Europos Sąjunga - rumunų - EMA (European Medicines Agency)

a. menarini industrie farmaceutiche riunite s.r.l. - delafloxacin meglumină - infecții dobândite în comunitate - antibacteriene pentru uz sistemic, - quofenix is indicated for the treatment of the following infections in adults:acute bacterial skin and skin structure infections (absssi),community-acquired pneumonia (cap), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4. 4 și 5. trebuie luate în considerare ghidurile oficiale referitoare la utilizarea adecvată a medicamentelor antibacteriene.

Europos Sąjunga - rumunų - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - upadacitinib - artrita, reumatoida - imunosupresoare - rheumatoid arthritisrinvoq is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (dmards). rinvoq may be used as monotherapy or in combination with methotrexate. psoriatic arthritisrinvoq is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more dmards. rinvoq may be used as monotherapy or in combination with methotrexate. axial spondyloarthritisnon-radiographic axial spondyloarthritis (nr-axspa)rinvoq is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri), who have responded inadequately to nonsteroidal anti-inflammatory drugs (nsaids). ankylosing spondylitis (as, radiographic axial spondyloarthritis)rinvoq is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. atopic dermatitisrinvoq is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. ulcerative colitisrinvoq is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.  crohn’s diseaserinvoq is indicated for the treatment of adult patients with moderately to severely active crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Europos Sąjunga - rumunų - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - imipenem monohidrat, cilastatin de sodiu, monohidrat relebactam - gram-negativi infectii bacteriene - carbapenems, antibacterials for systemic use, - recarbrio is indicated for:- treatment of hospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap), in adults (see sections 4. 4 și 5. - treatment of bacteraemia that occurs in association with, or is suspected to be associated with hap or vap, in adults. - treatment of infections due to aerobic gram-negative organisms in adults with limited treatment options (see sections 4. 2, 4. 4, și 5. trebuie luate în considerare ghidurile oficiale referitoare la utilizarea adecvată a medicamentelor antibacteriene.

Europos Sąjunga - rumunų - EMA (European Medicines Agency)

hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - imunosupresoare - idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. the use of idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.

Europos Sąjunga - rumunų - EMA (European Medicines Agency)

nabriva therapeutics ireland dac - lefamulin acetate - pneumonia, bacterial; community-acquired infections - antibacteriene pentru uz sistemic, - xenleta is indicated for the treatment of community-acquired pneumonia (cap) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of cap or when these have failed. trebuie luate în considerare ghidurile oficiale referitoare la utilizarea adecvată a medicamentelor antibacteriene.

Europos Sąjunga - rumunų - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - elivaldogene autotemcel - adrenoleukodystrophy - alte medicamente pentru sistemul nervos - treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an abcd1 genetic mutation, and for whom a human leukocyte antigen (hla) matched sibling haematopoietic stem cell donor is not available.

Europos Sąjunga - rumunų - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - azacitidină - leucemie, mieloidă, acută - agenți antineoplazici - onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (aml) who achieved complete remission (cr) or complete remission with incomplete blood count recovery (cri) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (hsct).

Europos Sąjunga - rumunų - EMA (European Medicines Agency)

roche registration gmbh  - pralsetinib - carcinom, pulmonar non-celulă mică - agenți antineoplazici - gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (ret) fusion-positive advanced non-small cell lung cancer (nsclc) not previously treated with a ret inhibitor.

Rumunija - rumunų - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

teva operations poland sp. z.o.o - polonia - lenalidomidum - caps. - 5mg - imunosupresoare alte imunosupresoare

Europos Sąjunga - rumunų - EMA (European Medicines Agency)

plusultra pharma gmbh - sirolimus - angiofibroma; tuberous sclerosis - hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older.