natgillin/translations-raw huggingface dataset:
• Risk Management Plan (RMP) 
• Načrt za obvladovanje tveganja (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe,
• elbasvir/grazoprevir (used to treat chronic hepatitis C virus [HCV]); 
zgoraj); - zdravila za zdravljenje tuberkuloze (bedakilin, delamanid); - protivirusna zdravila za zdravljenje kronične okužbe z virusom hepatitisa C (HCV) pri odraslih
Use the 2 ml oral dosing syringe to prepare a dose. 
Za pripravo odmerka uporabite 2 ml brizgo za peroralno dajanje.
Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of lurasidone are expected to increase. 
Zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem se pričakuje povečanje koncentracij lurasidona.
Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of pimozide are expected to increase. 
Zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem se pričakuje povečanje koncentracij pimozida.
Hepatitis including AST, ALT and GGT increases 
Bolezni jeter, žolčnika in žolčevodov pogosti hepatitis, vključno s povišanjem AST, ALT in
Serum concentrations may be increased due to CYP3A inhibition by lopinavir/ritonavir, resulting in increased risk of tumor lysis syndrome at the dose initiation and during the ramp-up phase (see section 4.3 and refer to the venetoclax SmPC). 
posledično se poveča tveganje za pojav sindroma tumorske lize pri začetnem odmerjanju in med fazo povečevanja odmerka (glejte poglavje 4.3 in povzetek glavnih značilnosti zdravila za venetoklaks).
Please refer to the Aptivus Summary of Product Characteristics for additional information on the use of tipranavir, including genotypic predictors of response, in treatment of lopinavir-resistant HIV-1 infection. 
Za dodatne informacije o tipranavirju (vključno z genotipsko napovedjo odziva,
The active substances are lopinavir and ritonavir. 
Zdravilni učinkovini sta lopinavir in ritonavir.
Each ml contains lopinavir 80 mg and ritonavir 20 mg. 
En ml vsebuje 80 mg lopinavirja in 20 mg ritonavirja.
• If the ‘ml' mark on the black ‘O' ring is more than the prescribed dose, push the plunger to the prescribed dose. 
• Če je črni obroč na oznaki z ‘ml', ki je večja od predpisanega odmerka, pritisnite na bat do predpisanega odmerka.
AUC: ↑ 5.7-fold Cmax: ↑ 3.5-fold 
AUC: ↑ 5,7-krat Cmax: ↑ 3,5-krat
AUC: ↑ 153% 
AUC: ↑ 153 % Cmax: ↑ 55 %
Film-coating: 
Filmska obloga
Uncommon Creatinine clearance decreased, nephritis, haematuria 
Bolezni sečil občasni zmanjšan očistek kreatinina, nefritis,
Due to CYP3A inhibition by lopinavir/ritonavir. 
Zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem.
Adverse events of nausea, dizziness, hypotension and syncope were observed following co-administration of trazodone and ritonavir. 
Po sočasni uporabi trazodona in ritonavirja so kot neželene učinke zabeležili navzeo, omotico, hipotenzijo in sinkopo.
The concomitant administration with lurasidone is contraindicated (see section 4.3). 
Sočasna uporaba z lurasidonom je kontraindicirana (glejte poglavje
Kaletra (80 mg + 20 mg) / ml oral solution 
Kaletra (80 mg + 20 mg) / ml peroralna raztopina
Refer to the ceritinib SmPC for dosage adjustment recommendations. 
Za priporočila glede prilagoditve odmerjanja glejte povzetek glavnih značilnosti zdravila za ceritinib.
Therefore, concomitant administration of Kaletra with salmeterol is not recommended (see section 4.4). 
Kaletra s salmeterolom ni priporočljiva (glejte poglavje
It is not recommended to co-administer Kaletra and sofosbuvir/velpatasvir/ voxilaprevir. 
Sočasna uporaba zdravila Kaletra in sofosbuvirja/velpatasvirja/
Kaletra oral solution: 
Kaletra peroralna raztopina:
Refer to the Summary of Product Characteristics for Kaletra oral solution for dosing instructions. 
Za navodila o odmerjanju glejte povzetek glavnih značilnosti zdravila Kaletra peroralna raztopina.
GI motility agent 
Zdravilo za motiliteto prebavil
Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of alfuzosin are expected to increase. 
Zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem je treba pričakovati zvišanje koncentracije alfuzosina.
Uncommon: may affect up to 1 in 100 people 
Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov - nenormalne sanje;
Digoxin: 
Trazodon:
Thereby, increasing the risk of serious arrhythmias from these agents (see section 4.5). 
saj lahko poveča tveganje resnih aritmij zaradi tega zdravila (glejte poglavje 4.3).
Increased plasma concentrations of neratinib which may increase the potential for serious and/or life-threatening reactions (see section 4.5). 
Zvišana koncentracija neratiniba v plazmi, ki lahko poveča tveganje za resne in/ali življenje ogrožajoče reakcije (glejte poglavje 4.5).
For larger volumes an alternative pack is available. 
Za volumne do 2 ml. Za večje volumne je na voljo drugo pakiranje.
Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 
Med protiretrovirusnim zdravljenjem se lahko poveča telesna masa ter zviša koncentracija lipidov in glukoze v krvi (glejte poglavje 4.4).
Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of ranolazine are expected to increase. 
Zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem se pričakuje povečanje koncentracij ranolazina.
All patients converted to open-label Kaletra at the 400/100 mg twice-daily dose between week 48 and week 72. 
Vsi bolniki so med 48. in 72. tednom prešli na odprto uporabo zdravila Kaletra v odmerku
• If the ‘ml' mark on the collar is less than the prescribed dose, draw up more solution to the prescribed dose. 
• Če je črni obroč na oznaki z ‘ml', ki je manjša od predpisanega odmerka, v brizgo potegnite dodatno raztopino, da dobite predpisani odmerek.
Concentrations may be reduced due to increased glucuronidation by lopinavir/ritonavir. 
Zmanjšana izpostavljenost zdravilu Kaletra lahko vodi v v zmanjšanje izpostavljenosti lopinavirju/ritonavirju.
PARTICULARS TO APPEAR ON THE ON THE IMMEDIATE PACKAGING 100 mg/25 mg tablets - bottle label 
PODATKI NA PRIMARNI OVOJNINI 100 mg/25 mg tablete - nalepka na plastenki
AUC: ↓ 35% Cmin: ↓ 45% Cmax: ↓ 30% 
AUC: ↓ 35 % Cmin: ↓ 45 % Cmax: ↓ 30 % Lopinavir :
Concentrations may be increased due to CYP3A inhibition by lopinavir/ritonavir. 
Koncentracije se lahko zvišajo zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem.
Since increased concentrations of HMG-CoA reductase inhibitors may cause myopathy, including rhabdomyolysis, the combination of these agents with Kaletra is contraindicated (see section 4.3). 
povzročijo miopatijo, vključno z rabdomiolizo, je uporaba teh zdravil hkrati z zdravilom Kaletra kontraindicirana (glejte poglavje
− Keep this leaflet. 
Glejte poglavje
Sorbitan laurate Colloidal anhydrous silica Sodium stearyl fumarate 
Vsebina tablete: kopovidon sorbitan lavrat koloidni brezvodni silicijev dioksid natrijev stearilfumarat
Due to the risk of QTc prolongation associated with DM-6705, if co-administration of delamanid with Kaletra is considered necessary, very frequent ECG monitoring throughout the full delamanid treatment period is recommended (see section 4.4 and refer to the delamanid SmPC). 
6705 priporočljivo zelo pogosto spremljanje EKG-ja skozi celotno obdobje zdravljenja (glejte poglavje 4.4 in glejte povzetek glavnih značilnosti zdravila za delamanid).
AUC: ↑ 13-fold Due to CYP3A inhibition by lopinavir/ritonavir. 
AUC: ↑ 11-krat zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem.
Trazodone: AUC: ↑ 2.4-fold 
AUC: ↑ 2,4-krat
PARTICULARS TO APPEAR ON THE ON THE IMMEDIATE PACKAGING 200 mg/50 mg tablets - Bottle label 
PODATKI NA PRIMARNI OVOJNINI 200 mg/50 mg tablete - nalepka na plastenki
Each ml of Kaletra oral solution contains 80 mg of lopinavir and 20 mg of ritonavir. 
1 ml zdravila Kaletra peroralna raztopina vsebuje 80 mg lopinavirja in 20 mg ritonavirja.
There were no reported events of failure attributed to therapy limiting toxicity. 
* Neuspeh je definiran kot klinično, imunološko napredovanje bolezni, virološki neuspeh ali toksičnost protiretrovirusnega zdravljenja, ki omejuje shemo zdravljenja.
HIV RNA < 50 copies/ml*† 
HIV RNA < 400 kopij/ml* HIV RNA < 50 kopij/ml*†
Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of lomitapide are expected to increase. 
Zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem se pričakuje povečanje koncentracij lomitapida.
Caution should be exercised in administering phenytoin with Kaletra. 
Pri uporabi fenitoina z zdravilom Kaletra je potrebna previdnost.
The median fold IC50 of lopinavir for these 18 isolates at baseline and rebound was 6.9- and 63-fold, respectively, compared to wild type virus. 
18 izolatih v primerjavi z divjim tipom virusa je bil izhodiščno 6,9-krat in po preobratu 63-krat.
Nervous system disorders 
- poškodbe perifenih živcev;
AUC: ↑ 7.2-fold Cmax: ↑ 4.7-fold Cmin: ↑ 14.4-fold 
AUC: ↑ 7,2-krat Cmax: ↑ 4,7-krat
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reconstitution; however, the reported time to onset is more variable and can occur many months after initiation of treatment. 
Čas nastopa bolezni, o katerem so poročali, je precej spremenljiv in je lahko več mesecev po začetku zdravljenja.
Patients should be monitored closely for a decreased VPA effect when Kaletra and valproic acid or valproate are given concomitantly. 
Pri bolnikih z okvarjenim delovanjem jeter ali ledvic je treba klaritromicin hkrati z zdravilom Kaletra uporabljati previdno.
Antidepressants and Anxiolytics Trazodone single dose 
Antidepresivi in anksiolitiki Trazodon, enkraten odmerek (Ritonavir, 200 mg dvakrat na dan)
Clinical recommendation concerning co-administration with Kaletra 
Klinično priporočilo glede sočasne uporabe z zdravilom
• deep vein inflammation related to a blood clot; 
- nekontrolirano tresenje telesa; - zaprtje; - globoka venska tromboza, povezana s krvnimi strdki; - suha usta;
Hepatic impairment 
Neželen učinek
Common: may affect up to 1 in 10 people 
Pogosti: pojavijo se lahko pri največ 1 do 10 bolnikov - vnetje trebušne slinavke;
Haemophilia 
hematurija
Serum concentrations may be increased due to CYP3A inhibition by lopinavir/ritonavir. 
Serumske koncentracije se lahko povečajo zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem.
Anaemia, leucopenia, neutropenia, lymphadenopathy 
Bolezni krvi in limfatičnega sistema pogosti anemija, levkopenija, nevtropenija in limfadenopatija
Clarithromycin: 
AUC klaritromicina.
Co-administration of encorafenib and Kaletra should be avoided. 
Sočasni uporabi enkorafeniba in zdravila Kaletra se je potrebno izogniti.
Posology 
Obroč
Package leaflet: Information for the user Kaletra 100 mg/25 mg film-coated tablets lopinavir/ritonavir 
Navodilo za uporabo Kaletra 100 mg/25 mg filmsko obložene tablete lopinavir/ritonavir
Anti-gout 
GGT
• antiviral medicine used to treat chronic hepatitis C virus (HCV) infection in adults (e.g. glecaprevir/pibrentasvir, simeprevir and sofosbuvir/velpatasvir/voxilaprevir); 
- elbasvir/grazoprevir (uporablja se za zdravljenje kronične okužbe z virusom hepatitisa C [HCV]); - ombitasvir/paritaprevir/ritonavir z ali brez dasabuvirja (uporablja se za zdravljenje kronične okužbe z virusom hepatitisa C [HCV]); - neratinib (uporablja se za zdravljenje raka dojk); - avanafil ali vardenafil (uporablja se za zdravljenje erektilne disfunkcije);
The pharmacokinetic data from HIV-1 infected pregnant women receiving lopinavir/ritonavir tablets 400/100 mg twice daily are presented in Table 6 (see section 4.2). 
400/100 mg tablete dvakrat dnevno, so prikazani v Preglednici 6 (glejte poglavje 4.2).
Increased plasma concentrations of fusidic acid. 
Večja koncentracija fusidne kisline v plazmi.
Tip 
Bat
Hypersensitivity including urticaria and angioedema 
Bolezni imunskega sistema pogosti preobčutljivost vključno z urtikarijo in angioedemom občasni vnetni sindrom imunske rekonstitucije
The selection of resistance to lopinavir in patients having failed prior protease inhibitor therapy was characterised by analysing the longitudinal isolates from 19 protease inhibitor-experienced subjects in 2 Phase II and one Phase III studies who either experienced incomplete virologic suppression or viral rebound subsequent to initial response to Kaletra and who demonstrated incremental in vitro resistance between baseline and rebound (defined as emergence of new mutations or 2-fold change in phenotypic susceptibility to lopinavir). 
Analiza odpornosti pri bolnikih, izkušenih z zaviralci proteaz Selekcijo odpornosti proti lopinavirju pri bolnikih, pri katerih je bilo predhodno zdravljenje z zaviralcem proteaz neuspešno, so opredelili z analizo longitudinalnih izolatov 19 bolnikov, izkušenih z zaviralci proteaz, in sicer v dveh študijah II.
Outcomes at Week 24: Study M97-765 
Rezultati v 24. tednu: Študija M97-765 Kaletra 400/100 mg (N=36)
Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of quetiapine are expected to increase. 
Zaradi zavrtja CYP3A z lopinavirjem/ritonavirjem je pričakovati povišane koncentracije kvetiapina.
Barrel Tip 
Cev Konica
Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway e.g. budesonide and triamcinolone. 
Pri bolnikih, ki so dobivali ritonavir in inhalirani ali intranazalni flutikazonpropionat, so opisani sistemski učinki kortikosteroidov, vključno s Cushingovim sindromom in adrenalno supresijo.
Rash including maculopapular rash, dermatitis/rash including eczema and seborrheic dermatitis, night sweats, pruritus 
Bolezni kože in podkožja pogosti izpuščaj vključno z makropapularnim izpuščajem, dermatitis/izpuščaj vključno z ekcemom in seboroičnim dermatitisom, nočno potenje, pruritus občasni alopecija, kapilaritis, vaskulitis neznana pogostnost
Herbal products 
Zdravila rastlinskega izvora
Package leaflet: Information for the user Kaletra 200 mg/50 mg film-coated tablets lopinavir/ritonavir 
Navodilo za uporabo Kaletra 200 mg/50 mg filmsko obložene tablete lopinavir/ritonavir
Kaletra must not be co-administered with oral midazolam (see section 4.3), whereas caution should be used with co-administration of Kaletra and parenteral midazolam. 
4.3), v primeru sočasne uporabe zdravila Kaletra in parenteralnega midazolama pa je potrebna previdnost.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton of multipacks of 120 (3 cartons of 40 film-coated 200 mg/50 mg film-coated tablets) - including the blue box 
Škatla z multipakiranji po 120 tablet (3 škatle s 40 filmsko obloženimi tabletami) - vključno z modrim okencem
− calcium channel antagonists (e.g. felodipine, nifedipine, nicardipine); 
zaviralci kalcijevih kanalčkov (npr. felodipin, nifedipin, nikardipin); zdravila za urejanje srčnega ritma (npr. bepridil, sistemski lidokain, kinidin);
vanilla flavour (containing p-hydroxybenzoic acid, p-hydroxybenzaldehyde, vanillic acid, vanillin, heliotropin, ethyl vanillin), polyoxyl 40 hydrogenated castor oil, cotton candy flavour (containing ethyl maltol, ethyl vanillin, acetoin, dihydrocoumarin, propylene glycol), acesulfame potassium, saccharin sodium, sodium chloride, peppermint oil, sodium citrate, citric acid, levomenthol. 
dihidrokumarin, propilenglikol), kalijev acesulfamat, natrijev saharinat, natrijev klorid, eterično olje poprove mete, natrijev citrat, citronska kislina, levomentol.
Oral solution contains: alcohol (42.4% v/v), high fructose corn syrup, propylene glycol (15.3% w/v), purified water, glycerol, povidone, magnasweet-110 flavour (mixture of monoammonium glycyrrhizinate and glycerol), 
Peroralna raztopina vsebuje: alkohol (42,4 % v/v) visokofruktozni koruzni sirup propilenglikol (15,3 % m/v)
Important to open 
Nujno odlepite.
Concentrations may be affected when co-administered with lopinavir/ritonavir due to CYP2C9 induction. 
zaradi večjih plazemskih koncentracij, ki jih povzroči lopinavir/ritonavir z zavrtjem CYP3A4.
Sildenafil used to treat erectile dysfunction may be taken under doctor's supervision 
Za zdravljenje erektilne disfunkcije lahko sildenafil uporabljate pod zdravniškim nadzorom (glejte poglavje Druga zdravila in zdravilo Kaletra).
Refer to the afatinib SmPC for dosage adjustment recommendations. 
Za priporočila glede prilagoditve odmerjanja glejte povzetek glavnih značilnosti zdravila za afatinib.
Paediatric dosing guidelines for the dose 230/57.5 mg/m2 > 6 months to < 18 years 
Shemi 230/57,5 mg/m2
Copovidone 
Bupropion
Outcomes at Week 48: Study M98-957 
Rezultati v 48. tednu: Študija M98-957 Kaletra 400/100 mg (N=57)
• medicines affecting the immune system (e.g. cyclosporin, sirolimus (rapamycin), tacrolimus); 
(npr. bosentan, riociguat, sildenafil, tadalafil); - zdravila z vplivom na imunski sistem (npr. ciklosporin, sirolimus (rapamicin), takrolimus); - zdravila, ki se uporabljajo za odvajanje od kajenja (npr. bupropion);
Hazard ratio for death or failure of therapy* * Failure defined as clinical, immunological disease progression, virological failure or regimen limiting ART toxicity p=0.0005 (40 week arm); p< 0.0008 (96 week arm) 
p=0.0005 (skupina s 40-tedenskim zdravljenjem); p< 0.0008 (skupina s 96-tedenskim zdravljenjem)
BSA (m2) = √ (Height (cm) X Weight (kg) / 3600) It is recommended that Kaletra not be administered in combination with efavirenz or nevirapine in patients less than 6 months of age. 
telesna površina (m2) = √ (višina (cm) X telesna masa (kg) / 3600) Otroci do 2. leta starosti
Concentrations may be reduced due to induction of CYP3A by the herbal preparation St John's wort. 
Lopinavir: zaradi indukcije CYP3A z zeliščnim pripravkom šentjanževko se koncentracija lahko zniža.
Collar 
Konica
Carbamazepine and phenobarbital levels should be monitored when co-administering with Kaletra. 
Kaletra, je treba kontrolirati koncentracijo karbamazepina oz. fenitoina.
An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy. 
Med protiretrovirusnim zdravljenjem se lahko poveča telesna masa ter zviša koncentracija lipidov in glukoze v krvi.
• protease inhibitors (e.g. fosamprenavir, indinavir, ritonavir, saquinavir, tipranavir); 
- peroralni kontraceptivi ali kontraceptivi v obližu za preprečevanje nosečnosti (glejte poglavje spodaj z naslovom “Kontraceptivi”); - zaviralci proteaz (npr. fosamprenavir, indinavir, ritonavir, sakvinavir, tipranavir); - pomirjevalna zdravila (npr. injicirani midazolam); - steroidi (npr. budezonid, deksametazon, flutikazonpropionat, etinilestradiol, triamcinolon);
For the treatment of pulmonary arterial hypertension: 
- zdravila za zdravljenje pljučne arterijske hipertenzije (visokega krvnega tlaka v pljučni arteriji)
The use of rivaroxaban is not recommended in patients receiving concomitant treatment with Kaletra (see section 4.4). 
Uporaba rivaroksabana ni priporočljiva pri bolnikih, ki sočasno prejemajo zdravilo
7.5 mg/ml Solution for injection 
Abilify 7,5 mg/ ml raztopina za injiciranje intramuskularn a uporaba steklena viala
Intramuscular use vial (glass) 
ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja peroralna pretisni omot
Outcome of a procedure under Article 6(12) of Regulation (EC) 1084/2003 as amended 
Izid postopka po členu 6(12) Uredbe (ES) 1084/2003, kakor je bila spremenjena
This variation was to be recognised in Austria, Belgium, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the United Kingdom 
Ta sprememba bi se morala priznati: v Avstriji, Belgiji, na Finskem, v Franciji, Grčiji, na Irskem, v Italiji, Luksemburgu, Nemčiji, na
The Committee looked at the studies presented by the company to support the new indication. 
Odbor je pregledal predložene študije družbe v podporo novi indikaciji.
The European Commission issued a decision on 02 September 2010. 
Evropska komisija je odločbo izdala dne 02. septembra 2010.
Rapporteur: 
Poročevalka:
Another point was the fact that the company had presented too few data on the final height reached by the patients in the studies. 
Pomembno je bilo tudi dejstvo, da je družba predstavila premalo podatkov o končni višini, ki so jo dosegli bolniki v študijah.
Because the Member States were not able to reach an agreement, the Netherlands referred the matter to the CHMP for arbitration on 28 October 2009. 
Vendar se države članice niso uspele dogovoriti in Nizozemska je dne 28. oktobra 2009 zadevo napotila na CHMP v arbitražo.
Why was Genotropin reviewed? 
Zakaj je bilo zdravilo Genotropin pregledano?
1 In all other Member States of the EU, the medicine has received a marketing authorisation at national level. 
1 V vseh ostalih državah članicah EU je bilo za zdravilo izdano dovoljenje za promet na nacionalni ravni.
The company that makes the medicine is Pfizer. 
Družba, ki izdeluje zdravilo, je Pfizer.
In 15 Member States of the EU, Genotropin is authorised under a mutual recognition procedure on the basis of the initial authorisation granted by Denmark on 7 May 19871. 
Zdravilo Genotropin je odobreno v 15 državah članicah EU s postopkom z medsebojnim priznavanjem na podlagi prvotnega dovoljenja za promet, ki je bilo odobreno na Danskem dne 7. maja 19871.
25 January 2010, 3 May 2010 and 24 May 2010 
25. januar 2010, 3. maj 2010 in 24. maj 2010
The European Medicines Agency has completed an arbitration procedure for Genotropin and associated names. 
Evropska agencija za zdravila je zaključila arbitražni postopek za zdravilo Genotropin in povezana imena.
The Committee concluded that the change to the marketing authorisation cannot be granted. 
Odbor je sklenil, da spremembe dovoljenja za promet z zdravilom ni mogoče odobriti.
Genotropin, also marketed under the trade name Genotonorm, is available throughout the European Union (EU). 
Zdravilo Genotropin se trži tudi z imenom Genotonorm in je na voljo po vsej Evropski Uniji (EU).
In July 2008, Pfizer applied for a change (variation) to the marketing authorisation to add a new indication in Denmark (the ‘reference Member State'). 
Družba Pfizer je julija 2008 vložila vlogo za spremembo (variacijo) dovoljenja za promet z zdravilom za vključitev nove indikacije na Danskem (v „referenčni državi članici“).
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the variation to the marketing authorisation for Genotropin cannot be approved in Denmark as well as in all concerned Member States. 
CHMP je po vrednotenju trenutno razpoložljivih podatkov in znanstveni razpravi v Odboru zaključil, da spremembe dovoljenja za promet z zdravilom Genotropin ni mogoče odobriti na Danskem in tudi ne v zadevnih državah članicah.
What is Genotropin? 
Kaj je zdravilo Genotropin?
Genotropin is a medicine that contains somatropin, which is a copy of natural growth hormone. 
Genotropin je zdravilo, ki vsebuje somatropin, kopijo naravnega rastnega hormona.
Growth hormone promotes growth during childhood and adolescence, and also acts on the way the body handles proteins, fat and carbohydrates. 
Rastni hormon spodbuja rast v času otroštva in adolescence ter vpliva na način, kako telo presnavlja beljakovine, maščobo in ogljikove hidrate.
The grounds for the referral were that fewer patients currently need to use steroids than in the past, because other medicines that do not affect growth have become available to control JIA. 
Podlaga za napotitev je temeljila na tem, da je trenutno manj bolnikov, ki morajo za nadzorovanje JIA uporabljati steroide kot v preteklosti, saj so na voljo druga zdravila, ki ne vplivajo na rast.
It also looked at published information on the use of growth hormone in patients with JIA, and convened a meeting of experts, which included experts both in the treatment of hormonal disorders (endocrinologists) and in the treatment of joint diseases (rheumatologists). 
Prav tako je proučil objavljene informacije o uporabi rastnega hormona pri bolnikih z JIA ter sklical srečanje strokovnjakov, na katerem so sodelovali strokovnjaki s področja zdravljenja hormonskih motenj (endokrinologi) in zdravljenja bolezni sklepov (revmatologi).
24 June 2010 
24. junij 2010