natgillin/translations-raw huggingface dataset:
EU/1/06/370/036 280 filmovertrukne tabletter (4x70) EU/1/06/370/039 280 filmovertrukne tabletter (20x14) 
EU/1/06/370/036 280 film-coated tablets (4x70) EU/1/06/370/039 280 film-coated tablets (20x14)
Exforge 5 mg/80 mg tabletter er runde og mørkegule, præget med ”NVR” på den ene side og ”NV” på den anden side. 
What Exforge looks like and contents of the pack Exforge 5 mg/80 mg tablets are round and dark yellow with “NVR” on one side and “NV” on the other side.
Exforge 5 mg/80 mg filmovertrukne tabletter amlodipin/valsartan 
Exforge 5 mg/80 mg film-coated tablets amlodipine/valsartan
Ikke almindelig Ikke almindelig Ikke kendt 
Uncommon Uncommon Not known
Exforge 5 mg/160 mg filmovertrukne tabletter amlodipin/valsartan 
Exforge 5 mg/160 mg film-coated tablets amlodipine/valsartan
Til sammenligning oplevede 68,5% af patienterne, som blev behandlet med en ACE-hæmmer, hoste (p <0,05). 
In a clinical trial of patients with a history of dry cough during ACE inhibitor therapy, 19.5% of trial subjects receiving valsartan and 19.0% of those receiving a thiazide diuretic experienced coughing, compared to 68.5% of those treated with an ACE inhibitor (p <0.05).
EU/1/06/370/001 7 filmovertrukne tabletter EU/1/06/370/002 14 filmovertrukne tabletter EU/1/06/370/003 28 filmovertrukne tabletter EU/1/06/370/004 30 filmovertrukne tabletter EU/1/06/370/005 56 filmovertrukne tabletter EU/1/06/370/006 90 filmovertrukne tabletter EU/1/06/370/007 98 filmovertrukne tabletter EU/1/06/370/008 280 filmovertrukne tabletter EU/1/06/370/025 56x1 filmovertrukket tablet (enhedsdosis) EU/1/06/370/026 98x1 filmovertrukket tablet (enhedsdosis) EU/1/06/370/027 280x1 filmovertrukket tablet (enhedsdosis) 
EU/1/06/370/001 7 film-coated tablets EU/1/06/370/002 14 film-coated tablets EU/1/06/370/003 28 film-coated tablets EU/1/06/370/004 30 film-coated tablets EU/1/06/370/005 56 film-coated tablets EU/1/06/370/006 90 film-coated tablets EU/1/06/370/007 98 film-coated tablets EU/1/06/370/008 280 film-coated tablets EU/1/06/370/025 56x1 film-coated tablet (unit dose) EU/1/06/370/026 98x1 film-coated tablet (unit dose) EU/1/06/370/027 280x1 film-coated tablet (unit dose)
EU/1/06/370/017 7 filmovertrukne tabletter EU/1/06/370/018 14 filmovertrukne tabletter EU/1/06/370/019 28 filmovertrukne tabletter EU/1/06/370/020 30 filmovertrukne tabletter EU/1/06/370/021 56 filmovertrukne tabletter EU/1/06/370/022 90 filmovertrukne tabletter EU/1/06/370/023 98 filmovertrukne tabletter EU/1/06/370/024 280 filmovertrukne tabletter EU/1/06/370/031 56x1 filmovertrukket tablet (enhedsdosis) EU/1/06/370/032 98x1 filmovertrukket tablet (enhedsdosis) EU/1/06/370/033 280x1 filmovertrukket tablet (enhedsdosis) 
EU/1/06/370/017 7 film-coated tablets EU/1/06/370/018 14 film-coated tablets EU/1/06/370/019 28 film-coated tablets EU/1/06/370/020 30 film-coated tablets EU/1/06/370/021 56 film-coated tablets EU/1/06/370/022 90 film-coated tablets EU/1/06/370/023 98 film-coated tablets EU/1/06/370/024 280 film-coated tablets EU/1/06/370/031 56x1 film-coated tablet (unit dose) EU/1/06/370/032 98x1 film-coated tablet (unit dose) EU/1/06/370/033 280x1 film-coated tablet (unit dose)
EU/1/06/370/009 7 filmovertrukne tabletter EU/1/06/370/010 14 filmovertrukne tabletter EU/1/06/370/011 28 filmovertrukne tabletter EU/1/06/370/012 30 filmovertrukne tabletter EU/1/06/370/013 56 filmovertrukne tabletter EU/1/06/370/014 90 filmovertrukne tabletter EU/1/06/370/015 98 filmovertrukne tabletter EU/1/06/370/016 280 filmovertrukne tabletter EU/1/06/370/028 56x1 filmovertrukket tablet (enhedsdosis) EU/1/06/370/029 98x1 filmovertrukket tablet (enhedsdosis) EU/1/06/370/030 280x1 filmovertrukket tablet (enhedsdosis) 
EU/1/06/370/009 7 film-coated tablets EU/1/06/370/010 14 film-coated tablets EU/1/06/370/011 28 film-coated tablets EU/1/06/370/012 30 film-coated tablets EU/1/06/370/013 56 film-coated tablets EU/1/06/370/014 90 film-coated tablets EU/1/06/370/015 98 film-coated tablets EU/1/06/370/016 280 film-coated tablets EU/1/06/370/028 56x1 film-coated tablet (unit dose) EU/1/06/370/029 98x1 film-coated tablet (unit dose) EU/1/06/370/030 280x1 film-coated tablet (unit dose)
Hvis du har taget for meget Exforge 
If you take more Exforge than you should
Dette er især vigtigt, hvis dit barn er nyfødt eller blev født for tidligt. 
Exforge is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Det skal du vide, før du begynder at tage Exforge Sådan skal du tage Exforge Bivirkninger 
What Exforge is and what it is used for What you need to know before you take Exforge How to take Exforge
Dette sammendrag blev sidst ajourført i 01-2016. 
This summary was last updated in 02-2012.
Den fuldstændige EPAR for Clopidogrel Acino findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR for Clopidogrel Acino can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel Acino den 28. juli 2009. 
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Acino on 28 July 2009.
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Clopidogrel Acino. 
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel Acino.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Clopidogrel Acino. 
This is a summary of the European public assessment report (EPAR) for Clopidogrel Acino.
Hvis du ønsker yderligere oplysninger om behandling med Clopidogrel Acino, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Clopidogrel Acino, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Dette efterfølges så af en standarddosis på 75 mg en gang dagligt i mindst fire uger (ved myokardieinfarkt med "STsegmentelevation") eller i op til 12 måneder (ved ustabil angina eller "non-Q-tak" myokardieinfarkt). 
This is then followed by the standard 75 mg dose once a day for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months (in non-ST segment elevation syndrome).
• for nylig har haft et myokardieinfarkt (hjertetilfælde). 
• patients who have recently had a myocardial infarction (heart attack).
Standarddosis af Clopidogrel Acino er en tablet på 75 mg en gang dagligt. 
The standard dose of Clopidogrel Acino is one 75 mg tablet once a day.
• har perifere kredsløbsforstyrrelser (problemer med blodgennemstrømningen i arterierne) 
• patients with peripheral arterial disease (problems with blood flow in the arteries);
CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Clopidogrel Acino er af sammenlignelig kvalitet og er bioækvivalent med Plavix. 
The CHMP concluded that, in accordance with EU requirements, Clopidogrel Acino has been shown to have comparable quality and to be bioequivalent to Plavix.
Det betyder, at Clopidogrel Acino er identisk med et referencelægemiddel, der allerede er godkendt i Den Europæiske Union, og som hedder Plavix. 
This means that Clopidogrel Acino is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Behandling med Clopidogrel Acino kan påbegyndes mellem få dage og indtil 35 dage efter anfaldet 
Clopidogrel Acino can be started between a few days and 35 days after the attack;
• for nylig har haft et iskæmisk slagtilfælde (et slagtilfælde forårsaget af manglende blodforsyning til en del af hjernen). 
• patients who have had a recent ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
Clopidogrel Acino er et "generisk lægemiddel". 
Clopidogrel Acino is a ‘generic medicine'.
Andre oplysninger om Clopidogrel Acino 
Other information about Clopidogrel Acino
Hvilke fordele og risici er der forbundet med Clopidogrel Acino? 
What are the benefits and risks of Clopidogrel Acino?
EPAR - sammendrag for offentligheden 
EPAR summary for the public clopidogrel
Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel Acino. 
The Committee recommended that Clopidogrel Acino be given marketing authorisation.
Da Clopidogrel Acino er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet. 
Because Clopidogrel Acino is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as those of the reference medicine.
Clopidogrel Acino er et lægemiddel, der indeholder det aktive stof clopidogrel. 
Clopidogrel Acino is a medicine that contains the active substance clopidogrel.
Behandling med Clopidogrel Acino kan påbegyndes syv dage efter slagtilfældet og indtil seks måneder efter 
Clopidogrel Acino can be started between seven days and six months after the stroke;
Da Clopidogrel Acino er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix. 
Because Clopidogrel Acino is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Ved akut koronart syndrom indledes behandlingen normalt med en startdosis på fire 75 mg-tabletter. 
In acute coronary syndrome, Clopidogrel Acino is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets.
• har en sygdom kaldet "akut koronart syndrom", når det skal gives sammen med aspirin (et andet lægemiddel, som forebygger blodpropper). 
• patients who have a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up).
Det aktive stof i Clopidogrel Acino, clopidogrel, er en trombocytfunktionshæmmer. 
The active substance in Clopidogrel Acino, clopidogrel, is an inhibitor of platelet aggregation.
Clopidogrel Acino anvendes til at forebygge problemer forårsaget af blodpropper hos voksne, som: 
Clopidogrel Acino is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Hvorfor blev Clopidogrel Acino godkendt? 
Why has Clopidogrel Acino been approved?
Hvad er Clopidogrel Acino? 
What is Clopidogrel Acino?
Hvordan blev Clopidogrel Acino undersøgt? 
How has Clopidogrel Acino been studied?
Hvad anvendes Clopidogrel Acino til? 
What is Clopidogrel Acino used for?
Hvordan anvendes Clopidogrel Acino? 
How is Clopidogrel Acino used?
Det anvendes til patienter, som har mindst en risikofaktor for vaskulære hændelser såsom hjerteanfald eller slagtilfælde, som ikke kan tage vitamin Kantagonister (andre lægemidler, der forebygger blodpropper), og som har en lav blødningsrisiko. 
It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or have had a ‘non-Q-wave' myocardial infarction.
Hvordan virker Clopidogrel Acino? 
How does Clopidogrel Acino work?
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cholib den 26. august 2013. 
The European Commission granted a marketing authorisation valid throughout the European Union for Cholib on 26 August 2013.
Cholib fenofibrat / simvastatin 
Cholib fenofibrate / simvastatin
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cholib. 
This is a summary of the European public assessment report (EPAR) for Cholib.
Den fuldstændige EPAR for Cholib findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR for Cholib can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Fenofibrat er en “PPARα-agonist”. 
Fenofibrate is a ‘PPARα agonist'.
Den anbefalede dosis er én tablet dagligt, der skal synkes hel med et glas vand. 
The recommended dose is one tablet a day to be swallowed whole with a glass of water.
Andre oplysninger om Cholib 
Other information about Cholib
Der er udarbejdet en risikostyringsplan for at sikre, at Cholib anvendes så risikofrit som muligt. 
A risk management plan has been developed to ensure that Cholib is used as safely as possible.
Udvalget bemærkede desuden, at kombinationen af fenofibrat og simvastatin i forvejen anvendes i klinisk praksis. 
The Committee also noted that the combination of fenofibrate and simvastatin is already being used in clinical practice.
Udvalget konkluderede derfor, at fordelene ved Cholib overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse til anvendelse i EU. 
The Committee therefore concluded that Cholib's benefits are greater than its risks and recommended that it be approved for use in the EU.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cholib? 
What measures are being taken to ensure the safe and effective use of Cholib?
Cholib udleveres kun på recept og leveres som tabletter (145/20 mg og 145/40 mg). 
Cholib can only be obtained with a prescription and is available as tablets (145/20 mg and 145/40 mg).
To yderligere undersøgelser sammenlignede Cholib med andre statiner (atorvastatin og pravastatin) og viste, at Cholib var mere effektivt end disse statiner givet alene. 
Two further studies compared Cholib with other statins (atorvastatin and pravastatin) and showed Cholib to be more effective than those statins given alone.
Hvad er Cholib, og hvad anvendes det til? 
What is Cholib and what is it used for?
Vedrørende sikkerheden af Cholib svarer de indberettede bivirkninger i undersøgelserne til dem, der kendes for de to aktive stoffer, og der var ingen større betænkeligheder. 
With regard to the safety of Cholib, the side effects reported in the studies were consistent with what is known about the two active substances and there were no major concerns.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at kombinationen af fenofibrat og simvastatin er påvist at være effektiv til at forbedre blodets indhold af fedtstoffer. 
The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the combination of fenofibrate and simvastatin has been shown to be effective at improving blood fat levels.
Det kolesterol, der på denne måde trækkes ud af blodet, er det “dårlige” kolesterol. 
The cholesterol drawn out of the blood in this way is the ‘bad' cholesterol.
Det må heller ikke anvendes hos gravide eller ammende kvinder, hos personer med kendte lysforårsagede reaktioner over for fibrater eller ketoprofen, med lever- eller galdeblæresygdom eller moderat eller svært nedsat nyrefunktion, eller hos personer, som tidligere har fået muskelproblemer ved at bruge statiner eller fibrater. 
It must also not be used in pregnant or breast-feeding women, in people known to have light-induced reactions to fibrates or ketoprofen, or those who have liver or gallbladder disease, pancreatitis, or moderately or severely reduced kidney function, or who have previously had muscle problems while taking statins or fibrates.
Hvorfor er Cholib blevet godkendt? 
Why is Cholib approved?
Det er ikke en praktisk vejledning i, hvordan Cholib bør anvendes. 
It is not intended to provide practical advice on how to use Cholib.
Hvilke risici er der forbundet med Cholib ? 
What are the risks associated with Cholib?
Cholib må ikke anvendes hos personer, der er overfølsomme (allergiske) over for jordnødder, sojalecitin eller nogen af indholdsstofferne i lægemidlet. 
Cholib must not be used in people who are hypersensitive (allergic) to peanuts, soya lecithin or any of the ingredients of the medicine.
Det andet aktive stof, simvastatin, tilhører lægemiddelgruppen statiner. 
The second active substance, simvastatin, belongs to the group called ‘statins'.
Før påbegyndelse af behandling med Cholib skal mulige årsager til det abnorme fedtstofindhold i blodet være behandlet tilstrækkeligt, og patienten skal følge en sædvanlig fedtsænkende diæt. 
Before starting treatment with Cholib, possible causes of the abnormal levels of blood fats should be adequately treated and patients should be placed on a standard fat-lowering diet.
Cholib er til anvendelse hos voksne, der har høj risiko for hjertesygdom, og hvis niveau af “dårligt” kolesterol i forvejen er reguleret med den tilsvarende dosis simvastatin alene. 
Cholib is to be used in adults at high risk of heart disease whose levels of ‘bad' cholesterol (LDL cholesterol) are already being controlled with the corresponding dose of simvastatin alone.
Grapefrugtjuice bør undgås under behandling med Cholib, da det ændrer indholdet af simvastatin i blodet. 
Grapefruit juice should be avoided during Cholib treatment as this is known to alter the amount of simvastatin in the blood.
I en anden undersøgelse blev Cholib, 145/40 mg, sammenlignet med simvastatin, 40 mg, hos 450 patienter, der ikke var tilstrækkeligt behandlet med 40 mg simvastatin alene. 
Another study compared Cholib 145/40 mg with simvastatin 40 mg in 450 patients not adequately treated with 40 mg simvastatin alone.
Cholib er et lægemiddel til forbedring af fordelingen af fedtstoffer i blodet. 
Cholib is a medicine for improving blood fat levels.
Det indeholder to aktive stoffer, fenofibrat og simvastatin, og anvendes sammen med fedtfattig diæt og motion til at sænke indholdet af triglycerider (en type fedtstoffer) og øge indholdet af det “gode” kolesterol (HDLkolesterol). 
It contains two active substances, fenofibrate and simvastatin, and is used together with a low fat diet and exercise with the aim of reducing patients' levels of triglycerides (a type of fat) and increasing their levels of ‘good' cholesterol (HDL cholesterol).
De hyppigste bivirkninger med Cholib er forhøjet indhold af kreatinin i blodet, øvre luftvejsinfektioner (forkølelse), øget antal blodplader, gastroenteritis (diarré og opkastning) og øget indhold af alaninaminotransferase (et leverenzym). 
The most common side effects with Cholib are raised blood creatinine levels, upper respiratory tract infection (colds), increased blood platelet counts, gastroenteritis (diarrhoea and vomiting) and increased levels of alanine aminotransferase (a liver enzyme).
Det vil sige, at det aktiverer receptoren “peroxisomproliferatoraktiveret receptor alpha” (PPARα), der medvirker ved nedbrydning af fedtstofferne i føden, navnlig triglycerider. 
This means that it activates a type of receptor called the ‘peroxisome proliferator-activated receptor alpha' (PPARα), which is involved in breaking down fats from diet, especially triglycerides.
De aktive stoffer i Cholib, fenofibrat og simvastatin, virker forskelligt og supplerer gensidigt hinandens virkning. 
The active substances in Cholib, fenofibrate and simvastatin, work in different ways and their actions have a complementary effect.
Hvis du ønsker yderligere oplysninger om behandling med Cholib, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Cholib, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Da leveren behøver kolesterol til at producere galde, vil det sænkede kolesterolindhold i blodet bevirke, at cellerne danner receptorer, der trækker kolesterol ud af blodet og derved nedsætter indholdet yderligere. 
As the liver needs cholesterol to produce bile, the reduced blood cholesterol level causes the liver cells to produce receptors that draw cholesterol from the blood, reducing its level even further.
Cholib er påvist at være mere effektivt end statiner alene til at nedsætte indholdet af triglycerider og øge indholdet af det gode kolesterol. 
Cholib has been shown to be more effective than statins alone in reducing levels of triglycerides and increasing levels of good cholesterol.
I produktresuméet og indlægssedlen for Cholib er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter. 
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cholib, including the appropriate precautions to be followed by healthcare professionals and patients.
Det nedsætter det totale kolesterolindhold i blodet ved at blokere virkningen af HMG-CoA-reduktase, et enzym i leveren, der medvirker ved dannelsen af kolesterol. 
It reduces total blood cholesterol by blocking the action of HMG-CoA reductase, an enzyme in the liver involved in the production of cholesterol.
Cholib medførte større fald i triglycerider (33 % mod 7 %) og større indhold af det gode kolesterol (6 % stigning mod et fald på 1 %). 
It showed that Cholib led to a greater reduction in triglyceride levels (33% versus 7%) and to higher levels of good cholesterol (6% increase versus a 1% decrease).
Den fuldstændige liste over indberettede bivirkninger med Cholib fremgår af indlægssedlen. 
For the full list of all side effects reported with Cholib, see the package leaflet.
Desuden medførte Cholib en stigning i indholdet af det gode kolesterol på ca. 7 %, sammenholdt med ca. 2 % for simvastatin. 
In addition, levels of good cholesterol increased by around 7% with Cholib compared with around 2% with simvastatin.
Hvis du ønsker praktisk vejledning om anvendelsen af Cholib, kan du læse indlægssedlen eller kontakte din læge eller dit apotek. 
For practical information about using Cholib, patients should read the package leaflet or contact their doctor or pharmacist.
Hvordan anvendes Cholib? 
How is Cholib used?
Hvilke fordele viser undersøgelserne, at der er ved Cholib? 
What benefits of Cholib have been shown in studies?
I alle undersøgelserne medførte Cholib større reduktion af triglycerider og større stigning i det gode kolesterol end statin alene. 
In all studies the reductions in triglycerides and the increases in good cholesterol were higher with Cholib than with a statin alone.
I en hovedundersøgelse blev Cholib, 145/20 mg, sammenlignet med simvastatin, 40 mg, hos 1 050 patienter, der ikke var tilfredsstillende behandlet med 20 mg simvastatin alene. 
In a main study comparing Cholib 145/20 mg with simvastatin 40 mg in 1,050 patients not adequately treated with 20 mg simvastatin alone, triglyceride levels decreased by around 36% with Cholib after 12 weeks compared with 12% with simvastatin.
Hvordan virker Cholib? 
How does Cholib work?
Når disse receptorer aktiveres, øges fedtstofnedbrydningen. 
When these receptors are activated, the breakdown of fats speeds up, which helps clear the blood of ‘bad' cholesterol and triglycerides.
10 ampuller 
10 ampoules
Hætteglas (glas) 6 ml 
Intravenous use ampoule (glass) 10 ml
Ampul (glas) 
Intravenous use vial (glass)
* Relativ styrke påvist vha. ELISA antigentest (in vitro styrketest) ved sammenligning med referencevaccine. 
* Relative potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine.
(3,5 mg/ml) 
Cartridge (glass) 3 ml (3.5 mg/ml) 1 cartridge
hætteglas (multipakning) 
Content (concentration)
1 cylinderampul 
Immediate Packaging
5 (5 x1) 
MA (EU) number
10 ml 
Pack size
suspension 
Route of administration
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Topotecan Eagle den 22 december 2011. 
The European Commission granted a marketing authorisation valid throughout the European Union for Topotecan Eagle on 22 December 2011.