Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

egis pharmaceuticals plc kereszturi ut 30-38 1106 boedapest (hongarije) - sunitinibcyclamaat 72,5 mg/stuk samenstelling overeenkomend met ; sunitinib 50 mg/stuk - capsule, hard - croscarmellose natrium (e 468) ; gelatine (e 441) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; magnesiumstearaat (e 470b) ; mannitol (d-) (e 421) ; povidon k 30 (e 1201) ; titaandioxide (e 171)

Europese Unie - Nederlands - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - a / indonesië / 05/2005 (h5n1) zoals gebruikte stam (pr8-ibcdc-rg2) - influenza, human; immunization; disease outbreaks - vaccins - actieve immunisatie tegen het h5n1-subtype van influenza-a-virus. deze indicatie is gebaseerd op immunogeniciteit gegevens van gezonde proefpersonen vanaf de leeftijd van 18 jaar na toediening van twee doses van het vaccin, bereid met h5n1 subtype stammen. prepandrix moet worden gebruikt in overeenstemming met officiële richtlijnen.

Europese Unie - Nederlands - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a.  - pandemic influenza vaccine (h5n1) (split virion, geïnactiveerd, adjuvanted) - influenza, human; immunization; disease outbreaks - vaccins - profylaxe van influenza in een officieel verklaarde pandemische situatie. pandemie van influenza vaccin moet worden gebruikt in overeenstemming met de officiële richtlijnen.

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

viatris healthcare sa-nv - citroenzuur 14,8 g; natriumcitraatdihydraat 39 g; kaliumcitraatmonohydraat 46 g - granulaat - citroenzuur 148 mg/g; natriumcitraat 390 mg/g; kaliumcitraat 460 mg/g - urinary concrement solvents

Europese Unie - Nederlands - EMA (European Medicines Agency)

pfizer europe ma eeig - tofacitinib - artritis, reumatoïde - immunosuppressiva - rheumatoid arthritistofacitinib in combination with methotrexate (mtx) is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (dmards) (see section 5. tofacitinib can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate (see sections 4. 4 en 4. psoriatic arthritistofacitinib in combination with mtx is indicated for the treatment of active psoriatic arthritis (psa) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (dmard) therapy (see section 5. ulcerative colitistofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5. tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [rf+] or negative [rf-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (psa) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (dmards). tofacitinib can be given in combination with methotrexate (mtx) or as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. ankylosing spondylitistofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (as) who have responded inadequately to conventional therapy.

Europese Unie - Nederlands - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochloride - multiple sclerose, relapsing-remitting - immunosuppressiva - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 en 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Europese Unie - Nederlands - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - spesolimab - psoriasis - immunosuppressiva - spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis (gpp) as monotherapy.

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

biotest pharma gmbh landsteinerstrasse 5 d-63303 dreieich (duitsland) - humaan, normaal immunoglobuline voor intraveneus gebruik 100 mg/ml - oplossing voor infusie - glycine (e 640) ; water voor injectie, - immunoglobulins, normal human, for intravascular adm.

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

biotest pharma gmbh landsteinerstrasse 5 d-63303 dreieich (duitsland) - humaan, normaal immunoglobuline voor intraveneus gebruik 50 mg/ml - oplossing voor infusie - glycine (e 640) ; water voor injectie, - immunoglobulins, normal human, for intravascular adm.

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

biotest pharma gmbh - humane plasmaproteïnen 50 mg/ml - oplossing voor infusie - 50 g/l - humane normale immunoglobulinen 50 mg/ml - immunoglobulins, normal human, for intravascular adm.