האיחוד האירופי - מלטית - EMA (European Medicines Agency)

cp-pharma handelsgesellschaft mbh - dexmedetomidine hydrochloride - psycholeptics, ipnotiċi u sedattivi - cats; dogs - proċeduri u eżamijiet mhux invażivi, ħfief sa moderatament bl-uġigħ li jeħtieġu trażżin, sedazzjoni u analġeżija fi klieb u qtates. sedazzjoni profonda u analġeżija fil-klieb fl-użu konkomitanti ma 'butorphanol għal proċeduri kirurġiċi mediċi u żgħar. premedikazzjoni fil-klieb u l-qtates qabel l-induzzjoni u l-manutenzjoni ta 'anestesija ġenerali.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

novartis europharm limited - travoprost - ocular hypertension; glaucoma, open-angle - ophthalmologicals, antiglaucoma preparations and miotics - tnaqqis ta 'pressjoni intraokulari elevata f'pazjenti adulti bi pressjoni għolja fl-għajn jew glawkoma b'angolu miftuħ (ara sezzjoni 5. tnaqqis ta ' pressjoni għolja f'pazjenti pedjatriċi b'età minn 3 snin sa < 18-il sena bi pressjoni għolja fl-għajn jew pedjatriċi glawkoma.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - aġenti antineoplastiċi - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. pazjenti b'egfr jew alkalini pożittivi tat-tumur mutazzjonijiet għandu wkoll rċevew terapija immirata qabel ma tirċievi keytruda. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - dexamethasone - macular edema; uveitis - ophthalmologicals, other ophthalmologicals - ozurdex huwa indikat għall-kura ta ' pazjenti adulti b'edema makulari tad-dijabete li ġejjin jew fergħa tar-retina-okklużjoni tal-vina (brvo) jew ċentrali tar-retina-okklużjoni tal-vina (crvo). ozurdex huwa indikat għall-kura ta 'pazjenti adulti b'infjammazzjoni ta' l-segment posterjuri ta ' l-għajn l-preżentazzjoni kif noninfectious uveite. ozurdex huwa indikat għall-kura ta 'pazjenti adulti b'indeboliment tal-vista minħabba ta' edima makulari dijabetika (dme) li huma pazjenti psewdoafakiċi jew li huma kkunsidrati bħala mhux biżżejjed li jirrispondu għal, jew li mhux tajbin għall-non-terapija tal-kortikosterojdi.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

accord healthcare s.l.u. - pregabalin - anxiety disorders; epilepsy - anti-epilettiċi, - epilepsypregabalin qbil huwa indikat bħala terapija aġġuntiva f'persuni adulti b'aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja. ta'ansjetà ġeneralizzata disorderpregabalin qbil huwa indikat għall-kura ta 'disturb ta' ansjetà Ġeneralizzata (gad-generalised anxiety disorder) f'persuni adulti.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

biopartners gmbh - somatropin - tkabbir - pituitary and hypothalamic hormones and analogues, somatropin and somatropin agonists - somatropin biopartners huwa indikat għat-terapija ta 'sostituzzjoni ta' ormon tat-tkabbir endoġenu f'adulti b'defiċjenza ta 'ormon tat-tkabbir tat-tfulija jew ta' adulti (ghd). adulti bidu: pazjenti b'ghd f'età adulta huma definiti bħala pazjenti b'patoloġija ipotalamika-pitwitarja magħrufa u mill-inqas defiċjenza oħra magħrufa ta'ormon pitwitarju li minbarra prolactin. dawn il-pazjenti għandu jkollhom test dinamiku wieħed sabiex tiġi ddijanjostikata jew eskluża ghd. tfulija-bidu: f'pazjenti bil-tfulija-bidu iżolati ghd (l-ebda evidenza ta assi ipotalamika-pitwitarja-marda jew irradjazzjoni kranjali), żewġ testijiet dinamiċi għandhom jiġu mwettqa wara t-tlestija tat-tkabbir, ħlief għal dawk li jkollhom baxx insulin-like-tkabbir tal-fattur-i (igf-i) fil-plażma (< -2 standard deviation score (sds)), li jistgħu jiġu kkunsidrati għal test wieħed. - il-punt ta'qtugħ tat-test dinamiku għandu jkun strett.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

mendelikabs europe ltd - nitisinone - tyrosinemias - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - trattament ta ' l-adulti u paediatric (fi kwalunkwe medda ta ' età) pazjenti ma dijanjosi konfermati ta ' tyrosinemia ereditarji tat-tip 1 (ht 1) flimkien ma ' restrizzjoni tad-dieta ta ' tyrosine u fenilalanina.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

cycle pharmaceuticals (europe) ltd - nitisinone - tyrosinemias - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - it-trattament tal-pazjenti adulti u pedjatriċi b'dijanjosi kkonfermata ta 'tirosinemia ereditarja ta' tip 1 (ht-1) flimkien ma 'restrizzjoni tad-dieta ta' tyrosine u phenylalanine.

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

novartis europharm limited  - brolucizumab - deġenerazzjoni makulari mxarrba - oftalmoloġiċi - beovu huwa indikat fl-adulti għall-kura ta neovaskulari (imxarrba) relatata mal-età deġenerazzjoni makulari (amd).

האיחוד האירופי - מלטית - EMA (European Medicines Agency)

eurogenerics holdings b.v. - teriparatide - l-osteoporożi - homeostasi tal-kalċju - qutavina is indicated in adults. trattament ta 'l-osteoporożi f'nisa wara l-menopawża u fl-irġiel b'riskju akbar ta' ksur. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. trattament ta 'osteoporożi assoċjat ma sostnut sistemika terapija bi glukokortikojdi f'nisa u l-irġiel f'riskju akbar ta' ksur.