natgillin/translations-raw huggingface dataset:
After the amount of Glybera to be administered has been calculated (see section 4.2) remove the correct number of single use vials from the freezer to thaw at room temperature (15oC to 25oC), approximately 30-45 minutes in advance of syringe filling.
Nakon izračuna količine Glybere koju treba primijeniti (vidjeti dio 4.2), uzmite odgovarajući broj bočica za jednokratnu uporabu iz zamrzivača i pričekajte da se odmrznu na sobnoj temperaturi (15 oC
Additional monitoring tests
Dodatne pretrage za praćenje bolesnika
Once thawed, the medicinal product must be used immediately; if not used immediately, the vials should be stored in a refrigerator at 2ºC to 8ºC, and protected from light for a maximum of 8 hours.
Kada se lijek odmrzne, mora se iskoristiti odmah; ako se ne iskoristi odmah, bočice se smiju čuvati najduže 8 sati u hladnjaku pri temperaturi od 2 ºC do 8 ºC, a pritom moraju biti zaštićene od svjetlosti.
If not stored in a refrigerator the medicinal product can be stored in syringes at not more than 25°C, and protected from light for a maximum of 8 hours.
Ako se lijek ne čuva u hladnjaku, smije se najduže 8 sati čuvati u štrcaljkama zaštićenima od svjetlosti pri temperaturi do najviše 25 °C.
People diagnosed with lipoprotein lipase deficiency are advised to be careful with their diet, both before and after Glybera therapy; they should not drink alcohol.
Preporučuje se da osobe s dijagnosticiranim nedostatkom lipoproteinske lipaze pridržavaju dijete prije liječenja Glyberom i nakon toga; i moraju izbjegavati alkohol.
The first 2 patients enrolled received a dose of 3 x 1011 gc/kg, the next 4 patients received a dose of 3 x 1011 gc/kg with immunosuppressant regiment (oral ciclosporin and oral mycophenolate mofetil from the day after Glybera administration until Week 12) and the final 8 patients received a dose of 1 x 1012gc/kg with immunosuppressant regiment.
Prva 2 bolesnika uključena u ispitivanje primila su dozu od 3 x 1011 gk/kg, sljedeća 4 bolesnika primila su dozu od 3 x 1011 gk/kg s imunosupresivnom terapijom (peroralni ciklosporin i peroralni mofetilmikofenolatom počevši od dana nakon injiciranja
Assessment of each individual subject's risk profile prior to Glybera administration is advised.
Prije primjene Glybere preporučuje se procjena profila rizika svakog pojedinog bolesnika.
Cell and tissue donation
Darivanje stanica i tkiva
Diabetic patients
Bolesnici s dijabetesom
• Guidance on the selection of suitable patients for treatment with Glybera including: o the need for genetic testing to be performed prior to the initiation of treatment in order to identify the patients who are eligible for treatment o that patients should not be taking anti-platelet or other anti-coagulation medicinal products at the time of injection o the need to exclude infection before starting immunosuppressant treatment o the need for all patients to be entered into a long term surveillance programme
• Smjernice o odabiru prikladnih bolesnika za liječenje Glyberom, uključujući: o potrebu za genetskim testiranjem, koje treba obaviti prije početka liječenja, kako bi se identificirali bolesnici koji su prikladni za liječenje;
There is limited experience in the use of Glybera in patients with renal or hepatic impairment.
Iskustvo s primjenom Glybere u bolesnika s bubrežnim ili jetrenim oštećenjem je ograničeno.
Keep this medicine out of the sight and reach of children.
Kako čuvati Glyberu Lijek čuvajte izvan pogleda i dohvata djece.
In case of contraindication for such procedure deep sedation is advised instead.
Ako je ona kontraindicirana, preporučuje se duboka sedacija.
Present this card to health care professionals (doctor, nurse) upon consultation or hospitalization!
U slučaju odlaska k liječniku ili prijema u bolnicu, tu karticu pokažite zdravstvenom djelatniku (liječniku, medicinskoj sestri)!
With the exception of a case of fever (39.9 °C) in study CT-AMT-011-01 which reversed within a day, no Glybera or immunosuppression related serious adverse events occurred.
Nisu se pojavile ozbiljne nuspojave povezane s Glyberom ili imunosupresijom, izuzev jednog slučaja vrućice (39,9 °C) u ispitivanju CT-AMT-011-01, koja je nestala unutar jednog dana.
Each vial of alipogene tiparvovec contains 1 ml of solution, containing 3 x 1012 genome copies (gc).
Jedna bočica alipogen tiparvoveka sadrži 1 ml otopine, koja sadrži 3 x 1012 genomskih kopija (gk).
Do not take oral contraceptives as they have the potential to worsen your disease; Use condoms so that as little Glybera as possible may be passed to/from your partner.
Koristite prezervative, na taj će način na/s Vašeg partnera prijeći što manje Glybere.
Immunogenicity
• Imunodeficijencija
The MAH shall set up a disease registry to collect information on the epidemiology of the disease and the demographics, safety and effectiveness outcomes of patients with familial LPLD treated with Glybera.
Nositelj odobrenja dužan je, unutar navedenog vremenskog roka, provesti niže navedene mjere: u kojem će sakupljati podatke o epidemiologiji bolesti i rezultate u pogledu demografije, sigurnosti i učinkovitosti kod bolesnika s obiteljskim LPLD-om koji su liječeni Glyberom.
Manufacturer uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, The Netherlands.
Proizvođač uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, Nizozemska.
Each vial contains 1 extractable ml of solution containing 3 × 1012 genome copies (gc) of alipogene tiparvovec.
Jedna bočica sadrži 1 ml otopine koja se može izvući, i sadrži 3 × 1012 genomskih kopija (gk) alipogen tiparvoveka.
The opportunity to treat diabetic patients suffering from LPLD should be carefully considered by the physician.
Liječnik mora pažljivo razmotriti mogućnost liječenja bolesnika s dijabetesom koji boluju od LPLD-a.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU
In CT-AMT-01102 faeces was also collected.
U ispitivanju CT-AMT-011-02 također je uzeta i stolica.
At this time a series of injections (27 to 60 injections) into the muscles of both upper and lower legs will be given.
Tijekom tog boravka primit ćete u mišiće natkoljenice i potkoljenice niz injekcija (od 27 do 60 injekcija).
Eight days after administration, high levels of vector DNA sequence were detected in injected muscle and the draining lymph nodes.
Osam dana nakon primjene, u injiciranom mišiću i drenažnim limfnim čvorovima utvrđene su visoke razine sekvence DNK vektora.
AAV1-LPLS447X was administered to 8 LPLD patients in a 12-week, open label dose escalating study (1 x 1011 gc to 3 x 1011 gc per kg body weight i.m.).
Kliničko ispitivanje CT-AMT-010-01 U 12-tjednom otvorenom ispitivanju s postupnim povećavanjem doze, AAV1-LPLS447X je primijenjen u 8 bolesnika s LPLD-om (1 x 1011 gk do 3 x 1011 gk po kg tjelesne težine, intramuskularno).
The patient's weight should be divided by 3, and rounded up to the next higher whole number.
Bolesnikovu tjelesnu težinu treba podijeliti s 3 i zaokružiti na sljedeći viši cijeli broj.
Further follow-up of patients who took part in study CT-AMT-11-03 (to a median of 5.8 years after exposure to Glybera) has shown a reduction in hospital stay of 1 day per patient per year when compared to the same length of time prior to exposure.
godina nakon izloženosti Glyberi) pokazalo je skraćenje boravka u bolnici za 1 dan po bolesniku godišnje u usporedbi s jednakim vremenom prije izloženosti.
• The necessity to carry the patient alert card, that is included in each pack, with them at all
• Potrebu da bolesnik ima uvijek sa sobom karticu s upozorenjima za bolesnika koja je sadržana u svakom pakiranju
Contusion
Kontuzija
The clear to slightly opalescent and colourless solution must be free of visible particles.
Bistra do blago opalescentna i bezbojna otopina ne smije sadržavati vidljive čestice.
Glybera is a clear to slightly opalescent, colourless solution for injection, supplied in a clear glass vial with a siliconised injection stopper and flip-off seal.
Glybera je bistra do blago opalescentna, bezbojna otopina za injekciju, koja dolazi u prozirnoj,
Potassium dihydrogen phosphate Sodium chloride
kalijev klorid kalijev dihidrogenfosfat natrijev klorid natrijev hidrogenfosfat saharoza voda za injekcije
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
• Not to donate organs nor blood nor cells
o zabrane darivanja organa, krvi ili stanica;
Pack size 2 vials
Veličina pakiranja: 2 bočice
Elderly There is limited experience in the use of Glybera in elderly subjects.
Kod starijih osoba, iskustvo s primjenom Glybere je ograničeno.
Clear, to slightly opalescent, colourless solution.
Bistra do blago opalescentna, bezbojna otopina.
Glybera should under no circumstances be administered intravascularly.
Glybera se ne smije nikada injicirati intravaskularno.
To calculate the number of vials, the patient's weight is determined to the nearest whole kg.
Pri izračunu broja bočica, bolesnikova se tjelesna težina zaokruži na najbliži cijeli kilogram.
Spinal or regional anaesthesia is advised prior to intramuscular administration, due to the number of injections required.
Prije intramuskularne primjene, zbog velikog broja potrebnih injekcija, preporučuje se spinalna ili regionalna anestezija.
The vector comprises a protein shell derived from adeno-associated virus serotype 1 (AAV1), the Cytomegalovirus (CMV) promoter, a woodchuck hepatitis virus posttranscriptional regulatory element and AAV2 derived inverted terminal repeats.
promotora citomegalovirusa (CMV), elementa za posttranskripcijsku regulaciju virusa hepatitisa svisca i inverznih terminalnih ponavljanja, dobivenih iz serotipa AAV2.
Package leaflet: Information for the user Glybera 3 x 1012 genome copies /ml solution for injection
Uputa o lijeku: Informacije za korisnika Glybera 3 × 1012 genomskih kopija/ml otopina za injekciju alipogen tiparvovek
SPECIAL STORAGE CONDITIONS Store and transport vial frozen at -25°C to -15°C.
POSEBNE MJERE ČUVANJA Čuvati i prevoziti bočice zamrznute pri temperaturi od -25 °C do -15 °C.
Correction of bleeding parameters should be instituted prior to Glybera administration.
Prije primjene Glybere moraju se korigirati parametri hemostaze.
including the need for injections to be administered under ultrasound or electrophysiological guidance
• Smjernice o prevenciji rizika povezanih s intramuskularnim injiciranjem Glybere, uključujući potrebu da se injiciranje izvede pod ultrazvučnim ili elektrofiziološkim nadzorom
Glybera 3 × 1012 genome copies/ml solution for injection
Glybera 3 × 1012 genomskih kopija/ml otopina za injekciju
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRANSPARENT SEALED PLASTIC CASING LABEL (3 vial pack)
NALJEPNICA NA PROZIRNOM, ZATVORENOM PLASTIČNOM OMOTU (pakiranje s 3 bočice)
Glybera should not be administered to pregnant women unless the possible benefit to the mother outweighs the possible risk to the foetus.
Ispitivanja na životinjama nisu pokazala štetne učinke Glybere na trudnoću ili na razvoj zametka/ploda (vidjeti dio Glybera se ne smije primjenjivati u trudnica, osim ako su moguće koristi za majku veće od potencijalnog rizika za plod.
• difficulty breathing, chest pain on breathing in and palpitations which may be caused by blockage of the main blood vessel of the lung
• bol u mišićima, tupi bolovi, probadanje i ukočenost zglobova • otežano disanje, bol u prsima kod udisanja i osjećaj lupanja srca što može nastati zbog začepljenosti glavne krvne žile pluća • osjećaj žarenja
This medicine contains potassium, less than 1 mmol (39 mg) per administration at 27 injection sites to 60 injection sites, i.e. essentially ‘potassium-free'.
Ovaj lijek sadrži manje od 1 mmol (39 mg) kalija po primjeni na 27-60 mjesta ubrizgavanja, tj. sadrži zanemarivu količinu kalija.
- Product information (summary of product characteristics, patient information leaflet and
- Informacije o lijeku (sažetak opisa svojstava lijeka, uputa o lijeku i kartica s upozorenjima za bolesnika) - Edukacijski materijal za zdravstvene djelatnike - Edukacijski materijal za bolesnike
• Increased blood level of the muscle enzyme creatine kinase
• povišena razina mišićnog enzima kreatin kinaze u krvi Često (mogu se javiti kod do 1 na 10 osoba)
Marketing Authorisation Holder uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, The Netherlands.
Nositelj odobrenja za stavljanje gotovog lijeka u promet uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, Nizozemska.
A transient reduction of triglycerides for up to 12 weeks in some individual patients has been observed.
Kod pojedinih bolesnika opaženo je prolazno smanjenje triglicerida u trajanju do 12 tjedana.
• You should continue to follow a fat-restricted, alcohol-free diet. People diagnosed with lipoprotein lipase deficiency are advised to be careful with their diet, both before and after Glybera therapy; they should restrict their intake of ‘normal diet fats' and should not drink
Preporučuje se da se osobe s dijagnosticiranim nedostatkom lipoproteinske lipaze pridržavaju svoje dijete prije liječenja Glyberom i nakon toga; one moraju ograničiti unos „masnoća uobičajene prehrane“ i ne smiju piti alkohol.
Side effects from your immunosuppressants
Nuspojave imunosupresivnih lijekova
- You should present this card to your health care professionals (doctor, nurse) upon consultation or hospitalisation.
- U slučaju odlaska k liječniku ili prijema u bolnicu, morate tu karticu pokazati zdravstvenom djelatniku (liječniku, medicinskoj sestri).
MedDRA System Organ Class Metabolism and nutrition disorders
Poremećaji metabolizma i prehrane
Pack size 3 vials
Veličina pakiranja: 3 bočice
Glybera 3 × 1012 genome copies/ml solution for injection Alipogene tiparvovec
Glybera 3 × 1012 genomskih kopija/ml otopina za injekciju alipogen tiparvovek
To avoid this, your doctor will also prescribe treatment that will suppress the immune system (known as immunosuppressants), starting 3 days before the day of injection with Glybera and for 12 weeks after.
Kako bi se to izbjeglo, liječnik će Vam također propisati terapiju koja će potisnuti imunološki sustav (poznata kao imunosupresivna terapija).
Injection site discomfort, Injection site oedema, Injection site pruritus
Nelagoda na mjestu injiciranja, edem na mjestu injiciranja, svrbež na mjestu injiciranja
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRANSPARENT SEALED PLASTIC CASING LABEL (2 vial pack)
NALJEPNICA NA PROZIRNOM, ZATVORENOM PLASTIČNOM OMOTU (pakiranje s 2 bočice)
Each patient-specific pack contains a sufficient amount of vials to dose each patient with 1 x 1012 gc/kg body weight.
Svako za bolesnika specifično pakiranje sadrži dovoljnu količinu bočica za primjenu doze od 1 x 1012
See package leaflet for further information.
Pogledajte uputu o lijeku za dodatne informacije.
In particular, tell your doctor if you are taking the following before you are given Glybera:
Prije nego počnete primati Glyberu, obavijestite svog liječnika naročito ako uzimate bilo koje od sljedećeg:
Pharmacokinetics in special populations e.g. elderly/renal impairment etc. Glybera is injected directly into the target organ, skeletal muscle.
Farmakokinetika u posebnim populacijama, npr. starijim bolesnicima/s bubrežnim oštećenjem itd.
Instructions for use, handling and disposal
Upute za pripremu i rukovanje te zbrinjavanje
People who are affected by this condition have a build up of very high fat levels in their blood (hyperchylomicronemia).
Kod osoba s tom bolešću, u krvi se akumuliraju vrlo visoke razine masnoća
Breast-feeding is not recommended during treatment with Glybera.
Tijekom liječenja Glyberom dojenje nije preporučljivo.
Tabulated list of adverse reactions Adverse reactions are listed below by MedDRA body system organ class and by frequency.
Dolje navedene nuspojave u skladu su s MedDRA klasifikacijom organskih sustava i učestalosti.
All patients were controlled on low fat diets in the 12-week main study period.
U glavnom 12-tjednom razdoblju ispitivanja, svi su bolesnici bili na kontroliranoj dijeti s niskim sadržajem masnoća.
Chiesi Hungary Kft. Tel.:++36-1-429 1060
Tel.:++36-1-429 1060
Patient-specific pack containing sufficient amount of vials to dose each patient Liquid absorbing sheet is also contained.
Pakiranje specifično za bolesnika koje sadrži dovoljni broj bočica za doziranje kod pojedinačnog bolesnika
A single intravenous bolus of methylprednisolone (1 mg/kg bodyweight) was given 30 minutes prior to alipogene tiparvovec administration.
Bolesnici su 30 minuta prije injiciranja alipogen tiparvoveka primili jednokratni intravenski bolus metilprednizolona (1 mg/kg tjelesne težine).
After you have been given Glybera, you may notice that your legs have a yellow colour; this might occur in case iodine was used to clean (sterilise) your legs before you received the medicine.
Nakon što primite Glyberu, možda ćete opaziti da su Vaše noge žute boje.
Tel: ++386-1-43 00 901
Chiesi Slovenija d.o.o. Tel: ++386-1-43 00 901
Name and address of the manufacturer(s) responsible for batch release uniQure biopharma B.V. Meibergdreef 61
Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet uniQure biopharma B.V.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE EFFECTIVE USE OF THE MEDICINAL PRODUCT
UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU
Water for injections
saharoza i voda za injekcije.
Clinical trial CT-AMT-11-05
Kliničko ispitivanje CT-AMT-11-05
The clinical efficacy and safety of Glybera has been evaluated in three interventional clinical studies with AAV1-LPLS447X in LPLD subjects.
Klinička djelotvornost i sigurnost Klinička djelotvornost i sigurnost Glybere ocijenjene su u tri intervencijska klinička ispitivanja s
Glybera should be administered to you in one treatment session only.
Glyberu morate primiti samo u obliku jednokratne terapije.
Glybera should not be administered to women who are breast-feeding as long as breastfeeding is ongoing.
Glybera se ne smije davati ženama koje doje,
• injection site discomfort, swelling, rash and pain
• rast dlaka • nelagoda na mjestu davanja injekcije, oticanje, osip i bol
Product manufacturer and license holder: uniQure biopharma B.V.
Naziv(i) i adresa(e) proizvođača biološke djelatne tvari uniQure biopharma B.V.
Clinical trial CT-AMT-11-03
Kliničko ispitivanje CT-AMT-11-03
After the amount of Glybera to be administered has been calculated (see section posology) remove the correct number of single use vials from the freezer to thaw at room temperature (15oC to 25oC), approximately 30-45 minutes in advance of syringe filling.
Kada izračunate količinu Glybere koju treba primijeniti (vidjeti dio Doziranje), uzmite odgovarajući broj bočica za jednokratnu uporabu iz zamrzivača i pričekajte da se odmrznu na sobnoj temperaturi
Diet
Dojenje
Clinical trial CT-AMT-011-02
Kliničko ispitivanje CT-AMT-011-02
- If you get any side effects, talk to your doctor.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
Dizziness was commonly observed after Glybera administration.
Nakon primjene Glybere često je opažena omaglica.
Clinical trial CT-AMT-011-01
Kliničko ispitivanje CT-AMT-011-01
• The need to provide the educational material to patients and request their informed consent to be enrolled into the registry prior to treatment o the need and duration of barrier contraception o not to donate organs nor blood nor cells o on the need to continue on a low-fat diet and avoid drinking alcohol o the necessity to carry the patient alert card, that is included in each pack, with them at o that enrolment is mandatory for patients treated with Glybera o that patients treated with Glybera in a clinical trial should be enrolled in the registry at o that, where possible, patients with familial LPLD who are not treated with Glybera o the need to obtain the patient's informed consent prior to treatment o how to enter patients in it - including those not treated with Glybera
o potrebe za nastavljanjem dijete s niskim sadržajem masnoća i potrebe za izbjegavanjem alkohola; o potrebe da bolesnik ima uvijek sa sobom karticu s upozorenjima za bolesnika, koja je sadržana u svakom pakiranju;
• Advice on the need and duration of barrier contraception
• Savjete o potrebi za barijernom kontracepcijom i trajanju njene uporabe • Zabrana darivanja organa, krvi ili stanica
Each vial of alipogene tiparvovec contains 1 extractable ml of solution, containing 3 x 1012 genome copies (gc).
Jedna bočica alipogen tiparvoveka sadrži 1 ml otopine, koja se može izvući, i sadrži 3 x 1012
Glybera will be given to you in a single therapy administration session in a hospital.
Glyberu ćete primiti u obliku više injekcija jednokratno po primitku u bolnicu.
In addition methylprednisolone might be administered half an hour prior to the Glybera administration.
Osim toga, pola sata prije ubrizgavanja Glybere možda ćete primiti metilprednizolon.
Chiesi CZ s.r.o.
Chiesi Farmaceutici S.p.A.
Renal impairment or hepatic impairment
Oštećenje bubrežne ili jetrene funkcije
No dose adjustment of Glybera is necessary in the elderly population.
Glybere u starije populacije.
Tel.: +48 22 620 1421
Chiesi Poland Sp. z.o.o. Tel.: +48 22 620 1421
Store and transport vial frozen -25oC to -15oC.
Čuvati i prevoziti bočice zamrznute pri temperaturi od -25 °C do -15 °C.
Chiesi Bulgaria EOOD Тел.
Chiesi Hungary Kft.
• tiredness (fatigue)
• omaglica
Potassium chloride
• kožni osip
No vector DNA could be detected in the foetuses after treatment of either the females or the males prior to mating.
Nakon liječenja ženki ili mužjaka prije parenja, kod fetusa nije otkriven DNK vektora.
Sodium content and potassium content
OBLIK I SADRŽAJ
Intramuscular use
Primjena u mišić
12 mg Concentrate for solution for infusion
12 mg Koncentrat za otopinu za infuziju
Intravenous use vial (glass)
Primjena u venu bočica (staklo)
Official languages:
Službeni jezici:
The European Union - key facts
Europska unija - ključne činjenice
Guidelines and scientific advice
Smjernice i znanstveni savjeti
EU Member States: 28
EU država članica: 28
• Right of initiative - it can propose new or amended legislation for the pharmaceutical sector;
• pravo inicijative - može predlagati novo ili izmijenjeno zakonodavstvo za farmaceutski sektor;
Different authorisation routes: one set of common rules.
Različiti kanali odobrenja: jedan skup zajedničkih pravila.
These guidelines reflect the latest thinking on developments in biomedical science.
Te smjernice odražavaju najnovija razmišljanja o dostignućima u biomedicinskoj znanosti.
The European system offers different routes for such an authorisation.
Europski sustav pruža različite kanale za takvo odobravanje.
Supporting regulatory science outside the EU - the Article 58 procedure
Podupiranje regulatorne znanosti izvan EU-a - postupak iz članka 58.
Pricing and reimbursement
Cijene i povrat troškova
Authorisation and supervision of manufacturers
Odobrenje i nadzor proizvođača
EMA is responsible for the scientific evaluation,
EMA je odgovorna za znanstvenu procjenu,
The role of the European Commission
Uloga Europske komisije
primarily of innovative and high-technology medicines developed by pharmaceutical companies for use in the EU.
prvenstveno inovativnih i visokotehnoloških lijekova koje razvijaju farmaceutske tvrtke za uporabu u EU-u.
When a company wants to authorise a medicine in several Member States, it can use one of the following procedures:
Kada tvrtka želi odobriti lijek u nekoliko država članica, može upotrijebiti jedan od sljedećih postupaka:
Public hearings
Javna saslušanja
Population: >500m
Stanovništvo: više od 500 milijuna
The European Economic Area (EEA) is formed of the 28 EU Member States plus:
Europski gospodarski prostor (EGP) broji 28 EU država članica plus:
The regulatory authorities of each Member State are responsible for granting licences for such activities taking place within their respective territories.
Regulatorna tijela svake države članice zadužena su za dodjelu dozvola za takve aktivnosti koje se odvijaju na njihovim područjima.
The European Commission plays an important role in the regulation of medicines in the EU.
Europska komisija ima ključnu ulogu u regulaciji lijekova u EU-u.