natgillin/translations-raw huggingface dataset:
Med dosering én gang dagligt er der klinisk signifikant reduktion i blodtrykket hele dagen og 24 timer efter administration af dosis..
11/ 24 With once daily dosing, clinically significant reductions in blood pressure are present throughout the day and at 24-hours post dose.
11/ 23 Der er ikke observeret tilvænning under længerevarende behandling med doxazosin- tabletter med umiddelbar frigivelse.
Habituation has not been observed during long-term treatment with doxazosin immediate release tablets.
Øgning i plasma- renin- aktivitet og takykardi er sjældent blevet set under længerevarende behandling.
Increase in plasma renin activity and tachycardia have rarely been seen during long-term treatment.
Doxazosin har en gavnlig virkning på blodlipider med significant øgning af HDL/ total cholesterol ratio (ca.
Doxazosin has a beneficial effect on blood lipids with significant increase of HDL/ total cholesterol ratio (app.
4- 13% af base line værdierne).
4-13% of base line values).
Behandling med doxazosin- tabletter med umiddelbar frigivelse har vist sig at resultere i regression af venstre ventrikulær hypertrofi.
Treatment with doxazosin immediate release tablets has been shown to result in regression of left ventricular hypertrophy.
Analyse af to dosis- effekt- undersøgelser (omfattende i alt 630 patienter behandlet med doxazosin) har vist, at patienter behandlet med tabletter med umiddelbar frigivelse i doseringer på 1 mg, 2 mg eller 4 mg kontrolleres lige så godt med doxazosin- depottabletter indeholdende 4 mg.
Analysis of two dose-effect studies (including a total of 630 patients treated with doxazosin) have shown that patients treated with immediate release tablets in dosages of 1 mg, 2 mg or 4 mg are equally controlled on doxazosin prolonged-release tablets containing 4 mg.
Interimanalyse af undersøgelsen “ Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial ” (ALLHAT) viser, at patienter i behandling med doxazosin, og som har hypertension og mindst én yderligere klinisk risikofaktor for koronar hjertelidelse, har dobbelt risiko for kronisk hjertesvigt sammenlignet med patienter behandlet med chlortalidon.
Interim analysis of the study “ Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial” (ALLHAT) shows that patients with hypertension and at least one other clinical risk factor for coronary heart disease treated with doxazosin are exposed to a doubled risk for chronic heart failure compared to patients treated with chlortalidone.
Doxazosin- armen af ALLHAT blev afbrudt som et resultat af disse fund.
The doxazosin arm of ALLHAT was discontinued as a result of these findings.
Disse grunde omfatter: virkningen på systolisk blodtryk samt seponering af diuretika i den doxazosin- behandlede gruppe forud for starten af behandlingen.
The results are difficult to interpret due to various reasons such as differences in effect on systolic blood pressure and discontinuation of diuretics in the doxazosin-treated group prior to commencement of the treatment.
Disse alfa- 1- adrenoreceptorer medicinerer glat muskeltonus i prostatadelen af urethra.
High levels of alpha-1-adrenoreceptors have been observed in the prostatic muscular stroma, the proximal part of the urethra and base of the urinary bladder, which medicates smooth muscle tonus in the prostatic part of the urethra.
Blokering af alfa- 1- adrenoreceptorer via doxazosin reducerer tonus af den glatte muskulatur i prostatadelen af urethra, hvilket letter urinflowet.
Blocking alpha-1-adrenoreceptors through doxazosin reduces the tonus of the smooth muscle in the prostatic part of the urethra which facilitates the urinary flow.
Effekt - og sikkerhedsundersøgelser (med en total på 1. 317 patienter behandlet med doxazosin) er kun blevet udført hos patienter med en baseline på ≥ 12 på International Prostate Symptom Score og et maksimalt urinflow på < 15 ml/ sek.
Effect and safety studies (with a total of 1,317 patients treated with doxazosin) have only been performed in patients with a baseline of ≥ 12 on the International Prostate Symptom Score and a maximum urinary flow of < 15 ml/ sec.
Data fra disse undersøgelser indikerer, at patienter, der er godt kontrollerede på doxazosin- tabletter med umiddelbar frigivelse i doseringer på 1 mg, 2 mg eller 4 mg, er lige så godt kontrollerede på doxazosin 4 mg depottabletter.
Data from these studies indicate that patients well controlled on immediate release tablets of doxazosin in doses of 1 mg, 2 mg or 4 mg are equally controlled on doxazosin 4 mg prolonged-release tablets.
Efter oral administration af terapeutiske doser bliver doxazosin- depottabletter godt absorberet med peak- blodniveauer, der gradvist bliver nået ved 6 til 8 timer efter dosering.
After oral administration of therapeutic doses, doxazosin prolonged-release tablets are well absorbed with peak blood levels gradually reached at 6 to 8 hours after dosing.
Peak- plasmaniveauer ligger på omkring en tredjedel af det niveau, der er opnået efter administration af doxazosin- tabletter med umiddelbar frigivelse.
Peak plasma levels are approximately one third of the level obtained after administration of immediate release doxazosin tablets.
Peak/ bølgedalsratio for doxazosin- depottabletter er mindre end halvdelen af den for doxazosin - tabletter med umiddelbar frigivelse.
12/ 24 Peak/ trough ratio of doxazosin prolonged-release tablets is less than half that of immediate release doxazosin tablets.
12/ 23 Ved steady- state var den relative biotilgængelighed for doxazosin fra depottabletter - sammenlignet med den umiddelbare frigivelsesform - 54% ved 4 mg dosis og 59% ved 8 mg dosis.
At steady-state, the relative bioavailability of doxazosin from prolonged-release tablets compared to that of immediate release form was 54% at the 4 mg dose and 59% at the 8 mg dose.
Cirka 98% af doxazosin er proteinbundet i plasma.
Approximately 98% of doxazosin is protein-bound in plasma.
Fordelingsvolumen:
Volume of distribution:
1 liter/ kg.
1 litre/ kg.
Doxazosin bliver primært metaboliseret ved O- demethylering og hydroxylering.
Doxazosin is primarily metabolised by O-demethylation and hydroxylation.
Doxazosin bliver omfattende metaboliseret med < 5% udskilt som uændret produkt.
Doxazosin is extensively metabolised with < 5% excreted as unchanged product.
Clearance af doxazosin er 1, 3 ml/ min/ kg.
Clearance of doxazosin is 1.3 ml/ min/ kg.
Dette giver derfor basis for doseringen én gang dagligt.
The plasma elimination is biphasic with the terminal elimination half-life being 22 hours and hence this provides the basic for once daily dosing.
Farmakokinetiske undersøgelser med doxazosin- depottabletter hos ældre har vist, at der ikke er signifikante ændringer sammenlignet med yngre patienter.
Pharmacokinetic studies with doxazosin prolonged-release tablets in the elderly have shown no significant alterations compared to younger patients.
Farmakokinetiske undersøgelser med doxazosin- tabletter med umiddelbar frigivelse hos patienter med nedsat nyrefunktion viste ingen signifikante ændringer sammenlignet med dem for patienter med normal nyrefunktion.
Pharmacokinetic studies with doxazosin immediate release tablets in patients with renal impairment did not show any significant alterations compared to that of patients with normal renal function.
Der er kun begrænsede data vedrørende patienter med nedsat leverfunktion og om virkningerne af lægemidler, der vides at have indflydelse på levermetabolismen (f. eks. cimetidin).
There are only limited data concerning patients with liver impairment and on the effects of medicinal products known to influence hepatic metabolism (e. g. cimetidine).
De ikke- kliniske data viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af sikkerhedsfarmakologi, gentagen toksicitet, toksicitet af reproduktion, genotoksicitet og carcinogent potentiale.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated toxicity, toxicity to reproduction, genotoxicity and carcinogenic potential.
Polyethylenoxid Mikrokrystallinsk cellulose Povidon All- rac- α- Tocopherol Kolloidalt vandfrit silica Natriumstearylfumarat Butylhydroxytoluen (E321)
Polyethylene oxide Microcrystalline cellulose Povidone All-rac-α -Tocopherol Colloidal anhydrous silica Sodium stearyl fumarate Butylhydroxytoluene (E321)
Tabletovertræk:
13/ 24 Tablet coat:
Methacrylsyre - ethylakrylat copolymer (1: 1) 13/ 23 Kolloidalt vandfrit silica Makrogol Titaniumdioxid (E171)
Methacrylic acid - ethyl acrylate copolymer (1:1) Colloidal anhydrous silica Macrogol Titanium dioxide (E171)
Blister (PVC/ PVDC/ aluminium)
Blister (PVC/ PVDC/ aluminium)
Æsker med 10, 20, 28, 30, 50, 56, 60, 90, 98, 100, 140 (10x14) depottabletter Kalenderpakninger med 28 og 98 depottabletter Enhedsdoseringspakning med 50 x 1 depottabletter
Cartons with 10, 20, 28, 30, 50, 56, 60, 90, 98, 100, 140 (10x14) prolonged-release tablets Calendar packs of 28 and 98 prolonged-release tablets Unit dose pack of 50 x 1 prolonged-release tablets
8 MARKEDSFØRINGSTILLADELSESNUMMER
8 MARKETING AUTHORISATION NUMBER
10 DATO FOR ÆNDRING AF TEKSTEN
14/ 24 10 DATE OF REVISION OF THE TEXT
14/ 23 ETIKETTERING
15/ 24 LABELLING
15/ 23 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
16/ 24 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Oral anvendelse Tages efter lægens anvisninger.
Oral use.
Læs indlægssedlen inden brug.
Take as directed by your doctor.
16/ 23 Udløbsdat
17/ 24 10.
[Udfyldes nationaltionalt]
[To be completed nationally]
17/ 23 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
18/ 24 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
18/ 23 INDLÆGSSEDDEL
19/ 24 PACKAGE LEAFLET
19/ 23 INDLÆGSSEDDEL
20/ 24 PACKAGE LEAFLET:
Doxastad 4 mg depottabletter og dermed forbundne navne [se Bilag I] (Doxazosin)
Doxastad 4 mg prolonged release tablets and associated names [See Annex I] (Doxazosin)
kunne skade dem, selv om deres symptomer er de samme som Deres.
even if their symptoms are the same as yours.
2.
What Doxastad 4 mg prolonged release tablets and associated names is and what it is used for 2.
Hvordan De opbevarer Doxastad 4 mg depottabletter og dermed forbundne navne 6.
How to store Doxastad 4 mg prolonged release tablets and associated names 6.
Hvis blodtrykket ikke bliver kontrolleret, kan det øge risikoen for hjertesygdomme eller hjerneblødning Det aktive stof i Deres tabletter, doxazosin, hører til den gruppe lægemidler, der kaldes alfa- 1 antagonister.
The active ingredient in your tablets, doxazosin, belongs to a group of medicines known as alpha-1 antagonists.
De bør ikke tage Doxastad 4 mg depottabletter og dermed forbundne navne • hvis De nogensinde har lidt af en allergisk reaktion (f. eks. kløen, rødmen af huden eller åndedrætsbesvær) over for det aktive stof, doxazosin, eller nogle af de andre indholdsstoffer angivet ovenfor • hvis De ved, at De er overfølsom over for quinazoliner (f. eks. prazosin, terazosin), der er den kemiske familie af lægemidler, hvortil doxazosin hører • hvis De har eller har haft tilstoppelse eller forsnævring af fordøjelseskanalen
Do not take Doxastad 4 mg prolonged release tablets and associated names • if you have ever suffered an allergic reaction (e. g. itching, reddening of the skin or difficulty breathing) to the active ingredient, doxazosin, or any of the other ingredients listed above • if you know that you are sensitive to quinazolines (e. g. prazosin, terazosin) which is the chemical family of medicines to which doxazosin belongs • if you have or have had any form of obstruction of the digestive tract • if you have benign prostatic hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary infectiond or bladder stones • if you have overflow bladder, anuria or progressive renal insufficiency 21/ 24 Take special care with Doxastad 4 mg prolonged release tablets and associated names • if you suffer from liver disease • if you have suffered acute heart disease such as heart failure • if you are undergoing dialysis • if you are under 18 years of age
Inden operation og bedøvelse (selv hos tandlægen), bør de fortælle Deres læge eller tandlæge, at De tager Doxastad 4 mg depottabletter og dermed forbundne navne.
Before surgery and anaesthesia (even at the dentist), you should tell the doctor or dentist that you are taking Doxastad 4 mg prolonged release tablets and associated names.
Indtagelse af anden medicin Fortæl det til Deres læge, hvis De allerede tager noget af følgende: • Non- steroide anti- inflammatoriske lægemidler (NSAID’ er) • Andre lægemidler, der anvendes til behandling af for højt blodtryk • Østrogener • Dopamin, efedrin, adrenalin, metaraminol, metoxamin, fenylefrin (lægemidler, der anvendes til behandling af hjerteproblemer) • Lægemidler indiceret til behandling af erektil dysfunktion (PDE- 5 hæmmer, f. eks. sildenafil, tadalafil, vardenafil)
Taking Doxastad 4 mg prolonged release tablets and associated names with other medicines Tell your doctor if you are already taking any of the following: • Non-steroidal anti-inflammatory drugs (NSAIDs) • Other medicines used in the treatment of high blood pressure • Oestrogens • Dopamine, ephedrine, adrenaline, metaraminol, metoxamine, phenylephrine (medicines used for the treatment of heart problems) • Drugs indicated for the treatment of erectile dysfunction (PDE-5 inhibitor, e. g. sildenafil, tadalafil, vardenafil)
Hvordan man tager Doxastad 4 mg depottabletter og dermed forbundne navne sammen med mad og drikkevarer Doxastad 4 mg depottabletter og dermed forbundne navne kan tages sammen med eller efter maden.
Taking Doxastad 4 mg prolonged release tablets and associated names with food and drink Doxastad 4 mg prolonged release tablets and associated names can be taken with or after food.
Graviditet og amning De må ikke tage Doxastad 4 mg depottabletter og dermed forbundne navne, hvis De er gravid eller ammer.
Pregnancy and breast-feeding Do not take Doxastad 4 mg prolonged release tablets and associated names if you are pregnant or breast-feeding.
Bilkørsel og betjening af maskiner Doxastad 4 mg depottabletter og dermed forbundne navne kan medføre døsighed.
Driving and using machines Doxastad 4 mg prolonged release tablets and associated names can cause drowsiness.
Tabletterne kan tages når som helst på dagen før, under 21/ 23 eller efter måltider.
The tablets can be taken at any time of the day before, during or after meals.
Hvis De tager flere Doxastad 4 mg depottabletter og dermed forbundne navne, end De bør Hvis De tager for mange tabletter, vil de mest sandsynlige symptomer på overdosering være en følelse af ørhed eller svimmelhed grundet et fald i blodtrykket.
22/ 24 If you take more Doxastad 4 mg prolonged release tablets and associated names than you should If you take too many tablets, the most likely symptoms of overdose would be a feeling of light- headedness or dizziness due to a fall in blood pressure.
Hvis De glemmer at tage Doxastad 4 mg depottabletter og dermed forbundne navne Hvis De glemmer at tage en dosis, er der ingen grund til bekymring, Tag bare den næste dags tablet, når det er tid til den.
Simply take the next day’ s tablet when it is due.
Som alle andre lægemidler kan Doxastad 4 mg depottabletter og dermed forbundne navne have bivirkninger, selvom ikke alle får bivirkninger.
4 POSSIBLE SIDE EFFECTS
Almindelige bivirkninger omfatter (forekommer hos mere end 1 patient ud af 100):
Like all medicines, Doxastad 4 mg prolonged release tablets and associated names can cause side effects, although not everybody gets them.
Usædvanlige bivirkninger omfatter (forekommer hos færre end 1 patient ud af 100):
Common side effects include (occurs in more than 1 patient of 100): dizziness, postural dizziness (dizziness as a result of getting up from a sitting or lying position), rhinitis (nasal stuffiness and/ or runny nose), diarrhoea, nausea, vomiting, gastritis (inflammation of the lining of the stomach), headache, fatigue, oedema (swelling), somnolence, asthenia (weakness), mouth dryness.
Thrombocytopeni (lavt antal blodplader, der kan resultere i let blødning), leukopeni (lavt antal hvide blodlegemer), podagra, nervøsitet, tremor (rysten), sløret syn, tinnitus (ringen eller støj i ørene), vertigo (en følelse af svimmelhed eller ‘ køren rundt ’), arytmi (en følelse af uregelmæssige hjerteslag), takykardi (øget hjertefrekvens), palpitationer, angina pectoris, myokardieinfarkt (hjerteanfald), cerebrovaskulær hændelse (hjerneblødning), dyspnøe (kortåndethed), hoste, bronchialspasmer, epistaxi (næseblod), anorexi (tab af appetit), obstipation (konstipation), øget appetit, ikterus (gulsot), stigning i leverenzymer, udslæt, pruritus (kløen), purpura (udslæt på grund af blødning under huden), myalgi (smertende muskler), arthralgi (smertende led), muskelkramper, øget diurese (øget mængde i vandladning), hæmaturi (blod i urinen), urin inkontinens, priapisme (smertefuld vedblivende erektion), impotens, brystsmerter, ophidselse, rødme i ansigtet.
Uncommon side effects include (occurs in less than 1 patient of 100): thrombocytopenia (low platelets, which may result in easy bleeding), leukopenia (low white blood cells), gout, nervousness, tremor (trembling), blurred vision, tinnitus (ringing or noise in the ears), vertigo (a feeling of dizziness or ‘ spinning’), arrythmia (a feeling of irregular heart beat), tachycardia (increased heart rate), palpitations, angina pectoris, myocardial infarction (heart attack), cerebrovascular accident (stroke), dyspnoea (shortage of breath), cough, bronchial spasms, epistaxis (nosebleed), anorexia (loss of appetite), obstipation (constipation), increased appetite, icterus (jaundice), liver enzyme increases, rash, pruritus (itching), purpura (rash caused by bleeding under the skin), myalgia (painful muscles), arthralgia (painful joints), muscle cramps, increased diuresis (increased volume of urine passed), haematuria (blood in the urine), urinary incontinence, priapism (painful persistent erection), impotence, chest pain, agitation, facial flushing.
Hvis en bivirkning bliver alvorlig, eller De bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør De fortælle det til Deres læge.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
HVORDAN DE OPBEVARER DOXASTAD 4 MG DEPOTTABLETTER OG DERMED FORBUNDNE NAVNE:
5 HOW TO STORE DOXASTAD 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES:
22/ 23 Anvend ikke Doxastad 4 mg depottabletter og de dermed forbundne navne efter udløbsdatoen, der er angivet på æsken.
Do not use Doxastad 4 mg prolonged release tablets and associated names after the expiry date which is stated on the carton.
Efter De har fået besked på at holde op med at tage Deres tabletter, skal De tilbagelevere alle ikke anvendte tabletter til apoteket for sikker bortskaffelse.
23/ 24 After you have been told to stop taking your tablets, return any unused tablets to your pharmacist for safe disposal.
Hvad Doxastad 4 mg depottabletter og dermed forbundne navne indeholder
What Doxastad 4 mg prolonged release tablets and associated names contains
- Det aktive stof er doxazosin (som mesilat).
- The active substance is doxazosin (as mesilate).
- De øvrige indholdsstoffer er polyethylenoxid, mikrokrystallinsk cellulose, povidon,
- The other ingredients are polyethylene oxide, microcrystalline cellulose, povidone,
butylhydroxytoluen (E321), all- rac- α- Tocopherol, kolloidalt vandfrit silica, natriumstearyl fumarat, methacrylsyre, ethylakrylat copolymer (1: 1) dispersion 30%, makrogol ogtitaniumdioxid (E171).
butylhydroxytoluene (E321), all-rac-α -Tocopherol, colloidal anhydrous silica, sodium stearyl fumarate, methacrylic acid ethyl acrylate copolymer (1:1) dispersion 30%, macrogol, and titanium dioxide (E171).
Hvordan Doxastad 4 mg depottabletter og dermed forbundne navne ser ud og pakningsstørrelsen Tabletterne er hvide, runde, bikonvekse tabletter med “ DL ” trykt på den ene side.
What Doxastad 4 mg prolonged release tablets and associated names looks like and contents of the pack The tablets are white, round, biconvex tablets with “ DL” embossed on one side.
Deres medicin findes i PVC/ PVDC/ aluminium blisterpakninger, der indeholder 28 tabletter [10, 20, 30, 50, 56, 60, 90, 98, 100, 140 (10x14) tabletter].
Your medicine is available in PVC/ PVDC/ aluminium blister packs containing 28 tablets [10, 20, 30, 50, 56, 60, 90, 98, 100, 140 (10x14) tablets].
[Udfyldes ved afslutningen af proceduren]
[To be completed on finalisation of the procedure]
London, 11/ 10/ 2006 EMEA/ CHMP/ 423384/ 2006
London, 11/ 10/ 2006 EMEA/ CHMP/ 423384/ 2006
21, OM Doxastad 4 mg depottabletter og tilknyttede navne Internationalt fællesnavn (INN):
OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Doxastad 4 mg prolonged release tablets and associated names International Non-Proprietary Name (INN):
Doxastad 4 mg depottabletter og tilknyttede navne (doxazosin) er et alfa- 1- receptor- blokerende stof, som anvendes til behandling af patienter med essentiel hypertension og til symptomatisk behandling af benign prostatahyperplasi.
Doxastad 4 mg prolonged release tablets and associated names (Doxazosin) is 1 is a receptor alfa blocking agent used in the treatment of patients with essential hypertension and in the symptomatic treatment of patients with benign prostatic hyperplasia.
Sverige fremsendte begrundelserne for uenighederne til EMEA den 3. marts 2006.
The Sweden referred the reasons for disagreement to the EMEA on 3 March 2006.
Formålet med indbringelsen var at opnå enighed om, hvor vidt frigivelsesprofilen for Doxastad 4 mg depottabletter afviger væsentligt fra det oprindelige lægemiddel og eventuelt medfører øget forekomst af bivirkninger såsom svimmelhed og hypotension, hvorvidt der er væsentlige forskelle i resultaterne af testbatcher i enkeltdosisfasen af undersøgelserne 5208 og 1995 og hvor vidt ansøgeren ved udformningen af bioækvivalensundersøgelserne afviger fra CHMP’ s retningslinjer, navnlig når det gælder virkningen af fødevarer.
The scope of the referral was to agree whether Doxastad 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food.
I lyset af de samlede data, der var blevet fremlagt, og den faglige debat i udvalget var CHMP på sit møde i juni 2006 af den opfattelse, at benefit- risk forholdet er gunstigt for Doxastad 4 mg depottabletter og tilknyttede navne, at de rejste indvendinger ikke bør forhindre udstedelse af en markedsføringstilladelse, og at referencemedlemsstatens produktresumé, etikettering og indlægsseddel bør ændres.
During the June 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Doxastad 4 mg prolonged release tablets and associated names, that the objections raised should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
1/ 24 Indehaver af Medlemsstat
Marketing Authorisation
markedsføringstilladelse
Pharmaceutical
Navn
Holder
00 44 207 612 7612 Fax 00 44 207 612 7620
Arrow Generics UK Ltd Unit 2 Eastman Way Stevenage Hertfordshire, SG1 4SZ United Kingdom Tel 00 44 207 612 7612 Fax 00 44 207 612 7620
Doxazosin "Arrow", 4mg depottabletter
Doxazosin "Arrow", 4mg depottabletter
00 351 21 896 51 05 Fax 00 351 21896 51 06
João II - Lisboa, Portugal Tel 00 351 21 896 51 05 Fax 00 351 21896 51 06
Doxazosin Arrow 4mg 4 mg comprimido de libertaçǎo prolongada
Doxazosin Arrow 4mg 4 mg comprimido de libertaçǎ o prolongada
Doksazosin Arrow 4mg 4 mg tablete s podaljšanim sproščanjem
Doksazosin Arrow 4mg 4 mg tablete s podaljš anim sprošč anjem
Cardozin XL 4mg
Cardozin XL 4mg
2/ 24 BILAG II
2/ 24 ANNEX II
3/ 24 FAGLIGE KONKLUSIONER
3/ 24 SCIENTIFIC CONCLUSIONS