natgillin/translations-raw huggingface dataset:
Teriflunomid skal seponeres, hvis der er mistanke om leverskader, og seponering bør overvejes, hvis leverenzymstigning (> 3 gange den øvre normalgrænse (ULN)) bekræftes.
Teriflunomide therapy should be discontinued if liver injury is suspected; consider discontinuing teriflunomide therapy if elevated liver enzymes (greater than 3-fold ULN) are confirmed.
I placebokontrollerede studier observeredes alvorlige infektioner ikke hyppigere i teriflunomid-gruppen (se pkt.
In placebo-controlled studies, no increase in serious infections was observed with teriflunomide (see section 4.8).
Patienter med svær, aktiv infektion (se pkt.
Patients with severe active infection until resolution (see section 4.4).
MÆRKNING, DER SKAL ANFØRES PÅ DEN MELLEMLIGGENDE EMBALLAGE HYLSTER
PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING WALLET
I en undergruppe af patienter med høj sygdomsaktivitet i TEMSO (n=127) blev der observere konsistent behandlingseffekt på attakker og tid til 3 måneders vedvarende progression.
A consistent treatment effect on relapses and time to 3-month sustained disability progression in a subgroup of patients in TEMSO (n 127) with high disease activity was observed.
Kvinder i den fødedygtige alder må kun tagedette lægemiddel, hvis de bruger en effektiv præventionsmetode.
Women of childbearing potential must not take this medicine without using reliable contraceptive measures.
Forhøjet gammaglutamyltransferase (GGT)b, Forhøjet aspartataminotransferaseb
Gammaglutamyltransfer ase (GGT) increaseb, Aspartate aminotransferas
Alvorlige hudreaktioner Efter markedsføringen er der rapporteret tilfælde om alvorlige hudreaktioner med teriflunomid (se pkt.
Severe skin reactions Cases of severe skin reactions have been reported with teriflunomide post-marketing (see section 4.4).
Risikoen for embryoføtal toksicitet på grund af mandlig partner i behandling med teriflunomid betragtes som lav (se pkt.
The risk of male-mediated embryo-foetal toxicity through teriflunomide treatment is considered low (see section 5.3).
Derfor anbefales tæt opfølgning og monitorering af INR, når warfarin administreres samtidigt med teriflunomid.
Therefore, when warfarin is co-administered with teriflunomide, close INR follow-up and monitoring is recommended.
tyndere) for at undgå blodpropper - p-piller (indeholdende ethinylestradiol og levonorgestrel) - cefaclor, benzylpenicillin eller ciprofloxacin mod infektioner - indomethacin eller ketoprofen mod smerter eller gigt - furosemid mod hjertelidelser - cimetidin for at nedsætte produktionen af mavesyre - zidovudin mod hiv - rosuvastin, simvastatin, atorvastatin, pravastatin mod forhøjet kolesterol (hyperkolesterolæmi) - sulfasalazin mod inflammatorisk tarmsygdom eller leddegigt (reumatoid artrit) - colestyramin mod forhøjet kolesterol eller mod kløe ved leversygdom - aktivt kul for at reducere optagelsen af medicin eller andre stoffer
- cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections - indometacin, ketoprofen for pain or inflammation - furosemide for heart disease - cimetidine for reducing gastric acid - zidovudine for HIV infection - rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol) - sulfasalazine for inflammatory bowel disease or rheumatoid arthritis - cholestyramine for high cholesterol or relief from itching in liver disease - activated charcoal to reduce absorption of medicines or other substances
Alvorligt nedsat nyrefunktion havde ingen indvirkning på teriflunomids farmakokinetik.
Severe renal impairment had no impact on the pharmacokinetic of teriflunomide.
Du skal især fortælle det til lægen eller på apoteket, hvis du tager nogle af følgende: - leflunomid, methotrexat eller andre lægemidler, der påvirker immunsystemet (ofte kaldet immununsuppressiva eller immunmodulatorer) - rifampicin mod tuberkulose og andre infektioner - carbamazepin, phenobarbital, phenytoin mod epilepsi - perikon - et naturlægemiddel mod depression - repaglinid, pioglitazon, nateglinid eller rosiglitazon mod sukkersyge - daunorubicin, doxorubicin, paclitaxel eller topotecan mod kræft - duloxetin mod depression, ufrivillig vandladning (urininkontinens) eller nyresygdom ved sukkersyge
In particular, tell your doctor or pharmacist if you are taking any of the following: - leflunomide, methotrexate and other medicines that affect the immune system (often called immunosuppressants or immunomodulators) - rifampicin (a medicine used to treat tuberculosis and other infections) - carbamazepine, phenobarbital, phenytoin for epilepsy - St John's wort (a herbal medicine for depression) - repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes - daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer - duloxetine for depression, urinary incontinenece or in kidney disease in diabetics - alosetron for the management of severe diarrhea - theophylline for asthma - tizanidine, a muscle relaxant - warfarin, an anticoagulant used to make the blood thinner (i.e. more fluid) in order to avoid blood clots - oral contraceptives (containing ethinylestradiol and levonorgestrel)
Virkningen af teriflunomid på CYP1A2-substrat: caffein Gentagne doser teriflunomid gav et fald i middel-caffein-Cmax og -AUC på henholdsvis 18 % og 55 %, hvilket tyder på, at teriflunomid kan være en svag CYP1A2-induktor in vivo.
Repeated doses of teriflunomide decreased mean Cmax and AUC of caffeine (CYP1A2 substrate) by 18% and 55%, respectively, suggesting that teriflunomide may be a weak inducer of CYP1A2 in vivo.
Ammende kvinder (se pkt.
Breast-feeding women (see section 4.6).
Virkningen af teriflunomid på CYP2C8-substrat: repaglinid Der var en stigning i middel-repaglinid-Cmax og -AUC (henholdsvis 1,7 og 2,4 gange) efter gentagne doser teriflunomid, hvilket tyder på, at teriflunomid hæmmer CYP2C8 in vivo.
Effect of teriflunomide on CYP2C8 substrate: repaglinide There was an increase in mean repaglinide Cmax and AUC (1.7- and 2.4-fold, respectively), following repeated doses of teriflunomide, suggesting that teriflunomide is an inhibitor of CYP2C8 in vivo.
Virkningen af teriflunomid på organisk aniontransporter 3- (OAT3-) substrater Der var en stigning i middel-cefaclor-Cmax og -AUC (henholdsvis 1,43 og 1,54 gange) efter gentagne doser teriflunomid, hvilket tyder på, at teriflunomid hæmmer OAT3 in vivo.
Effect of teriflunomide on organic anion transporter 3 (OAT3) substrates There was an increase in mean cefaclor Cmax and AUC (1.43- and 1.54-fold, respectively), following repeated doses of teriflunomide, suggesting that teriflunomide is an inhibitor of OAT3 in vivo.
(AIDS) - hvis du har alvorlige problemer med rygmarven, eller hvis du har et lavt antal røde eller hvide blodlegemer eller et nedsat antal blodplader - hvis du lider af en alvorlig infektion - hvis du har en alvorlig nyresygdom, som kræver dialyse - hvis du har en meget lav koncentration af proteiner i blodet (hypoproteinæmi) Spørg lægen eller apotekspersonalet, før du tager dette lægmiddel, hvis der er noget, du er i tvivl om.
- if you are allergic to teriflunomide or any of the other ingredients of this medicine (listed in section 6), - if you have severe liver problems, - if you are pregnant, think you may be pregnant, or are breast-feeding, - if you suffer from a serious problem which affects your immune system e.g. acquired immunodeficiency syndrome (AIDS), - if you have a serious problem with your bone marrow, or if you have low numbers of red or white cells in your blood or a reduced number of blood platelets, - if you are suffering from a serious infection, - if you have severe kidney problems which require dialysis, - if you have very low levels of proteins in your blood (hypoproteinaemia), If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer) - Nedsat antal blodplader (mild trombocytopeni) - Øget følsomhed særligt i huden, jagende eller dunkende smerter langs en eller flere nerver,
Uncommon (may affect up to 1 in 100 people) - Decrease in the number of blood platelets (mild thrombocytopenia) - Increased feeling or sensitivity, especially in the skin; stabbing or throbbing pain along one or more nerves, problems in the nerves of the arms or legs (peripheral neuropathy) - Nail disorders - Post-traumatic pain
Den sædvanlige dosis er 1 tablet på 14 mg dagligt.
The recommended dose is one film-coated tablet (14 mg) daily.
(37,5 %) og urin (22,6 %).
Over 21 days, 60.1% of the administered dose is excreted via feces (37.5%) and urine (22.6%).
AUBAGIO 14 mg tabletter teriflunomid
AUBAGIO 14 mg tablets teriflunomide
Forhøjet blodtryk skal behandles passende før og under behandlingen med AUBAGIO.
Blood pressure elevation should be appropriately managed before and during treatment with teriflunomide.
Hæmatologiske virkninger
Haematological effects
p<0.05 sammenlignet med placebo (1) BOD: Sygdomsbyrde (Burden of Disease): samlet læsionsvolumen (T2 and T1 hypointense) i ml
Change relative to placebo (CI95%) Number of unique active lesions /scan Change relative to placebo (CI95%)  p<0.0001  p<0.001  p<0.01  p<0.05 compared to placebo (1) BOD: burden of disease: total lesion volume (T2 and T1 hypointense) in ml
o at stoppe behandlingen med teriflunomid straks, hvis de har mistanke om at være gravid, og kontakte deres læge med det samme.
• For women of child-bearing potential o to emphasise the need for effective contraception during treatment with teriflunomide o to stop treatment with teriflunomide immediately if they suspect they might be pregnant and also to contact their doctor immediately
Spørg lægen, hvis du vil have yderligere oplysninger om laboratorieprøverne.
For further information on the laboratory testing please contact your doctor.
Patienten skal informeres om omgående at kontakte lægen, hvis menstruationen er forsinket, eller der er andre tegn på graviditet, så en graviditetstest kan udføres.
The patient must be advised that if there is any delay in onset of menses or any other reason to suspect pregnancy, they must notify the physician immediately for pregnancy testing, and if positive, the physician and patient must discuss the risk to the pregnancy.
Karpaltunnelsyndrom,
Musculoskeletal pain,
Teriflunomid er kontraindiceret til patienter med alvorligt nedsat leverfunktion (se pkt.
Teriflunomide is contraindicated in patients with severe hepatic impairment (see section 4.3).
MÆRKNING, DER SKAL ANFØRES PÅ DEN MELLEMLIGGENDE EMBALLAGE HYLSTER MED BLISTERKORT
PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING PROTECTIVE SLEEVE CONTAINING WALLET
Viral gastroenteritis,
Gastrointestinal disorders
AUBAGIO er beregnet til at blive taget gennem munden (oral anvendelse).
AUBAGIO is for oral use.
Hvis du tror, du har en infektion, vil lægen muligvis tage blodprøver for at kontrollere de hvide blodlegemer.
Your doctor may do blood tests to check your white blood cells if you think you have an infection.
Hypoproteinæmi
Hypoproteinaemia
Benigne, maligne og uspecificerede neoplasmer (herunder cyster og polypper) På baggrund af erfaringen fra de kliniske forsøg synes der ikke at være en øget risiko for malignitet med teriflunomid.
cysts and polyps) There does not appear to be an increased risk of malignancy with teriflunomide in the clinical trial experience.
Muskel- og knoglesmerter, Myalgi, Arthralgi
Myalgia, Arthralgia
- Allergiske reaktioner der kan have symptomer som udslæt, nældefeber, hævede læber, tunge eller ansigt eller pludseligt åndedrætsbesvær.
Tell your doctor immediately, if you notice any of the following serious side effects: - allergic reactions which might include symptoms of rash, hives, swelling of lips, tongue or face or sudden difficulty breathing.
Relativ risiko (95 % KI) 6-måneders vedvarende progression uge 108
Hazard ratio (CI95%) 6-month Sustained Disability Progression week
Smerter, Astenia
Pain, Astheniaa
Lever og galdeveje Forhøjet alaninaminotransferase (ALT)b
Alanine aminotransfer ase (ALT) increaseb
Dosisjustering er ikke nødvendig til patienter med let og moderat nedsat leverfunktion.
No dosage adjustment is necessary for patients with mild and moderate hepatic impairment.
AUBAGIO 14 mg filmovertrukne tabletter teriflunomid
AUBAGIO 14 mg film-coated tablets teriflunomide
Sanofi-aventis Sp. z o.o.
Polska sanofi-aventis Sp. z o.o.
Anvendelsesmåde
Method of administration
AUBAGIO 14 mg filmovertrukne tabletter
AUBAGIO 14 mg film-coated tablets
Størstedelen af patienterne havde recidiverenderemitterende multipel sklerose (91,5 %), men en undergruppe havde sekundær progressiv (4,7%) eller progressiv recidiverende multipel sklerose (3,9 %).Det gennemsnitslige antal attakker i året inden studiestart var 1,4, og 36,2 % af patienterne havde gadolinium-forstærkede læsioner ved baseline.
The majority of patients had relapsing-remitting multiple sclerosis (91.5%), but a subgroup of patients had secondary progressive (4.7%) or progressive relapsing multiple sclerosis (3.9%).
Relativ risiko (95 % KI) 3-måneders vedvarende progression uge 108
Hazard ratio (CI95%) 3-month Sustained Disability Progression week
Fortæl det til din læge, hvis du planlægger at blive gravid efter behandlingen med AUBAGIO.
Tell your doctor if you plan to become pregnant after stopping treatment with AUBAGIO, as you need to ensure that most of this medicine has left your body before trying to become pregnant.
Efter gentagen oral administration af teriflunomid var mediantiden til at nå maksimal plasmakoncentration mellem 1 til 4 timer efter dosering.
Median time to reach maximum plasma concentrations occurs between 1 to 4 hours post-dose following repeated oral administration of teriflunomide, with high bioavailability (approximately 100%).
Tél : 0 800 222 555
France sanofi-aventis France Tél: 0 800 222 555
Indigocarmin-aluminiumpigment (E132)
Tablet coating hypromellose titanium dioxide (E171) talc macrogol 8000 indigo carmine aluminum lake (E132)
der er mørkere end normalt, uforklarlig kvalme eller opkastning eller mavesmerter - Lungebetændelse der kan have symptomer som åndenød eller vedvarende hoste - Betændelse i bugspytkirtlen der kan have symptomer som svære smerter i den øvre maveregion, som også kan mærkes på ryggen, kvalme eller opkastning
- severe skin reactions which might include symptoms of skin rash, blistering, or ulcers in your mouth - severe infections or sepsis (a potentially life-threatening type of infection) which might include symptoms of high fever, shaking, chills, reduced urine flow, or confusion - serious liver disease which might include symptoms of yellowing of your skin or the whites of your eyes, darker urine than normal, unexplained nausea and vomiting, or abdominal pain - inflammation of the lungs which might include symptoms of shortness of breath or persistent cough - inflammation of the pancreas which might include symptoms of severe pain in the upper abdominal area that may also be felt in your back, nausea, or vomiting
ALAT >3 ULN og total-bilirubin >2 ULN 5/994 (0,5 %)
ALT >3 ULN and TBILI >2 ULN
Lør
Tue
Sådan skal du tage AUBAGIO
How to take AUBAGIO
Derfor forventes dosisjustering ikke at være nødvendig hos patienter med let, moderat eller alvorligt nedsat nyrefunktion.
Therefore no dose adjustment is anticipated in mild, moderate and severe renal-impaired patients.
Teriflunomid
Breast-feeding
Almindelige (kan forekomme hos op til 1 ud af 10 personer) - Influenza, infektion i de øvre luftveje, urinvejsinfektion, bronkitis, bihulebetændelse, ondt i halsen og ubehag, når der skal synkes, blærebetændelse, mave-tarminfektion forårsaget af virus, forkølelsessår, tandinfektion, strubekatar, fodsvamp
Common (may affect up to 1 in 10 people) - Influenza, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort when swallowing, cystitis, gastroenteritis viral, oral herpes, tooth infection, laryngitis, fungal infection of the foot - Laboratory values: a decrease in the number of red blood cells (anaemia), changes in liver and white blood cell test results (see section 2), as well as elevations in a muscle enzyme (creatine phosphokinase) have been observed.
Teriflunomid er kontraindiceret under amning (se pkt.
Teriflunomide is contraindicated during breast-feeding (see section 4.3).
Derfor frarådes brugen af teriflunomid i denne population (se pkt.
Teriflunomide is contraindicated in this population (see section 4.3).
- Hvis du har forhøjet blodtryk (hypertension), uanset om dette behandles med medicin eller ej. Aubagio kan forårsage en stigning i blodtrykket.
- you have high blood pressure (hypertension) whether it is controlled with medicines or not.
- Lette allergiske reaktioner - Angstfølelse - Prikkende, snurrende fornemmelse i huden, følelse af svaghed, følelsesløshed, snurrende fornemmelse eller smerter over lænden (iskias), følelsesløse, brændende, prikkende eller smertende hænder og fingre (karpaltunnelsyndrom) - Følelse af hjertebanken - Forhøjet blodtryk - Opkastning, tandpine, smerter i den øverste del af maven - Udslæt, akne - Smerter i sener, led, knogler eller muskler - Hyppigere vandladning - Kraftig menstruation - Smerter - Manglende energi eller følelse af kraftesløshed (asteni) - Vægttab
- Feeling your heartbeat - Increase in blood pressure - Being sick (vomiting), toothache, upper abdominal pain - Rash, acne - Pain of the tendons, joints, bones, muscle pain (musculoskeletal pain), - Needing to urinate more often than usual - Heavy periods - Pain - Lack of energy or feeling weak (asthenia) - Weight loss
I placebokontrollerede studier fandtes følgende: - systolisk blodtryk var >140 mmHg hos 19,9 % af de patienter, der fik 14 mg teriflunomid/dag,
In placebo-controlled studies the following was established: - systolic blood pressure was >140 mm Hg in 19.9% of patients receiving 14 mg/day teriflunomide as compared to 15.5% receiving placebo; - systolic blood pressure was >160 mm Hg in 3.8% of patients receiving 14 mg/day teriflunomide as compared to 2.0% receiving placebo; - diastolic blood pressure was >90 mm Hg in 21.4% of patients receiving 14 mg/day teriflunomide as compared to 13.6% receiving placebo.
Endvidere er en venteperiode på 1½ måned fra første gang, der registreres en plasmakoncentration på under 0,02 mg/l, og indtil befrugtning nødvendig.
However, also following either of the accelerated elimination procedures, verification by 2 separate tests at an interval of at least 14 days and a waiting period of one-and-a-half months between the first occurrence of a plasma concentration below 0.02 mg/l and fertilisation is required.
Forhøjede leverenzymer er blevet observeret hos patienter, der fik AUBAGIO (se pkt.
Elevations of liver enzymes have been observed in patients receiving teriflunomide (see section 4.8).
Teriflunomid er derimod kontraindiceret til patienter med alvorligt nedsat leverfunktion (se pkt.
However, teriflunomide is contraindicated in patients with severe hepatic impairment (see sections 4.2 and 4.3).
Søn
Sun
Fre
Fri
Mave-tarm-kanalen Diarre, Kvalme
Diarrhoea, Nausea
Amning
Menorrhagia
• colestyramin 8 g administreres 3 gange dagligt i en periode på 11 dage.
• cholestyramine 8 g is administered 3 times daily for a period of 11 days, or cholestyramine 4 g three times a day can be used, if cholestyramine 8 g three times a day is not well tolerated,
o Informerere patienten om tegn og symptomer ved leversygdom og nødvendigheden af at fortælle det til sundhedspersonalet, hvis patienten oplever tegn på leversygdom.
• Risk of hepatic effects o liver function tests are needed prior to treatment and periodically during treatment o To educate the patient about the signs and symptoms of liver disease and the need to report to their HCP if they experience any of them
Tor
Thu
Nyrer og urinveje
Vomiting, Toothache
o Hvis en kvinde bliver gravid på trods af anvendelse af antikonception, skal hun stoppe med at tage teriflunomid og straks kontakte sin læge, som vil: Overveje og drøfte den accelerede eliminationsprocedure med kvinden.
• Potential risk of teratogenicity o To check pregnancy status before starting treatment o To educate female patients of child-bearing potential on the need for effective contraception before starting, and during treatment with teriflunomide o To inform their doctor immediately if they stop contraception, or prior to changing contraceptive measures o If female patients become pregnant despite using contraceptive measures, they should stop teriflunomide and contact their doctor immediately who should: Consider and discuss with the patient the accelerated elimination procedure encourage them to enrol in a pregnancy registry (in countries where a pregnancy registry is on-going),
Hjerteforstyrrelser
Cardiac disorders
Derfor forventes dosisjustering ikke at være nødvendig hos patienter med let til moderat nedsat leverfunktion.
Therefore no dose adjustment is anticipated in mild and moderate hepatic-impaired patients.
Bivirkninger
Serious side effects
Neglelidelser
Asthenia
Asteni
Sat
• Risiko for leverpåvirkning o Leverfunktionstest er nødvendige før behandling og periodevist under behandlingen.
• Risk of hypertension o to check for a history of hypertension and that blood pressure should be appropriately managed during treatment o the need for blood pressure checks before treatment and periodically during treatment,
Potente CYP- og transport-induktorer
Musculoskeletal and connective tissue disorders
5.1 for vigtig information om de populationer, for hvilke effekt er fastslået).
AUBAGIO is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established).
Andre bivirkninger kan forekomme med følgende hyppigheder:
Other side effects can occur with the following frequencies: Very common (may affect more than 1 in 10 people) Headache
- Laboratorieværdier: Et nedsat antal røde blodlegemer (anæmi), ændring i testresultater for lever og hvide blodlegemer (se pkt.
Increase in ALT (increase in blood levels of certain hepatic enzymes) shown in tests Hair thinning
FR - Frankrig EG LABO - Laboratoires EuroGenerics "Le Quintet" - Bâtiment A
FR - France EG LABO - Laboratoires EuroGenerics "Le Quintet" - Bâtiment A
Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker, indgivelsesvej og indehavere af markedsføringstilladelser i medlemsstaterne
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
HU - Ungarn sanofi-aventis zrt.
HU - Hungary sanofi-aventis zrt.
PL - Polen Zentiva a.s. U Kabelovny 130
PL - Poland Zentiva a.s. U Kabelovny 130
HU - Ungarn PannonPharma Kft. Pannonpharma út 1.
HU - Hungary PannonPharma Kft. Pannonpharma út 1.
HU - Ungarn Eurodrug Lab. BV Laan Copes van Cattenbruch 74.
HU - Hungary Eurodrug Lab. BV Laan Copes van Cattenbruch 74.
50 MG/5ML Oral suspension Oral anvendelse
50 MG/5ML Oral suspension Oral use
Evropská 846/176a 160 00 Prague
Evropská 846/176a 160 00 Prague Czech republic
FR - Frankrig CLL PHARMA Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03
FR - France CLL PHARMA Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03
PL - Polen Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka J. Piłsudskiego 5,
PL - Poland Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka J. Piłsudskiego 5,
200 MG/SUPP Suppositorier
200 MG/SUPP Suppository
BG - Bulgarien Chaikapharma - Highquality medicines AD, 1 G.M.Dimitrov Blvd
BG - Bulgaria Chaikapharma - Highquality medicines AD, 1 G.M.Dimitrov Blvd
SK - Slovakiet Zentiva k.s., Evropská 846/176a, 160 00, Praha
SK - Slovakia Zentiva k.s., Evropská 846/176a, 160 00, Praha
BG - Bulgarien Sopharma AD 16 Iliensko shosse str. 1220 Sofia
BG - Bulgaria Sopharma AD 16 Iliensko shosse str. 1220 Sofia
FR - Frankrig THERABEL LUCIEN PHARMA 19 rue Alphonse de Neuville 75017 PARIS
FR - France THERABEL LUCIEN PHARMA 19 rue Alphonse de Neuville 75017 PARIS
BG - Bulgarien Actavis EAD 29 Atanas Dukov str. Sofia 1407
BG - Bulgaria Actavis EAD 29 Atanas Dukov str. Sofia 1407
BG - Bulgarien CSC Pharmaceuticals Ltd-Bulgaria EOOD, 10 Assen Jordanov str.,
BG - Bulgaria CSC Pharmaceuticals Ltd-Bulgaria EOOD, 10 Assen Jordanov str.,