.
English: Luxembourg S.M.B.
Swedish: Luxemburg S.M.B.
English: Vajnorská 100/A, SK-841 01 Bratislava
Swedish: Vajnorská 100/A, SK-841 01
English: SSRIs are described as 'selective' because they affect only the reuptake pumps responsible for serotonin.
Swedish: SSRI sägs vara ”selektiva” eftersom de endast berör serotonintransportörerna.
English: Note: This section of the Summary of Product Characteristics is the one that was Annexed to the Commission Decision on this Article 31 referral .
Swedish: Anmärkning: Denna del av produktresumén var bilagd till kommissionens beslut för detta hänskjutande enligt artikel 31.
English: Organon GmbH Mittenheimer Str. 62
Swedish: Tyskland Organon GmbH Mittenheimer Str. 62
English: If your doctor has prescribed [Invented Name] for a patient under 18 and you want to discuss this, please go back to your doctor.
Swedish: Om du är under 18 år och vill diskutera varför du fått detta läkemedel, ska du vända dig till din läkare igen.
English: A/S GEA Farmaceut.
Swedish: Slovakien A/S GEA Farmaceut.
English: Belgium LAGEPHA S.A. Avenue Mercator 1 1300 Wavre, Belgium
Swedish: LAGEPHA S.A. Avenue Mercator 1 1300 Wavre, Belgium
English: Netherlands Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova
Swedish: Nederländerna Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova
English: Synthon Bv Microweg 22
Swedish: Frankrike Synthon Bv Microweg 22
English: KLEVA, 189 Parnithos, 13671 Aharne Attikis, Greece
Swedish: Grekland KLEVA, 189 Parnithos, 13671 Aharne Attikis, Greece
English: Pfizer Luxembourg SARL, 283, route d' Arlon, L-8011 Strassen, Luxembourg
Swedish: Slovenien Pfizer Luxembourg SARL, 283, route d' Arlon, L-8011 Strassen,
English: ELI LILLY ČR s.r.o., Praha, Czech Republic
Swedish: Tjeckien ELI LILLY ČR s.r.o., Praha, Czech Republic
English: Sirowa Riga A/S, Katrīnas dambis 16 Rīga, LV - 1045
Swedish: Lettland Sirowa Riga A/S, Katrīnas dambis 16 Rīga, LV - 1045
English: Solution for infusion Intravenous use
Swedish: Solution for infusion Intravenös användning
English: Solvay Pharmaceuticals B.V., [P.O.Box 900
Swedish: Lettland Solvay Pharmaceuticals B.V., [P.O.Box 900
English: Belgium 3 DDD PHARMA Diestersteenweg 349, 3510 Kermt, Belgium
Swedish: 3 DDD PHARMA Diestersteenweg 349, 3510 Kermt, Belgium
English: STADA Arzneimittel AG Stadastr.
Swedish: Tyskland STADA Arzneimittel AG Stadastr.
English: TORREX PHARMA S.R.O., 140 00 PRAHA
Swedish: Tjeckien TORREX PHARMA S.R.O., 140 00 PRAHA
English: PAS “Grindeks”, Krustpils iela 53 LV-1057, Rīga
Swedish: Lettland PAS “Grindeks”, Krustpils iela 53 LV-1057, Rīga
English: Denmark PSI NV, Kraanlei 27, B-9000 Gent, Belgium
Swedish: Danmark PSI NV, Kraanlei 27, B-9000 Gent, Belgium
English: Molteni Farmaceutici S.p.A. Strada Statale, 76 Loc. Granatieri 50018 Scandicci - Firenze Italy
Swedish: Strada Statale, 76 Loc. Granatieri 50018 Scandicci - Firenze Italy
English: Glaxo Group Limited, Greenford, Middlesex, UB6 ONN
Swedish: Lettland Glaxo Group Limited, Greenford, Middlesex, UB6 ONN
English: HELP, 4 Valaoritou, 14452 Metamorfosi Attikis, Greece
Swedish: Grekland HELP, 4 Valaoritou, 14452 Metamorfosi Attikis, Greece
English: FAMAR ABE, P.Marinopopulou 7, P.O Box 3327 17456 Kalamaki, Greece
Swedish: Grekland FAMAR ABE, P.Marinopopulou 7, P.O Box 3327 17456 Kalamaki, Greece
English: Netherlands Merck Generics BV Dieselweg 25
Swedish: Nederländerna Merck Generics BV Dieselweg 25
English: 23 -25 Avenue du Docteur Lannelongue
Swedish: Frankrike BERAL 23 -25 Avenue du Docteur Lannelongue
English: Pliva Pharma Ltd; Vision House; Bedford Road; Petersfield, Hampshire GU32 3QB; UK
Swedish: Storbritannien Pliva Pharma Ltd; Vision House; Bedford Road; Petersfield, Hampshire GU32 3QB; UK
English: Dr Reddy's Laboratories (UK) Limited; 208-214 York Road, London SW11 3SD; UK
Swedish: Storbritannien Dr Reddy's Laboratories (UK) Limited; 208-214 York Road, London SW11 3SD; UK
English: FARMEDIA AE, 2 B Aigaiou Pelagous, 15343 Agia Paraskevi, Greece
Swedish: Grekland FARMEDIA AE, 2 B Aigaiou Pelagous, 15343 Agia Paraskevi, Greece
English: Luxembourg SOLVAY PHARMA, 3 Avenue du Bourgmestre, E. Demunter, B-1090
Swedish: Luxemburg SOLVAY PHARMA, 3 Avenue du Bourgmestre, E. Demunter, B-1090
English: Denmark Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark
Swedish: Danmark Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark
English: Arrow generiques 26 avenue Tony Garnier 69007 Lyon - France
Swedish: Frankrike Arrow generiques 26 avenue Tony Garnier 69007 Lyon - France
English: 1 A Pharma GmbH Keltenring 1 + 3
Swedish: Tyskland 1 A Pharma GmbH Keltenring 1 + 3
English: Box 7071
Swedish: Postbus 7071
English: Wessex Fine Chemicals Limited, Thornhill Works, Coolham, West Sussex RH13 8QN; UK
Swedish: Storbritannien Wessex Fine Chemicals Limited, Thornhill Works, Coolham, West Sussex RH13 8QN; UK
English: Lithuania Nycomed SEFA AS, Jaama 55B, 63308 Polva, Estonia
Swedish: Nycomed SEFA AS, Jaama 55B, 63308 Polva, Estonia
English: GlaxoSmithKline Slovakia s.r.o.
Swedish: Slovakien GlaxoSmithKline Slovakia s.r.o.
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS
Swedish: SKÄL FÖR ÄNDRING AV PRODUKTRESUMÉERNA
English: Waymade PLC, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR; UK
Swedish: Storbritannien Waymade PLC, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR; UK
English: Netherlands Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts
Swedish: Nederländerna Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts
English: H-1103, Budapest Hungary
Swedish: H-1103, Budapest
English: REMEDINA, 25 Gounari & Areos, 13451 Kamatero Attikis, Greece
Swedish: Grekland REMEDINA, 25 Gounari & Areos, 13451 Kamatero Attikis, Greece
English: 2 SNRI stands for ‘Serotonin-Norepinephrine Reuptake Inhibitor'.
Swedish: 2 SNRI står för Serotonin Norepinephrine Reuptake Inhibitors (serotonin-norepinefrinåterupptagshämmare).
English: Merz Pharmaceuticals GmbH Eckenheimer Landstr.
Swedish: Tyskland Merz Pharmaceuticals GmbH Eckenheimer Landstr.
English: [Invented Name] should normally not be used for children and adolescents under 18 years < except for patients with [approved indication]>.
Swedish: Användning hos barn och ungdomar under 18 år [Fantasinamn] ska normalt inte användas vid behandling av barn och ungdomar under 18 år <, förutom till patienter med [godkänd indikation]>.
English: Netherlands Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
Swedish: Nederländerna Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
English: RAFARM AEBEE, Kapodistriou & Korinthou 12, 15451 N.Psyhiko, Greece
Swedish: Grekland RAFARM AEBEE, Kapodistriou & Korinthou 12, 15451 N.Psyhiko, Greece
English: In addition there were some trials with patients suffering from Attention Deficit/Hyperactivity Disorder (ADHD).
Swedish: Därutöver gjordes några försök med patienter som lider av ADHD.
English: Netherlands Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
Swedish: Nederländerna Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
English: Oral solution, single dose Oral use
Swedish: Oral lösning, enkel dose Oral användning
English: Netherlands Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
Swedish: Nederländerna Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
English: Denmark Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
Swedish: Danmark Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
English: 10 Rue Godefroy Immeuble Optima 92821 Puteaux cedex - France
Swedish: Frankrike ORGANON 10 Rue Godefroy Immeuble Optima 92821 Puteaux cedex - France
English: LUNDBECK HELLAS, 64a Kifissias Aven, 15125 Maroussi, Greece
Swedish: Grekland LUNDBECK HELLAS, 64a Kifissias Aven, 15125 Maroussi, Greece
English: Lange Munteplein 7b 4, 8500
Swedish: Lange Munteplein 7b 4, 8500 Kortrijk, Belgium
English: SIEMENS & CO Postfach 1262
Swedish: Tyskland SIEMENS & CO Postfach 1262
English: ANTOR EPE, 4 Omirou Street, Maroussi Attikis 15126, Greece
Swedish: Grekland ANTOR EPE, 4 Omirou Street, Maroussi Attikis 15126, Greece
English: Luxembourg LUNDBECK S.A., 225 AV. Moliére B-1050 Bruxelles
Swedish: Luxemburg LUNDBECK S.A., 225 AV. Moliére B-1050 Bruxelles
English: Netherlands Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
Swedish: Nederländerna Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
English: PharmaSelect GmbH Am Saegewerk 13
Swedish: Tyskland PharmaSelect GmbH Am Saegewerk 13
English: H - 1103 Budapest HUNGARY
Swedish: H - 1103 Budapest
English: AAI Deutschland GmbH & Co.KG Wegenerstr.
Swedish: Tyskland AAI Deutschland GmbH & Co.KG Wegenerstr.
English: Merck, Proizvodnja in prodaja farmacevtskih in kemijskih proizvodov, d.o.o., Dunajska 156, SI1000 Ljubljana, Slovenia
Swedish: Slovenien Merck, Proizvodnja in prodaja farmacevtskih in kemijskih proizvodov, d.o.o., Dunajska 156, SI1000 Ljubljana, Slovenia
English: ALLERTEC HELLAS AE, 20 Phaethonos, 55132 N.Krini Thessaloniki, Greece
Swedish: Grekland ALLERTEC HELLAS AE, 20 Phaethonos, 55132 N.Krini Thessaloniki, Greece
English: BOUCHARA RECORDATI 68 Rue Marjolin BP 67
Swedish: Frankrike BOUCHARA RECORDATI 68 Rue Marjolin
English: PHARMACIA LTD., MILTON KEYNES, Davy Avenue, Knowlhill, MK5 8PH KnoMilton Keynes, UK
Swedish: Tjeckien PHARMACIA LTD., MILTON KEYNES, Davy Avenue, Knowlhill, MK5 8PH KnoMilton Keynes, UK
English: Belgium OLYMPO PHARMA B.V.B.A.
Swedish: OLYMPO PHARMA B.V.B.A.
English: Teva Pharmaceuticals Limited, Barclays House, 1 Gatehouse Way, Aylesbury, Bucks HP19 8DB; UK
Swedish: Storbritannien Teva Pharmaceuticals Limited, Barclays House, 1 Gatehouse Way, Aylesbury, Bucks HP19 8DB; UK
English: ORGANON HELLAS Vouliagmenis Avenue 122 P.O Box 73893, 16777 Elliniko, Greece
Swedish: Grekland ORGANON HELLAS Vouliagmenis Avenue 122 P.O Box 73893, 16777
English: Netherlands AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
Swedish: Nederländerna AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
English: CP Pharmaceuticals Limited, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK
Swedish: Storbritannien CP Pharmaceuticals Limited, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK
English: Lundbeck Pharma svetovalno podjetje d.o.o., Prešernova 1, SI-2000 Maribor, Slovenia
Swedish: Slovenien Lundbeck Pharma svetovalno podjetje d.o.o., Prešernova 1, SI-2000 Maribor, Slovenia
English: Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Republic of Ireland
Swedish: Storbritannien Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Republic of Ireland
English: RATIOPHARM Graf Arco Strasse 3
Swedish: Frankrike RATIOPHARM Graf Arco Strasse 3
English: HEXAL AG Postfach 1263
Swedish: Tyskland HEXAL AG Postfach 1263
English: Holsten Pharma GmbH Im Buergerstock 7
Swedish: Tyskland Holsten Pharma GmbH Im Buergerstock 7
English: SALUS Ljubljana, d.d., Mašera Spasićeva ulica 10, SI-1000 Ljubljana, Slovenia
Swedish: Slovenien SALUS Ljubljana, d.d., Mašera Spasićeva ulica 10, SI-1000 Ljubljana, Slovenia
English: Winthrop Arzneimittel GmbH Industriestr.
Swedish: Tyskland Winthrop Arzneimittel GmbH Industriestr.
English: Netherlands Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
Swedish: Nederländerna Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
English: BIOMEDICA-CHEMICA AE, 25 G.LYRA 14564 K.Kifissia, Greece
Swedish: Grekland BIOMEDICA-CHEMICA AE, 25 G.LYRA 14564 K.Kifissia, Greece
English: Denmark Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
Swedish: Danmark Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
English: 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.
Swedish: CHMP kom fram till att det finns ett potentiellt symptom på ökat självmordsbeteende, inbegripet självmordsförsök och självmordstankar och/eller relaterat beteende såsom självskadebeteende, fientlighet och humörsvängningar hos barn och ungdomar som behandlas med SSRI
English: TEVA Generics GmbH Kandelstr.
Swedish: Tyskland TEVA Generics GmbH Kandelstr.
English: SVUS PHARMA A.S., HRADEC KRÁLOVÉ, Škroupova 957, 500 02 Hradec Králové, Czech Republic
Swedish: Tjeckien SVUS PHARMA A.S., HRADEC KRÁLOVÉ, Škroupova 957, 500 02
English: SOLVAY PHARMA, 63 Agiou Dimitriou 17456 Alimos, Greece
Swedish: Grekland SOLVAY PHARMA, 63 Agiou Dimitriou 17456 Alimos, Greece
English: ZYDUS France 40 RUE Lécuyer 93300 aubervilliers - France
Swedish: Frankrike ZYDUS France 40 RUE Lécuyer 93300 aubervilliers - France
English: Cipramil 40 mg/ml, drops oral drops, solution Oral use
Swedish: Cipramil 40 mg/ml, drops oral drops, solution Oral användning
English: ELPEN AE, 21Km Leoforos Marathonos, 19009 Pikermi Attikis, Greece
Swedish: Grekland ELPEN AE, 21Km Leoforos Marathonos, 19009 Pikermi Attikis, Greece
English: IV.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE PL FOR ATOMOXETINE
Swedish: IV.2 ÄNDRINGAR SOM SKALL FÖRAS IN I RELEVANT AVDELNING PÅ BIPACKSEDELN FÖR ATOMOXETIN
English: Desitin Arzneimittel GmbH Postfach 630164
Swedish: Tyskland Desitin Arzneimittel GmbH Postfach 630164
English: SmithKline Beecham Phamraceuticals Limited, Stockley Park West, Uxbridge, Middx UB11 1BT, UK
Swedish: Storbritannien SmithKline Beecham Phamraceuticals Limited, Stockley Park West, Uxbridge, Middx UB11 1BT, UK
English: Belgium ORGANON BELGIE Terhulpsesteenweg 166 1070
Swedish: ORGANON BELGIE Terhulpsesteenweg 166 1070 BRUSSEL, Belgium
English: Ratiopharm UK Limited, 5 Jackson Close, Grove Road, Cosham, Portsmouth, Hants PO6 1UP; UK
Swedish: Storbritannien Ratiopharm UK Limited, 5 Jackson Close, Grove Road, Cosham, Portsmouth, Hants PO6 1UP; UK
English: 11, avenue Dubonnet 92400 Courbevoie France
Swedish: Frankrike CHIESI 11, avenue Dubonnet 92400 Courbevoie France
English: III.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE SPC FOR ATOMOXETINE
Swedish: III.2 ÄNDRINGAR SOM SKALL FÖRAS IN I RELEVANT AVDELNING I PRODUKTRESUMÉN FÖR ATOMOXETIN
English: PHARMACYPRIA HELLAS, 6 Paster, 11521 Ampelokipi Athens, Greece
Swedish: Grekland PHARMACYPRIA HELLAS, 6 Paster, 11521 Ampelokipi Athens, Greece
English: - 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;
Swedish: - Kommittén fann, med beaktande av de uppgifter från kliniska försök som fanns tillgängliga, att det finns tecken på självmordsbeteende, inbegripet självmordsförsök och självmordstankar och/eller relaterat beteende såsom självskadebeteende, fientlighet och humörsvängningar hos barn och ungdomar som behandlas med selektiva serotoninåterupptagshämmare samt serotonin-norepinefrinupptagshämmare såsom de ovan angivna läkemedlen.
English: Wyeth Whitehall, Podružnica v Sloveniji, Topniška 4a, SI-1000 Ljubljana, Slovenia
Swedish: Slovenien Wyeth Whitehall, Podružnica v Sloveniji, Topniška 4a, SI-1000
English: Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
Swedish: Storbritannien Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
English: Denmark Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
Swedish: Danmark Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
English: Denmark Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
Swedish: Danmark Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
English: Netherlands ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
Swedish: Nederländerna ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
English: GlaxoSmithKline d.o.o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, SI-1000 Ljubljana, Slovenia
Swedish: Slovenien GlaxoSmithKline d.o.o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, SI-1000 Ljubljana, Slovenia
English: Belgium ETHIMED N.V., Leuvensestraat 28 B2, 1800 Vilvoorde, Belgium
Swedish: ETHIMED N.V., Leuvensestraat 28 B2, 1800 Vilvoorde, Belgium
English: Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX; UK
Swedish: Storbritannien Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX; UK
English: The CHMP reviewed the data submitted by the MAHs in relation to the signal of suicidal behaviour in children and adolescents.
Swedish: CHMP granskade de uppgifter som innehavarna av godkännande för försäljning lämnat in och som har samband med självmordsbeteende hos barn och ungdomar.
English: VERISFIELD LTD UK, 41 Chalton Street, London, NW1 1JD, U.K.
Swedish: Grekland VERISFIELD LTD UK, 41 Chalton Street, London, NW1 1JD, U.K.
English: Netherlands Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
Swedish: Nederländerna Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
English: ANNEX IV AMENDMENTS TO THE PACKAGE LEAFLET
Swedish: BILAGA IV ÄNDRINGAR I BIPACKSEDELN
English: Netherlands GenRx B.V., Postbus 75, NL-6920 AB Duiven
Swedish: Nederländerna GenRx B.V., Postbus 75, NL-6920 AB Duiven
English: Belgium SOLVAY PHARMA & CIE Avenue Demunter 3 1090 Brussel, Belgium
Swedish: SOLVAY PHARMA & CIE Avenue Demunter 3 1090 Brussel, Belgium
English: Angenerico S.p.A. via Nocera Umbra 75 00100 Roma Italy
Swedish: via Nocera Umbra 75 00100 Roma Italy
English: Eli Lilly Nederland BV Postbus 379
Swedish: Nederländerna Eli Lilly Nederland BV Postbus 379
English: Denmark 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
Swedish: Danmark 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
English: WYETH HELLAS, Kyprou 126& 25 Martiou, 164 52 Argyroupoli, Greece
Swedish: Grekland WYETH HELLAS, Kyprou 126& 25 Martiou, 164 52 Argyroupoli, Greece
English: GLAXOSMITHKLINE AEBE, 266 Kifissias Av 15232 Halandri, Greece
Swedish: Grekland GLAXOSMITHKLINE AEBE, 266 Kifissias Av 15232 Halandri, Greece
English: Denmark Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
Swedish: Danmark Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
English: Luxembourg Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
Swedish: Luxemburg Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
English: Denmark PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
Swedish: Danmark PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
English: PFIZER SPOL.
Swedish: Tjeckien PFIZER SPOL.
English: Luxembourg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Swedish: Luxemburg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
English: Concentrate for oral solution Oral use
Swedish: Koncentrat för oral lösning Oral användning
English: 42 rue d'Aguesseau 92100 Boulogne Billancourt - France
Swedish: Frankrike Mundipharma 42 rue d'Aguesseau 92100 Boulogne Billancourt - France
English: Netherlands Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
Swedish: Nederländerna Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
English: ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS
Swedish: BILAGA III ÄNDRINGAR I PRODUKTRESUMÉN
English: Torrex Pharma, d.o.o., Trdinova 4, SI1000 Ljubljana, Slovenia
Swedish: Slovenien Torrex Pharma, d.o.o., Trdinova 4, SI1000 Ljubljana, Slovenia
English: ALLEN FARMAKEUTIKI AE, 34 Filellinon Street, 15232 Halandri, Greece
Swedish: Grekland ALLEN FARMAKEUTIKI AE, 34 Filellinon Street, 15232 Halandri, Greece
English: Neuraxpharm Arzneimittel GmbH & Co.KG
Swedish: Tyskland Neuraxpharm Arzneimittel GmbH & Co.KG
English: Zoloft 25 mg + 50 mg 25 mg + 50 mg Film-coated tablet
Swedish: Zoloft 25 mg + 50 mg 25 mg + 50 mg Filmdragerad tablett
English: Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
Swedish: Storbritannien Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
English: Belgium APOGENPHARMA B.V. Europark Oost 34, 9100 St. Niklaas, Belgium
Swedish: Europark Oost 34, 9100 St. Niklaas, Belgium
English: Esparma GmbH Postfach 1461
Swedish: Tyskland Esparma GmbH Postfach 1461
English: Netherlands Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Swedish: Nederländerna Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
English: Ashbourne Industrial Estate Unit 107
Swedish: Frankrike Pharmascope Ashbourne Industrial Estate Unit 107
English: GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli Greece
Swedish: Grekland GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli Greece
English: Netherlands Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Swedish: Nederländerna Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
English: Despite this, your doctor may prescribe [Invented Name] for patients under 18 because he/she decides that this is in their best interests.
Swedish: Trots detta kan [Fantasinamn] skrivas ut av läkare till patienter under 18 år, om läkaren anser att detta är lämpligt.
English: Netherlands Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Swedish: Nederländerna Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
English: Krewel Meuselbach GmbH Postfach 1263
Swedish: Tyskland Krewel Meuselbach GmbH Postfach 1263
English: Hormosan-Kwizda GmbH Postfach 600340
Swedish: Tyskland Hormosan-Kwizda GmbH Postfach 600340
English: Synthon B.V.
Swedish: Tyskland Synthon B.V.
English: Netherlands Hexal AG, Postfach 1263, D-83602 Holzkirchen
Swedish: Nederländerna Hexal AG, Postfach 1263, D-83602 Holzkirchen
English: SMTIHKLINE BEECHAM PHARMACEUTICALS, TW8 9EP Brentford, Middlesex, New Horizont Court, UK
Swedish: Tjeckien SMTIHKLINE BEECHAM PHARMACEUTICALS, TW8 9EP Brentford, Middlesex, New Horizont Court, UK
English: B.V. Postbus 75
Swedish: Postbus 75