Avrupa Birliği - Hollandaca - EMA (European Medicines Agency)

corza medical gmbh - menselijk fibrinogeen, menselijk trombine - hemostase, chirurgisch - antihemorragica - tachosil is indicated in adults and children from 1 month of age for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing and for suture support in vascular surgery where standard techniques are insufficient. tachosil is indicated in adults for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery (see section 5.

Hollanda - Hollandaca - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

baxter b.v. kobaltweg 49 3542 ce utrecht - aprotinine (synthetisch) 2250 - 3750 ki-e/ml ; calciumchloride 2-water (e 509) 36 - 44 µmol/ml ; fibrinogeen, humaan 72 - 110 mg/ml ; thrombine, humaan 3,2 - 5 ie/ml - weefsellijm - histidine, (l-) ; humaan albumine ; natriumchloride ; nicotinamide ; polysorbaat 80 (e 433) ; trinatriumcitraat 2-water (e 331) ; water voor injectie, - combinations

Hollanda - Hollandaca - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

baxter b.v. kobaltweg 49 3542 ce utrecht - aprotinine (synthetisch) 2250 - 3750 ki-e/ml ; calciumchloride 2-water (e 509) 36 - 44 mmol/l ; factor xiii 10 <= ie/ml ; fibrinogeen, humaan 72 - 110 mg/ml ; thrombine, humaan 400 - 625 ie/ml - weefsellijm - histidine, (l-) ; humaan albumine ; natriumchloride ; nicotinamide ; polysorbaat 80 (e 433) ; trinatriumcitraat 2-water (e 331) ; water voor injectie, - combinations

Hollanda - Hollandaca - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

baxter b.v. kobaltweg 49 3542 ce utrecht - aprotinine (synthetisch) 2250 - 3750 ki-e/ml ; calciumchloride 2-water (e 509) 36 - 44 mmol/l ; factor xiii 10 <= ie/ml ; fibrinogeen, humaan 72 - 110 mg/ml ; thrombine, humaan 400 - 625 ie/ml - weefsellijm - histidine, (l-) ; humaan albumine ; natriumchloride ; nicotinamide ; polysorbaat 80 (e 433) ; trinatriumcitraat 2-water (e 331) ; water voor injectie, - combinations

Hollanda - Hollandaca - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

baxter b.v. kobaltweg 49 3542 ce utrecht - aprotinine (synthetisch) 2250 - 3750 ki-e/ml ; calciumchloride 2-water (e 509) 36 - 44 mmol/l ; factor xiii 10 <= ie/ml ; fibrinogeen, humaan 72 - 110 mg/ml ; thrombine, humaan 400 - 625 ie/ml - weefsellijm - histidine, (l-) ; humaan albumine ; natriumchloride ; nicotinamide ; polysorbaat 80 (e 433) ; trinatriumcitraat 2-water (e 331) ; water voor injectie, - combinations

Belçika - Hollandaca - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

baxter sa-nv - humaan fibrinogeen 45,5 mg/ml (component 1); aprotinine 1500 e/ml (component 1); humaan trombine 2 ie/ml (component 2); calciumchloride 40 µmol/ml (component 2) - oplossing voor weefsellijm - humaan fibrinogeen 45.5 mg/ml; humaan trombine 2 ie/ml; aprotinine 1500 e/ml; calciumchloride 40 µmol/ml - combinations; v03ak tissue adhesives

Belçika - Hollandaca - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

baxter sa-nv - humaan fibrinogeen 45,5 mg/ml (component 1); aprotinine 1500 e/ml (component 1); humaan trombine 2 ie/ml (component 2); calciumchloride 40 µmol/ml (component 2) - oplossing voor weefsellijm - humaan fibrinogeen 45.5 mg/ml; humaan trombine 2 ie/ml; aprotinine 1500 e/ml; calciumchloride 40 µmol/ml - combinations; v03ak tissue adhesives

Belçika - Hollandaca - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

baxter sa-nv - humaan fibrinogeen 45,5 mg/ml (component 1); aprotinine 1500 e/ml (component 1); humaan trombine 2 ie/ml (component 2); calciumchloride 40 µmol/ml (component 2) - oplossing voor weefsellijm - humaan trombine 2 ie/ml; humaan fibrinogeen 45.5 mg/ml; aprotinine 1500 e/ml; calciumchloride 40 µmol/ml - combinations; v03ak tissue adhesives

Avrupa Birliği - Hollandaca - 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.

Avrupa Birliği - Hollandaca - 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.