Evrópusambandið - maltneska - EMA (European Medicines Agency)

life molecular imaging gmbh - florbetaben (18f) - radionuclide imaging; alzheimer disease - radjofarmaċewtiċi dijanjostiċi - dan il-prodott mediċinali huwa għal użu dijanjostiku biss. neuraceq hija prodott radjufarmaċewtiku indikat għall-positron emission tomography (pet) tal-immaġini tal-β amyloid neuritic-plakka densità fl-imħuħ tal-pazjenti adulti b'indeboliment konjittiv li jkunu qed jiġu evalwati għall-marda ta'alzheimer (ad) u kawżi oħra ta ' indeboliment konjittiv. neuraceq għandhom jintużaw flimkien ma ' evalwazzjoni klinika. negattiv scan jindika skarsa jew l-ebda plakek, li mhuwiex konsistenti mal-dijanjosi tal ad.

Evrópusambandið - maltneska - EMA (European Medicines Agency)

pfizer europe ma eeig  - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulanti, - filgrastim huwa indikat għall-tnaqqis fit-tul tal-neutropenia u l-inċidenza tal-marda bid-deni neutropenia fil-pazjenti trattati ma chemotherapy ċitotossiċi stabbiliti għall-malignancy (bl-eċċezzjoni tal-lewċemja myeloid kronika u myelodysplastic sindromi) u għat-tnaqqis fit-tul tal-neutropenia fil-pazjenti sottoposti għal terapija myeloablative segwit mill-mudullun trapjant meqjusa li huma f'riskju akbar ta ' neutropenia ħorox imtawla. is-sigurtà u l-effikaċja ta 'filgrastim huma simili fl-adulti u fit-tfal li qed jirċievu kimoterapija ċitotossika. filgrastim huwa indikat għall-mobilizzazzjoni ta ' ċelluli proġenituri tad-demm (pbpcs). f'pazjenti, tfal jew adulti, b'severa konġenitali, ċiklika, jew newtropenja idjopatika bl-għadd assolut ta 'newtrofili (anc) ta' ≤0. 5 x 109/l, u storja ta severi jew infezzjonijiet rikorrenti, l-għoti fit-tul ta 'filgrastim hu indikat biex iżid l-għadd tan-newtrofili u biex inaqqas l-inċidenza u t-tul ta' l-infezzjoni avvenimenti relatati mal-. filgrastim huwa indikat għall-kura ta ' newtropenja persistenti (anc ≤1. 0 x 109 / l) f'pazjenti b'infezzjoni avvanzata ta 'l-hiv, sabiex jitnaqqas ir-riskju ta' infezzjonijiet batteriċi meta għażliet oħra biex tiġi amministrata n-newtropenija mhumiex xierqa.

Evrópusambandið - maltneska - EMA (European Medicines Agency)

recordati netherlands b.v. - siltuximab - iperplażja tal-node tal-linfoma Ġigant - immunosoppressanti - sylvant huwa indikat għall-kura tal-pazjenti adulti bil-marda tal-castleman multicentric (mcd li huma negattivi negattivi u l-bniedem herpesvirus-8 (hhv-8) immunodefiċjenza umani virus (hiv).

Evrópusambandið - maltneska - EMA (European Medicines Agency)

astrazeneca ab - ticagrelor - peripheral vascular diseases; acute coronary syndrome - aġenti antitrombotiċi - possia, ko amministrati bl-aċidu aċetilsaliċiliku (asa), huwa indikat għall-prevenzjoni ta ' l-avvenimenti ta ' atherothrombotic fil-pazjenti adulti ma sindromi coronary akuta (anġina instabbli, mhux-st-elevazzjoni myocardial infarzjoni [nstemi]-tnaqqis jew il-st-elevazzjoni myocardial infarzjoni [stemi]); inklużi pazjenti amministrati medikament, u dawk li huma amministrati bl-intervent coronary perkutanja (pci) jew coronary artery by-pass tilqim (cabg).

Evrópusambandið - maltneska - EMA (European Medicines Agency)

ratiopharm gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulanti, - ratiograstim huwa indikat għall-tnaqqis fit-tul tal-neutropenia u l-inċidenza tal-marda bid-deni neutropenia fil-pazjenti trattati ma chemotherapy ċitotossiċi stabbiliti għall-malignancy (bl-eċċezzjoni tal-lewċemja myeloid kronika u myelodysplastic sindromi) u għat-tnaqqis fit-tul tal-neutropenia fil-pazjenti sottoposti għal terapija myeloablative segwit mill-mudullun trapjant meqjusa li huma f'riskju akbar ta ' neutropenia ħorox imtawla. is-sigurtà u l-effikaċja ta 'filgrastim huma simili fl-adulti u fit-tfal li qed jirċievu kimoterapija ċitotossika. ratiograstim huwa indikat għall-mobilizzazzjoni tal-taċ-ċelluli proġenitriċi tad-demm periferali (pbpc). f'pazjenti, tfal jew adulti, b'severa konġenitali, ċiklika, jew newtropenja idjopatika bl-għadd assolut ta 'newtrofili (anc) ta' ≤ 0. 5 x 109/l, u storja ta severi jew infezzjonijiet rikorrenti fit-tul fit-amministrazzjoni ta 'ratiograstim huwa indikat biex jiżdied l-għadd ta'newtrofili u biex inaqqas l-inċidenza u t-tul ta' l-infezzjoni avvenimenti relatati mal-. ratiograstim huwa indikat għall-kura ta ' newtropenja persistenti (anc ≤ 1. 0 x 109 / l) f'pazjenti b'infezzjoni avvanzata ta 'l-hiv, sabiex jitnaqqas ir-riskju ta' infezzjonijiet batteriċi meta għażliet oħra biex tiġi amministrata n-newtropenija mhumiex xierqa.

Evrópusambandið - maltneska - EMA (European Medicines Agency)

teva gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulanti, - tevagrastim huwa indikat għall-tnaqqis fit-tul tal-neutropenia u l-inċidenza tal-marda bid-deni neutropenia fil-pazjenti trattati ma chemotherapy ċitotossiċi stabbiliti għall-malignancy (bl-eċċezzjoni tal-lewċemja myeloid kronika u myelodysplastic sindromi) u għat-tnaqqis fit-tul tal-neutropenia fil-pazjenti sottoposti għal terapija myeloablative segwit mill-mudullun trapjant meqjusa li huma f'riskju akbar ta ' neutropenia ħorox imtawla. is-sigurtà u l-effikaċja ta 'filgrastim huma simili fl-adulti u fit-tfal li qed jirċievu kimoterapija ċitotossika. tevagrastim huwa indikat għall-mobilizzazzjoni tal-taċ-ċelluli proġenitriċi tad-demm periferali (pbpc). f'pazjenti, tfal jew adulti, b'severa konġenitali, ċiklika, jew newtropenja idjopatika bl-għadd assolut ta 'newtrofili (anc) ta' 0. 5 x 109/l, u storja ta severi jew infezzjonijiet rikorrenti fit-tul fit-amministrazzjoni ta 'tevagrastim huwa indikat biex jiżdied l-għadd ta'newtrofili u biex inaqqas l-inċidenza u t-tul ta' l-infezzjoni avvenimenti relatati mal-. tevagrastim huwa indikat għall-kura ta 'newtropenja persistenti (anc ta' inqas minn jew ugwali għal 1. 0 x 109 / l) f'pazjenti b'infezzjoni avvanzata ta 'l-hiv, sabiex jitnaqqas ir-riskju ta' infezzjonijiet batteriċi meta għażliet oħra biex tiġi amministrata n-newtropenija mhumiex xierqa.

Evrópusambandið - maltneska - EMA (European Medicines Agency)

pfizer europe ma eeig - tigecycline - bacterial infections; skin diseases, bacterial; soft tissue infections - antibatteriċi għal użu sistemiku, - tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections: , complicated skin and soft tissue infections (cssti), excluding diabetic foot infections, complicated intra-abdominal infections (ciai) , tygacil should be used only in situations where other alternative antibiotics are not suitable. għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi. l-użu xieraq ta ' sustanzi antibatteriċi.

Evrópusambandið - maltneska - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - daunorubicin hydrochloride, cytarabine - lewkimja, mijelojda, akuta - aġenti antineoplastiċi - vyxeos liposomali huwa indikat għall-kura ta ' adulti li jkunu għadhom kif ġew dijanjostikati, it-terapija relatata mal-lewkimja majelojde akuta (t-aml) jew aml mal-majelodisplasija-bidliet relatati mal (aml-mrc).

Evrópusambandið - maltneska - EMA (European Medicines Agency)

samsung bioepis nl b.v. - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - aġenti antineoplastiċi - aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. aybintio in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. għal aktar informazzjoni dwar l-istatus tal-fattur tat-tkabbir tal-epidermide tal-bniedem 2 (her2), jekk jogħġbok irreferi għat-taqsima 5. 1 of the smpc. aybintio in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with aybintio in combination with capecitabine. għal aktar informazzjoni dwar l-istatus ta 'her2, jekk jogħġbok irreferi għat-taqsima 5. 1 of the smpc. aybintio, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. aybintio, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. 1 of the smpc). aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. aybintio, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. 1 of the smpc). aybintio, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. aybintio, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents (see section 5. 1 of the smpc). aybintio, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5. 1 of the smpc).

Evrópusambandið - maltneska - EMA (European Medicines Agency)

sfl pharmaceuticals deutschland gmbh - nyxthracis - anthrax - sera immuni u immunoglobulini, - obiltoxaximab sfl is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to bacillus anthracis (see section 5. obiltoxaximab sfl is indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available (see section 5.