natgillin/translations-raw huggingface dataset:
The CHMP decided that Instanyl’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Instanyl večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Insulatard’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Insulatard večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Insuman’s benefits are greater than its risks for the treatment of type 1 and type 2 diabetes.
CHMP je zaključil, da so koristi zdravila Insuman pri zdravljenju sladkorne bolezni tipa 1 in tipa 2 večje od z njim povezanih tveganj.
The CHMP decided that Intanza’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Intanza večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Intelence’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Intelence večje od z njim povezanih tveganj,, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Intrinsa’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Intrinsa večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Invega’s benefits are greater than its risks in adults and recommended that it be given marketing authorisation for schizophrenia and schizoaffective disorder.
CHMP je zaključil, da so koristi zdravila Invega večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet za zdravljenje shizofrenije in shizoafektivne motnje.
The CHMP decided that Invirase’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Invirase večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Irbesartan Hydrochlorothiazide Zentiva’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Irbesartan Hydrochlorothiazide Zentiva večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Irbesartan Zentiva’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Irbesartan Zentiva večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Iscover’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Iscover večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Isentress’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Isentress večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Ivemend’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Ivemend večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Ixiaro’s benefits are greater than its risks and noted that the production of the only other vaccine for protection against Japanese encephalitis that was in use outside Asia had been discontinued.
Odbor CHMP je zaključil, da so koristi cepiva Ixiaro večje od z njim povezanih tveganj, in opozoril, da se je proizvodnja edinega drugega cepiva za zaščito proti japonskemu encefalitisu, ki se je uporabljalo zunaj Azije, ustavila.
The CHMP decided that Jakavi’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Jakavi večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Januvia’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Januvia večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Javlor’s benefits are greater than its risks and recommended that Javlor be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Javlor večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Kaletra’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Kaletra večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Karvea’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Karvea večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Karvezide’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Karvezide večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Keppra’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Keppra večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Kineret’s benefits are greater than its risks for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in patients with an inadequate response to methotrexate alone.
Odbor za zdravila za uporabo v humani medicini (CHMP) je menil, da so koristi zdravila Kineret pri zdravljenju znakov in simptomov revmatoidnega artritisa v kombinaciji z metotreksatom pri bolnikih z nezadostnim odzivom na zgolj metotreksat večji od z njim povezanih tveganj.
The CHMP decided that Kinzalkomb’s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone.
CHMP je zaključil, da so koristi zdravila Kinzalkomb pri zdravljenju esencialne hipertenzije pri bolnikih, katerih krvni tlak ni zadostno uravnan samo s telmisartanom, večje od z njim povezanih tveganj.
The CHMP decided that Kinzalmono’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Kinzalmono večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Kivexa’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Kivexa večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Kogenate Bayer’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Kogenate Bayer večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Kuvan’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor CHMP je zaključil, da so koristi zdravila Kuvan večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Lantus’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Lantus večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Leflunomide Winthrop’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Leflunomide Winthrop večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Leganto’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Leganto večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Levemir’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Levemir večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Levitra’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor CHMP je zaključil, da so koristi zdravila Levitra večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Levodopa/Carbidopa/Entacapone Orion’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Levodopa/Carbidopa/Entacapone Orion večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Livensa’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Livensa večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Lucentis’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Lucentis večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Luminity’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Luminity večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Luveris’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Luveris večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Lyrica’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Lyrica večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Lysodren’s benefits are greater than its risks for the treatment of advanced adrenal cortical carcinoma, but noted that the effect of Lysodren has not been established in adrenal cortical carcinoma that is not producing high levels of steroid hormones.
CHMP je zaključil, da so koristi zdravila Lysodren pri zdravljenju napredovalega karcinoma skorje nadledvične žleze večje od z njim povezanih tveganj, vendar je hkrati opomnil, da učinki zdravila Lysodren pri karcinomu skorje nadledvične žleze, ki ne tvori visokih ravni steroidnih hormonov, niso bili ugotovljeni.
The CHMP decided that M-M-RVAXPRO’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi cepiva M-M-RVAXPRO večje od z njim povezanih tveganj,in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Macugen’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zaključil je, da so koristi zdravila Macugen večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Memantine Merz’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Memantine Merz večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Mepact’s benefits are greater than its risks when used with other anticancer medicines and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Mepact, kadar se uporablja v kombinaciji z drugimi zdravili proti raku, večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Mirapexin’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Mirapexin večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Mixtard’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Mixtard večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Modigraf’s benefits are greater than its risks for prophylaxis of transplant rejection in kidney, liver and heart recipients, and in the treatment of rejection resistant to treatment with other immunosuppressive medicinal products.
Odbor za zdravila za uporabo v humani medicini je zaključil, da so koristi zdravila Modigraf za preprečevanje zavrnitve presadkov ledvic, jeter in srca ter pri zdravljenju zavrnitve, ki je ni mogoče zdraviti z drugimi imunosupresivnimi zdravili, večje od z njim povezanih tveganj.
The CHMP decided that Mycamine’s benefits are greater than its risks for the treatment of invasive candidiasis and of oesophageal candidiasis, and for the prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation or who are expected to have neutropenia for 10 or more days.
CHMP je zaključil, da so koristi zdravila Mycamine večje od z njim povezanih tveganj za zdravljenje invazivne kandidoze in kandidoze požiralnika ter za preprečevanje okužbe s Candido pri bolnikih po alogenski presaditvi hematopoetskih matičnih celic ali pri bolnikih, za katere predvidevajo, da bodo imeli 10- ali večdnevno nevtropenijo.
The CHMP decided that Myozyme’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Myozyme večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Naglazyme’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Naglazyme večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Neoclarityn’s benefits are greater than its risks for the relief of symptoms associated with allergic rhinitis or urticaria and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Neoclarityn pri lajšanju simptomov alergijskega rinitisa ali urtikarije večji od z njim povezanih tveganj, in priporočil da se zanj odobri dovoljenje za promet.
The CHMP decided that NeoRecormon’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila NeoRecormon večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Neulasta’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Neulasta večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Neupro’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Neupro večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that NeuroBloc’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila NeuroBloc večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Nevanac’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Nevanac večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Nexavar’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Nexavar večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that NexoBrid’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zaključil je, da so koristi zdravila NexoBrid večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Nonafact’s benefits are greater than its risks for the treatment and prevention of bleeding in patients with haemophilia B. They recommended that Nonafact be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Nonafact za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo B večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Norvir’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Norvir večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that NovoMix’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila NovoMix večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that NovoSeven’s benefits are greater than its risks for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in patients with congenital haemophilia, acquired haemophilia, congenital factor VII deficiency or Glanzmann’s thrombasthenia.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila NovoSeven pri zdravljenju krvavitev in preprečevanju krvavitev pri kirurških posegih ali invazivnih postopkih pri bolnikih s pridobljeno hemofilijo, prirojenim pomanjkanjem faktorja VII ali Glanzmannovo trombastenijo večje od z njim povezanih tveganj.
The CHMP decided that Nplate’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zaključil je, da so koristi zdravila Nplate večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Onbrez Breezhaler’s benefits are greater than its risks and recommended that Onbrez Breezhaler be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Onbrez Breezhaler večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Onsenal’s benefits are greater than its risks but noted that no effect of Onsenal on the risk of developing cancer of the intestine had been shown.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Onsenal večje od z njim povezanih tveganj, vendar je pripomnil, da vpliv zdravila Onsenal na tveganje za nastanek raka v črevesju ni bil dokazan.
The CHMP decided that Opatanol’s benefits are greater than its risks for the treatment of ocular signs and symptoms of seasonal allergic conjunctivitis and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Opatanol večje od z njim povezanih tveganj pri zdravljenju očesnih znakov in simptomov sezonskega alergijskega konjunktivitisa, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Opgenra’s benefits are greater than its risks for posterolateral lumbar spinal fusion in adult patients with spondylolisthesis where autograft has failed or is contra-indicated.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Opgenra pri posterolateralni lumbalni spinalni fuziji pri odraslih bolnikih s spondilolistezo, pri katerih avtologni presadek ni bil uspešen ali pa je kontraindiciran, večje od z njim povezanih tveganj.
The CHMP decided that Optaflu’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi cepiva Optaflu večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Optimark’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Optimark večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Orgalutran’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Orgalutran večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Osigraft’s benefits are greater than its risks and recommended that Osigraft be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Osigraft večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Oslif Breezhaler’s benefits are greater than its risks and recommended that Oslif Breezhaler be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Oslif Breezhaler večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Osseor’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Osseor večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Ovitrelle’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Ovitrelle večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Pandemic Influenza Vaccine H5N1 Baxter AG’s benefits are greater than its risks in all age groups investigated and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Pandemic Influenza Vaccine H5N1 Baxter AG pri vseh proučevanih starostnih skupinah večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Pandemrix’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Pandemrix večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Panretin’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Panretin večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Pedea’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Pedea večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.