natgillin/translations-raw huggingface dataset:
Cylatron was studied in one main study involving 1,256 adults with stage III melanoma. 
Cylatroni uuriti ühes põhiuuringus, milles osales 1256 III staadiumi melanoomiga täiskasvanut.
Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180. 
Kui ettevõte on küsimustele vastanud, vaatab komitee vastused läbi ja võib enne otsuse tegemist esitada 180. päeval veel küsimusi.
In melanoma, interferon alfa-2b is thought to work by suppressing the growth and multiplication of cancerous cells, by causing these cells to die and by stimulating the immune system (the body's natural defences) to attack and kill the cancer cells. 
Arvatakse, et melanoomi korral pärsib alfa-2b-interferoon vähirakkude kasvu ja paljunemist, põhjustab nende hävimist ja stimuleerib immuunsüsteemi (organismi loomulikke kaitsemehhanisme) ründama ja hävitama vähirakke.
Questions and answers on the withdrawal of the marketing application for Cylatron 
Teave müügiloa taotluse tagasivõtmise kohta Cylatron
International non-proprietary name (INN): peginterferon alfa-2b 
Rahvusvaheline mittekaubanduslik nimetus (INN): alfa-2b-peginterferoon
The CHMP had concerns over side effects of Cylatron, particularly fatigue (tiredness) and depression. 
Inimravimite komitee ettevaatlikkus oli seotud Cylatroni kõrvalnähtude, eelkõige väsimuse ja depressiooniga.
When the study began, all of the patients had recently had surgery to remove lymph nodes containing melanoma cells. 
Uuringu alguses oli kõigil patsientidel hiljuti tehtud operatsioon, millel eemaldati melanoomirakke sisaldavad lümfisõlmed.
IntronA is authorised for the treatment of malignant melanoma after surgery, along with other diseases. 
IntronA on heaks kiidetud pahaloomulise melanoomi operatsioonijärgseks raviks ning ka muude haiguste raviks.
Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Cylatron could not have been approved for adjuvant treatment of stage III melanoma. 
Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, nägi komitee taotluse tagasivõtmise ajal põhjuseid ettevaatlikkuseks ning oli esialgsel seisukohal, et Cylatroni kasutamist III staadiumi melanoomi adjuvantraviks ei ole võimalik heaks kiita.
Cylatron was expected to be used in adults with stage III (advanced) melanoma as an add-on treatment after surgery, to prevent the disease from coming back. 
Cylatroni kavatseti kasutada III staadiumi (kaugelearenenud) melanoomiga täiskasvanutel täiendava ravina, et ennetada pärast operatsiooni haiguse taastumist.
Cylatron is a powder and solvent that is made up into a solution for injection. 
Cylatron on pulber ja lahusti, millest valmistatakse süstelahus.
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Cylatron? 
Kuidas mõjutab tagasivõtmine praegu Cylatroni kliinilistes uuringutes või eriloaga kasutamise programmides osalevaid patsiente?
Melanoma is a type of skin cancer affecting cells called melanocytes. 
Melanoom on nahavähi liik, mis kahjustab melanotsüütideks nimetatavaid rakke (pigmendirakke).
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate programmes with Cylatron. 
Ettevõte teatas inimravimite komiteele, et praegu Cylatroni kliinilistes uuringutes või eriloaga kasutamise programmides osalevatele patsientidele tagasivõtmine mõju ei avalda.
Cylatron was expected to be given to patients whose lymph nodes contained melanoma cells as visible under a microscope, but not when the cancer had caused the lymph nodes to become large enough to be felt through the skin. 
Cylatroni kavatseti manustada patsientidele, kelle lümfisõlmedes on mikroskoopilisi melanoomirakke, kuid kellel melanoom ei ole põhjustanud lümfisõlmede sellist suurenemist, et need oleksid läbi naha kombatavad.
Peginterferon alfa-2b has been authorised in the European Union (EU) since May 2000 as PegIntron and ViraferonPeg for the treatment hepatitis C. Unpegylated interferon alfa-2b has also been authorised in the EU since March 2000 as IntronA. 
Alfa-2b-peginterferoon on ravimitena PegIntron ja ViraferonPeg Euroopa Liidus C-hepatiidi raviks heaks kiidetud alates 2000. aasta maist.
The active substance in Cylatron, peginterferon alfa-2b, belongs to the group ‘interferons'. 
Cylatroni toimeaine alfa-2b-peginterferoon kuulub interferoonide rühma.
The effects of Cylatron were first tested in experimental models before being studied in humans. 
Enne inimuuringuid kontrolliti Cylatroni toimet muude katsetega.
What was Cylatron expected to be used for? 
Milleks kavatseti Cylatroni kasutada?
How is Cylatron expected to work? 
Milline on Cylatroni eeldatav toime?
It contains the active substance peginterferon alfa-2b. 
Ravim sisaldab toimeainena alfa-2bpeginterferooni.
‘Stage III' means that some cancer cells have spread to the lymph nodes (part of the lymphatic system that drains fluids from the body's tissues). 
Lümfisõlmed moodustavad osa lümfisüsteemist, mille kaudu toimub vedelike äravool organismi kudedest.
It consists of a substance called interferon alfa-2b, which has been ‘pegylated' (coated with a chemical called polyethylene glycol). 
Toimeaines sisalduv alfa-2binterferoon on pegüleeritud (kaetud polüetüleenglükooliga), mis suurendab toimeaine püsimist organismis ja võimaldab manustada ravimit harvem.
EU number 
Müügiloa nr Euroopa Liidus
Invented name Strength Pharmaceutical 
Ravimi väljamõeldud nimetus
Packaging 
Manustamistee Pakendi iseloomustus
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States 
I lisa Ravimite nimetuste, ravimvormide, tugevuste, manustamisviiside, taotlejate, müügiloa hoidjate loetelu liikmesriikides
C. G. Papaloisou Ltd. Office address: 
C. G. Papaloisou Ltd.
Coated Tablet 
Kaetud tablett
Modified-release tablet 
Toimeainet modifitseeritult vabastav tablett
Gebouw Jupiter Herikerbergweg 100 Postbus 12021 
Gebouw Jupiter Herikerbergweg
Modified-release capsule, hard 
Toimeainet modifitseeritult vabastav kõvakapsel
Intramuscular use intravenous use 
Intramuskulaarn e
--1 Inactivated influenza A virus/human, strain A/Jena/VI5258/2009(H1N1)pdm09 ≥ 16 HU* *HU = haemagglutinating units 
--1 Inaktiveeritud A-gripi viirus/inimpäritolu Tüvi: A/Jena/VI5258/2009(H1N1)pdm09 ≥ 16 HU*
EU (MA) Number Invented name 
EL (ML) number Väljamõeldud nimetus
Annex A 
Lisa A
Strength Pharmaceutical form 
Tugevus Ravimvorm Loomaliigid Manustamisviis Pakend Sisaldus Pakendi suurus
United Kingdom Trading as Sterling Health or 
Ühendkuningriik Trading as Sterling Health or
The Netherlands ratiopharm Nederland B.V. 
Holland ratiopharm Nederland B.V.
ALMIRALL, S.A. Ronda General Mitre, 
Hispaania ALMIRALL, S.A. Ronda General Mitre,
Al. Armii Ludowej 26 00-609 Warszawa Poland 
Al. Armii Ludowej 26 00-609 Warszawa Poola
Belgium Aktuapharma nv Ambachtenlaan 13E 3001 Leuven 
Aktuapharma nv Ambachtenlaan 13E 3001 Leuven Belgia
Tipperary, Ireland 
Tipperary, Iirimaa
2 Ellinikou Str 16777,Elliniko, Athens Greece 
2 Ellinikou Str 16777,Elliniko, Athens Kreeka
Hameenlinna Finland 
Hameenlinna Soome
Norway ratiopharm Oy- Teva Group Menmber, Keilaranta 10 E, 02150 Espoo, 
Norra ratiopharm Oy- Teva Group Menmber, Keilaranta 10 E, 02150 Espoo,
Niepodleglosci 18 02-653 Warsaw Poland 
Niepodleglosci 18 02-653 Warsaw Poola
13500 HÄMEENLINNA Finland 
13500 HÄMEENLINNA Soome
2333 CR Leiden The Netherlands 
2333 CR Leiden Holland
Belgium Mylan BVBA/SPRL Terhulpsesteenweg 6A, 
Mylan BVBA/SPRL Terhulpsesteenweg 6A,
26.200 28700 San Sebastián de los Reyes (Madrid) Spain 
28700 San Sebastián de los Reyes (Madrid) Hispaania
851 01 Bratislava Slovak Republic 
851 01 Bratislava Slovakkia Vabariik
Belgium Teva Pharma Belgium Laarstraat 16 
Teva Pharma Belgium Laarstraat 16
Merck Medication Familiale 
Prantsusmaa Merck Medication Familiale
EG LABOLaboratoires EuroGenerics "Le Quintet"bâtiment A 12, rue Danjou 
EuroGenerics "Le Quintet"bâtiment A 12, rue Danjou
Souffelweyersheim France 
Souffelweyersheim Prantsusmaa
Mylan Sas 117, allée des Parcs 69800 Saint-Priest France 
Prantsusmaa Mylan Sas 117, allée des Parcs 69800 Saint-Priest Prantsusmaa
B-1560 Hoeilaart Belgium 
B-1560 Hoeilaart Belgia
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States 
I lisa Ravimite nimetuste, ravimvormide, tugevuste, manustamisviiside, müügiloa hoidjate loetelu liikmesriikides
Actavis Group hf.Reykjavikurvegur 7678 - 220 Hafnarfjörður Iceland 
Actavis Group hf.Reykjavikurvegur 7678 - 220 Hafnarfjörður Island
Sweden sanofi-aventis AB Box: 14142 
Rootsi sanofi-aventis AB Box: 14142
Germany Berlin-Chemie AG Glienicker Weg 125 
Saksamaa Berlin-Chemie AG Glienicker Weg 125
37, rue Saint-Romain 69379 Lyon Cedex 08 France 
37, rue Saint-Romain 69379 Lyon Cedex 08
Elaiapharm2881, Route des Crêtes 
Prantsusmaa Elaiapharm 2881, Route des Crêtes
ITALFARMACO, S.A. San Rafael, 3 
Hispaania ITALFARMACO, S.A. San Rafael, 3
Unipharm JSC Traiko Stanoev str. № 3 + Sofia 1797 
Bulgaaria Unipharm JSC Traiko Stanoev str. № 3 + Sofia 1797
NOVARTIS CONSUMER HEALTH, S.A. 
Hispaania NOVARTIS CONSUMER HEALTH, S.A.
Meda Pharma (France) 25 boulevard de l'amiral bruix 
Prantsusmaa Meda Pharma (France) 25 boulevard de l'amiral bruix
Barcelona Spain 
Barcelona Hispaania
Chefaro Ireland Limited, First Floor, Block A, The Crescent Building, Northwood Office Park, Dublin 9, Ireland 
Chefaro Ireland Limited, First Floor, Block A, The Crescent Building, Northwood Office Park, Dublin 9, Iirimaa
Sweden Evolan Pharma AB Box: 120 
Evolan Pharma AB Box: 120
Teva Sante 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex France 
Prantsusmaa Teva Sante 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex Prantsusmaa
Actavis EAD 29 Atanas Dukov Str. + Sofia 1407 
Bulgaaria Actavis EAD 29 Atanas Dukov Str. + Sofia 1407
Pharmastra 2c, rue du marchal de lattre de tassigny 
Prantsusmaa Pharmastra 2c, rue du marchal de lattre de tassigny
Societe Cilfa Developpement 20, Rue Jean Daudin 75015 - Paris France 
Prantsusmaa Societe Cilfa Developpement 20, Rue Jean Daudin 75015 - Paris
10237 Dolni Mecholupy Czech Republic 
10237 Dolni Mecholupy Tšehhi Vabariik
Belgium Sterop Laboratoires nv Avenue de Scheut 46 
Sterop Laboratoires nv Avenue de Scheut 46
Bega Nr. 4, TârguMureş, 540390 
Mureş, 540390
92700 Colombes France 
92700 Colombes Prantsusmaa
69151 Décines Cedex France 
69151 Décines Cedex Prantsusmaa
Sweden Meda AB Box 906 
Meda AB Box 906
S.C. TERAPIA S.A Str. Fabricii Nr.124, Cluj-Napoca, Judeţul Cluj, 400632 
Rumeenia S.C. TERAPIA S.A Str. Fabricii Nr.124, Cluj-Napoca, Judeţul Cluj, 400632
69007 Lyon France 
69007 Lyon
Belgium Laboratoires SMB SA rue de la Pastorale 26 
Laboratoires SMB SA rue de la Pastorale 26
Gifrer Barbezat8 10, Rue Paul Bert Bp 165 
Prantsusmaa Gifrer Barbezat8 10, Rue Paul Bert Bp 165
Alkaloid-Int. d.o.o. 
Sloveenia Alkaloid-Int. d.o.o.
6.1% w/v 
6.1% w/v süstelahus intramuskulaarne
08228 Tarrasa (Barcelona) Spain 
08228 Tarrasa (Barcelona)
Sweden Recip AB Box: 906 
Recip AB Box: 906
Omega Pharma Baltics SIA, K. Ulmana 119, Marupe, LV-2167, Latvia 
Omega Pharma Baltics SIA, K. Ulmana 119, Marupe, LV-2167, Läti
Luxembourg Mylan bvba/sprl Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium 
Luksemburg Mylan bvba/sprl Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgia
Luxembourg MEDA PHARMA 25 boulevard de l'amiral Bruix F-75016 Paris France 
Luksemburg MEDA PHARMA 25 boulevard de l'amiral Bruix F-75016 Paris Prantsusmaa
de Burgos, 91 28050 Madrid Spain 
de Burgos, 91 28050 Madrid Hispaania
92300 Levallois-Perret France 
92300 Levallois-Perret Prantsusmaa
HIPOCRATE 2000 S.R.L. 
Rumeenia HIPOCRATE 2000 S.R.L.
Luxembourg GlaxoSmithKline Consumer Healthcare S.A. Site Apollo avenue Pascal 2-6 B1300 Wavre 
Luksemburg GlaxoSmithKline Consumer Healthcare S.A. Site Apollo avenue Pascal 2-6 B1300 Wavre
S.C. Farmacom S.A. Str. Zizinului Nr. 112, 2200 Braşov, 
Rumeenia S.C. Farmacom S.A. Str. Zizinului Nr. 112, 2200 Braşov,
Aspar Pharmaceuticals Limited, 29-30 Capitol Way, Colindale, London NW9 0EQ United Kingdom 
Aspar Pharmaceuticals Limited, 29-30 Capitol Way, Colindale, London NW9 0EQ Ühendkuningriik
Germany Dr. R. Pfleger Chemische Fabrik GmbH 
Saksamaa Dr. R. Pfleger Chemische Fabrik GmbH
Denmark Amgros I/S, Dampfærgevej 22, DK-2100 København Ø, Denmark 
Amgros I/S, Dampfærgevej 22, DK-2100 København Ø, Taani
Arrow Generiques 26, avenue Tony Garnier 
Prantsusmaa Arrow Generiques 26, avenue Tony
CIPLA (EU) LIMITED, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW United Kingdom 
CIPLA (EU) LIMITED, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW Ühendkuningriik
Luxembourg Meda Pharma GmbH&Co. 
Luksemburg Meda Pharma GmbH&Co.
15, boulevard Charles de Gaulle 
Prantsusmaa Biogaran 15, boulevard Charles de Gaulle
92517 Boulogne Billancourt Cedex France 
92517 Boulogne Billancourt Cedex Prantsusmaa
Germany codeinphosphathemihydrat codi OPT 
Kodeiinfosfaat hemihüdraat codi OPT
MAX REMEDIES LIMITED, Stoney Gate House, 2 Greenfield Road, Holmfirth, West Yorkshire, HD9 2JT, United Kingdom 
MAX REMEDIES LIMITED, Stoney Gate House, 2 Greenfield Road, Holmfirth, West Yorkshire, HD9 2JT, Ühendkuningriik
HEALTHCARE, Conway street,Hove, East sussex, BN3 3LW United Kingdom 
HEALTHCARE, Conway street,Hove, East sussex, BN3 3LW Ühendkuningriik
Germany Merck Serono GmbH Alsfelder Str. 17 
Saksamaa Merck Serono GmbH Alsfelder Str. 17
LABORATORIOS ASOCIADOS NUPEL, S.L. 
Hispaania LABORATORIOS ASOCIADOS NUPEL, S.L.
Nitrianska 100, Hlohovec 920 27 Slovak Republic codeine 
Nitrianska 100, Hlohovec 920 27 Slovaki Vabariik kodeiin
INTERNACIONAL, S.A. Gran Vía Carlos III, 94 08028 Barcelona Spain 
Hispaania FERRER INTERNACIONAL, S.A. Gran Vía Carlos III, 94 08028 Barcelona Hispaania
Denmark Alternova A/S, Lodshusvej 11, DK4230 Skælskør, Denmark 
Alternova A/S, Lodshusvej 11, DK4230 Skælskør, Taani
28042 Madrid Spain 
28042 Madrid Hispaania
Bayer Limited, The Atrium, Blackthorn Road, Dublin 18, Ireland 
Bayer Limited, The Atrium, Blackthorn Road, Dublin 18, Iirmaa
Sanofi-Aventis France 1-13, Boulevard Romain Rolland 
France 1-13, Boulevard Romain Rolland
Denmark Takeda Pharma A/S, Langebjerg 1, DK4000 Roskilde 
Takeda Pharma A/S, Langebjerg 1, DK4000 Roskilde Taani
Luxembourg Bristol-Myers Squibb Belgium S.A. Avenue de Finlande, 8 B-1420 
Luksemburg Bristol-Myers Squibb Belgium S.A. Avenue de Finlande, 8 B-1420
FOURRTS (UK)PHARMACARE LIMITED, 30 Chaul End Lane, Luton, Bedfordshire, LU4 8EZ, United Kingdom 
FOURRTS (UK)PHARMACARE LIMITED, 30 Chaul End Lane, Luton, Bedfordshire, LU4 8EZ, Ühendkuningriik
Clonmel Healthcare Ltd, Waterford Road, Conmel, Co. Tipperary Ireland 
Clonmel Healthcare Ltd, Waterford Road, Conmel, Co. Tipperary Iirimaa
Seton Products Ltd., Tubiton House, Medlock Street, Oldham, OL1 3HS, United Kingdom 
Seton Products Ltd., Tubiton House, Medlock Street, Oldham, OL1 3HS, Ühendkuningriik
Belgium Glaxosmithkline Consumer Healthcare sa 
Glaxosmithkline Consumer Healthcare sa
LABORATORIES (HOLDINGS)LIMITED, Unit 2A Sefton Business Park, Aintree, Liverpool, L30 1RD, United Kingdom 
LABORATORIES (HOLDINGS)LIMITED, Unit 2A Sefton Business Park, Aintree, Liverpool, L30 1RD, Ühendkuningriik
Str. Ştirbei Vodă Nr. 53-55, Sector 1, Bucureşti, 
Str. Ştirbei Vodă Nr. 53-55,
032266 Bucureşti, Romania codeinum 
032266 Bucureşti, Rumeenia
CRESCENT PHARMA LTD, Polhampton Lane, Units 3&4, Quidhampton Business units, Overton, Hampshire, RG25 3ED, United Kingdom 
CRESCENT PHARMA LTD, Polhampton Lane, Units 3&4, Quidhampton Business units, Overton, Hampshire, RG25 3ED, Ühendkuningriik
Algocod powder 
Algocod pulber
Str. Prahova, Nr. 6A, Sector 1, Bucureşti 012423, România paracetamol, fosfat de codeină hemihidrat, cafeină anhidră 
Str. Prahova, Nr. 6A, Sector 1, Bucureşti 012423, Rumeenia atsetüülsalitsüülhape, paratsetamool, kodeiinfosfaat hemihüdraat
22 quai Gallieni 92150 Suresnes France 
Prantsusmaa Cristers 22 quai Gallieni 92150 Suresnes Prantsusmaa
Germany MEDA Manufacturing GmbH 
Saksamaa MEDA Manufacturing GmbH
SW1V 2SA United Kingdom 
SW1V 2SA
49, avenue Georges Pompidou 
Prantsusmaa SANDOZ 49, avenue Georges Pompidou
Bristol Myers Squibb3, rue Joseph Monier 92500 RueilMalmaison 
Prantsusmaa Bristol Myers Squibb3, rue Joseph Monier 92500 Rueil
Germany Aristo Pharma GmbH Wallenroder Str. 8-10 
Saksamaa Aristo Pharma GmbH Wallenroder Str. 8-10
Pierre Fabre Medicament 45, Place Abel Gance 92654 Boulogne Cedex 
45, Place Abel Gance 92654 Boulogne Cedex
Manx Pharma Limited, Taylor Group House, Wedgnock Lane, Warwick CV34 5YA United Kingdom 
Manx Pharma Limited, Taylor Group House, Wedgnock Lane, Warwick CV34 5YA Ühendkuningriik
Germany Temmler Werke GmbH Weihenstephaner Str. 
Saksamaa Temmler Werke GmbH Weihenstephaner Str.
00101 Helsinki Finland 
00101 Helsinki Soome
Germany Astellas Pharma GmbH Gearg-Brauchle-Ring 
Saksamaa Astellas Pharma GmbH Gearg-Brauchle-Ring
2610 Wilrijk 
2610 Wilrijk Belgia
Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG United Kingdom 
Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG Ühendkuningriik
ENNOGEN PHARMA LIMITED, Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS United Kingdom 
ENNOGEN PHARMA LIMITED, Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS Ühendkuningriik
Bouchara Recordati 68, Rue Marjolin Bp 67 
Prantsusmaa Bouchara Recordati 68, Rue Marjolin
Slovak Republic 
Slovaki Vabariik
S.C. SINTOFARM S.A.Str. 
Rumeenia S.C. SINTOFARM S.A.Str.
S.C. Fabiol S.A, B-dul Timişoara nr. 50, Bucureşti, 
Rumeenia S.C. Fabiol S.A, B-dul Timişoara nr. 50,
Luxembourg bene-Arzneimittel GmbH Herterichstraße 1-3 D-81479 München Germany 
Luksemburg bene-Arzneimittel GmbH Herterichstraße 1-3 D-81479 München Saksamaa
S.C. Bio EEL S.R.L.Str. 
Rumeenia S.C. Bio EEL S.R.L.Str.
Apotex Europe B.V. Darwinweg 20 
Apotex Europe B.V.
LABORATORIES, S.A. Avda. 
Hispaania ABBOTT LABORATORIES, S.A. Avda.
00351 Helsinki Finland 
00351 Helsinki Soome
1170 Brussels Belgium 
1170 Brussels Belgia
Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 
Saksamaa ALIUD PHARMA GmbH Gottlieb-Daimler-Str.
Azur compositum SC Suppositorien suppository rectal use 
Azur compositum SC Suppositorien rektaalsuposiit rektaalne
FARMASIERRA LABORATORIOS, S.L. 
Hispaania FARMASIERRA LABORATORIOS, S.L.
75014 Paris France 
75014 Paris Prantsusmaa
LABORATORIOS ERN, S.A. 
Hispaania LABORATORIOS ERN, S.A.
TEOFARMA, S.R.L. 
Hispaania TEOFARMA, S.R.L.
Germany OPTIMED Pharma GmbH 
Saksamaa OPTIMED Pharma GmbH
Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom 
Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS Ühendkuningriik
Soluble Cupanol-Co Lemon Flavour effervescent tablet 
Soluble Cupanol-Co Lemon Flavour kihisev tablett
1080 Brussels Belgium 
1080 Brussels Belgia
Germany Novartis Pharma GmbH 
Saksamaa Novartis Pharma GmbH
Wrafton Laboratories Limited, Exeter Road, Wrafton, Braunton, Devon EX33 2DL United Kingdom 
Wrafton Laboratories Limited, Exeter Road, Wrafton, Braunton, Devon EX33 2DL Ühendkuningriik
C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta 
C/ Anabel Segura, 11
Belgium Bristol-Meyers Squibb Belgium sa 
Bristol-Meyers Squibb Belgium sa
Germany Stadapharm GmbH Stadastr. 
Saksamaa Stadapharm GmbH Stadastr.
LABORATORIOS LLORENS, S.A. 
Hispaania LABORATORIOS LLORENS, S.A.
TEVA PHARMA, S.L.U. 
Hispaania TEVA PHARMA, S.L.U.
CANTABRIA PHARMA, S.L. 
Hispaania CANTABRIA PHARMA, S.L.
Luxembourg Laboratoires SMB S.A. Rue de la Pastorale 26- 28 B 1080 
Rue de la Pastorale 26- 28 B 1080
Germany Pfizer Pharma GmbH Linkstr. 
Saksamaa Pfizer Pharma GmbH Linkstr.
Paracetamol/Codeine PARACETAMOL CODEINE SANOFI-AVENTIS 
Paratsetamool/kodeiin PARACETAMOL CODEINE SANOFI-AVENTIS
The Czech Republic 
Tšehhi Vabariik
S.C. Slavia Pharm S.R.L. 
Rumeenia S.C. Slavia Pharm S.R.L.
Hämeenlinna 13500 Finland paracetamol, codeine, 
Hämeenlinna 13500 Soome paratsetamool, kodeiin PARCODIN
Nitrianska 100, Hlohovec 920 27 Slovak Republic acetylsalicylic acid + codeine + caffeine 
Nitrianska 100, Hlohovec 920 27 Slovaki Vabariik atsetüülsalitsüülhape + kodeiin + kofeiin
KERN PHARMA, S.L. 
Hispaania KERN PHARMA, S.L.
Brentford TW89GS United Kingdom paracetamol, codeine, caffeine 
Brentford TW89GS Ühendkuningriik paratsetamool, kodeiin, kofeiin
GlaxoSmithKline Export Ltd 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom 
GlaxoSmithKline Export Ltd 980 Great West Road Brentford Middlesex TW8 9GS Ühendkuningriik
GlaxoSmithKline Consumer Healthcare (Ireland) Limited, Stonemasons Way, Rathfarnham, Dublin 16, Ireland 
GlaxoSmithKline Consumer Healthcare (Ireland) Limited, Stonemasons Way, Rathfarnham, Dublin 16, Iirimaa
08022 Barcelona Spain 
08022 Barcelona Hispaania
DOLODENS GRAGEAS 10 mg, 15 mg and 100 mg coated tablet 
DOLODENS GRAGEAS 10 mg, 15 mg and 100 mg kaetud tablett
125/5 ml mg + 7,5/5 ml mg syrup 
125/5 ml mg + 7,5/5 ml mg siirup
300 mg/10 mg capsule 
300 mg/10 mg kapsel
1070 Brussels Belgium 
1070 Brussels Belgia
Wockhardt UK Ltd., Ash Road North Wrexham, LL13 9 UF, United Kingdom 
Wockhardt UK Ltd., Ash Road North Wrexham, LL13 9 UF, Ühendkuningriik
25 mg/ml + 1,5 mg/ml syrup 
25 mg/ml + 1,5 mg/ml siirup
Via Nocera Umbra, 75 00181 Roma Italy paracetamol + codeine 'PARACETAMOLO + CODEINA ANGENERICO 
Via Nocera Umbra, 75 00181 Roma Itaalia paratsetamool + kodeiin
182 12 Danderyd Sweden codeine phosphate hemihydrate/ paracetamol 
182 12 Danderyd Rootsi kodeiinfosfaat hemihüdraat / paratsetamool
9GS Brentford United Kingdom codeine + paracetamol + caffeine 
9GS Brentford Ühendkuningriik kodeiin + paratsetamool + kofeiin
M&A Pharmachem Limited, Allenby Laboratories, Wigan Road, Westhoughton Bolton BL5 2AL United Kingdom 
M&A Pharmachem Limited, Allenby Laboratories, Wigan Road, Westhoughton Bolton BL5 2AL Ühendkuningriik
Vía F. Lli Cervi, 8 27010 Valle Salimbene (Pavia) 
27010 Valle Salimbene (Pavia)
1 mg/ml syrup 
1 mg/ml siirup
Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG, United Kingdom codeine phosphate 
Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG, Ühendkuningriik kodeiinfosfaat
LABORATORIOS ALTER, S.A. 
Hispaania LABORATORIOS ALTER, S.A.
Great West Road 980 Brentford TW8 9GS United Kingdom 
Great West Road 980 Brentford TW8 9GS Ühendkuningriik
ASA + codeine 
ASA + kodeiin
75016 Paris France 
75016 Paris
21,17 mg +325 mg tablet 
21,17 mg +325 mg tablett
Talvosilen forte 1000/60 1000mg/60 mg suppository rectal use 
Talvosilen forte 1000/60 1000mg/60 mg rektaalsuposiit rektaalne
Czech Republic codeine + paracetamol + fenpiverine + pitofenon 
Tšehhi Vabariik kodeiin + paratsetamool + fenpiveriin + pitofenoon
GEDEON RICHTER ROMÂNIA SA Str. Cuza Vodă nr. 99105, Târgu-Mureş, Romania acid acetilsalicilic, paracetamol , fosfat de codeină hemihidrat , cafeină anhidră 
Str. Cuza Vodă nr. 99105, Târgu-Mureş, Rumeenia atsetüülsalitsüülhape, paratsetamool, kodeiinfosfaat hemihüdraat, veevaba kofeiin
McNeil Products Limited, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG United Kingdom 
McNeil Products Limited, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG Ühendkuningriik
5 mg/5ml 200 mg/5ml suspension 
5 mg/5ml 200 mg/5ml suspensioon suukaudne
Rua Carpeinteiros, 25 Polígono Industrial Ceao 
Rua Carpeinteiros, 25
Codeine phosphate+paracetamo l custom Healthcare cocodamol 8/500mg capsules capsule 
Kodeiinfosfaat +paratsetamool custom Healthcare cocodamol 8/500mg capsules kapsel
Paracetamol/Codeine SEDARENE, gélule 
Paratsetamool/kodeiin SEDARENE, gélule
28,73 mg + 325 mg tablet 
28,73 mg + 325 mg tablett
0,8mg, 40 mg, 13 mg, 0,5 mg, 6 mg suppository rectal use 
0,8mg, 40 mg, 13 mg, 0,5 mg, 6 mg rektaalsuposiit rektaalne
08013 Barcelona Spain 
08013 Barcelona