natgillin/translations-raw huggingface dataset:
• CBP15+-arm: Fem serier af bevacizumab (15 mg/kg hver 3. uge startende i serie 2) i kombination med carboplatin (AUC 6) og paclitaxel (175 mg/m2) i 6 serier, efterfulgt af fortsat behandling med bevacizumab (15 mg/kg hver 3. uge) som monoterapi, i op til sammenlagt 15 måneders behandling.
• CPB15+ arm: Five cycles of bevacizumab (15 mg/kg q3w started cycle 2) in combination with carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles followed by continued use of bevacizumab (15 mg/kg q3w) as single agent for a total of up to 15 months of therapy.
Tabel 10. Effektresultater fra studie E2100
Trial E2100 efficacy results
Pulmonal blødning/ Hæmoptyseb,d Lungeemboli Hypoksi
Pulmonary haemorrhage/ Haemoptysisb,d,
PFS1-resultater efter sygdomsstadie og tumorreduktionsstatus fra studie BO17707 (ICON7)
PFS1 results by disease stage and debulking status from study BO17707 (ICON7) Randomised patients stage III optimally debulked disease2,3 CP (n = 368)
Median PFS** Hazard ratio (97,5 % konfidensinterval)a Sekundære endepunkter
Primary endpoint Median PFS** Hazard ratio (97.5% CI)a
Ca. 50 % af patienterne havde en ECOG PS på 1, og 7 % af patienterne i de 2 behandlingsarme havde en ECOG PS på 2.
The majority of patients included in the study were white (96%), the median age was 57 years in both treatment arms, 25% of patients in each treatment arm were 65 years of age or over, and approximately 50% of patients had an ECOG PS of 1; 7% of patients in each treatment arm had an ECOG PS of 2.
Det skal du vide, før du begynder at bruge MVASI Sådan skal du bruge MVASI Bivirkninger
What you need to know before you use MVASI 3.
Kemoterapi + bevacizumab (n = 227)
Chemotherapy + bevacizumab (n = 227)
Den anbefalede dosis af MVASI er 15 mg/kg kropsvægt en gang hver 3. uge som intravenøs infusion.
The recommended dose of MVASI is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
1,4 % af patienterne, som fik bevacizumab i kombination med kemoterapi, sammenlignet med op til 0,7 % af patienterne, som fik kemoterapi alene.
Myocardial infarction was reported in up to 1.4% of patients treated with bevacizumab in combination with chemotherapy compared to up to 0.7% of patients treated with chemotherapy alone.
MVASI bruges også hos voksne til behandling af fremskreden nyrekræft.
MVASI is also used for treatment of adult patients with advanced kidney cancer.
• komparativ incidens, som er konstateret mellem behandlingsarme i kliniske studier (med mindst 10 % forskel i forhold til kontrolarmen for NCI-CTCAE grad 1-5 bivirkninger eller med mindst 2 % forskel i forhold til kontrolarmen for NCI-CTCAE grad 3-5 bivirkninger),
difference compared to the control arm for NCI-CTCAE grade 1-5 reactions or at least a 2%
Idet maternel IgG udskilles i mælk, og da bevacizumab kan skade barnets vækst og udvikling (se pkt.
As maternal IgG is excreted in milk and bevacizumab could harm infant growth and development (see section 5.3), women must discontinue breast-feeding during therapy and not breast-feed for at least six months following the last dose of bevacizumab.
Den anbefalede MVASI-dosis er 10 mg/kg kropsvægt en gang hver 2. uge som intravenøs infusion.
The recommended dose of MVASI is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion.
Samlet responsrate
Response rate
Hazard ratio (95 % konfidensinterval)
Hazard ratio [95% CI]
De fleste havde tidligere eller samtidigt fået behandling med intravenøse bisfosfonater, hvor osteonekrose af kæben er en kendt risiko.
Cases of ONJ have been reported in cancer patients treated with bevacizumab, the majority of whom had received prior or concomitant treatment with intravenous bisphosphonates, for which ONJ is an identified risk.
Frekvenser for bivirkninger
Adverse reactions by frequency
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert engangshætteglas indeholder 100 mg bevacizumab i 4 ml koncentrat.
Each single use vial contains 100 mg of bevacizumab in 4 mL of concentrate.
(17,5 vs 14,3 måneder; p =
(17.5 vs.14.3 months; p = 0.0609)
Søvnighed Hovedpine
Hepatic impairment
Den progressionsfrie overlevelse og den objektive tumorresponsrate forøgedes signifikant ved tillæg af bevacizumab til IFN alfa-2a behandlingen.
The addition of bevacizumab to IFN alfa-2a significantly increased PFS and objective tumour response rate.
Sårhelingskomplikationerb,d Eksfoliativ dermatitis Tør hud
Exfoliative dermatitis, Dry skin, Skin discolouration
# I alt blev 154 patienter (ECOG-performancestatus 0 eller 1) randomiseret.
p-value Overall response rate Rate (n) p-value Overall survival* (months) Median HR (95% CI) p-value A total of 154 patients (ECOG Performance Status 0 or 1) were randomised.
Dette var et fase III, randomiseret, aktivt kontrolleret, ublindet studie, som undersøgte bevacizumab 10 mg/kg i kombination med leucovorin og 5-fluoruracil bolus efterfulgt af 5-fluoruracil infusion med i.v.
This was a phase III randomised, active-controlled, open-label trial investigating bevacizumab 10 mg/kg in combination with leucovorin with 5-fluorouracil bolus and then 5-fluorouracil infusional, with IV oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule in previously-treated patients (second-line) with advanced colorectal cancer.
Median OS (måneder) Hazard ratio (95 % konfidensinterval) p-værdi
Median OS (months) Hazard ratio (95% CI) p-value
over 3 timer på dag 1 og topotecan 0,75 mg/m2 i.v.
• Paclitaxel 175 mg/m2 IV over 3 hours on day 1 and topotecan 0.75 mg/m2 IV over 30 minutes on days 1-3 (q3w)
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert engangshætteglas indeholder 400 mg bevacizumab i 16 ml koncentrat.
Each single use vial contains 400 mg of bevacizumab in 16 mL of concentrate.
over 3 timer på dag 1 og cisplatin 50 mg/m i.v på dag 1 plus bevacizumab 15 mg/kg i.v.
Paclitaxel 175 mg/m2 IV over 3 hours on day 1 and cisplatin 50 mg/m2 IV on day 1 plus bevacizumab 15 mg/kg IV on day 1 (q3w)
Median PFS (måneder) Hazard ratio (95 % konfidensinterval)4
Median PFS (months) Hazard ratio (95% CI)4
(16,2 vs 17,5 måneder; p =
(16.2 vs. 17.5 months; p = 0.3769)
Arteriel tromboemboli: En forøget forekomst af arterielle tromboemboliske bivirkninger blev observeret hos patienter, som blev behandlet med bevacizumab, uanset indikation.
Arterial thromboembolism: An increased incidence of arterial thromboembolic reactions was observed in patients treated with bevacizumab across indications, including cerebrovascular accidents, myocardial infarction, transient ischaemic attacks, and other arterial thromboembolic reactions.
Hos patienter, behandlet med MVASI for persisterende, recidiverende eller metastatisk cervixcancer, er tidligere strålebehandling en risikofaktor for gastrointestinal perforation, og alle patienter, som fik gastrointestinal perforation, havde tidligere fået strålebehandling, Behandlingen skal seponeres permanent hos patienter, som udvikler gastrointestinal perforation.
Prior radiation is a risk factor for GI perforation in patients treated for persistent, recurrent or metastatic cervical cancer with MVASI and all patients with GI perforation had a history of prior radiation.
MVASI bruges også i behandlingen af voksne patienter med vedvarende livmoderhalskræft, med livmoderhalskræft, som er kommet igen, eller med livmoderhalskræft, der har spredt sig (dannet metastaser).
MVASI is also used for the treatment of adult patients with persistent, recurrent or metastatic cervical cancer.
over 24 timer på dag 1 og cisplatin 50 mg/m2 i.v på dag 2 plus bevacizumab 15 mg/kg i.v.
Paclitaxel 175 mg/m2 IV over 3 hours on day 1 and cisplatin 50 mg/m2 IV on day 2 plus bevacizumab 15 mg/kg IV on day 2 (q3w); or
Objektiv responsrate (%) for patienter med målelig sygdom N Responsrate p-værdi < 0,0001)
Objective response rate (%) in patients with measurable disease
Frekvens af alvorlige bivirkninger
Severe adverse reactions by frequency
Oxaliplatin Capecitabin
Capecitabine
(11,9 vs 14,3 måneder; p =
(11.9 vs.14.3 months; p = 0.4825)
Antal patienter Samlet overlevelse Median tid (måneder)
a patients with measurable disease at baseline Overall survival Median (months)
Forskel i responsrate
N Response rate
Cellulitis
Oxaliplatin
130 mg/m i.v.
130 mg/m2 IV 2 h
Dette var et fase III, randomiseret, dobbeltblindet (med hensyn til bevacizumab), klinisk studie, hvori bevacizumab 7,5 mg/kg i kombination med oral capecitabin og i.v.
This was a phase III randomised, double-blind (for bevacizumab), clinical trial investigating bevacizumab 7.5 mg/kg in combination with oral capecitabine and IV oxaliplatin (XELOX), administered on a 3-weekly schedule; or bevacizumab 5 mg/kg in combination with leucovorin with 5-fluorouracil bolus, followed by 5-fluorouracil infusional, with IV oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule.
Hovedpine Dysgeusi
Hypoxia, Dysphoniaa
Rate (n) p-værdi
p-value (Chi-squared test)
Responsrate
AUTHORISATION
Median OS (måneder) Hazard ratio (95 % konfidensinterval)
Median OS (months) Hazard ratio (95% CI)
Der er observeret tilfælde af anormaliteter hos fostre, hvor moderen er blevet behandlet med bevacizumab alene eller i kombination med kemoterapeutika med kendt embryotoksicitet (se pkt.
Cases of foetal abnormalities in women treated with bevacizumab alone or in combination with known embryotoxic chemotherapeutics have been observed (see section 4.6) * If specified, the frequency has been derived from clinical trial data.
Dyspnø
Leucovorin
Det blev udført med patienter med lokalt fremskreden (stadie IIIb med supraklaviculære lymfekirtelmetastaser eller med malignt pleural eller perikardial effusion), metastatisk eller recidiverende ikke-planocellulær NSCLC, som ikke tidligere havde fået kemoterapi.
Trial BO17704 was a randomised, double-blind phase III trial of bevacizumab in addition to cisplatin and gemcitabine versus placebo, cisplatin and gemcitabine in patients with locally advanced (stage IIIB with supraclavicular lymph node metastases or with malignant pleural or pericardial effusion), metastatic or recurrent non-squamous NSCLC, who had not received prior chemotherapy.
Der er i sjældne tilfælde rapporteret nekrotiserende fasciitis, inklusive dødelige tilfælde, hos patienter behandlet med bevacizumab; dette har som regel været sekundært til sårhelingskomplikationer, gastrointestinal perforation eller fisteldannelse.
This condition is usually secondary to wound healing complications, gastrointestinal perforation or fistula formation.
Kemoterapi + bevacizumab (n = 179)
CT + BV (n = 179)
Pulmonal hypertensiona Næseseptumperforationa
Pulmonary hypertensiona, Nasal septum perforationa
Cisplatin/Gemcitabin + placebo
Efficacy results for trial BO17704 Cisplatin/Gemcitabine + placebo
Median PFS (måneder) Hazard ratio (95 % konfidensinterval)2 p-værdi3, 4
Median OS (months) Hazard ratio (95% CI)2 p-value3
Randomiserede patienter med stadie III optimalt tumorreduceret sygdom CPP (n = 219)
Randomised patients stage III optimally debulked disease2,3
Det sekundære endepunkt var progessionsfri overlevelse.
The main secondary efficacy endpoint was progression-free survival (PFS).
Tromboemboli (arteriel)a,b
Hypertensiona,b Thromboembolism arteriala,b,
• vægttab,
• tiredness,
Synkope
SN
Dette skal ses i sammenligning med < 1 % af de patienter, der kun fik kemoterapi (NCI-CTCAE v. 3).
Grade 3-5 reactions have been observed in up to 2.3% of patients treated with bevacizumab plus chemotherapy as compared with < 1% with chemotherapy alone (NCI-CTCAE v.3).
Knogler, led, muskler og bindevæv
Cerebrovascular accident, Syncope, Somnolence, Headache
Artralgi
Lethargy
Bevacizumab kan nedsætte fertiliteten hos kvinder (se pkt.
Bevacizumab may impair female fertility (see sections 4.6 and 4.8).
Followup-analyse blev udført ved data cut-off 7. marts 2014.
Follow-up analysis was performed with a data cut-off date of 07 March 2014. p-value displayed for descriptive purpose only.
Hazard ratio (95 % konfidenstinterval) (eCRF)
Median OS (months) Hazard ratio (95% CI) (eCRF)a
Renal trombotisk mikroangiopatia,b Aneurismer og arterielle dissektioner
Aneurysms and artery dissections
Epidermal Growth Factor Receptor (EGFR)-monoklonale antistoffer i kombination med kemoterapi, som indeholder bevacizumab
EGFR monoclonal antibodies in combination with bevacizumab chemotherapy regimens
Antal patienter Samlet overlevelse Median tid (måneder) 95 % konfidensinterval Hazard ratiob
Number of patients Overall survival Median time (months) 95% CI
EU/1/08/465/015 Clopidogrel Zentiva
Package size blister (PVC/PVDC/alu) 50 x 1 tablet
Filmovertrukket tablet
Strength Pharmaceutical Form Route of Administration Packaging
300 mg
10x1 tablets
Ofte har disse patienter ikke andre behandlingsmuligheder.
These patients often do not have other treatment options.
Den anbefalede dosis er én tablet to gange dagligt.
The recommended dose is one tablet twice a day.
Behandlingen fortsættes i seks uger, men kan forlænges i op til yderligere seks uger, hvis det skønnes nødvendigt.
Treatment is continued for 6 weeks, but may be extended for up to another 6 weeks if needed.
Tabletterne må ikke tygges eller synkes hele.
Tablets must not be chewed or swallowed whole.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Jorveza.
This is a summary of the European public assessment report (EPAR) for Jorveza.
Jorveza budesonid
Jorveza budesonide
Tabletten placeres på tungen og presses derefter mod den øverste del af munden i ca. to minutter, indtil den smelter.
The tablet is placed on the tongue and pressed against the roof of the mouth for around two minutes until it dissolves.
Andre oplysninger om Jorveza
Other information about Jorveza
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Jorveza?
What measures are being taken to ensure the safe and effective use of Jorveza?
Efter 6 uger havde ca. 58 % af de patienter, der fik Jorveza (34 ud af 59 patienter), en reduceret koncentration af eosinofiler og ingen eller kun meget få symptomer, mens ingen af de 29 patienter, der fik placebo, oplevede disse virkninger.
After 6 weeks, around 58% of the patients taking Jorveza (34 out of 59 patients) had reduced eosinophils and no symptoms or only minimal symptoms, whereas none of the 29 patients taking placebo had these effects.
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Jorveza opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The European Medicines Agency decided that Jorveza's benefits are greater than its risks and recommended that it be approved for use in the EU.
Bivirkningerne ved Jorveza er stort set de samme som ved lignende lægemidler.
Side effects with Jorveza are mainly the same as those of other similar medicines.
Hvorfor blev Jorveza godkendt?
Why is Jorveza approved?
Da antallet af patienter med eosinofil øsofagitis er lavt, betragtes sygdommen som "sjælden", og Jorveza blev udpeget som "lægemiddel til sjældne sygdomme" den 5. august 2013.
Because the number of patients with eosinophilic oesophagitis is low, the disease is considered ‘rare', and Jorveza was designated an ‘orphan medicine' (a medicine used in rare diseases) on 5 August
Den fuldstændige EPAR for Jorveza findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Jorveza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Hvad er Jorveza, og hvad anvendes det til?
What is Jorveza and what is it used for?
Det er ikke en praktisk vejledning i, hvordan Jorveza bør anvendes.
It is not intended to provide practical advice on how to use Jorveza.
Hvilke risici er der forbundet med Jorveza?
What are the risks associated with Jorveza?
Jorveza fås som smeltetabletter (1 mg).
Jorveza is available as orodispersible tablets (1 mg).
Jorveza indeholder det aktive stof budesonid.
Jorveza contains the active substance budesonide.
Kortikosteroider medvirker til at reducere betændelse ved at binde til receptorer på immunceller, hvormed de reducerer frigivelsen af stoffer, der er involveret i betændelsesprocessen.
Corticosteroids help reduce inflammation by attaching to receptors of immune cells and reducing the release of substances that are involved in the inflammation process.
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Jorveza findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of the opinion of the Committee for Orphan Medicinal Products for Jorveza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Jorveza blev sammenlignet med placebo (et uvirksomt stof).
Jorveza was compared with placebo (a dummy treatment).
Hvis du ønsker yderligere oplysninger om behandling med Jorveza, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Jorveza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Det aktive stof i Jorveza, budesonid, er et binyrebarkhormon (kortikosteroid).
The active substance in Jorveza, budesonide, is a corticosteroid medicine.
Imens skal patienten synke det mundvand, der dannes med den opløste medicin.
During this time the patient should steadily swallow the saliva with the dissolved medicine.
De hyppigste bivirkninger ved Jorveza (som optræder hos op til 3 ud af 10 patienter) er svampeinfektioner i munden, svælget og spiserøret.
The most common side effects with Jorveza (which may affect up to 3 in 10 people) are fungal infections in the mouth, pharynx (throat) and oesophagus.
Den fuldstændige liste over bivirkninger og begrænsninger ved Jorveza fremgår af indlægssedlen.
For the full list of all side effects and restrictions with Jorveza, see the package leaflet.
Det er påvist, at Jorveza er effektivt i én hovedundersøgelse med 88 voksne med eosinofil øsofagitis.
Jorveza was shown to be effective in one main study involving 88 adults with eosinophilic oesophagitis.
Det primære mål for virkningen var koncentrationen af eosinofiler i spiserøret og forbedring af symptomerne.
The main measure of effectiveness was the level of eosinophils in the oesophagus and improvement in symptoms.
Hvis du ønsker praktisk vejledning om anvendelsen af Jorveza, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Jorveza, patients should read the package leaflet or contact their doctor or pharmacist.
Jorveza hjælper patienter med eosinofil øsofagitis ved at forbedre symptomerne på sygdommen og reducere koncentrationen af eosinofiler.
Jorveza benefits patients with eosinophilic oesophagitis by improving the symptoms of the disease and reducing the excess of eosinophils.
Jorveza udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i diagnosticering og behandling af patienter med eosinofil øsofagitis.
Jorveza can only be obtained with a prescription and treatment should be started by a doctor experienced with diagnosing and treating eosinophilic oesophagitis.
Eosinofil øsofagitis er betændelse i spiserøret (der går fra munden til maven), som forårsager symptomer som f.eks. synkebesvær og blokering af spiserøret.
Eosinophilic oesophagitis is inflammation of the oesophagus (the food-pipe that leads from the mouth to the stomach), which causes symptoms including dysphagia (difficulty swallowing) and obstruction of the oesophagus.
Hvordan virker Jorveza?
How does Jorveza work?
Hvilke fordele viser undersøgelserne, at der er ved Jorveza?
What benefits of Jorveza have been shown in studies?
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Jorveza.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jorveza have been included in the summary of product characteristics and the package leaflet.
Jorveza er et lægemiddel til behandling af voksne med eosinofil øsofagitis.
Jorveza is a medicine used to treat adults with eosinophilic oesophagitis.
Efter Jorveza er smeltet i munden, føres det med mundvandet til spiserøret, hvor det reducerer betændelsen og lindrer symptomerne på eosinofil øsofagitis.
After Jorveza dissolves in the mouth, the saliva carries it to the oesophagus where it reduces the inflammation and relieves the symptoms of eosinophilic oesophagitis.
Hvordan anvendes Jorveza?
How is Jorveza used?
Sygdommen forårsages af en stor ophobning af eosinofiler (en type hvide blodlegemer) i spiserørets slimhinde.
It is caused by a large build-up of white blood cells called eosinophils in the lining of the oesophagus.
Pulver: Multidosis hætteglas (glas) Solvens: Ampul (glas)
Subcutaneous or intravenous use powder: multidose vial (glass); solvent: ampoule (glass)
Solvens: 10 ml (Rekonstitueret opløsning 5.000 IE/ml)
solvent: 10 ml (reconst.
EU/1/97/031/019 NeoRecormon 50.000 IE Pulver og solvens til injektionsvæske, opløsning
50000 IU Powder and solvent for solution for injection
Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker, indgivelsesveje, indehavere af markedsføringstilladelser i medlemsstaterne
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Tyskland Hexal Aktiengesellschaft Industriestr.
Germany Hexal Aktiengesellschaft Industriestr.
28230 Las Rozas (Madrid) Spain
Oficina D 28230 Las Rozas (Madrid) Spain
11-15 Quai Dion Bouton 92800 Puteaux
11-15 Quai Dion Bouton 92800 Puteaux France
Frankrig MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France
MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France
Danmark Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark
Denmark Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark
Rumænien S.C.
Romania S.C.
Tyskland IIP - Institut für industrielle Pharmazie Forschungs- und Entwicklungsgesellschaft mbH
Germany IIP - Institut für industrielle Pharmazie Forschungs- und Entwicklungsgesellschaft mbH
Belgien Takeda Belgium Gentsesteenweg 615
Belgium Takeda Belgium Gentsesteenweg 615
Grækenland DEMO ABEE 21st Km Athens-Lamias National Highway 14568 Kryoneri Greece
DEMO ABEE 21st Km Athens-Lamias National Highway 14568 Kryoneri Greece
Litauen UAB „SANOFI-AVENTIS LIETUVA“
Lithuania UAB „SANOFI-AVENTIS LIETUVA“
Estland Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2
Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2
Cypern Remedica Ltd Aharnon Street Limassol Industrial Estate 3056 Lemesos Cyprus
Remedica Ltd Aharnon Street Limassol Industrial Estate 3056 Lemesos Cyprus
Rumænien GEROT PHARMAZEUTIKA Ges.m.b.H.
Romania GEROT PHARMAZEUTIKA Ges.m.b.H.
Frankrig Arrow Generiques 26, avenue Tony Garnier 69007 Lyon
Arrow Generiques 26, avenue Tony Garnier 69007 Lyon
Frankrig TEVA SANTE 110, Esplanade du Général de Gaulle
110, Esplanade du Général de Gaulle
Østrig sanofi-aventis GmbH SATURN Tower, Vienna DC Leonard-Bernstein-Straße
Austria sanofi-aventis GmbH SATURN Tower, Vienna DC Leonard-Bernstein-Straße
Frankrig Biogaran 15, boulevard Charles de Gaulle
15, boulevard Charles de Gaulle
Spanien SANOFI AVENTIS, S.A. Josep Plá, 2
SANOFI AVENTIS, S.A. Josep Plá, 2
Danmark Sanofi-aventis Denmark A/S
Denmark Sanofi-aventis Denmark A/S
Grækenland Sanofi-Aventis AEBE 348 Syngrou Avenue, Building A'
Sanofi-Aventis AEBE 348 Syngrou Avenue, Building A'
Frankrig Laboratoire AGUETTANT 1, rue Alexander Fleming 69007 Lyon
Laboratoire AGUETTANT 1, rue Alexander Fleming 69007 Lyon
Tyskland Mylan dura GmbH Wittichstr.
Germany Mylan dura GmbH Wittichstr.
Belgien Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
Belgium Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
Tyskland Heumann Pharma GmbH & Co. Generica KG Südwestpark 50
Germany Heumann Pharma GmbH & Co. Generica KG Südwestpark 50
Sanofi-aventis Ireland Ltd. T/A SANOFI
Ireland Sanofi-aventis Ireland Ltd. T/A SANOFI
Tyskland Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1
Germany Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1
Tyskland Sanofi-Aventis Deutschland GmbH
Germany Sanofi-Aventis Deutschland GmbH
Tyskland 1 A Pharma GmbH Keltenring 1 + 3
Germany 1 A Pharma GmbH Keltenring 1 + 3