FrancophonIA/ELRC3.0 huggingface dataset:
English: (A/Vietnam/1194/2004) dose, all vaccine schedule groups after 3 weeks from the 2nd vaccination achieved high levels of antibodies as evaluated with SRH.
Slovenian: starih 18 do 60 let, kjer je drugi odmerek sledil 1, 2, 3 ali 6 tednov po prvem odmerku cepiva AFLUNOV (A/Vietnam/1194/2004), so vsi režimi cepljenja po 3. tednih po 2. cepljenju dosegli visoke ravni protiteles, ocenjene s SRH.
English: AFLUNOV
Slovenian: EXP
English: Muscoskeletal, connective tissue and bone disorders Muscular weakness, pain in extremities.
Slovenian: Oslabelost mišic, bolečine v okončinah
English: Immunocompromised
Slovenian: Z oslabljenim imunskim odzivom
English: Healthy
Slovenian: Zdravi
English: Non-clinical data obtained with AFLUNOV and with seasonal influenza vaccine containing MF59C.1 adjuvant reveal no special hazard for humans based on conventional studies of repeated dose toxicity, local tolerance, female fertility, and reproductive and developmental toxicity (through the end of the lactation period).
Slovenian: MF59C.1, na osnovi običajnih študij toksičnosti pri ponavljajočih odmerkih, lokalnega prenašanja,
English: Adults (20- 60 years)a
Slovenian: Odrasli (20-60 le t)*
English: Gastrointestinal disorders Gastrointestinal disorders such as nausea, vomiting, abdominal pain and diarrhoea.
Slovenian: Prebavne težave, kot so navzea, bruhanje, bolečine v trebuhu in driska
English: MARKETING AUTHORISATION HOLDER
Slovenian: Spremljanje v obdobju trženja
English: How to store AFLUNOV
Slovenian: Shranjevanje cepiva AFLUNOV
English: Anti-HA antibody Study V87P12 21 days after 2nd dose N=60
Slovenian: Študija V87P12 21. dni po 2. odmerku N = 60
English: The side effects listed below have occurred in the days or weeks after vaccination with another vaccine called Focetria H1N1v similar to AFLUNOV.
Slovenian: imenovanim Focetria H1N1v, ki je podobno cepivu AFLUNOV.
English: Suspension for injection in pre-filled syringe.
Slovenian: suspenzija za injiciranje v napolnjeni injekcijski brizgi mlečno-bela tekočina
English: Other rare side effects observed after routine use:
Slovenian: Drugi redki neželeni učinki, ki so jih opazili po rutinski uporabi: Spodaj našteti neželeni učinki so se pojavili v dneh ali tednih po cepljenju z drugim cepivom,
English: a actual age range of population enrolled * Seroprotection: SRH area≥25 mm2
Slovenian: * izmerjeno s testom SRH; serozaščita: površina SRH ≥ 25 mm2; serokonverzija: površina SRH
English: • if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to egg and chicken protein, ovalbumin, formaldehyde, kanamycin and neomycin sulphate (antibiotics) or cetyltrimethylammonium bromide (CTAB) (see section 6.
Slovenian: • če ste imeli kakršno koli alergijsko reakcijo, ki ni bila nenadna, življenje ogrožajoča, na katero koli sestavino cepiva, na jajčne in piščančje beljakovine, na ovalbumin, formaldehid,
English: Seroprotection rate (95%CI)* Seroconversion rate (95%CI)** Seroconversion factor (95%CI)***
Slovenian: (95-% IZ)* Stopnja serokonverzije (95-% IZ)* Faktor serokonverzije (95-% IZ)**
English: The side effects listed below have occurred with AFLUNOV in clinical studies in adults, including the elderly:
Slovenian: Neželeni učinki, opisani v nadaljevanju, so se pojavili po cepljenju odraslih oseb in starostnikov s cepivom AFLUNOV v kliničnih študijah: Zelo pogosti (pojavijo se pri več kot 1 od 10 bolnikov):
English: Name and address of the manufacturer responsible for batch release Seqirus Vaccines Ltd
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij
English: There are no data with AFLUNOV using the subcutaneous route of administration.
Slovenian: Podatkov o subkutani poti uporabe cepiva AFLUNOV ni.
English: MedDRA System Organ class Very common
Slovenian: Organski sistem po MedDRA
English: Clinical trials with AFLUNOV have been conducted with either the former A/Vietnam/1194/2004 (H5N1) (clade 1) or the current A/turkey/Turkey/1/2005 (H5NI) vaccine strain (clade 2.2.1).
Slovenian: A/Vietnam/1194/2004 (H5N1) ali sedanjim sevom A/turkey/Turkey/1/2005 (H5N1) (gruča 2.2.1).
English: Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=66
Slovenian: Študija V87P13 A/Vietnam/1194/2004 21. dni po 2. odmerku N = 66
English: Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=128
Slovenian: Študija V87P13 A/Vietnam/1194/2004 21. dni po 2. odmerku N = 128
English: Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=69
Slovenian: Študija V87P13 A/Vietnam/1194/2004 21. dni po 2. odmerku N = 69
English: Study V87P1 A/Vietnam/1194/2004 21 days after 2nd dose N=149
Slovenian: Študija V87P1 A/Vietnam/1194/2004 21. dan po 2. odmerku N = 149
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec: Imetnik dovoljenja za promet z zdravilom
English: • Injection site swelling
Slovenian: • oteklo mesto injiciranja,
English: Posology
Slovenian: sistemom
English: Study V87P1 A/Vietnam/1194/2004 21 days after 2nd dose N=84a
Slovenian: Študija V87P1 A/Vietnam/1194/2004 21. dan po 2. odmerku N = 84
English: Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=143
Slovenian: Študija V87P13 A/Vietnam/1194/2004 21. dni po 2. odmerku N = 143
English: * measured by SRH assay seroprotection: SRH area ≥25 mm2, seroconversion: SRH area ≥25 mm2 for subjects with a baseline SRH area ≤4 mm2 or a minimum 50% increase in SRH area for subjects with >4 mm2.
Slovenian: ≥ 25 mm2 za osebe s površino SRH ≤ 4 mm2 ob izhodišču ali z vsaj 50 % povečanjem površine
English: Immune system disorders
Slovenian: Limfadenopatija Bolezni imunskega sistema
English: Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=210b
Slovenian: Študija V87P13 A/Vietnam/1194/2004 21. dan po 2. odmerku N = 210
English: Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=197
Slovenian: Študija V87P13 A/Vietnam/1194/2004 21. dan po 2. odmerku N = 197
English: Cardiac disorders Palpitation, tachycardia.
Slovenian: Palpitacije, tahikardija Bolezni dihal Kašelj
English: • Vomiting
Slovenian: • mravljinčenje,
English: Immunocompromised N=139
Slovenian: sistemom N = 139
English: They should not be used during pregnancy and breastfeeding.
Slovenian: Ne smejo se uporabljati med nosečnostjo in dojenjem.
English: This means that there are bibliographic data providing scientific evidence of their effectiveness and safety when used in this way, covering a period of at least 10 years in the EU.
Slovenian: To pomeni, da obstajajo podatki iz literature z znanstvenimi dokazi o njihovi učinkovitosti in varnosti pri uporabi na navedeni način, ki zajemajo obdobje vsaj 10 let v EU.
English: Castor oil medicines should only be used in adults, and should not be taken for longer than one week without medical supervision.
Slovenian: Zdravila, ki vsebujejo ricinusovo olje, se smejo uporabljati samo pri odraslih in se brez zdravniškega nadzora ne smejo uporabljati več kot en teden.
English: This means that the oil is extracted from the seeds by crushing and pressing them without heating.
Slovenian: To pomeni, da se olje ekstrahira iz semen tako, da se semena brez segrevanja zdrobijo in stisnejo.
English: Castor oil EMA/108531/2016
Slovenian: Ricinusovo olje EMA/108531/2016
English: This summary is not intended to provide practical advice on how to use medicines containing castor oil.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo ricinusovo olje.
English: 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.
Slovenian: Ricinusovo olje je splošno ime za olje, pridobljeno iz semen rastline Ricinus communis L. Zaključki odbora HMPC zajemajo samo pripravke z ricinusovim oljem, ki se pridobivajo s „hladnim iztiskanjem“ semen.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of castor oil.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo ricinusovega olja.
English: Herbal medicines containing these castor oil preparations are usually available in solid or liquid forms to be taken by mouth.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo te pripravke z ricinusovim oljem, so navadno na voljo v trdni ali tekoči obliki za jemanje skozi usta.
English: What is castor oil?
Slovenian: Kaj je ricinusovo olje?
English: Castor oil medicines should not be taken in case of obstruction or narrowing of the gut, atony (loss of normal movement in the gut muscle), appendicitis (inflammation of the appendix, a small organ connected to the bowel), inflammatory diseases of the colon (the lower part of the bowel), unexplained abdominal pain and severe dehydration.
Slovenian: Zdravila, ki vsebujejo ricinusovo olje, se ne smejo uporabljati pri črevesni zapori ali zožitvi, atoniji (izgubi normalnega gibanja črevesnih mišic), apendicitisu (vnetju slepiča, majhnega organa, povezanega s črevesjem), vnetni bolezni debelega črevesa (spodnjega dela črevesa), nepojasnjeni bolečini v trebuhu in hudi dehidraciji.
English: Further information on the risks associated with castor oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo ricinusovo olje, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: How does castor oil work as a medicine?
Slovenian: Kako ricinusovo olje deluje kot zdravilo?
English: In its assessment, the HMPC considered two clinical studies which showed a laxative effect for castor oil medicines in constipated patients.
Slovenian: V svoji oceni je odbor HMPC upošteval dve klinični študiji, ki sta pokazali, da imajo zdravila, ki vsebujejo ricinusovo olje, pri bolnikih z zaprtjem odvajalni učinek.
English: Castor oil
Slovenian: Ricinusovo olje
English: In one of the studies the effects of castor oil capsules were similar to those of senna capsules (another herbal preparation commonly used to treat constipation).
Slovenian: V eni od študij so bili učinki ricinusovega olja podobni učinkom kapsul sene (drugega pripravka rastlinskega izvora, ki se pogosto uporablja za zdravljenje zaprtosti).
English: This increases the water content of stools, making them softer and easier to pass.
Slovenian: S tem se poveča vsebnost vode v blatu, zato blato postane mehkejše in se lažje odvaja.
English: The HMPC conclusions on the use of these castor oil medicines as laxatives are based on their ‘wellestablished use'.
Slovenian: Zaključki odbora HMPC v zvezi z uporabo zdravil, ki vsebujejo ricinusovo olje, kot odvajal temeljijo na njihovi „dobro uveljavljeni medicinski uporabi“.
English: These include nausea, vomiting abdominal (belly) pain and severe diarrhoea.
Slovenian: Ti vključujejo slabost, bruhanje, bolečine v trebuhu in hudo drisko.
English: Castor oil preparations may also be found in combination with other herbal substances in some herbal medicines.
Slovenian: Pripravki z ricinusovim oljem so v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
English: 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.
Slovenian: Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo ricinusovo olje, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
English: Information on the use and licensing of castor oil medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in registraciji zdravil, ki vsebujejo ricinusovo olje, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: 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.
Slovenian: Dodatne informacije o oceni zdravil, ki vsebujejo ricinusovo olje, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC concluded that these castor oil preparations can be used for short term as laxatives for occasional constipation.
Slovenian: Odbor HMPC je zaključil, da se lahko ti pripravki, ki vsebujejo ricinusovo olje, uporabljajo kratkotrajno kot odvajalo pri občasni zaprtosti.
English: How are castor oil medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo ricinusovo olje, odobrena v EU?
English: 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).
Slovenian: Ob zaužitju se ricinusovo olje razgradi v ricinoleinsko kislino, ki zmanjšuje absorpcijo tekočin in soli v tankem črevesu (zgornjem delu črevesja).
English: What evidence supports the use of castor oil medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo ricinusovo olje?
English: Other information about castor oil medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo ricinusovo olje
English: 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.
Slovenian: Podrobna navodila o jemanju zdravil, ki vsebujejo ricinusovo olje, in o tem, kdo sme ta zdravila jemati, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
English: What are the risks associated with castor oil medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo ricinusovo olje?
English: For more information about treatment with castor oil medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravili, ki vsebujejo ricinusovo olje, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: 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.
Slovenian: Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
English: In addition, castor oil stimulates movement in the intestines which will help to pass the stools.
Slovenian: Poleg tega ricinusovo olje spodbuja gibanje črevesa, zato je odvajanje blata lažje.
English: Member States when evaluating applications for the licensing of herbal medicines containing castor oil.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo ricinusovo olje.
English: Side effects have been reported with castor oil.
Slovenian: Pri uporabi ricinusovega olja so poročali o neželenih učinkih.
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging Pack size EU/1/08/498/002 Thymanax
Slovenian: Jakost Farmacevtska oblika Pot uporabe
English: Conclusions presented by the European Medicines Agency on:
Slovenian: Sklepne ugotovitve, ki jih je predstavila Evropska agencija za zdravila, o:
English: <Similarity>
Slovenian: <podobnosti>
English: <Derogation>
Slovenian: <odstopanju>
English: <the holder of the marketing authorisation for <authorised orphan medicinal product> has given his consent to the applicant.>
Slovenian: <imetnik dovoljenja za promet z <odobrenim zdravilom siroto> je dal svoje soglasje predlagatelju.>
English: <one-year <marketing protection><data exclusivity>>
Slovenian: <enoletni <tržni zaščiti> <ekskluzivnosti podatkov>>
English: Conditional marketing authorisation
Slovenian: pridobitvi pogojnega dovoljenja za promet z zdravilom
English: 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
Slovenian: SKLEPNE UGOTOVITVE O PRIDOBITVI POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER <PODOBNOSTI IN ODSTOPANJU> <IN> <ZAHTEVKU ZA ENOLETNO <TRŽNO ZAŠČITO> <EKSKLUZIVNOST PODATKOV>>, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: <the holder of the marketing authorisation for <authorised orphan medicinal product> is unable to supply sufficient quantities of the medicinal product> <and>
Slovenian: <imetnik dovoljenja za promet z <odobrenim zdravilom siroto> ni sposoben dobavljati zadostnih količin zdravila>; <in>
English: [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.
Slovenian: [For Art 14(11)] <Odbor za zdravila za uporabo v humani medicini (CHMP) je pregledal podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom, pri čemer je upošteval določbe člena 14(11) Uredbe (ES) št. 726/2004, in meni, da nova terapevtska indikacija prinaša pomembno klinično korist v primerjavi z obstoječimi terapijami, kot je podrobneje razloženo v evropskem javnem poročilu o oceni zdravila.>
English: <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>
Slovenian: <predlagatelj je v svoji vlogi lahko utemeljil, da je zdravilo, čeprav je podobno <odobrenemu zdravilu siroti>, varnejše, učinkovitejše ali kako drugače klinično boljše (kot je opredeljeno v členu 3 Uredbe Komisije (ES) št. 847/2000) za isto terapevtsko indikacijo>; <in>
English: <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 :
Slovenian: <Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da v skladu s členom 8 Uredbe (ES) št. 141/2000 in <členom 3 Uredbe Komisije (ES) št. 847/2000> [only for the superiority derogation] velja(-jo) naslednje(-a) odstopanje(-a), določeno(-a) v členu 8(3) iste uredbe, kot je podrobneje razloženo v evropskem javnem poročilu o oceni zdravila:
English: 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.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) po obravnavi vloge meni, da je razmerje med tveganji in koristmi ugodno, da lahko priporoči izdajo pogojnega dovoljenja za promet z zdravilom, kot je podrobneje razloženo v evropskem javnem poročilu o oceni zdravila.
English: [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.
Slovenian: [Art 10(5)] <Odbor za zdravila za uporabo v humani medicini (CHMP) je pregledal podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom, pri čemer je upošteval določbe člena 10(5) Direktive 2001/83/ES, in meni, da so bili(-e) <predklinični testi> <in> <klinične študije>, ki so bili(-e) izvedeni(-e) v zvezi z novo indikacijo pomembni(-e), kot je podrobneje razloženo v evropskem javnem poročilu o oceni zdravila.>
English: <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.
Slovenian: <Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da je zdravilo <ime zdravila> podobno odobrenim zdravilom sirotam v smislu opredelitve iz člena 3 Uredbe Komisije (ES) št. 847/2000, kot je podrobneje razloženo v evropskem javnem poročilu o oceni zdravila.>
English: Belgium APOTEX NV Av. du Bourg.
Slovenian: APOTEX NV Av. du Bourg.
English: Belgium LABORATORIA QUALIPHAR N.V/S.A
Slovenian: LABORATORIA QUALIPHAR N.V/S.A
English: Hungary ratiopharm Hungária Kereskedelmi Kft. Uzsoki u. 36/a
Slovenian: Madžarska ratiopharm Hungária Kereskedelmi Kft. Uzsoki u. 36/a
English: Laboratórios Vitória, S.A. Rua Elias Garcia, 28 - Venda Nova
Slovenian: Portugalska Laboratórios Vitória, S.A. Rua Elias Garcia, 28 - Venda Nova
English: Rua Félix Correia, 1-B 1500-271 Lisboa Portugal
Slovenian: Rua Félix Correia, 1-B 1500-271 Lisboa
English: Laboratório B. A. Farma, Lda.
Slovenian: Portugalska Laboratório B. A. Farma, Lda.
English: 2700-327 Amadora Portugal
Slovenian: 2700-327 Amadora
English: ARENA GROUP S.A. Str. Stefan Mihaileanu nr.31, sector 2;
Slovenian: Str. Stefan Mihaileanu nr.31, sector 2;
English: Austria ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse 3 1140 Vienna
Slovenian: Avstrija ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse 3 1140 Vienna
English: Pharmaswiss Eesti OÜ Tammsaare tee 47 11316 Tallinn Estonia
Slovenian: Pharmaswiss Eesti OÜ Tammsaare tee 47 11316 Tallinn Estonia dikofenak
English: United Kingdom Crescent Pharma Limited Unit 3&4
Slovenian: Crescent Pharma Limited Unit 3&4
English: United Kingdom Aptil Pharma limited 9th Floor
Slovenian: Aptil Pharma limited 9th Floor
English: United Kingdom Galen Limited Seagoe Industrial Estate Craigavon
Slovenian: Galen Limited Seagoe Industrial Estate Craigavon
English: The Netherlands Wise Pharmaceuticals Ltd. Hamwells Business Park Unit No. 7, Hardicker Street M19 2RB Manchester
Slovenian: Nizozemska Wise Pharmaceuticals Ltd. Hamwells Business Park Unit No. 7, Hardicker Street M19 2RB Manchester
English: Capsule
Slovenian: kapsula
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Slovenian: Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravil, poti uporabe zdravila,
English: Finland ratiopharm Oy P.O.Box 67
Slovenian: Finska ratiopharm Oy P.O.Box 67
English: Laboratoires Genevrier 280, rue de Goa Les Trois Moulins - Parc de Sophia Antipolis 06600 Antibes France
Slovenian: Laboratoires Genevrier 280, rue de Goa Les Trois Moulins - Parc de Sophia Antipolis 06600 Antibes France epolaminijev diklofenakat
English: United Kingdom Chelonia Healthcare Limited Boumpoulinas 11
Slovenian: Chelonia Healthcare Limited Boumpoulinas 11
English: Luxembourg Daiichi Sankyo Belgium SA Rue Fond Jean Pâques 5
Slovenian: Luksemburg Daiichi Sankyo Belgium SA Rue Fond Jean Pâques 5
English: Luxembourg Continental Pharma Rijksweg, 12
Slovenian: Luksemburg Continental Pharma Rijksweg, 12