FrancophonIA/ELRC3.0 huggingface dataset:
English: Weekly dosing in metatstatic breast cancer The efficacy results from the monotherapy and combination therapy studies are summarised in Table
Icelandic: Vikuleg skömmtun fyrir brjóstakrabbamein með meinvörpum Niðurstöður á virkni úr rannsóknum einlyfjameðferðar og samsettrar meðferðar eru teknar saman í Töflu 3:
English: Patients were either naïve to Herceptin IV treatment (20.3%) or preexposed to Herceptin IV (79.7%).
Icelandic: (20,3%) eða höfðu áður fengið Herceptin í æð (79,7%).
English: Herceptin intravenous infusion should be administered by a healthcare provider prepared to manage anaphylaxis and an emergency kit should be available.
Icelandic: Heilbrigðisstarfsmaður sem er hæfur til að bregðast við bráðaofnæmi á að annast Herceptin innnrennsli í bláæð og búnaður til endurlífgunar verður að vera til staðar.
English: Cardiac dysfunction
Icelandic: 1Óreglulegur hjartsláttur
English: Summary of the safety profile
Icelandic: Svörunarhlutfall öryggismörk)
English: Table 7 Summary of Efficacy results from the joint analysis of the NSABP B-31 and NCCTG N9831
Icelandic: Lokagreining á heildarlifun úr sameiginlegri greiningu NSABP B-31 og NCCTG N9831 rannsóknanna
English: - No. patients with event - No. patients without event
Icelandic: - Fjöldi sjúklinga án tilviks
English: AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; AC→DH = doxorubicin plus cyclophosphamide, followed by docetaxel plus trastuzumab; CI = confidence interval
Icelandic: AC→D = doxórúbicín ásamt cýklófosfamíði, fylgt eftir af docetaxeli; AC→DH = doxórúbicín ásamt cýklófosfamíði, fylgt eftir af docetaxeli ásamt trastúzumabi; CI = öryggismörk Tafla 9:
English: +Pleural effusion
Icelandic: +Fleiðruvökvi
English: The efficacy results from the joint analysis of the NSABP B-31 and NCCTG 9831 trials at the time of the definitive analysis of DFS* are summarized in Table 6.
Icelandic: Niðurstöður varðandi virkni, úr sameiginlegri greiningu NSABP B-31 og NCCTG 9831 rannsóknanna á þeim tíma sem endanleg greining var gerð á lifun án sjúkdóms*, eru dregnar saman í töflu 6.
English: Keep the vial in the outer carton to protect from light.
Icelandic: Geymið hettuglasið í ytri umbúðum til varnar gegn ljósi Má ekki frjósa
English: Patients experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of a fatal infusion reaction.
Icelandic: Sjúklingar sem finna fyrir hvíldarmæði vegna fylgikvilla langt gengins æxlisvaxtar og annarra sjúkdóma geta verið í meiri hættu á lífshættulegum viðbrögðum við lyfjagjöf.
English: Uncommon side effects of Herceptin: may affect up to 1 in 100 people
Icelandic: Sjaldgæfar aukaverkanir af Herceptin: geta komið fyrir hjá allt að 1 af hverjum 100 einstaklingum
English: Either of which was administered with: - cisplatin - 80 mg/m2 every 3 weeks for 6 cycles on day 1 of each cycle.
Icelandic: - 80 mg/m2 á 3 vikna fresti í 6 lotum á 1. degi hverrar lotu.
English: FP + H: Fluoropyrimidine/cisplatin + Herceptin FP: Fluoropyrimidine/cisplatin a Odds ratio
Icelandic: Flúorópýrímidín/cisplatín a Líkindahlutfall
English: The results of these simulations indicate that at least 95% of patients will reach concentrations that are <1 μg/mL (approximately 3% of the population predicted Cmin,ss, or about 97%
Icelandic: 95% sjúklinganna muni ná þéttni <1 μg/ml (u.þ.b.
English: Serious IRRs to Herceptin infusion including dyspnoea, hypotension, wheezing, hypertension, bronchospasm, supraventricular tachyarrhythmia, reduced oxygen saturation, anaphylaxis, respiratory distress, urticaria and angioedema have been reported (see section 4.8).
Icelandic: Alvarlegar innrennslistengdar aukaverkanir af Herceptin innrennsli sem greint hefur verið frá eru m.a. mæði, lágþrýstingur, sog- eða blísturshljóð við öndun, háþrýstingur, berkjukrampi, ofanslegils hraðsláttarglöp, minnkuð súrefnismettun, bráðaofnæmi, andnauð, ofsakláði og ofsabjúgur (sjá kafla 4.8).
English: In the clinical study comparing these two formulations, infections and cardiac events leading to hospitalisation were more frequent with the subcutaneous formulation.
Icelandic: Í samanburði milli lyfjaformanna í klínískum rannsóknum voru sýkingar og hjartatilfelli sem leiddu til sjúkrahúsinnlagnar algengari hjá sjúklingum sem fengu lyfið undir húð.
English: Description of selected adverse reactions with the subcutaneous formulation
Icelandic: Lýsing valinna aukaverkana við gjöf lyfsins undir húð Viðbrögð sem tengjast lyfjagjöf
English: In an exploratory subgroup analysis performed in the TOGA (BO18255) trial there was no apparent benefit on overall survival with the addition of Herceptin in patients with ECOG PS 2 at baseline [HR 0.96 (95 % CI 0.51-1.79)], non measurable [HR 1.78 (95 % CI 0.87-3.66)] and locally advanced disease [HR 1.20 (95 % CI 0.29-4.97)].
Icelandic: [HR 0,96 (95% CI 0,51-1,79)], ekki mælanlegur [HR 1,78 (95% CI 0.87-3,66)] og langt genginn staðbundið [HR 1,20 (95% CI 0,29-4,97)].
English: The systemic reactions included hypersensitivity, hypotension, tachycardia, cough, and dyspnoea.
Icelandic: Meðal almennra aukaverkana voru ofnæmi, lágþrýstingur, hraðsláttur, hósti og mæði.
English: No. patients with event (%)
Icelandic: Fjöldi sjúklinga með tilvik (%) 261 (15,5)
English: which was followed by - Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles,
Icelandic: Paclitaxel 175 mg/m gefið í 4 lotur með 3 vikna millibili,
English: Subsequent Herceptin maintenance doses (weekly regimen: 2 mg/kg; three-weekly regimen 6 mg/kg respectively) should be administered 7 days or 21 days later according to the weekly or three-weekly schedules respectively.
Icelandic: 2 mg/kg; þriggja vikna áætlun: 6 mg/kg) eins fljótt og auðið er.
English: Pharmacokinetic data from studies BO15935 and M77004 in women with HER2-positive MBC suggested that exposure to paclitaxel and doxorubicin (and their major metabolites 6-α hydroxyl paclitaxel, POH, and doxorubicinol, DOL) was not altered in the presence of trastuzumab (8 mg/kg or
Icelandic: Gögn um lyfjahvörf úr rannsóknunum BO15935 og M77004, sem gerðar voru á konum með HER2 jákvætt brjóstakrabbamein með meinvörpum, bentu til þess að útsetning fyrir paclitaxeli og doxorubicini (og helstu niðurbrotsefnum þeirra:
English: The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 2: Table 2: Recommended scoring system to evaluate the IHC staining patterns Score Staining pattern
Icelandic: Ráðlagt stigakerfi til þess að meta IHC litamynstur er eins og fram kemur í töflu 2:
English: - intravenous push doxorubicin, at 60 mg/ m2, given every 3 weeks for 4 cycles.
Icelandic: - doxorúbicín með inndælingu í bláæð, 60 mg/m2, 4 lotur á 3 vikna fresti.
English: • respiratory failure
Icelandic: • óeðlilegur hjartsláttartaktur
English: Severe adverse events (defined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE grade ≥3) version 3.0) were equally distributed between both Herceptin formulations (52.3 % versus 53.5 % in the intravenous formulation versus subcutaneous formulation respectively).
Icelandic: útgáfa 3.0) voru jafn algengar við notkun beggja lyfjaforma Herceptin (52,3% hjá þeim sem fengu lyfið í æð og 53,5 % hjá þeim sem fengu lyfið undir húð).
English: This dose should be administered subcutaneously over 2-5 minutes every three weeks.
Icelandic: Gefa á þennan skammt undir húð á 25 mínútum á þriggja vikna fresti.
English: In addition a post-hoc exploratory analysis was performed on the data sets from the joint analysis (JA) NSABP B-31/NCCTG N9831* and BCIRG006 clinical studies combining DFS events and symptomatic cardiac events and summarised in Table 10: Table 10: Post-hoc exploratory analysis results from the joint analysis NSABP B-31/NCCTG N9831*
Icelandic: Að auki var gerð könnunargreining á niðurstöðum úr tengdu klínísku rannsóknunum NSABP B31/NCCTG N9831* og BCIRG006 sem tekur saman tilfelli um lifun án sjúkdóms og hjartatilfelli með einkennum, niðurstöður er að finna í töflu 10:
English: The local reactions included erythema, pruritus, oedema, rash and pain at the site of the injection.
Icelandic: Meðal staðbundinna aukaverkana voru hörundsroði, kláði, bjúgur, útbrot og verkur á stungustað.
English: When Herceptin was administered after completion of adjuvant chemotherapy NYHA Class III-IV heart failure was observed in 0.6 % of patients in the one-year arm after a median follow-up of 12 months.
Icelandic: NYHA flokki III-IV hjá 0,6% sjúklinga í hópnum sem fékk meðferð í eitt ár, eftir eftirfylgni með
English: No incompatibilities between Herceptin subcutaneous formulation and polypropylene or polycarbonate syringe material or stainless steel transfer and injection needles and polyethylene Luer cone stoppers have been observed.
Icelandic: Ekki hefur orðið vart við neinn ósamrýmanleika milli Herceptin stungulyfs til notkunar undir húð og sprautuhluta úr pólýprópýleni eða pólýkarbónati, sprautunála úr ryðfríu stáli til að draga upp eða gefa lyfið, eða Luer loka úr pólýetýleni.
English: Herceptin subcutaneous fixed dose formulation is not for intravenous use and should be given as a subcutaneous injection only.
Icelandic: Lyfjaform Herceptin til gjafar í bláæð er ekki ætlað til notkunar undir húð og ætti einungis að gefa í bláæð.
English: The reconstituted Herceptin results in a colourless to pale yellow transparent solution and should be essentially free of visible particulates.
Icelandic: Þegar búið er að blanda verður Herceptin litlaus eða fölgul, gegnsæ lausn, og nauðsynlegt er að hún sé laus við sjáanlegar smáagnir.
English: Patients are eligible for Herceptin treatment if they show strong HER2 overexpression as described by a 3+ score by IHC or a positive FISH or CISH result.
Icelandic: Sjúklingar eru ákjósanlegir fyrir Herceptin meðferð ef þeir yfirtjá HER2 eins og lýst er við stig 3+ skv.
English: Instructions for aseptic reconstitution:
Icelandic: ● Viðbrögð sem tengjast lyfjagjöf:
English: A faint/barely perceptible membrane staining is detected in > 10 % of the tumour cells.
Icelandic: Dauf/naumlega merkjanleg himnuvirkni í ≥ 10 % æxlisfrumna.
English: (AC→TH) arm, and 217/1073 in the AC→D (AC→T) arm had a Karnofsky performance status ≤90 (either 80 or 90).
Icelandic: hópnum Karnofsky færnistig ≤90 (annaðhvort 80 eða 90).
English: +Anaphylactic shock
Icelandic: +Ofnæmislost
English: At 8 years, the disease-free survival rate was estimated to be 77.2% (95% CI: 75.4, 79.1) in the AC→PH arm, an absolute benefit of 11.8% compared with the AC→P arm.
Icelandic: 75,4, 79,1) í AC→PH hópnum, sem er heildarávinningur sem nemur 11,8% í samanburði við AC→P hópinn.
English: weeks for 6 cycles (day 2 of cycle 1, then day 1 of each subsequent cycle) which was followed by: - carboplatin - at target AUC = 6 mg/mL/min administered by intravenous infusion over 3060 minutes repeated every 3 weeks for a total of six cycles
Icelandic: - carbóplatín - markgildi AUC = 6 mg/ml/mín, gefið með innrennsli í bláæð á 3060 mínútum, endurtekið á 3 vikna fresti, alls sex lotur
English: 1 Heart beat irregular
Icelandic: • nýru fósturs þroskast ekki eðlilega
English: • bruising
Icelandic: • bakverkur
English: The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 3: Table 3 Recommended Scoring System to Evaluate the IHC Staining Patterns in Gastric Cancer Score Surgical specimen - staining pattern
Icelandic: Tafla 3 Ráðlagt stigakerfi til þess að meta IHC litamynstur í magakrabbameini Stig
English: Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.
Icelandic: Hormónameðferð þarf einnig að hafa mistekist hjá sjúklingum með hormónajákvæðan sjúkdóm, að því tilskildu að frábendingar séu ekki til staðar fyrir þeirri meðferð. - ásamt paclitaxeli til meðferðar hjá þeim sjúklingum sem ekki hafa fengið lyfjameðferð við brjóstakrabbameini með meinvörpum og antracýklín eru talin ónothæf.
English: White blood cell count decreased/leukopenia
Icelandic: Fækkun hvítra blóðkorna/hvítfrumnafæð Mjög algeng Blóðflagnafæð
English: NSABP B-31/NCCTG N9831* and BCIRG006 clinical studies combining DFS events and symptomatic cardiac events and summarised in Table 11:
Icelandic: Að auki var gerð könnunargreining á niðurstöðum úr tengdu klínísku rannsóknunum NSABP B31/NCCTG N9831* og BCIRG006 sem tekur saman tilfelli um lifun án sjúkdóms og hjartatilfelli með einkennum, niðurstöður er að finna í töflu 11:
English: 1Palpitation
Icelandic: 1Hjartaflökt
English: Bone pain
Icelandic: Alls fengu
English: During the treatment course with Herceptin subcutaneous formulation other medicinal products for subcutaneous administration should preferably be injected at different sites.
Icelandic: Meðan á meðferð með Herceptin skömmtum undir húð stendur á að leitast við að velja aðra stungustaði til að gefa önnur lyf til notkunar undir húð.
English: Oligohydramnios
Icelandic: IHC litamynstur
English: NAME OF THE MEDICINAL PRODUCT Herceptin 150 mg powder for concentrate for solution for infusion
Icelandic: HEITI LYFS Herceptin 150 mg stofn fyrir innrennslisþykkni, lausn.
English: The non-linear elimination parameter values were 8.81 mg/day for the maximum elimination rate (Vmax) and 8.92
Icelandic: Breytur fyrir ólínulegt brotthvarf voru 8,81 mg/dag fyrir hámarkshraða brotthvarfs (Vmax) og 8,92 µg/ml fyrir Michaelis-Menten fasta (Km) hjá sjúklingum með MBC, EBC og AGC.
English: Pre-medication may be used to reduce risk of occurrence of ARRs.
Icelandic: Nota má lyfjaforgjöf til að draga úr hættu á því að viðbrögð sem tengjast lyfjagjöfinni komi fram.
English: The rate of asymptomatic cardiac dysfunction was increased in the 2-year treatment arm (8.1 % versus 4.6 % in the 1-year treatment arm).
Icelandic: 2 ár (8,1%, borið saman við 4,6% hjá hópnum sem fékk meðferð í 1 ár).
English: +Respiratory failure
Icelandic: +Ofanslegils hraðsláttarglöp
English: • acne • leg cramps
Icelandic: • fótkrampar
English: Primary tumor type and Regimen
Icelandic: Upprunaleg æxlisgerð og skömmtunaráætlun
English: Hazard Ratio versus Observation *Co-primary endpoint of DFS of 1 year versus observation met the pre-defined statistical boundary **Final analysis (including crossover of 52 % of patients from the observation arm to Herceptin) *** There is a discrepancy in the overall sample size due to a small number of patients who were randomized after the cut-off date for the 12-month median follow-up analysis
Icelandic: Herceptin) *** Misræmi er í heildarfjölda vegna lítils fjölda sjúklinga sem var slembiraðað eftir lokadagsetningu fyrir greiningu á eftirfylgni að miðgildislengd 12 mánuðir
English: • inflammation or scarring of the lungs
Icelandic: bólga eða örvefsmyndun í lungum
English: Retinal haemorrhage
Icelandic: Stökkar neglur
English: (95 % CI) p-value p<0.0001
Icelandic: p-gildi p<0,0001
English: Herceptin IV is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Icelandic: Herceptin til gjafar í bláæð er í sæfðum einnota hettuglösum, án rotvarnarefna eða hitavaldandi efna.
English: Herceptin subcutaneous formulation is not intended for intravenous administration and should be administered via a subcutaneous injection only.
Icelandic: Herceptin til notkunar í æð er ekki ætlað til notkunar undir húð og á aðeins að gefa með innrennsli í æð.
English: • pain in the arms and/or legs
Icelandic: verkir í handleggjum og/eða fótleggjum • lungnasýking
English: Nasopharyngitis
Icelandic: Naglakvilli
English: The solution is clear to opalescent and colourless to yellowish.
Icelandic: Lausnin er tær eða ópallýsandi og litlaus eða fölgul.
English: • Hypertension: 4.7 % versus 9.8 % for the intravenous formulation versus subcutaneous formulation respectively.
Icelandic: 4,7 % hjá þeim sem fengu lyfið í æð og 9,8 % hjá þeim sem fengu lyfið undir húð.
English: Determine the volume of the solution required:
Icelandic: Leiðbeiningar um þynningu blandaðrar lausnar að viðhafðri smitgát Ákvarðið rúmmál þeirrar lausnar sem þarf:
English: Herceptin should be inspected visually to ensure there is no particulate matter or discolouration prior to administration.
Icelandic: Lausnir í æð á að skoða með berum augum áður en þær eru gefnar til að ganga úr skugga um að engar smáagnir eða upplitun séu til staðar.
English: Tabulated list of adverse reactions with the intravenous formulation
Icelandic: Tafla yfir aukaverkanir við gjöf lyfsins í æð
English: For early breast cancer, metastatic breast cancer and metastatic gastric cancer, Herceptin is given every 3 weeks.
Icelandic: Í lykilrannsóknum á langt gengnu krabbameini og Herceptini í æð var tíðni hjartavanstarfsemi á bilinu
English: The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 2: Table 2 Recommended Scoring System to Evaluate the IHC Staining Patterns in Breast Cancer Score Staining pattern
Icelandic: Tafla 2 Ráðlagt stigakerfi til þess að meta IHC litamynstur í brjóstakrabbameini
English: Patients with MBC or MGC should be treated with Herceptin until progression of disease.
Icelandic: Sjúklinga með brjóstakrabbamein með meinvörpum eða magakrabbamein með meinvörpum á að meðhöndla með Herceptin þar til sjúkdómurinn versnar.
English: The population predicted PK exposure parameter values (median with 5th - 95th Percentiles) for Herceptin SC dosing regimens in EBC patients are shown in Table 13 below.
Icelandic: Tafla 15 Spáð þýðisgildi fyrir útsetningu við jafnvægi (miðgildi með 5. - 95. hundraðshlutabili) hjá sjúklingum með MBC, EBC og AGC sem fá Herceptin í æð samkvæmt mismunandi skömmtunaráætlunum
English: Table 4: Efficacy results from the non-comparative monotherapy and combination therapy studies Parameter
Icelandic: Niðurstöður varðandi virkni úr rannsóknum á einlyfjameðferð og samsettri meðferð án samanburðar
English: For the sequence IV→SC (SC vial and SC formulation in administration system cohorts combined), adverse event rates (all grades) were described preswitching (Cycles 1-4) and post-switching (Cycles 5-8) as 53.8% vs. 56.4%, respectively; for the sequence SC→IV (SC vial and SC formulation in administration system cohorts combined), adverse event rates (all grades) were described pre- and post-switching as 65.4% vs. 48.7%, respectively.
Icelandic: Fyrir lotur undir húð→ í æð (stungulyf undir húð úr hettuglasi og stungulyf undir húð úr lyfjagjafarbúnaði samanlagt) var tíðni aukaverkana (af öllum stigum) 65,4% fyrir skiptin samanborið við 48,7% eftir skiptin.
English: trials at the time of the definitive DFS analysis*
Icelandic: Nákvæm 95% öryggismörk fyrir tíðni pCR*
English: 1Muscle tightness
Icelandic: 1Stífleiki í vöðvum (muscle tightness)
English: Glomerulonephritis membranous
Icelandic: Mikil, alger himnulitun greinist í
English: Breast inflammation/mastitis
Icelandic: Bólga í lungum (pneumonitits)
English: • The unopened vial should be stored in a refrigerator (2°C - 8°C).
Icelandic: Geyma á óopnað hettuglas í kæli (2°C - 8°C).
English: Trastuzumab
Icelandic: INNIHALDSLÝSING
English: Not known +Acute respiratory distress syndrome Not known +Bronchospasm
Icelandic: Könnunargreining með lifun án sjúkdóms og hjartatilfelli með einkennum
English: Clear to opalescent solution, colourless to yellowish.
Icelandic: Tær eða ópallýsandi lausn, litlaus eða gulleit.
English: +Dyspnoea
Icelandic: +Andnauð
English: Nervous system disorders 1Tremor
Icelandic: Sýking í efri hluta öndunarfæra
English: Pain
Icelandic: hópnum
English: INSTRUCTIONS ON USE
Icelandic: Aðalgreining á verkun
English: Hepatic Failure
Icelandic: Geðræn vandamál
English: NAME OF THE MEDICINAL PRODUCT Herceptin 600 mg solution for injection in vial Trastuzumab
Icelandic: HEITI LYFS Herceptin 600 mg stungulyf, lausn í hettuglasi.
English: Biopsy specimenstaining pattern
Icelandic: Bandvefsmyndun í lungum
English: The most frequent severe reaction was drug hypersensitivity.
Icelandic: Algengasta alvarlega aukaverkunin var lyfjaofnæmi.
English: If the patient has missed a dose of Herceptin by one week or less, then the usual maintenance dose (weekly regimen: 2 mg/kg; three-weekly regimen: 6 mg/kg) should be administered as soon as possible.
Icelandic: Ef sjúklingurinn hefur misst af Herceptin skammti í eina viku eða skemur á að gefa venjulegan viðhaldsskammt (vikuáætlun:
English: Tumour cell cluster with a faint ⁄
Icelandic: INNRI UMBÚÐUM LÍTILLA EININGA
English: for Herceptin IV Dosing Regimens in MBC, EBC and AGC Patients
Icelandic: Tafla 16 Spáð þýðisgildi fyrir lyfjahvarfabreytur við jafnvægi hjá sjúklingum með MBC, EBC og AGC sem fá Herceptin í æð samkvæmt mismunandi skömmtunaráætlunum
English: • nausea.
Icelandic: • bólur
English: Invented name StrengthPharmaceutical form
Icelandic: Lyfjaform Íkomuleið Innri umbúðir
English: Belgium Teva Pharma Belgium NV Laarstraat 16
Icelandic: Teva Pharma Belgium NV Laarstraat 16
English: Austria ratiopharm ArzneimitteiVertriebs-GmbH Albert-Schweitzer-Gasse 3 1140 Wien
Icelandic: Austurríki ratiopharm ArzneimitteiVertriebs-GmbH Albert-Schweitzer-Gasse 3 1140 Wien
English: Plus Pharmacie SA 26 Boulevard Paul VaillantCouturier
Icelandic: SA 26 Boulevard Paul VaillantCouturier
English: Pharmazac SA 31 Naoussis street Athens 1447
Icelandic: SA 31 Naoussis street Athens 1447
English: 20052 Monza
Icelandic: 20052 Monza Italy
English: Trakt Lubelski 135
Icelandic: z o.o. Trakt Lubelski 135
English: Moll de Barcelona s/n. World Trade Center.
Icelandic: Moll de Barcelona s/n.
English: Peseri Trading Limited 20 Queen Frederica Street El-Greco House, office 301 1066 Nicosia Cyprus
Icelandic: Limited 20 Queen Frederica Street El-Greco House, office 301 1066 Nicosia Cyprus
English: Capsule
Icelandic: Capsules
English: ul.Ziębicka 40
Icelandic: z o.o. ul.Ziębicka 40
English: Generics Pharma Hellas Ltd 577a Vouliagmenis Avenue Argyroupoli
Icelandic: Hellas Ltd 577a Vouliagmenis Avenue Argyroupoli
English: Ranbaxy Italia S.P.A. Piazza Filippo Meda, 4, 3 20121 - Milano Italy
Icelandic: Ranbaxy Italia S.P.A. Piazza Filippo Meda, 4, 3 20121
English: Czech Republic Abdi Farma, Unipessoal Lda.
Icelandic: Abdi Farma, Unipessoal Lda.
English: Sandoz Hungária Kft. H-1114 Budapest Bartók Béla út 43-47.
Icelandic: H-1114 Budapest Bartók Béla út 43-47.
English: Rua Henrique Paiva Couceiro, 29 - Venda Nova 2700-451 Amadora Portugal
Icelandic: Rua Henrique Paiva Couceiro, 29 - Venda Nova 2700-451
English: Daquimed - Comércio de Produtos Farmacêuticos, S.A. Av. Associação Comercial e Industrial de Gondomar, 330 - Zona Industrial da Portelinha
Icelandic: Av. Associação Comercial e Industrial de Gondomar, 330 - Zona Industrial da Portelinha
English: Slovak Republic Genericon s.r.o., Anny Letenské 1108/15, 120 00 Praha 2 - Vinohrady Czech Republic
Icelandic: Genericon s.r.o., Anny Letenské 1108/15, 120 00 Praha 2 - Vinohrady Czech Republic
English: Radlická 3185/1c
Icelandic: Radlická 3185/1c 150 00 Prague 5
English: 821 02 Bratislava
Icelandic: 821 02 Bratislava Slovak Republic
English: Levodopa + Carbidopa + Entacapona Generis
Icelandic: + Carbidopa + Entacapona Generis
English: SE-11123 Stockholm
Icelandic: SE-11123
English: Kiełczowska 2 55-095 Mirków Poland
Icelandic: z o.o. ul. Kiełczowska 2 55-095 Mirków Poland
English: Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal
Icelandic: José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139
English: Ulica grada Vukovara 226 F Zagreb 10000
Icelandic: Vukovara 226 F Zagreb 10000
English: Laboratórios AzevedosIndústria Farmacêutica, S.A. Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal
Icelandic: Laboratórios AzevedosIndústria Farmacêutica, S.A. Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504
English: Via dei Sabini, 28 63100 - Ascoli Piceno Italy
Icelandic: FB Health S.p.A. Via dei Sabini, 28 63100 - Ascoli Piceno Italy
English: DESLORATADINA DOC GENERICI
Icelandic: DOC GENERICI
English: Edificio Tejo, Rua Quinta do Pinheiro, 16 - 6º 2790-143 Carnaxide Portugal
Icelandic: Tejo, Rua Quinta do Pinheiro, 16 - 6º 2790-143 Carnaxide Portugal
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Icelandic: Viðauki I Listi yfir heiti, lyfjaform, styrkleika lyfsins/lyfjanna, íkomuleið(ir), markaðsleyfishafa í aðildarríkjunum