natgillin/translations-raw huggingface dataset:
The company presented data from three main studies involving over 3,000 patients.
Tvrtka je dostavila podatke iz triju glavnih ispitivanja koja su obuhvatila više od 3 000 bolesnika.
10 November 2017 EMA/727596/2017 EMEA/H/C/004165
EMA/727596/2017 EMEA/H/C/004165
What is Plivensia?
Što je Plivensia?
It was to be available as a solution for injection in pre-filled pens and syringes (50 mg).
Trebao je biti dostupan kao otopina za injekciju u napunjenim brizgalicama i štrcaljkama (50 mg).
The main measure of effectiveness was a reduction in symptoms of 20% or more, based on a standard rating score (ACR-20), after 16 weeks of treatment.
Glavna mjera djelotvornosti bilo je smanjenje simptoma za 20 % ili više nakon 16 tjedana liječenja na temelju standardne ljestvice (ACR 20).
On 26 October 2017, Janssen-Cilag International NV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Plivensia, for the treatment of rheumatoid arthritis.
Dana 26. listopada 2017. tvrtka Janssen-Cilag International NV službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Plivensia za liječenje reumatoidnog artritisa.
Withdrawal of the marketing authorisation application for Plivensia (sirukumab)
Povlačenje zahtjeva za izdavanje odobrenja za stavljanje u promet lijeka Plivensia (sirukumab)
The CHMP's main concern was that the long-term safety of Plivensia had not been well characterised due to limitations in the design of the main studies.
Glavna zabrinutost CHMP-a bila je da dugoročna sigurnost lijeka Plivensia nije dovoljno dobro utvrđena zbog ograničenja u izvedbi glavnih ispitivanja.
By blocking interleukin-6, sirukumab reduces inflammation and other symptoms associated with rheumatoid arthritis.
Blokiranjem interleukina-6 sirukumab smanjuje upalu i druge simptome povezane s reumatoidnim artritisom.
The company informed the CHMP that it will discontinue the ongoing long-term extension study with Plivensia in patients with rheumatoid arthritis.
Tvrtka je obavijestila CHMP da će prekinuti dugoročni produžetak ispitivanja lijeka Plivensia u tijeku na bolesnicima s reumatoidnim artritisom.
In its letter notifying the Agency of the withdrawal of the application, the company stated that, given the need for additional clinical data and the fact that other treatments blocking the action of interleukin-6 are available, it wishes to prioritise other programs in its portfolio.
U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva, tvrtka je navela da želi dati prednost drugim programima iz svog portfelja s obzirom na potrebu za dodatnim kliničkim podatcima i činjenicu da su dostupni drugi oblici liječenja za blokiranje djelovanja interleukina-6.
How does Plivensia work?
Kako djeluje Plivensia?
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Plivensia could not have been approved for the treatment of moderate to severe rheumatoid arthritis.
Na temelju pregleda podataka i odgovora tvrtke na popise pitanja CHMP-a, u trenutku povlačenja CHMP je smatrao da postoje razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Plivensia za liječenje umjerenog do teškog oblika reumatoidnog artritisa.
The third study compared Plivensia with adalimumab (a monoclonal antibody targeting a chemical messenger called tumour necrosis factor - TNF) in patients who could not take methotrexate or whose condition had not responded adequately to methotrexate; the study looked at the improvement in how patients' joints worked (based on a standard rating score called DAS28-ESR) after 24 weeks of treatment.
U trećem ispitivanju lijek Plivensia uspoređen je s adalimumabom (monoklonsko protutijelo koje djeluje na kemijskog glasnika naziva faktor tumorske nekroze - TNF) u bolesnika koji nisu mogli uzimati metotreksat ili čija bolest nije primjereno reagirala na metotreksat; u ispitivanju se istraživalo poboljšanje u radu zglobova bolesnika nakon 24 tjedna liječenja (na temelju standardne ljestvice pod nazivom DAS28-ESR).
The active substance in Plivensia, sirukumab, is a monoclonal antibody, a type of protein which has been designed to block a molecule called interleukin-6.
Djelatna tvar lijeka Plivensia, sirukumab, monoklonsko je protutijelo, vrsta proteina koja inhibira djelovanje molekule naziva interleukin-6.
Withdrawal of the marketing authorisation application for Plivensia (sirukumab) EMA/727596/2017
(sirukumab) EMA/727596/2017
Plivensia is a medicine that contains the active substance sirukumab.
Plivensia je lijek koji sadržava djelatnu tvar sirukumab.
The medicine was to be used in patients when treatment with one or more medicines known as disease-modifying anti-rheumatic drugs (DMARDs) had not worked well enough or had led to troublesome side effects.
Lijek se trebao primjenjivati u bolesnika u kojih liječenje jednim ili više lijekova poznatih kao antireumatski lijekovi koji mijenjaju tijek bolesti (DMARD-ovi) nije dovoljno dobro djelovalo ili je dovelo do teško podnošljivih nuspojava.
Plivensia was expected to be used in adults with moderate to severe rheumatoid arthritis, a disease that causes inflammation of the joints.
Lijek Plivensia trebao se koristiti za liječenje odraslih osoba s umjerenim do teškim reumatoidnim artritisom, bolesti koja uzrokuje upalu zglobova.
What was Plivensia expected to be used for?
Za što se lijek Plivensia trebao koristiti?
Therefore, at the time of the withdrawal, the CHMP was of the opinion that, because of lack of proven long-term safety, the benefits of Plivensia did not outweigh its risks, and that further studies were needed.
Sukladno navedenome, CHMP je u vrijeme povlačenja smatrao kako koristi od lijeka Plivensia ne nadmašuju s njim povezane rizike zbog izostanka potvrde dugoročne sigurnosti te da su potrebna daljnja ispitivanja.
Plivensia was to be used with methotrexate (a DMARD) or alone if the patient could not take methotrexate.
Lijek Plivensia trebao se primjenjivati s metotreksatom (DMARD) ili kao monoterapija kod bolesnika koji nisu mogli uzimati metotreksat.
Two studies compared Plivensia with placebo (a dummy treatment) in patients with moderate to severe rheumatoid arthritis for whom treatment with a DMARD or with an anti-TNF agent (another type of medicine for rheumatoid arthritis) had not worked well enough or had led to troublesome side effects.
Lijek Plivensia uspoređen je s placebom (prividno liječenje) u dvama ispitivanjima na bolesnicima s umjerenim do teškim reumatoidnim artritisom u kojih liječenje DMARD-om ili TNF blokatorom (druga vrsta lijeka za liječenje reumatoidnog artritisa) nije dovoljno dobro djelovalo ili je dovelo do teško podnošljivih nuspojava.
Interleukin-6 is involved in causing inflammation and is found at high levels in the joints of patients with rheumatoid arthritis.
Interleukin-6 jedan je od uzroka upala i utvrđeno je da je u zglobovima bolesnika koji boluju od reumatoidnog artritisa prisutan u velikim količinama.
Date of first authorisation: 16 July 2008 Date of latest renewal: 17 December 2012
Datum posljednje obnove odobrenja: 17. prosinca 2012.
You should take Clopidogrel Zentiva for as long as your doctor continues to prescribe it.
Clopidogrel Zentiva trebate uzimati sve dok Vam ga liječnik propisuje.
What Clopidogrel Zentiva is and what it is used for What you need to know before you take Clopidogrel Zentiva How to take Clopidogrel Zentiva Possible side effects
Što je Clopidogrel Zentiva i za što se koristi Što morate znati prije nego počnete uzimati Clopidogrel Zentiva Kako uzimati Clopidogrel Zentiva Moguće nuspojave
- If you suffer from severe liver disease.
• ako patite od teške bolesti jetre.
Some other medicines may influence the use of Clopidogrel Zentiva or vice versa.
Neki lijekovi mogu utjecati na djelovanje lijeka Clopidogrel Zentiva i obratno.
The other ingredients are (see section 2 ‘Clopidogrel Zentiva contains lactose' and ‘Clopidogrel Zentiva contains hydrogenated castor oil'):
Drugi sastojci su (vidjeti dio 2. „Clopidogrel Zentiva sadrži laktozu“ i „Clopidogrel Zentiva sadrži hidrogenirano ricinusovo ulje“):
What Clopidogrel Zentiva is and what it is used for
Što je Clopidogrel Zentiva i za što se koristi
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
For the 7, 14, 28 and 84 tablets pack sizes, you can check the day on which you last took a tablet of Clopidogrel Zentiva by referring to the calendar printed on the blister.
Za pakiranja od 7, 14, 28 i 84 tablete možete provjeriti dan kada ste zadnji put uzeli tabletu lijeka Clopidogrel Zentiva pomoću kalendara otisnutog na blisteru.
You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Clopidogrel Zentiva and acetylsalicylic acid for this condition.
Trebalo Vam je biti rečeno da su za ovo stanje 'oralni antikoagulansi' učinkovitiji od acetilsalicilatne kiseline ili kombinirane primjene lijeka Clopidogrel Zentiva i acetilsalicilatne kiseline.
• Hypersensitivity to the active substance or to any of the excipients listed in section 2 or section 6.1.
• Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 2 ili dijelu 6.1.
This is linked to the way your medicine works as it prevents the ability of blood clots to form.
To je povezano s načinom na koji lijek djeluje, jer sprječava mogućnost stvaranja krvnih ugrušaka.
If you take more Clopidogrel Zentiva than you should
Ako uzmete više lijeka Clopidogrel Zentiva nego što ste trebali
As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Zentiva.
Kao mjera opreza, treba prestati s dojenjem za vrijeme liječenja lijekom Clopidogrel Zentiva.
What you need to know before you take Clopidogrel Zentiva Do not take Clopidogrel Zentiva:
Što morate znati prije nego počnete uzimati Clopidogrel Zentiva Nemojte uzimati Clopidogrel Zentiva
If you forget to take a dose of Clopidogrel Zentiva, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Ako zaboravite uzeti jednu dozu lijeka Clopidogrel Zentiva, ali se toga sjetite u roku od 12 sati, odmah uzmite tabletu, a sljedeću tabletu uzmite u uobičajeno vrijeme.
While you are taking Clopidogrel Zentiva:
Dok uzimate Clopidogrel Zentiva:
Other medicines and Clopidogrel Zentiva
Drugi lijekovi i Clopidogrel Zentiva
Film-coated tablet (tablet).
Filmom obložena tableta.
If you become pregnant while taking Clopidogrel Zentiva, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Ako zatrudnite za vrijeme uzimanja lijeka Clopidogrel Zentiva, odmah se posavjetujte s liječnikom, jer nije preporučeno uzimati klopidogrel za vrijeme trudnoće.
The recommended dose, including for patients with a condition called ‘atrial fibrillation' (an irregular heartbeat), is one 75 mg tablet of Clopidogrel Zentiva per day to be taken orally with or without food, and at the same time each day.
Preporučena doza, uključujući za bolesnike sa stanjem zvanim "fibrilacija atrija" (nepravilni otkucaji srca), je jedna tableta lijeka Clopidogrel Zentiva od 75 mg dnevno koja se uzima kroz usta, s obrokom ili bez obroka, i u isto vrijeme svaki dan.
Clopidogrel Zentiva contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Clopidogrel Zentiva sadrži klopidogrel i pripada skupini lijekova koji se nazivaju antitrombocitni lijekovi.
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel Zentiva in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Ako ste imali jaku bol u prsištu (nestabilna angina ili srčani udar), liječnik Vam može propisati Clopidogrel Zentiva u kombinaciji s acetilsalicilatnom kiselinom, tvari prisutnom u mnogim lijekovima za ublažavanje boli i snižavanje temperature.
In a relative bioavailability study in adults, the constituted solution of clopidogrel showed a similar extent and slightly higher rate of absorption of the main circulating (inactive) metabolite compared to the authorised tablet.
U relativnoj studiji biodostupnosti lijeka u odraslih, konstituirana otopina klopidogrela pokazala je sličan raspon i neznatno veću brzinu apsorpcije glavnog cirkulirajućeg (inaktivnog) metabolita, u usporedbi s tabletom.
What Clopidogrel Zentiva looks like and contents of the pack
Kako Clopidogrel Zentiva izgleda i sadržaj pakiranja
NSAIDs: in a clinical study conducted in healthy volunteers, the concomitant administration of clopidogrel and naproxen increased occult gastrointestinal blood loss.
Nesteroidni protuupalni lijekovi (NSAIL): u jednoj kliničkoj studiji provedenoj na zdravim dobrovoljcima, istodobna primjena klopidogrela i naproksena povećala je gubitak krvi okultnim krvarenjem iz probavnog trakta.
Patients randomized in the ACTIVE program were those presenting with documented AF, i.e., either permanent AF or at least 2 episodes of intermittent AF in the past 6 months, and had at least one of the following risk factors: age ≥75 years or age 55 to 74 years and either diabetes mellitus requiring drug therapy, or documented previous MI or documented coronary artery disease; treated for systemic hypertension; prior stroke, transient ischaemic attack (TIA), or non-CNS systemic embolus; left ventricular dysfunction with left ventricular ejection fraction <45%; or documented peripheral vascular disease.
Bolesnici randomizirani u programu ACTIVE imali su dokumentiranu fibrilaciju atrija (AF), tj. ili permanentnu AF ili najmanje 2 epizode intermitentne AF u zadnjih 6 mjeseci te su imali najmanje jedan od sljedećih faktora rizika: dob ≥75 godina ili 55 do 74 godine te ili dijabetes koji zahtijeva terapiju lijekovima ili dokumentirani prethodni infarkt miokarda ili dokumentiranu bolest koronarnih arterija; ako su primali terapiju za sistemsku hipertenziju; prethodni moždani udar, prolazni ishemijski napadaj (TIA) ili ne-CNS sistemska embolija; disfunkcija lijevog ventrikula s ejekcijskom frakcijom lijevog ventrikula <45% ili dokumentirana periferna vaskularna bolest.
In a randomised, double-blind, parallel-group study (CLARINET), 906 paediatric patients (neonates and infants) with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt were randomised to receive clopidogrel 0.2 mg/kg (n=467) or placebo (n=439) along with concomitant background therapy up to the time of second stage surgery.
U randomiziranoj, dvostruko slijepoj studiji s paralelnim skupinama (CLARINET), 906 pedijatrijskih bolesnika (novorođenčad i dojenčad) s cijanotičnom kongenitalnom bolešću srca ublaženom sistemsko-plućnim arterijskim šantom, bilo je randomizirano da primaju klopidogrel u dozi od 0,2 mg/kg (n=467) ili placebo (n=439) zajedno s istodobnom popratnom terapijom sve do drugog operativnog zahvata.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
UVJETI ILI OGRANIČENJA VEZANA UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Zentiva (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment.
Ako ste imali jake bolove u prsištu (nestabilna angina ili srčani udar), liječnik Vam u početku liječenja može jednokratno dati 300 mg lijeka Clopidogrel Zentiva (1 tableta od 300 mg ili 4 tablete od po 75 mg).
Your doctor should have prescribed Clopidogrel Zentiva plus acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding.
Liječnik Vam treba propisati Clopidogrel Zentiva i acetilsalicilatnu kiselinu ako ne možete uzimati oralne antikoagulanse te nemate rizik od velikog krvarenja.
The guided de-escalation did not result in an increased combined risk of ischemic events (2.5% in the de escalation group vs 3.2% in the control group; p non-inferiority=0.0115), nor in the key secondaryendpoint of BARC bleeding ≥2 ((5%) in the de-escalation group versus 6% in the control group (p=0.23)).
Vođena de-eskalacija nije rezultirala povećanjem u kombiniranom riziku od ishemijskih događaja (2,5 % u skupini sa vođenom de-eskalacijom u odnosu na 3,2% u kontrolnoj skupini; p neinferiornosti=0,0115) niti u ključnoj sekundarnoj mjeri ishoda BARC stupnja krvarenja ≥ 2 ((5%) u skupini s vođenom de-eskalacijom nasuprot 6% u kontrolnoj skupini (p=0,23)).
Omeprazole 80 mg once daily administered either at the same time as clopidogrel or with 12 hours between the administrations of the two drugs decreased the exposure of the active metabolite by 45% (loading dose) and 40% (maintenance dose).
Omeprazol primijenjen u dozi od 80 mg dnevno, istodobno s klopidogrelom ili s razmakom od 12 sati od primjene dvaju lijekova, smanjio je koncentraciju aktivnog metabolita klopidogrela za 45% (udarna doza) i 40% (doza održavanja).
The ACTIVE-A study (N=7,554) was a multicenter, randomized, double-blind, placebo-controlled study which compared clopidogrel 75 mg/day + ASA (N=3,772) to placebo + ASA (N=3,782).
Studija ACTIVE-A (n=7554) bila je multicentrična, randomizirana, dvostruko slijepa, placebom kontrolirana studija u kojoj se uspoređivao učinak klopidogrela u dozi od 75 mg/dnevno uz ASK (n=3772) u odnosu na placebo (n=3782).
If you forget to take Clopidogrel Zentiva
Ako ste zaboravili uzeti Clopidogrel Zentiva
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER / 30, 50, 50x1, 90 or 100 tablets
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER / 30, 50, 50x1, 90 ili 100 tableta
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Zentiva.
Ako ste trudni ili sumnjate na trudnoću, obavijestite svog liječnika ili ljekarnika prije nego što uzmete Clopidogrel Zentiva.
Each film-coated tablet contains 12 mg of lactose and 13.2 mg of hydrogenated castor oil.
Jedna filmom obložena tableta sadrži 12 mg laktoze i 13,2 mg hidrogeniranog ricinusovog ulja.
In patients with acute ST-segment elevation MI, safety and efficacy of clopidogrel have been evaluated in 2 randomised, placebo-controlled, double-blind studies, CLARITY and COMMIT.
U bolesnika s akutnim infarktom miokarda sa ST elevacijom (STEMI), sigurnost primjene i djelotvornost klopidogrela procijenjena je u 2 randomizirane, dvostruko slijepe, placebom kontrolirane studije, CLARITY i COMMIT.
Consistent with the above results, in a meta-analysis including 6 studies of 335 clopidogrel-treated subjects at steady state, it was shown that active metabolite exposure was decreased by 28% for intermediate metabolisers, and 72% for poor metabolisers while platelet aggregation inhibition (5 μM ADP) was decreased with differences in IPA of 5.9% and 21.4%, respectively, when compared to extensive metabolisers.
U skladu s gore navedenim rezultatima, u meta analizi koja je uključivala 6 studija sa 335 osoba liječenih klopidogrelom u stanju dinamičke ravnoteže, pokazano je da je izloženost aktivnom metabolitu smanjena za 28% za umjerene metabolizatore te 72% za slabe metabolizatore, dok je inhibicija agregacije trombocita (5 μM ADP) smanjena s razlikama za vrijednosti IPA-e od 5,9%, odnosno 21,4%, u usporedbi s brzim metabolizatorima.
Co-administration of heparin had no effect on the inhibition of platelet aggregation induced by clopidogrel.
Istodobna primjena heparina nije imala učinak na inhibiciju agregacije trombocita induciranu klopidogrelom.
- If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
• ako imate poremećaj koji izaziva krvarenje, kao što je, primjerice, želučani čir ili krvarenje u mozgu;
The incidence of clinically significant bleeding was similar to that observed when thrombolytic agents and heparin are co-administered with ASA (see section 4.8)
Incidencija klinički značajnog krvarenja bila je slična onoj zamijećenoj pri istodobnoj uporabi trombolitika i heparina s ASK (vidjeti dio 4.8).
Each film-coated tablet contains 3 mg of lactose and 3.3 mg of hydrogenated castor oil.
Jedna filmom obložena tableta sadrži 3 mg laktoze i 3,3 mg hidrogeniranog ricinusovog ulja.
If Clopidogrel Zentiva is supplied in all aluminium blisters, it does not require any special storage conditions.
Ako je Clopidogrel Zentiva opremljen u aluminijske blistere, lijek ne zahtijeva posebne uvjete čuvanja.
14 film--coated tablets 28 film-coated tablets 30 film-coated tablets 50x1 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets 7 film-coated tablets 50 film-coated tablets
14 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 50x1 filmom obloženih tableta 84 filmom obložene tablete 90 filmom obloženih tableta 100 filmom obloženih tableta 7 filmom obloženih tableta 50 filmom obloženih tableta
If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Zentiva:
Ako se na Vas odnosi bilo koje od dolje navedenih stanja morate obavijestiti liječnika, prije nego što uzmete Clopidogrel Zentiva:
This statistically significant difference was mainly driven by fewer bleeding events, with no difference reported in ischaemic endpoints (p=0.36), while BARC ≥2 bleeding occurred less frequently in the de-escalated DAPT group (4.0%) versus 14.9% in the unchanged
Ova statistički značajna razlika uglavnom je posljedica manjeg broja događaja krvarenja, bez prijavljene razlike u ishemijskim mjerama ishoda (p=0,36), dok se BARC stupanj krvarenja ≥ 2 javljao rjeđe u skupini s de-eskaliranim DAPT-om (4,0%) u odnosu na skupinu sa nepromijenjenim DAPT-om (p < 0,01).
Clopidogrel Zentiva may be taken with or without food.
Clopidogrel Zentiva s hranom i pićem Clopidogrel Zentiva se može uzimati s obrokom ili bez obroka.
Clopidogrel Zentiva contains hydrogenated castor oil
Clopidogrel Zentiva sadrži hidrogenirano ricinusovo ulje
Clopidogrel Zentiva is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Clopidogrel Zentiva uzimaju odrasli za sprječavanje stvaranja krvnih ugrušaka (tromba) u otvrdnutim krvnim žilama (arterijama), a taj poremećaj zove se aterotromboza i može dovesti do aterotrombotičkih događaja (kao što su moždani udar, srčani udar ili smrt).
EU/1/08/465/001 14 tablets EU/1/08/465/002 14 tablets EU/1/08/465/003 28 tablets EU/1/08/465/004 28 tablets EU/1/08/465/005 30 tablets EU/1/08/465/006 30 tablets EU/1/08/465/007 50x1 tablets EU/1/08/465/008 50x1 tablets EU/1/08/465/009 84 tablets EU/1/08/465/010 84 tablets EU/1/08/465/011 90 tablets EU/1/08/465/012 90 tablets EU/1/08/465/013 100 tablets EU/1/08/465/014 100 tablets EU/1/08/465/018 7 tablets EU/1/08/465/019 7 tablets EU/1/08/465/021 50 tablets
EU/1/08/465/001 14 tableta EU/1/08/465/002 14 tableta EU/1/08/465/003 28 tableta EU/1/08/465/004 28 tableta EU/1/08/465/005 30 tableta EU/1/08/465/006 30 tableta EU/1/08/465/007 50x1 tableta EU/1/08/465/008 50x1 tableta EU/1/08/465/009 84 tableta EU/1/08/465/010 84 tableta EU/1/08/465/011 90 tableta EU/1/08/465/012 90 tableta EU/1/08/465/013 100 tableta EU/1/08/465/014 100 tableta EU/1/08/465/018 7 tableta EU/1/08/465/019 7 tableta EU/1/08/465/021 50 tableta