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

vifor france s.a. - ijzersucrose - eq. ijzer 20 mg/ml - oplossing voor injectie/infusie - 20 mg/ml - ijzersucrose - iron, parenteral preparations

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

vifor france s.a. - ijzersucrose - eq. ijzer 20 mg/ml - oplossing voor injectie/infusie - 20 mg/ml - ijzersucrose - iron, parenteral preparations

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

vifor fresenius medical care renal pharma france 100-101 terrassa boieldieu, tour franklin la défense 8 92042 paris la dÉfen - calcifediol 1-water 31,4 µg/stuk samenstelling overeenkomend met ; calcifediol 30 µg/stuk - capsule met verlengde afgifte, zacht - briljantblauw fcf (e 133) ; butylhydroxytolueen (e 321) ; carrageenan (e 407) ; dinatriumwaterstoffosfaat 0-water (e 339) ; ethanol 3,9 mg/stuk ; glycerolmonostearaat 40-55 (e 471) ; hypromellose (e 464) ; hypromellose, type 2208 (release controlling polymer), k100m (e 464) ; lauroylmacrogolglyceriden ; maÏszetmeel, gemodificeerd (modificatie onbekend, (e 1450) ; paraffine, hard (e 905) ; paraffine, vloeibaar (e905) ; propyleenglycol (e 1520) ; sorbitol vloeibaar, gedeeltelijk gedehydrateerd ; titaandioxide (e 171) ; triglyceriden middellange keten ; water, gezuiverd ; witte inkt, briljantblauw fcf (e 133) ; butylhydroxytolueen (e 321) ; carrageenan (e 407) ; dinatriumwaterstoffosfaat 0-water (e 339) ; ethanol 3,9 mg/stuk ; glycerolmonostearaat 40-55 (e 471) ; hypromellose (e 464) ; hypromellose, type 2208 (release controlling polymer), k15m, k100m (e 464) ; lauroylmacrogolglyceriden ; maÏszetmeel, gemodificeerd (modificatie onbekend, (e 1450) ; paraffine, hard (e 905) ; paraffine, vloeibaar (e905)

Europese Unie - Nederlands - EMA (European Medicines Agency)

merck sharp dohme ltd - human papillomavirus type 6 l1-eiwit, humaan papillomavirus type 11 l1-eiwit, humaan papillomavirus type 16-l1-eiwit, humaan papillomavirus type 18-l1-eiwit - papillomavirus infections; uterine cervical dysplasia; condylomata acuminata; immunization - vaccins - silgard is een vaccin voor gebruik vanaf de leeftijd van 9 jaar ter preventie van:premaligne genitale laesies (cervicale, vulvaire en vaginale), premaligne anale laesies, cervicale kanker en anale kanker causaal verband met bepaalde oncogene humaan papillomavirus (hpv) typen;genitale wratten (condyloma acuminata) causaal verband met specifieke hpv-typen. zie hoofdstuk 4. 4 en 5. 1 voor belangrijke informatie over de gegevens die deze indicatie ondersteunen. het gebruik van silgard moet gebeuren in overeenstemming met officiële aanbevelingen.

Europese Unie - Nederlands - EMA (European Medicines Agency)

samsung bioepis nl b.v. - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastische middelen - onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. onbevzi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. zie rubriek 5 voor meer informatie over de status van humane epidermale groeifactorreceptor 2 (her2). onbevzi in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with onbevzi in combination with capecitabine. raadpleeg sectie 5 voor meer informatie over her2-status. onbevzi, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. onbevzi, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations. onbevzi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. onbevzi, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer. onbevzi, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. onbevzi, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. onbevzi, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

Europese Unie - Nederlands - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - human papillomavirus type 6 l1-eiwit, humaan papillomavirus type 11 l1-eiwit, humaan papillomavirus type 16-l1-eiwit, humaan papillomavirus type 18-l1-eiwit - papillomavirus infections; uterine cervical dysplasia; condylomata acuminata; immunization - vaccins - gardasil is een vaccin voor gebruik vanaf de leeftijd van 9 jaar ter preventie van:premaligne genitale laesies (cervicale, vulvaire en vaginale), premaligne anale laesies, cervicale kanker en anale kanker causaal verband met bepaalde oncogene humaan papillomavirus (hpv) typen;genitale wratten (condyloma acuminata) causaal verband met specifieke hpv-typen. zie hoofdstuk 4. 4 en 5. 1 voor belangrijke informatie over de gegevens die deze indicatie ondersteunen. het gebruik van gardasil dient te gebeuren in overeenstemming met officiële aanbevelingen.

Europese Unie - Nederlands - EMA (European Medicines Agency)

merck sharp & dohme b.v. - humaan papillomavirusvaccin [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, geadsorbeerd) - condylomata acuminata; papillomavirus infections; immunization; uterine cervical dysplasia - papillomavirus vaccins - gardasil 9 is geïndiceerd voor actieve immunisatie van personen vanaf de leeftijd van 9 jaar tegen de volgende hpv ziekten:premaligne laesies en kanker beïnvloedt de baarmoederhals, vulva, de vagina en de anus veroorzaakt door het hpv-vaccin typesgenital wratten (condyloma acuminata) veroorzaakt door bepaalde hpv-types. zie hoofdstuk 4. 4 en 5. 1 voor belangrijke informatie over de gegevens die deze indicaties. het gebruik van gardasil 9 moet gebeuren in overeenstemming met officiële aanbevelingen.

Europese Unie - Nederlands - EMA (European Medicines Agency)

samsung bioepis nl b.v. - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastische middelen - aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. aybintio in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. zie rubriek 5 voor meer informatie over de status van humane epidermale groeifactorreceptor 2 (her2). 1 of the smpc. aybintio in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with aybintio in combination with capecitabine. raadpleeg sectie 5 voor meer informatie over her2-status. 1 of the smpc. aybintio, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. aybintio, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. 1 of the smpc). aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. aybintio, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. 1 of the smpc). aybintio, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. aybintio, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents (see section 5. 1 of the smpc). aybintio, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5. 1 of the smpc).

Europese Unie - Nederlands - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - pneumococcal polysaccharide conjugate vaccine (adsorbed) - pneumokokkeninfecties - pneumococcus, purified polysaccharides antigen conjugated - vaxneuvance is indicated for active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age. vaxneuvance is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by streptococcus pneumoniae in individuals 18 years of age and older. zie hoofdstuk 4. 4 en 5. 1 voor informatie over bescherming tegen specifieke pneumokokken-serotypen. the use of vaxneuvance should be in accordance with official recommendations.

Europese Unie - Nederlands - EMA (European Medicines Agency)

glaxo group ltd - retapamuline - impetigo; staphylococcal skin infections - antibiotica en chemotherapeutica voor dermatologisch gebruik - short term treatment of the following superficial skin infections: , impetigo;, infected small lacerations, abrasions or sutured wounds. hoofdstuk 4. 4 en 5. 1 voor belangrijke informatie met betrekking tot de klinische activiteit van retapamulin tegen verschillende soorten staphylococcus aureus. aandacht moet worden gegeven aan de officiële richtlijnen betreffende het juiste gebruik van antibacteriële agentia.