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

medcor pharmaceuticals b.v. artemisweg 232 8239 de lelystad - lamotrigine 100 mg/stuk - dispergeerbare tablet, kauwtablet - aluminiummagnesiumsilicaat ; calciumcarbonaat (e 170) ; hydroxypropylcellulose, laag gesubstitueerd (e 463a) ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat ; povidon k 30 (e 1201) ; saccharoide natrium x-water (e 954) ; zwarte bessen smaakstof 502.009 / ap 0551, aluminiummagnesiumsilicaat ; calciumcarbonaat (e 170) ; hydroxypropylcellulose, laag gesubstitueerd (e 463) ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat ; povidon k 30 (e 1201) ; saccharoide natrium x-water (e 954) ; zwarte bessen smaakstof 502.009 / ap 0551

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

bmodesto b.v. minervaweg 2 8239 dl lelystad - lamotrigine - dispergeerbare tablet, kauwtablet - aluminiummagnesiumsilicaat ; calciumcarbonaat (e 170) ; hydroxypropylcellulose, laag gesubstitueerd (e 463) ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat ; povidon k 30 (e 1201) ; saccharoide natrium x-water (e 954) ; zwarte bessen smaakstof 502.009 / ap 0551

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

euro registratie collectief b.v. van der giessenweg 5 2921 lp krimpen a/d ijssel - lamotrigine 25 mg/stuk - dispergeerbare tablet, kauwtablet - aluminiummagnesiumsilicaat ; calciumcarbonaat (e 170) ; hydroxypropylcellulose, laag gesubstitueerd (e 463a) ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat ; povidon k 30 (e 1201) ; saccharoide natrium x-water (e 954) ; zwarte bessen smaakstof 502.009 / ap 0551, aluminiummagnesiumsilicaat ; calciumcarbonaat (e 170) ; hydroxypropylcellulose, laag gesubstitueerd (e 463) ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat ; povidon k 30 (e 1201) ; saccharoide natrium x-water (e 954) ; zwarte bessen smaakstof 502.009 / ap 0551

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

euro registratie collectief b.v. van der giessenweg 5 2921 lp krimpen a/d ijssel - lamotrigine 5 mg/stuk - dispergeerbare tablet, kauwtablet - aluminiummagnesiumsilicaat ; calciumcarbonaat (e 170) ; hydroxypropylcellulose, laag gesubstitueerd (e 463a) ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat ; povidon k 30 (e 1201) ; saccharoide natrium x-water (e 954) ; zwarte bessen smaakstof 502.009 / ap 0551, aluminiummagnesiumsilicaat ; calciumcarbonaat (e 170) ; hydroxypropylcellulose, laag gesubstitueerd (e 463) ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat ; povidon k 30 (e 1201) ; saccharoide natrium x-water (e 954) ; zwarte bessen smaakstof 502.009 / ap 0551

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

euro registratie collectief b.v. van der giessenweg 5 2921 lp krimpen a/d ijssel - lamotrigine 50 mg/stuk - dispergeerbare tablet, kauwtablet - aluminiummagnesiumsilicaat ; calciumcarbonaat (e 170) ; hydroxypropylcellulose, laag gesubstitueerd (e 463a) ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat ; povidon k 30 (e 1201) ; saccharoide natrium x-water (e 954) ; zwarte bessen smaakstof 502.009 / ap 0551, aluminiummagnesiumsilicaat ; calciumcarbonaat (e 170) ; hydroxypropylcellulose, laag gesubstitueerd (e 463) ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat ; povidon k 30 (e 1201) ; saccharoide natrium x-water (e 954) ; zwarte bessen smaakstof 502.009 / ap 0551

Europese Unie - Nederlands - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - antineoplastische middelen - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.

Europese Unie - Nederlands - EMA (European Medicines Agency)

roche registration gmbh - baloxavir marboxil - influenza, human - antivirale middelen voor systemisch gebruik - treatment of influenzaxofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above. post exposure prophylaxis of influenzaxofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above. xofluza should be used in accordance with official recommendations.

Europese Unie - Nederlands - EMA (European Medicines Agency)

roche registration gmbh - pertuzumab, trastuzumab - neoplasmata van de borst - antineoplastische middelen - early breast cancer (ebc)phesgo is indicated for use in combination with chemotherapy in:the neoadjuvant treatment of adult patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrencethe adjuvant treatment of adult patients with her2-positive early breast cancer at high risk of recurrencemetastatic breast cancer (mbc)phesgo is indicated for use in combination with docetaxel in adult patients with her2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-her2 therapy or chemotherapy for their metastatic disease.

Europese Unie - Nederlands - EMA (European Medicines Agency)

roche registration gmbh  - risdiplam - spier-atrofie, spinale - andere geneesmiddelen voor aandoeningen van het musculo-skeletale systeem - evrysdi is indicated for the treatment of 5q spinal muscular atrophy (sma) in patients with a clinical diagnosis of sma type 1, type 2 or type 3 or with one to four smn2 copies.

Europese Unie - Nederlands - EMA (European Medicines Agency)

roche registration gmbh - satralizumab - neuromyelitis optica - immunosuppressiva - satralizumab (enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of neuromyelitis optica spectrum disorders (nmosd) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 igg (aqp4-igg) seropositive.