natgillin/translations-raw huggingface dataset:
Der var dog tydelige signaler på selvmordsrelateret adfærd i undersøgelserne af depression og mindre stærke signaler i undersøgelserne af angst. 
However, there was a clear suicide-related behaviours signal from the depression studies and a less strong signal from the anxiety studies.
[Særnavn] er ikke indiceret til behandling af svære depressive episoder og/eller angst, da resultaterne af de kliniske undersøgelser, der er udført på voksne, ikke viste nogen virkning i forhold til placebo og derfor var negative. 
[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.
6XA, Great Britain 
6XA, United Kingdom
Tyskland KSK-Pharma Vertriebs AG Finkenstr. 
KSK-Pharma Vertriebs AG Finkenstr.
Latvian JSC Grindeks, Krustpils ul. 
Lithuania Latvian JSC Grindeks, Krustpils ul.
Derudover var der nogle undersøgelser med patienter, der led af ADHD - Attention Deficit/Hyperactivity Disorderopmærksomhedsforstyrrelse og hyperaktivitet. 
In addition there were some trials with patients suffering from Attention Deficit/Hyperactivity Disorder (ADHD).
Bemærk: Dette afsnit af SPCet, er det afsnit, der var bilag til Europa-Kommissionens beslutning vedrørende denne artikel 31 arbitreringssag. 
Note: This section of the Package Leaflet is the one that was Annexed to the Commission Decision on this Article 31 referral .
CHMP var af den opfattelse, at der ikke var noget signal om øget risiko for selvmordsrelateret adfærd i atomoxetin-undersøgelserne, men der var dog et signal om øget risiko for adfærdsafvigelser med større aggression og fjendtlighed til følge. 
The CHMP considered that there wasn't any signal of increased risk of suicide related behaviour in the atomoxetine studies, however, there was a signal of an increased risk of behavioural abnormalities with more aggression and hostility effects.
I størsteparten af undersøgelserne indgik patienter med svære depressive forstyrrelser (MDD), mens enkelte undersøgelser omfattede patienter med forskellige angstforstyrrelser (obsessivkompulsiv tilstand (OCD), generaliseret angst (GAD) og social angst (SAD)). 
The majority of trials included patients with major depressive disorders (MDD) while a few included patients with various anxiety disorders (Obsessive Compulsive Disorder (OCD), Generalised Anxiety Disorder (GAD), and Social Anxiety Disorder (SAD)).
[Særnavn] bør normalt ikke anvendes til børn og unge under 18 år < undtagen til patienter med [godkendt indikation]>. 
[Invented Name] should normally not be used for children and adolescents under 18 years < except for patients with [approved indication]>.
Desuden var der signaler om relaterede bivirkninger, f.eks. fjendtlighed, selvbeskadigelse og emotionel labilitet i næsten alle lægemidler og indikationer. 
Moreover there was a signal concerning related adverse events like hostility, self-harm and emotional lability in almost all products and indications.
Du bør underrette din læge, hvis nogle af de ovennævnte symptomer opstår eller forværres, når patienter under 18 år indtager [særnavn]. 
You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking [Invented Name].
[Særnavn] bør ikke anvendes til behandling af børn og unge under 18 år < undtagen til patienter med [godkendt indikation]>. 
[Invented Name] should not be used in the treatment of children and adolescents under the age of 18 years <, except for patients with [approved indication]>.
Kun nogle af disse lægemidler er godkendt til behandling af børn og unge med obsessivkompulsiv tilstand, heraf en til behandling af opmærksomhedsforstyrrelse og hyperaktivitet. 
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.
Patienter under 18 år har øget risiko for bivirkninger som f.eks. fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) og emotionel labilitet. 
Patients under 18 have an increased risk of side-effects such as hostility (predominantly aggression, oppositional behaviour and anger) and emotional lability.
1 SSRI står for ‘Serotonin-Selective Reuptake Inhibitor' (selektiv serotonin-genoptagelseshæmmer). 
1 SSRI stands for ‘Serotonin-Selective Reuptake Inhibitor'.
LABORATORIOS CINFA, S.A., Olaz-Chipi, 10. Polig. 
LABORATORIOS CINFA, S.A., Olaz-Chipi, 10.
LAGEPHA S.A. Avenue Mercator 1 1300 Wavre, Belgium 
Belgium LAGEPHA S.A. Avenue Mercator 1 1300 Wavre, Belgium
Tyskland Organon GmbH Mittenheimer Str. 62 
Organon GmbH Mittenheimer Str. 62
CHMP har gennemgået de data, der er fremlagt af indehaverne af markedsføringstilladelse vedrørende signalet om selvmordsadfærd hos børn og unge. 
The CHMP reviewed the data submitted by the MAHs in relation to the signal of suicidal behaviour in children and adolescents.
Slovenien Pfizer Luxembourg SARL, 283, route d' Arlon, L-8011 Strassen, 
Pfizer Luxembourg SARL, 283, route d' Arlon, L-8011 Strassen, Luxembourg
Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova 
Netherlands Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova
Tyskland STADA Arzneimittel AG Stadastr. 
STADA Arzneimittel AG Stadastr.
Danmark PSI NV, Kraanlei 27, B-9000 Gent, Belgium 
Denmark PSI NV, Kraanlei 27, B-9000 Gent, Belgium
Derudover foreligger der ikke langtidsdata om sikkerhed for[særnavn] med hensyn til vækst, modning og kognitiv og adfærdsmæssig udvikling i denne aldersgruppe. 
Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of [Invented Name] in this age group have not yet been demonstrated.
BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMEERNE 
GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS
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