natgillin/translations-raw huggingface dataset:
Further information on the HMPC assessment of castor oil medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use. 
Lisateave riitsinusõli sisaldavate ravimite hindamise kohta, sh komitee kokkuvõtte üksikasjalik kirjeldus, on Euroopa Ravimiameti veebilehe jaotises „All documents”: ema.europa.eu/Find medicine/Herbal medicines for human use.
What is castor oil? 
Mis on riitsinusõli?
Any applications for the licensing of medicines containing castor oil have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC. 
Riitsinusõli sisaldavate ravimite müügiloa taotlus tuleb esitada riiklikule ravimiametile, mis hindab taimsete ravimite müügiloa taotlust, võttes arvesse taimsete ravimite komitee teaduslikke järeldusi.
Detailed instructions on how to take castor oil medicines and who can use them can be found in the package leaflet that comes with the medicine. 
Üksikasjalik teave, kuidas võtta riitsinusõli sisaldavaid ravimeid ja kes neid tohib kasutada, on ravimi pakendi infolehel.
These include nausea, vomiting abdominal (belly) pain and severe diarrhoea. 
Nende hulka kuuluvad iiveldus, oksendamine, kõhuvalu ja raske kõhulahtisus.
When ingested, castor oil is broken down into ricinoleic acid which works by reducing absorption of fluid and salts in the small intestine (the upper part of the bowel). 
Allaneelamisel laguneb riitsinusõli ritsinoolhappeks, mis vähendab vedeliku ja soolade imendumist peensooles (soolestiku ülaosas).
In its assessment, the HMPC considered two clinical studies which showed a laxative effect for castor oil medicines in constipated patients. 
Taimsete ravimite komitee uuris hinnangu andmisel kaht kliinilist uuringut, mis tõendasid riitsinusõli sisaldavate ravimite lahtistavat toimet kõhukinnisusega patsientidel.
Information on the use and licensing of castor oil medicines in EU Member States should be obtained from the relevant national authorities. 
ELi liikmesriikides saab riitsinusõli sisaldavate ravimite kasutamise ja müügilubade teavet asjakohastelt riiklikelt ravimiametitelt.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of castor oil. 
See on taimsete ravimite komitee teaduslike järelduste kokkuvõte, mis käsitleb riitsinusõli meditsiinilisi kasutusviise.
Castor oil preparations may also be found in combination with other herbal substances in some herbal medicines. 
Mõnes taimses ravimis võib esineda riitsinusõli valmistisi ka kombinatsioonis teiste taimsete ainetega.
What are the risks associated with castor oil medicines? 
Mis riskid riitsinusõli sisaldavate ravimitega kaasnevad?
What evidence supports the use of castor oil medicines? 
Mis tõendid toetavad riitsinusõli sisaldavate ravimite kasutamist?
This summary is not intended to provide practical advice on how to use medicines containing castor oil. 
Kokkuvõttes ei anta riitsinusõli sisaldavate ravimite kasutamise praktilisi nõuandeid.
Herbal medicines containing these castor oil preparations are usually available in solid or liquid forms to be taken by mouth. 
Neid riitsinusõli sisaldavaid taimseid ravimeid turustatakse tavaliselt suukaudsete tahkete või vedelate valmististena.
For more information about treatment with castor oil medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist. 
Kui vajate riitsinusõli sisaldavate ravimitega toimuva ravi kohta lisateavet, lugege palun ravimi pakendi infolehte või pöörduge oma arsti või apteekri poole.
The HMPC concluded that these castor oil preparations can be used for short term as laxatives for occasional constipation. 
Taimsete ravimite komitee järeldas, et neid riitsinusõli valmistisi tohib kasutada lühiajaliselt lahtistitena juhusliku kõhukinnisuse korral.
In addition, castor oil stimulates movement in the intestines which will help to pass the stools. 
Lisaks stimuleerib riitsinusõli soolestiku motoorikat, mis aitab väljaheitel soolestikus edasi liikuda.
How are castor oil medicines approved in the EU? 
Kuidas antakse Euroopa Liidus riitsinusõli sisaldavate ravimite müügiluba?
For practical information about using castor oil medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist. 
Kui vajate riitsinusõli sisaldavate ravimite kasutamise kohta praktilisi nõuandeid, lugege ravimi pakendi infolehte või pöörduge oma arsti või apteekri poole.
Side effects have been reported with castor oil. 
Riitsinusõli kasutamisel on teatatud kõrvalnähtudest.
The HMPC conclusions on the use of these castor oil medicines as laxatives are based on their ‘wellestablished use'. 
Taimsete ravimite komitee järeldused nende riitsinusõli sisaldavate ravimite kasutamise kohta lahtistitena põhinevad nende tõendatud kasutusel.
How does castor oil work as a medicine? 
Kuidas riitsinusõli ravimina toimib?
What are the HMPC conclusions on its medicinal uses? 
Mis on taimsete ravimite komitee järeldused riitsinusõli meditsiiniliste kasutusalade kohta?
Member States when evaluating applications for the licensing of herbal medicines containing castor oil. 
ELi liikmesriigid võtavad taimsete ravimite komitee järeldusi arvesse, kui nad hindavad riitsinusõli sisaldavate taimsete ravimite müügilubade taotlusi.
Castor oil is the common name for the oil obtained from the seeds of the plant Ricinus communis L. The HMPC conclusions only cover castor oil preparations which are obtained by ‘cold expression' of the seeds. 
Riitsinusõli on taime Ricinus communis L. seemnetest saadud õli üldnimetus.
MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging Pack size EU/1/08/498/002 Thymanax 
Müügiloa nr Euroopa Liidus Ravimi väljamõeldud nimetus Tugevus Ravimvorm
Conditional marketing authorisation 
Tingimuslik müügiluba
<Similarity> 
<Sarnasus>
<Derogation> 
<Erand>
<the holder of the marketing authorisation for <authorised orphan medicinal product> is unable to supply sufficient quantities of the medicinal product> <and> 
<<müügiloa saanud harvikravimi> müügiloa hoidja ei suuda tarnida ravimit piisavas koguses> <ja>
<the holder of the marketing authorisation for <authorised orphan medicinal product> has given his consent to the applicant.> 
<<müügiloa saanud harvikravimi> müügiloa hoidja on taotlejale andnud oma nõusoleku.>
<one-year <marketing protection><data exclusivity>> 
<Ühe aasta pikkune <müügikaitse><andmete ainuõiguse periood>>
<The CHMP is of the opinion that pursuant to Article 8 of Regulation (EC) No. 141/2000 and <Article 3 of Commission Regulation (EC) No 847/2000> [only for the superiority derogation] the following derogation
 laid down in Article 8.3 of the same Regulation apply(ies) as further explained in European Public Assessment Report : 
<Inimravimite komitee on arvamusel, et määruse (EÜ) nr 141/2000 artikli 8 <ning komisjoni määruse (EÜ) nr 847/2000 artikli 3>[only for the superiority derogation] kohaselt kehtib järgmine (kehtivad järgmised) sama määruse artikli 8 lõikes 3 sätestatud erand(id), nagu on kirjeldatud Euroopa avalikus hindamisaruandes:
CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETING AUTHORISATION AND <SIMILARITY AND DEROGATION> <AND> < THE REQUEST FOR ONE-YEAR <MARKETING PROTECTION> <DATA EXCLUSIVITY>> PRESENTED BY THE EUROPEAN MEDICINES AGENCY 
EUROOPA RAVIMIAMETI ESITATUD JÄRELDUSED TINGIMUSLIKU MÜÜGILOA ANDMISE JA <SARNASUSE JA ERANDI> <JA> <ÜHE AASTA PIKKUSE <MÜÜGIKAITSE> <ANDMETE AINUÕIGUSE PERIOODI> TAOTLUSE> KOHTA
<the applicant could establish in the application that the medicinal product, although similar to <authorised orphan medicinal product>, is safer, more effective or otherwise clinically superior (as defined in Article 3 of Commission Regulation (EC) No. 847/2000) for the same therapeutic indication> <and> 
<taotleja suutis taotluses tõestada, et ravim, kuigi <müügiloa saanud harvikravimiga> sarnane, on samal näidustusel ohutum, efektiivsem või muul viisil kliiniliselt parem (komisjoni määruse (EÜ) nr 847/2000 artiklis 3 esitatud määratluse järgi)> <ja>
[For Art 14(11)] <The CHMP reviewed the data submitted by the Marketing Authorisation Holder, taking into account the provisions of Article 14(11) of Regulation (EC) No 726/2004, and considers that the new therapeutic indication brings significant clinical benefit in comparison with existing therapies as further explained in the European Public Assessment Report. 
[For Art 14(11)] <Inimravimite komitee vaatas määruse (EÜ) nr 726/2004 artikli 14 lõike 11 sätteid arvesse võttes läbi müügiloa hoidja esitatud andmed ning leiab, et uus näidustus lisab olulist kliinilist kasulikkust võrreldes olemasoleva raviga, nagu on kirjeldatud Euroopa avalikus hindamisaruandes.>
The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the conditional marketing authorisation as further explained in the European Public Assessment Report. 
Pärast taotluse arutamist on inimravimite komitee arvamusel, et ravimi riski/kasu suhe on soodne ning seega võib sellele anda tingimusliku müügiloa, nagu on kirjeldatud Euroopa avalikus hindamisaruandes.
[Art 10(5)] <The CHMP reviewed the data submitted by the Marketing Authorisation Holder, taking into account the provisions of Article 10(5) of Directive 2001/83/EC, and considers that <the <pre-clinical tests> <and> <clinical studies> carried out in relation to the new indication were significant as further explained in the European Public Assessment Report. 
[Art 10(5)] <Inimravimite komitee vaatas direktiivi 2001/83/EÜ artikli 10 lõike 5 sätteid arvesse võttes läbi müügiloa hoidja esitatud andmed ning leiab, et <uue näidustuse <prekliinilised uuringud> <ja> <kliinilised uuringud> olid olulised, nagu on kirjeldatud Euroopa avalikus hindamisaruandes.>>
<The CHMP is of the opinion that <name of product> is similar to authorised orphan medicinal products within the meaning of Article 3 of Commission Regulation (EC) No. 847/2000 as further explained in the European Public Assessment Report. 
<Inimravimite komitee on arvamusel, et <ravimpreparaadi nimetus> on komisjoni määruse (EÜ) nr 847/2000 artikli 3 mõistes sarnane müügiloa saanud harvikravimitega, nagu on kirjeldatud Euroopa avalikus hindamisaruandes.>
Belgium APOTEX NV Av. du Bourg. 
APOTEX NV Av. du Bourg.
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
United Kingdom Waymade Plc Regency House 
Ühendkuningriik Waymade Plc Regency House
ARENA GROUP S.A. Str. Stefan Mihaileanu nr.31, sector 2; 
S.C. ARENA GROUP S.A. Str. Stefan Mihaileanu nr.31, sector 2;
Belgium LABORATORIA QUALIPHAR N.V/S.A 
LABORATORIA QUALIPHAR N.V/S.A
United Kingdom Generics (UK) Limited Station Close 
Ühendkuningriik Generics (UK) Limited Station Close
United Kingdom Bristol Laboratories Limited Unit 3, Canal side 
Ühendkuningriik Bristol Laboratories Limited Unit 3, Canal side
United Kingdom RI Pharma Limited First floor,6 St John's Court Upper Fforest Way 
Ühendkuningriik RI Pharma Limited First floor,6 St John's Court Upper Fforest Way
Pfizer Holding France 23-25, avenue du Docteur Lannelongue 
Prantsusmaa Pfizer Holding France 23-25, avenue du Docteur Lannelongue
Hungary ratiopharm Hungária Kereskedelmi Kft. Uzsoki u. 36/a 
Ungari ratiopharm Hungária Kereskedelmi Kft. Uzsoki u. 36/a
United Kingdom Daichi-Sankyo UK Limited Chiltern Place 
Ühendkuningriik Daichi-Sankyo UK Limited Chiltern Place
ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon 
Prantsusmaa ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon
United Kingdom Therabel pharma UK Limited Compass House, vision Park Chivers, Histon 
Ühendkuningriik Therabel pharma UK Limited Compass House, vision Park Chivers, Histon
United Kingdom Actavis UK Limited Whiddon Valley 
Ühendkuningriik Actavis UK Limited Whiddon Valley
United Kingdom Dexcel Pharma Limited 7 Sopwith Way 
Ühendkuningriik Dexcel Pharma Limited 7 Sopwith Way
Oral drops, suspension 
Suukaudsed tilgad, suspensioon
Luxembourg Continental Pharma Rijksweg, 12 
Luxemburg Continental Pharma Rijksweg, 12
15, boulevard Charles de Gaulle 
Prantsusmaa BIOGARAN 15, boulevard Charles de Gaulle
110, Esplanade du Général de Gaulle 
Prantsusmaa TEVA SANTE 110, Esplanade du Général de Gaulle
CRISTERS 22 quai Gallieni 92150 Suresnes France 
Prantsusmaa CRISTERS 22 quai Gallieni 92150 Suresnes France
United Kingdom Galen Limited Seagoe Industrial Estate Craigavon 
Ühendkuningriik Galen Limited Seagoe Industrial Estate Craigavon
The Netherlands Wise Pharmaceuticals Ltd. Hamwells Business Park Unit No. 7, Hardicker Street M19 2RB Manchester 
Wise Pharmaceuticals Ltd. Hamwells Business Park Unit No. 7, Hardicker Street M19 2RB Manchester United Kingdom
Luxembourg Hexal AG Industriestraße 25 
Luxemburg Hexal AG Industriestraße 25
Czech Republic Krka, d.d. 
Tšehhi Vabariik Krka, d.d.
United Kingdom Chiesi Limited Cheadle Royal Business Park Highfield, Cheadle Cheshire SK8 3GY United Kingdom 
Ühendkuningriik Chiesi Limited Cheadle Royal Business Park Highfield, Cheadle Cheshire SK8 3GY United Kingdom
Luxembourg Socobom S.A Avenue Louise 149 b24 B-1050 Bruxelles Belgium 
Luxemburg Socobom S.A Avenue Louise 149 b24 B-1050 Bruxelles Belgium
United Kingdom Pfizer Limited Ramsgate Road 
Ühendkuningriik Pfizer Limited Ramsgate Road
United Kingdom Crescent Pharma Limited Unit 3&4 
Ühendkuningriik Crescent Pharma Limited Unit 3&4
United Kingdom Teva UK Limited Brampton Road 
Ühendkuningriik Teva UK Limited Brampton Road
United Kingdom Aptil Pharma limited 9th Floor 
Ühendkuningriik Aptil Pharma limited 9th Floor
United Kingdom Focus Pharmaceuticals Limited Unit 5, Faraday court 
Ühendkuningriik Focus Pharmaceuticals Limited Unit 5, Faraday court
United Kingdom Mercury Pharma Group Limited No. 1 Croydon 
Ühendkuningriik Mercury Pharma Group Limited No. 1 Croydon
Finland ratiopharm Oy P.O.Box 67 
Soome ratiopharm Oy P.O.Box 67
Luxembourg Daiichi Sankyo Belgium SA Rue Fond Jean Pâques 5 
Luxemburg Daiichi Sankyo Belgium SA Rue Fond Jean Pâques 5
United Kingdom Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire WD18 9SS United Kingdom 
Ühendkuningriik Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire WD18 9SS United Kingdom
Slovak Republic MEDOPHARM s.r.o., Lehárova 143 00, Praha 4 
MEDOPHARM s.r.o., Lehárova 143 00, Praha 4
United Kingdom Chelonia Healthcare Limited Boumpoulinas 11 
Ühendkuningriik Chelonia Healthcare Limited Boumpoulinas 11
United Kingdom Ennogen Pharma Limited Unit G4, Riverside Way Dartford, DA1 5BS 
Ühendkuningriik Ennogen Pharma Limited Unit G4, Riverside Way Dartford, DA1 5BS
2880 Bornem 
2880 Bornem Belgium
United Kingdom Sandoz Limited Frimley Business Park Frimley 
Ühendkuningriik Sandoz Limited Frimley Business Park Frimley
Czech Republic Winthrop Arzneimittel GmbH Industriestrasse 26 
Tšehhi Vabariik Winthrop Arzneimittel GmbH Industriestrasse 26
NOVARTIS PHARMA 2-4, rue Lionel Terray 92500 Rueil-Malmaison France 
Prantsusmaa NOVARTIS PHARMA 2-4, rue Lionel Terray 92500 Rueil-Malmaison France
United Kingdom Chatfield Pharmaceuticals Limited 
Ühendkuningriik Chatfield Pharmaceuticals Limited
Czech Republic Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. 
Tšehhi Vabariik Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.
Czech Republic Vitabalans OY Varastokatu 8 
Tšehhi Vabariik Vitabalans OY Varastokatu 8
United Kingdom Morningside Healthcare Limited 115 Narborough Road 
Ühendkuningriik Morningside Healthcare Limited 115 Narborough Road
Belgium Continental Pharma Rijksweg, 12 
Continental Pharma Rijksweg, 12
The Netherlands Manston Pharma Limited 3 Montpelier Avenue, Bexley DA5 3AP Kent 
Manston Pharma Limited 3 Montpelier Avenue, Bexley DA5 3AP Kent
Czech Republic Zentiva, k.s. 
Tšehhi Vabariik Zentiva, k.s.
United Kingdom Mercury Pharma International Limited 
Ühendkuningriik Mercury Pharma International Limited
Etienne Demunter 5, box 8 
Etienne Demunter 5, box 8 1090 Jette
6824 DP Arnhem 
6824 DP Arnhem The Netherlands
Luxembourg Mylan bvba Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium 
Luxemburg Mylan bvba Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium
Belgium N.V. Eurogenerics S.A Esplanade Heysel b 22 
Eurogenerics S.A Esplanade Heysel b 22
Luxembourg Novartis Consumer Health S.A. Medialaan, 40 
Luxemburg Novartis Consumer Health S.A. Medialaan, 40
1200 Woluwé-saint-lambert Belgium 
Rue Saint-Lambert 141 1200 Woluwé-saint-lambert Belgium
Belgium Mylan bvba Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium 
Mylan bvba Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium
2333 CN Leiden The Netherlands 
Archimedesweg 2 2333 CN Leiden The Netherlands
7255 PZ Hengelo 
7255 PZ Hengelo The Netherlands
Diclofenac potassium VOLTATABS 12,5 MG(EX:ZYMAMED) 
Diclofenac potassium VOLTATABS 12,5 MG(EX:ZYMAM ED)
EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex 
Prantsusmaa EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou
United Kingdom Novartis Consumer Health UK Limited 
Ühendkuningriik Novartis Consumer Health UK Limited
Czech Republic Herbacos Recordati s.r.o. 
Tšehhi Vabariik Herbacos Recordati s.r.o.
Intramuscular injection or intravenous infusion. 
Parenteraalne, intramuskulaarne või intravenoosne infusioon.
Czech Republic Medochemie Ltd 1-10 Constantinoupoleos str P.O. 
Tšehhi Vabariik Medochemie Ltd 1-10 Constantinoupoleos str P.O.
Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany 
KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany
Czech Republic Apotex Europe B.V. Darwinweg 20 
Tšehhi Vabariik Apotex Europe B.V.
Luxembourg Novartis Pharma GmbH Roonstrasse 25 
Luxemburg Novartis Pharma GmbH Roonstrasse 25
Czech Republic Alfa Wassermann S.p.A. 
Tšehhi Vabariik Alfa Wassermann S.p.A.
United Kingdom Actavis Group PTC ehf Reykjavikurvegi 76-78 
Ühendkuningriik Actavis Group PTC ehf Reykjavikurvegi 76-78
Prolonged-release tablet hameln pharma plus gmbh Langes Feld 13 
Saksamaa hameln pharma plus gmbh Langes Feld 13
Parenteral use, Intramuscular use 
Parenteraalne, Intramuskulaarne
Belgium Novartis Consumer Health S.A. Medialaan, 40 
Novartis Consumer Health S.A. Medialaan, 40
Czech Republic Fresenius Kabi Austria GmbH Hafnerstrasse 36 
Tšehhi Vabariik Fresenius Kabi Austria GmbH Hafnerstrasse 36
Luxembourg ratiopharm GmbH Graf Arco Strasse 3 
Luxemburg ratiopharm GmbH Graf Arco Strasse 3
Diclofenacum natricum Voltaren Retard 100 mg modified-release film-coated tablets 
Diclofenacum natricum Voltaren Retard 100 mg modifiedrelease film-coated tablets
Czech Republic ratiopharm GmbH Graf Arco Strasse 3 
Tšehhi Vabariik ratiopharm GmbH Graf Arco Strasse 3
ARTOTEC 75 mg/0,2 mg, comprimé gastro-résistant 
ARTOTEC 75 mg/0,2 mg, comprimé gastrorésistant
Czech Republic Dr. R. Pfleger Chemische Fabrik GmbH 
Tšehhi Vabariik Dr. R. Pfleger Chemische Fabrik GmbH
The Netherlands Actavis Group PTC ehf Reykjavikurvegi 76-78 
Prantsusmaa Actavis Group PTC ehf Reykjavikurvegi 76-78
Prolonged-release tablet sigapharm GmbH Temmlerstr. 
Saksamaa sigapharm GmbH Temmlerstr.
Diclofenac potassium Voltfast Sachets 50 mg Powder for Oral 
Diclofenac potassium Voltfast Sachets 50 mg Powder for
Czech Republic IBSA Slovakia s.r.o. 
Tšehhi Vabariik IBSA Slovakia s.r.o.
The Netherlands ratiopharm Nederland B.V. Florapark 4 
Holland ratiopharm Nederland B.V.
Na Pankraci 1724/129 
Na Pankraci 1724/129 140 00 Praha 4
ARTOTEC 50 mg/0,2 mg, comprimé gastro-résistant 
ARTOTEC 50 mg/0,2 mg, comprimé gastrorésistant
Rectal use betapharm Arzneimittel GmbH Kobelweg 95 
Saksamaa betapharm Arzneimittel GmbH Kobelweg 95
Actavis Deutschland GmbH & Co. KG 
Actavis Deutschland GmbH & Co.
Slovak Republic IBSA Slovakia s.r.o. 
IBSA Slovakia s.r.o.
Laboratoires Genevrier 280, rue de Goa Les Trois Moulins - Parc de Sophia Antipolis 06600 Antibes France 
Les Trois Moulins - Parc de Sophia Antipolis
Czech Republic PharmaSwiss Česká republika s.r.o. 
Tšehhi Vabariik PharmaSwiss Česká republika s.r.o.
Granules for oral suspension 
Suukaudse suspensiooni graanulid
Powder for oral solution 
Oral Solution
Diclofenac sodium Diclofenac EG 100 suppositoire suppository 
Diclofenac sodium Diclofenac EG 100 suppositoire
Belgium Teva Pharma Belgium N.V. Laarstraat 16 
Teva Pharma Belgium N.V.
Intramuscular use, Subcutaneous use 
Intramuskulaarne, Subkutaanne
Prolonged-release capsule 
Toimeainet prolongeeritult vabastav kapsel
United Kingdom Novartis Pharmaceuticals UK ltd. 
Ühendkuningriik Novartis Pharmaceuticals UK ltd.
Gastro-resistant capsule 
Gastroresistent ne kapsel
Intramuscular use, intravenous use 
Intramuskulaarne, Intravenoosne
Novartis Farma S.p.A. Largo Umberto Boccioni, 1 Origgio - 21040 Varese Italy 
Largo Umberto Boccioni, 1 Origgio - 21040 Varese Italy
Slovak Republic Herbacos Recordati s.r.o. 
Herbacos Recordati s.r.o.
AWD.pharma GmbH & Co. KG 
AWD.pharma GmbH & Co.
The Netherlands Apotex Europe B.V. Darwinweg 20 
Apotex Europe B.V.
Not applicable for bolus intravenous injection 
Ei kasutata intravenoosse boolussüstena.
NOVARTIS SANTE FAMILIALE 14, boulevard Richelieu 92500 Rueil-Malmaison France 
Prantsusmaa NOVARTIS SANTE FAMILIALE 14, boulevard Richelieu
Belgium Daiichi Sankyo Belgium SA Rue Fond Jean Pâques 5 
Daiichi Sankyo Belgium SA Rue Fond Jean Pâques 5 B-1348 Louvain-la-Neuve Belgium
Olfen 75 mg/20 mg/2 ml solution for injection 
75 mg/20 mg/2 ml solution for injection
Parenteral use 
Parenteraalne
The Netherlands Teva Nederland B.V. Swensweg 5 
Teva Nederland B.V.
Czech Republic ALIUD PHARMA GmbH & Co. KG 
Tšehhi Vabariik ALIUD PHARMA GmbH & Co.
Diclofenac sodium Diclofenacnatrium Sandoz injectie 75 mg/3 ml, oplossing voor injectie 25 mg/ml 
Diclofenac sodium Diclofenacnatrium Sandoz injectie 75 mg/3 ml, oplossing voor injectie
The Netherlands Disphar International B.V. Winkelskamp 6 
Disphar International B.V.
Diclofenac sodium Voltaren-100 Zäpfchen suppository 
Diclofenac sodium Voltaren-100 Zäpfchen
ALIUD PHARMA GmbH & Co. KG 
ALIUD PHARMA GmbH & Co.
Orodispersible tablet 
Dispergeeruv tablett
Diclofenac kalium Diclo-CT akut 12,5 mg Filmtabletten 
Diclofenac kalium Diclo-CT akut 12,5 mg
DICLOMELAN 50 MG 50mg 
DICLOMELAN 50 G 50 mg
Gastro-resistant coated tablet 
Gastroresistent ne kaetud tablett
Diclofenac sodium Diclofenac EG 75 mg/3 ml solution injectable solution for injection 
Diclofenac sodium Diclofenac EG 75 mg/3 ml solution injectable
The Netherlands Pharmacin B.V. Molenvliet 103 
Molenvliet 103
Diclofenac sodium Diclac-50 Zäpfchen 50mg suppository 
Diclofenac sodium Diclac-50 Zäpfchen 50 mg
Iceland ratiopharm GmbH Graf-Arco Strasse 3 89079 Ulm Germany 
Island ratiopharm GmbH Graf-Arco Strasse 3 89079 Ulm Germany
Diclofenac sodium Diclac 75 mg/3 ml Injektionslösung solution for injection 
Diclofenac sodium Diclac 75 mg/3 ml Injektionslösung
Diclofenac sodium Difene ampoules 75 mg/3 ml Solution for 
Diclofenac sodium Difene ampoules 75 mg/3 ml Solution for Injection or
Film-coated prolonged release tablet 
Toimeainet prolongeeritult vabastav kaetud tablett
Diclofenac sodium Diclac-100 Zäpfchen 100mg suppository 
Diclofenac sodium Diclac-100 Zäpfchen 100 mg
Diclofenac potassium VOLTAREN ACTI-GO 12,5mg Coated tablet 
Diclofenac potassium VOLTAREN ACTI-GO 12,5 mg
Diclofenac sodium Xelaran Brausetablette 25 mg 
Diclofenac sodium Xelaran Brausetablette
Belgium RATIOPHARM BELGIUM S.A. Rue Saint-Lambert 141 
RATIOPHARM BELGIUM S.A.
Diclofenac potassium Voltaren Express 12,5mg Capsule, soft 
Diclofenac potassium Voltaren Express 12,5 mg
Intramuscular use, Intravenous use 
Infusioonilahus Parenteraalne, Intravenoosne
DICLOFENAC AL 50 mg gyomornedvellenálló filmtabletta 
50 mg gyomornedvellenálló filmtabletta
The Netherlands Pfizer B.V. Rivium Westlaan 142 
Rivium Westlaan 142