natgillin/translations-raw huggingface dataset:
• “if you have diabetes mellitus or impaired kidney function and you are treated with either of the following classes of medicines used to treat high blood pressure: - an ACE-inhibitor such as enalapril, lisinopril, ramipril.
• “če imate sladkorno bolezen ali okvarjeno delovanje ledvice in jemljete zdravilo iz katere od naslednjih skupin zdravil za zdravljenje visokega krvnega tlaka: - zaviralec ACE, na primer enalapril, lizinopril ali ramipril, ali - blokator receptorjev angiotenzina II, na primer valsartan, telmisartan ali irbesartan).”
If you are being treated with an ACE-inhibitor together with certain other medicines to treat your heart failure, which are known as mineralocorticoid receptors antagonists (MRA) (for example spironolactone, eplerenone) or betablockers (for example metoprolol).”
Če jemljete zaviralec ACE skupaj z določenimi drugimi zdravili za zdravljenje srčnega popuščanja, ki jih imenujemo antagonisti mineralokortikoidnih receptorjev (na primer spironolakton ali eplerenon), ali zdravili, ki jih imenujemo blokatorji beta (na primer metoprolol).
For products containing aliskiren, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below
Za zdravila, ki vsebujejo aliskiren, je treba obstoječe informacije o zdravilu (z vstavljanjem, nadomeščanjem ali črtanjem besedila, kot je ustrezno) spremeniti tako, da bodo odražale dogovorjeno besedilo, navedeno spodaj.
For products containing valsartan, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below
Za zdravila, ki vsebujejo valsartan, je treba obstoječe informacije o zdravilu (z vstavljanjem, nadomeščanjem ali črtanjem besedila, kot je ustrezno) spremeniti tako, da bodo odražale dogovorjeno besedilo, navedeno spodaj.
- an angiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan,
- blokator receptorjev angiotenzina II (ARB) (ta zdravila imenujemo tudi "sartani" - mednje spadajo na primer valsartan, telmisartan in irbesartan), še zlasti če imate kakšne težave z ledvicami, ki so povezane s sladkorno boleznijo - aliskiren”
For products containing candesartan, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below
Za zdravila, ki vsebujejo kandesartan, je treba obstoječe informacije o zdravilu (z vstavljanjem, nadomeščanjem ali črtanjem besedila, kot je ustrezno) spremeniti tako, da bodo odražale dogovorjeno besedilo, navedeno spodaj.
“Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).”
“Podatki kliničnih preskušanj so pokazali, da je dvojna blokada sistema renin-angiotenzin-aldosteron (RAAS) s hkratno uporabo zaviralcev ACE, blokatorjev receptorjev angiotenzina II ali aliskirena povezana z večjo pogostnostjo neželenih učinkov, npr. hipotenzije, hiperkaliemije in zmanjšanega delovanja ledvic (vključno z akutno odpovedjo ledvic) kot uporaba enega samega zdravila, ki deluje na RAAS (glejte poglavja 4.3, 4.4. in 5.1).”
“Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, stroke, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).”
“Podatki kliničnih preskušanj so pokazali, da je dvojna blokada sistema renin-angiotenzin-aldosteron (RAAS) s hkratno uporabo zaviralcev ACE, blokatorjev receptorjev angiotenzina II ali aliskirena povezana z večjo pogostnostjo neželenih učinkov, npr. hipotenzije, možganske kapi, hiperkaliemije in zmanjšanega delovanja ledvic (vključno z akutno odpovedjo ledvic) kot uporaba enega samega zdravila, ki deluje na RAAS (glejte poglavja 4.3, 4.4. in 5.1).”
• “if you are taking either of the following classes of medicines used to treat high blood pressure: - an ACE-inhibitor such as enalapril, lisinopril, ramipril.
• “če jemljete zdravilo iz katere od naslednjih skupin zdravil za zdravljenje visokega krvnega tlaka: - zaviralec ACE, na primer enalapril, lizinopril ali ramipril, ali - blokator receptorjev angiotenzina II, na primer valsartan, telmisartan ali irbesartan).
The following wording should be included in the specified sections:
V navedena poglavja je treba vključiti naslednje besedilo:
For angiotensin II receptor blockers with wording in section 4.1 stating that they can be used alone or in combination with other antihypertensive agents, the following cross-reference should be added: “(see sections 4.3, 4.4, 4.5 and 5.1)”.
Pri blokatorjih receptorjev angiotenzina II, ki imajo v poglavju 4.1 besedilo o tem, da jih je mogoče uporabljati same ali v kombinaciji z drugimi antihipertenzivi, je treba dodati naslednjo navzkrižno referenco: “(glejte poglavja 4.3, 4.4, 4.5 in 5.1)”.
Section 4.4 - Special warnings and precautions for use The following wording should be reflected in this section: “Dual blockade of the renin-angiotensin-aldosterone-system (RAAS) Hypotension, syncope, stroke, hyperkalaemia and decreased renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system (see section 5.1).
To poglavje mora predstaviti naslednjo kontraindikacijo: “Sočasna uporaba zdravila [Ime zdravila] in zaviralcev ACE ali blokatorjev receptorjev angiotenzina II je kontraindicirana pri bolnikih s sladkorno boleznijo ali z okvaro ledvic (hitrost glomerularne filtracije < 60 ml/min/1,73 m2) (glejte poglavja 4.4, 4.5 in 5.1).” Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi To poglavje mora predstaviti naslednje besedilo: “Dvojna blokada sistema renin-angiotenzin-aldosteron (RAAS) Pri dovzetnih osebah so bile opisane hipotenzija, sinkopa, možganska kap, hiperkaliemija in zmanjšanje delovanja ledvic (vključno z akutno odpovedjo ledvic), zlasti v kombinaciji z zdravili, ki vplivajo na ta sistem (glejte poglavje 5.1).
For all ACE-inhibitors with wording in section 4.2 stating that they can be used alone or in combination with other antihypertensive agents, the following cross-reference should be added: “(see sections 4.3, 4.4, 4.5 and 5.1)”.
Pri vseh zaviralcih ACE, ki imajo v poglavju 4.2 besedilo o tem, da jih je mogoče uporabljati same ali v kombinaciji z drugimi antihipertenzivi, je treba dodati naslednjo navzkrižno referenco: “(glejte poglavja 4.3, 4.4, 4.5 in 5.1)”.
For all ACE-inhibitors with wording in section 4.1 stating that they can be used alone or in combination with other antihypertensive agents, the following cross-reference should be added: “(see sections 4.3, 4.4, 4.5 and 5.1)”.
Pri vseh zaviralcih ACE, ki imajo v poglavju 4.1 besedilo o tem, da jih je mogoče uporabljati same ali v kombinaciji z drugimi antihipertenzivi, je treba dodati naslednjo navzkrižno referenco: “(glejte poglavja 4.3, 4.4, 4.5 in 5.1)”.
For valsartan-containing products with wording in section 4.2 stating that they can be used alone or in combination with other antihypertensive agents, the following cross-reference should be added: “(see sections 4.3, 4.4, 4.5 and 5.1)”.
Pri zdravilih, ki vsebujejo valsartan in imajo v poglavju 4.2 besedilo o tem, da jih je mogoče uporabljati same ali v kombinaciji z drugimi antihipertenzivi, je treba dodati naslednjo navzkrižno referenco: “(glejte poglavja 4.3, 4.4, 4.5 in 5.1)”.
Section 1.
Priloga II
For valsartan-containing products with wording in section 4.1 stating that they can be used alone or in combination with other antihypertensive agents, the following cross-reference should be added: “(see sections 4.3, 4.4, 4.5 and 5.1)”.
Pri zdravilih, ki vsebujejo valsartan in imajo v poglavju 4.1 besedilo o tem, da jih je mogoče uporabljati same ali v kombinaciji z drugimi antihipertenzivi, je treba dodati naslednjo navzkrižno referenco: “(glejte poglavja 4.3, 4.4, 4.5 in 5.1)”.
“Your doctor may need to change your dose and/or to take other precautions: If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not <take> <use> X” and “Warnings and precautions”)”
Če jemljete blokator receptorjev angiotenzina II (ARB) ali aliskiren (glejte tudi informacije pod naslovoma "Ne <jemljite> <uporabljajte> zdravila X" in "Opozorila in previdnostni ukrepi")"
For candesartan-containing products with wording in section 4.1 stating that they can be used alone or in combination with other antihypertensive agents, the following cross-reference should be added: “(see sections 4.3, 4.4, 4.5 and 5.1)”.
Pri zdravilih, ki vsebujejo kandesartan in imajo v poglavju 4.1 besedilo o tem, da jih je mogoče uporabljati same ali v kombinaciji z drugimi antihipertenzivi, je treba dodati naslednjo navzkrižno referenco: “(glejte poglavja 4.3, 4.4, 4.5 in 5.1)”.
London, 19 March 2009 Doc.
London, 19. marca 2009 Sklic dok.
Ref. EMEA/156698/2009
EMEA/291357/2009
The main measure of effectiveness was the how long the patients survived until the disease came back.
Glavno merilo učinkovitosti je bilo, kako dolgo so bolniki preživeli do ponovitve bolezni.
The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Dopis družbe, s katerim agencijo EMEA obvešča o umiku vloge, je na voljo tukaj.
Following the CHMP's opinion, it usually takes around two months for the European Commission to grant a licence.
Potem ko CHMP izda svoje mnenje, običajno traja približno dva meseca, preden Evropska komisija dovoljenje odobri.
The effects of Cylatron were first tested in experimental models before being studied in humans.
Učinki zdravila Cylatron so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Patients were either given Cylatron for up to five years or received no treatment.
Bolniki so v obdobju petih let jemali zdravilo Cylatron ali pa jih niso zdravili.
Cylatron was studied in one main study involving 1,256 adults with stage III melanoma.
Zdravilo Cylatron so proučili v eni glavni študiji, ki je vključevala 1 256 odraslih z melanomom III. stadija.
It was also concerned that, although the medicine showed some effects in delaying the return of the cancer, it had not been shown to be effective in increasing how long the patients survived.
Prav tako je imel zadržke, da se zdravilo, kljub temu, da je pokazalo nekatere učinke pri upočasnitvi ponovitve raka, ni pokazalo kot učinkovito pri podaljšanju časa preživetja bolnikov.
This withdrawal of application has no consequences on the use of PegIntron, ViraferonPeg and IntronA in their authorised indications, for which the balance of benefits and risks remains unchanged.
Ta umik vloge nima nobenih posledic za uporabo zdravil PegIntron, ViraferonPeg in IntronA za odobrene indikacije, pri katerih ostaja razmerje med koristmi in tveganji nespremenjeno.
Questions and answers on the withdrawal of the marketing application for Cylatron
Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Cylatron
This decreases the rate at which the substance is removed from the body and allows the medicine to be given less often.
Tako se zmanjša hitrost izločanja kemične spojine iz telesa in dopušča manj pogosto jemanje zdravila.
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.
Pri melanomu naj bi interferon alfa-2b deloval z zaviranjem rasti in množenja rakastih celic, saj povzroči smrt teh celic in stimulira imunski sistem (naravno obrambo telesa), da napade in ubije rakaste celice.
Melanoma is a type of skin cancer affecting cells called melanocytes.
Melanom je vrsta kožnega raka, ki prizadene celice, imenovane melanociti.
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.
Peginterferon alfa-2b je odobren v Evropski uniji (EU) od maja 2000 kot zdravili PegIntron in ViraferonPeg za zdravljenje hepatitisa C. Prav tako je od marca 2000 v EU odobren nepegiliran interferon alfa-2b kot zdravilo IntronA.
On 11 March 2009, SP Europe officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cylatron for the adjuvant treatment of stage III melanoma.
Družba SP Europe je 11. marca 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Cylatron, namenjenim za adjuvantno zdravljenje melanoma III. stadija.
What documentation did the company present to support its application to the CHMP?
Katero dokumentacijo je družba predložila CHMP v podporo svoji vlogi ?
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Cylatron?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Cylatron?
The CHMP had concerns over side effects of Cylatron, particularly fatigue (tiredness) and depression.
CHMP je imel zadržke glede neželenih učinkov zdravila Cylatron, zlasti glede utrujenosti in depresije.
What is Cylatron?
Kaj je zdravilo Cylatron?
International non-proprietary name (INN): peginterferon alfa-2b
Mednarodno nelastniško ime (INN): peginterferon alfa-2b
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.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Cylatron ni mogoče odobriti za adjuvantno zdravljenje melanoma III. stadija.
‘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).
stadij“ pomeni, da se je nekaj rakastih celic razširilo na bezgavke (to je del limfnega sistema, ki črpa tekočino iz telesnih tkiv).
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.
Zdravilo Cylatron naj bi se uporabljalo pri odraslih z melanomom III. (napredovalega) stadija kot dodatno zdravljenje po operativnem posegu za preprečevanje ponovitve bolezni.
When the study began, all of the patients had recently had surgery to remove lymph nodes containing melanoma cells.
Ob začetku študije bili vsi bolniki pred kratkim operirani, pri čemer so jim odstranili bezgavke z melanomskimi celicami.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate programmes with Cylatron.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Cylatron.
What is happening with PegIntron and ViraferonPeg for the treatment of hepatitis C and with IntronA for the treatment of malignant melanoma?
Kakšne so posledice za zdravili PegIntron in VirafeornPeg, indicirani za zdravljenje hepatitisa C in kakšne za zdravilo IntronA, indicirano za zdravljenje malignega melanoma?
IntronA is authorised for the treatment of malignant melanoma after surgery, along with other diseases.
Zdravilo IntronA je odobreno za zdravljenje malignega melanoma po operativnem posegu, skupaj z drugimi boleznimi.
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.
Zdravilo Cylatron naj bi se dajalo bolnikom, pri katerih je vsebnost melanomskih celic v bezgavkah vidna pod mikroskopom, ne pa takrat, ko so bezgavke zaradi raka tako povečane, da se tipajo skozi kožo.
Cylatron is a powder and solvent that is made up into a solution for injection.
Zdravilo Cylatron sestavljata prašek in topilo, ki ju zmešamo v raztopino za injiciranje.
It consists of a substance called interferon alfa-2b, which has been ‘pegylated' (coated with a chemical called polyethylene glycol).
Sestavljen je iz snovi, imenovane interferon alfa-2b, ki je „pegilirana“ (prevlečena s kemično spojino polietilenglikol).
What was Cylatron expected to be used for?
Za kaj naj bi se zdravilo Cylatron uporabljalo?
How is Cylatron expected to work?
Kako naj bi zdravilo Cylatron delovalo?
It contains the active substance peginterferon alfa-2b.
Vsebuje zdravilno učinkovino peginterferon alfa-2b.
The active substance in Cylatron, peginterferon alfa-2b, belongs to the group ‘interferons'.
Zdravilno učinkovino zdravila Cylatron, peginterferon alfa-2b, uvrščamo v skupino „interferonov“.
Invented name Strength Pharmaceutical
Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
Lundbeck B.V.
Nizozemska Lundbeck B.V.
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Dodatek I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
Modified-release capsule, hard
75 mg kapsula s prirejenim sproščanjem, trda
Intramuscular use intravenous use
50 mg/2 ml raztopina za injiciranje intramuskularna uporaba intravenska uporaba
Coated Tablet
10 mg obložena tableta
Sarotex Retard 50 mg
Saroten retard Tabs 75 mg tableta s prirejenim sproščanjem
--1 Inactivated influenza A virus/human, strain A/Jena/VI5258/2009(H1N1)pdm09 ≥ 16 HU* *HU = haemagglutinating units
--1 Inaktivirani virus influence A (humani) Sev: A/Jena/VI5258/2009(H1N1)pdm09 ≥ 16 HU*
Annex A
Dodatek A
EU (MA) Number Invented name
EU (MA) številka
Package size
Velikost pakiranja
Packaging Content
Način uporabe Pakiranje Vsebina
United Kingdom Trading as Sterling Health or
Velika Britanija Trading as Sterling Health or
Johnson & Johnson, Lda.
Portugalska Johnson & Johnson, Lda.
Al. Armii Ludowej 26 00-609 Warszawa Poland
Al. Armii Ludowej 26 00-609 Warszawa Poljska
Niepodleglosci 18 02-653 Warsaw Poland
Niepodleglosci 18 02-653 Warsaw Poljska
2 Ellinikou Str 16777,Elliniko, Athens Greece
2 Ellinikou Str 16777,Elliniko, Athens Grčija
26.200 28700 San Sebastián de los Reyes (Madrid) Spain
26.200 28700 San Sebastián de los Reyes (Madrid) Španija
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravil, načinov aplikacije, imetnikov dovoljenj za promet v državah članicah
Belgium Aktuapharma nv Ambachtenlaan 13E 3001 Leuven
Aktuapharma nv Ambachtenlaan 13E 3001 Leuven Belgija
Hameenlinna Finland
Hameenlinna Finska
Mylan Sas 117, allée des Parcs 69800 Saint-Priest France
Mylan Sas 117, allée des Parcs 69800 Saint-Priest Francija
13500 HÄMEENLINNA Finland
13500 HÄMEENLINNA Finska
B-1560 Hoeilaart Belgium
B-1560 Hoeilaart Belgija
Souffelweyersheim France
Souffelweyersheim Francija
Teva Sante 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex France
Teva Sante 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex Francija
Bayer Sante Familiale 33, Rue De L'industrie 74240 Gaillard France
Bayer Sante Familiale 33, Rue De L'industrie 74240 Gaillard Francija
10237 Dolni Mecholupy Czech Republic
10237 Dolni Mecholupy Češka
Societe Cilfa Developpement 20, Rue Jean Daudin 75015 - Paris France
Societe Cilfa Developpement 20, Rue Jean Daudin 75015 - Paris Francija
37, rue Saint-Romain 69379 Lyon Cedex 08 France
37, rue Saint-Romain 69379 Lyon Cedex 08 Francija
Bayer Portugal, S.A. Rua Quinta do Pinheiro
Portugalska Bayer Portugal, S.A. Rua Quinta do Pinheiro
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, Irska
S.C. TERAPIA S.A Str. Fabricii Nr.124, Cluj-Napoca, Judeţul Cluj, 400632
Romunija S.C. TERAPIA S.A Str. Fabricii Nr.124, Cluj-Napoca, Judeţul Cluj, 400632
92700 Colombes France
92700 Colombes Francija
22 quai Gallieni 92150 Suresnes France
22 quai Gallieni 92150 Suresnes Francija
69007 Lyon France
69007 Lyon Francija
Alkaloid-Int. d.o.o.
Slovenija Alkaloid-Int. d.o.o.
69151 Décines Cedex France
69151 Décines Cedex Francija
Omega Pharma Baltics SIA, K. Ulmana 119, Marupe, LV-2167, Latvia
Omega Pharma Baltics SIA, K. Ulmana 119, Marupe, LV-2167, Latvija
Denmark Amgros I/S, Dampfærgevej 22, DK-2100 København Ø, Denmark
Amgros I/S, Dampfærgevej 22, DK-2100 København Ø, Danska
08228 Tarrasa (Barcelona) Spain
08228 Tarrasa (Barcelona) Španija
hard capsule
trda kapsula
Bayer Limited, The Atrium, Blackthorn Road, Dublin 18, Ireland
Bayer Limited, The Atrium, Blackthorn Road, Dublin 18, Irska
Actavis Group hf.Reykjavikurvegur 7678 - 220 Hafnarfjörður Iceland
Actavis Group hf.Reykjavikurvegur 7678 - 220 Hafnarfjörður Islandija
SW1V 2SA United Kingdom
SW1V 2SA Velika Britanija
Mateo Inurria, 30 28036 Madrid Spain
Mateo Inurria, 30 28036 Madrid Španija
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 Francija
28042 Madrid Spain
28042 Madrid Španija
Luxembourg Mylan bvba/sprl Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium
Luksemburg Mylan bvba/sprl Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgija
FARMALIDER, S.A. Aragoneses, 15 28108 Madrid Spain
FARMALIDER, S.A. Aragoneses, 15 28108 Madrid Španija
032266 Bucureşti, Romania codeinum
032266 Bucureşti, Romunija kodein
Denmark Alternova A/S, Lodshusvej 11, DK4230 Skælskør, Denmark
Alternova A/S, Lodshusvej 11, DK4230 Skælskør, Danska
Barcelona Spain
Barcelona Španija
00101 Helsinki Finland
00101 Helsinki Finska
92300 Levallois-Perret France
92300 Levallois-Perret Francija
HIPOCRATE 2000 S.R.L.
Romunija HIPOCRATE 2000 S.R.L.
92517 Boulogne Billancourt Cedex France
92517 Boulogne Billancourt Cedex Francija
INTERNACIONAL, S.A. Gran Vía Carlos III, 94 08028 Barcelona Spain
INTERNACIONAL, S.A. Gran Vía Carlos III, 94 08028 Barcelona Španija
00351 Helsinki Finland
00351 Helsinki Finska
75014 Paris France
75014 Paris Francija
Denmark Takeda Pharma A/S, Langebjerg 1, DK4000 Roskilde
Takeda Pharma A/S, Langebjerg 1, DK4000 Roskilde Danska
Seton Products Ltd., Tubiton House, Medlock Street, Oldham, OL1 3HS, United Kingdom
Seton Products Ltd., Tubiton House, Medlock Street, Oldham, OL1 3HS, Velika Britanija
Clonmel Healthcare Ltd, Waterford Road, Conmel, Co. Tipperary Ireland
Clonmel Healthcare Ltd, Waterford Road, Conmel, Co. Tipperary Irska
Azur compositum SC Suppositorien suppository rectal use
Azur compositum SC Suppositorien svečka rektalna uporaba
Nitrianska 100, Hlohovec 920 27 Slovak Republic codeine
Nitrianska 100, Hlohovec 920 27 Slovaška kodein
de Burgos, 91 28050 Madrid Spain
de Burgos, 91 28050 Madrid Španija
S.C. Farmacom S.A. Str. Zizinului Nr. 112, 2200 Braşov,
Str. Zizinului Nr. 112, 2200 Braşov,
Quintanavides, 15 28050 Madrid Spain
Quintanavides, 15 28050 Madrid Španija
Germany codeine, paracetamol,
Nemčija kodein, paracetamol,
2610 Wilrijk
2610 Wilrijk Belgija
LABORATORIOS ERN, S.A. Pedro IV, 499 08022 Barcelona Spain
LABORATORIOS ERN, S.A. Pedro IV, 499 08022 Barcelona Španija