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16 results on '"Turoctocog alfa"'

1. EMA|PRAC|73812|2018 Inspections, Human Medicines Pharmacovigilance and Committees Division Pharmacovigilance Risk Assessment Committee (PRAC)

Subjects
Anti-HIV agents, Bictegravir, Liraglutide, Naldemedine, Lenvatinib, Anakinra, Dimethyl fumarate, Alectinib, Varenicline, Sufentanil, Olaparib, Albiglutide, Nivolumab, Protease inhibitors, Roflumilast, Nitisinone, Monoclonal antibodies, Alitretinoin, Pembrolizumab, Pegfilgrastim, Enzyme inhibitors, Sofosbuvir, Florbetapir, Sevelamer carbonate, Tocilizumab, Ulipristal acetate, Enoxacin, Nusinersen, Evolocumab, Anticoagulants, Erenumab, Telotristat ethyl, Turoctocog alfa, Risk assessment, Antineoplastic agents, Lopinavir, Emtricitabine, Dabigatran etexilate, Efavirenz, Health, Dasatinib, Atazanavir, Bosutinib, Darunavir, Rivaroxaban, Denosumab, Raltegravir, Apixaban, Ipilimumab, Cobicistat, Drugs, Adalimumab, Sunitinib, Business, international
Abstract

Amsterdam: European Medicines Agency has issued the following document: Draft agenda for the meeting on 05-08 February 2018 Chair: June Raine - Vice-Chair: Almath Spooner 05 February 2018, 13:00 - [...]

Published
2019

2. EMA|PRAC|218598|2018 Inspections, Human Medicines Pharmacovigilance and Committees Division Pharmacovigilance Risk Assessment Committee (PRAC)

Subjects
Bayer AG, Bictegravir, Naldemedine, Sufentanil, Emtricitabine, Olaparib, Protease inhibitors, Perampanel, Alitretinoin, Pegfilgrastim, Icatibant, Canagliflozin, Idelalisib, Cariprazine, Pegvisomant, Ulipristal acetate, Enoxacin, Anticoagulants, Pseudoephedrine, Erenumab, Pharmaceutical industry -- Inspection, Turoctocog alfa, Risk assessment, Antineoplastic agents, Adalimumab, Dabigatran etexilate, Lopinavir, Sorafenib, Rivaroxaban, Health, Apixaban, Carfilzomib, Drugs, Aflibercept, Business, international
Abstract

Amsterdam: European Medicines Agency has issued the following document: Minutes of the meeting on 05-08 February 2018 Chair: June Raine - Vice-Chair: Almath Spooner Health and safety information In accordance [...]

Published
2019

3. EMA|504524|2018 Corr.1 Inspections, Human Medicines Pharmacovigilance and Committees Division Committee for medicinal products for human use (CHMP)

Subjects
Deferiprone, Vigabatrin, Tildrakizumab, Tofacitinib, Voretigene neparvovec, Atazanavir, Ivacaftor, Nivolumab, Tezacaftor, Pegvaliase, Monoclonal antibodies, Abaloparatide, Miglustat, Rivaroxaban, Pegfilgrastim, Pembrolizumab, Fingolimod, Betrixaban, Neratinib, Durvalumab, Sevelamer carbonate, Blinatumomab, Abemaciclib, Eltrombopag, Turoctocog alfa, Antineoplastic agents, Ipilimumab, Drugs, Adalimumab, Enzalutamide, Business, international
Abstract

Amsterdam: European Medicines Agency has issued the following document: Draft agenda for the meeting on 23-26 July 2018 Chair: Tomas Salmonson - Vice-Chair: Harald Enzmann 23 July 2018, 13:00 - [...]

Published
2019

4. EMA|527853|2018 Information Management Division Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use

Subjects
Cabazitaxel, Edaravone, Ambrisentan, Naldemedine, Avatrombopag, Ioflupane, Meropenem, Voretigene neparvovec, Atazanavir, Febuxostat, Trientine, Deferasirox, Vaborbactam, Brigatinib, Pegvaliase, Posaconazole, Enasidenib, Angiotensin II, Miglustat, Pegfilgrastim, Apalutamide, Delafloxacin, Treprostinil, Crisaborole, Bevacizumab, Dapagliflozin, Silodosin, Knowledge management, Macimorelin, Turoctocog alfa, Adalimumab, Web sites (World Wide Web), Marketing, Drugs, Company business management, Knowledge management, Business, international
Abstract

Amsterdam: European Medicines Agency has issued the following document: 30 Churchill Place * Canary Wharf * London E14 5EU * United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 [...]

Published
2019

5. EMA|674542|2018 - corr Information Management Division Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use

Subjects
Cabazitaxel, Edaravone, Ambrisentan, Naldemedine, Avatrombopag, Tigecycline, Ioflupane, Ibalizumab, Canakinumab, Atazanavir, Febuxostat, Trientine, Deferasirox, Pegvaliase, Posaconazole, Enasidenib, Angiotensin II, Miglustat, Pegfilgrastim, Apalutamide, Delafloxacin, Crisaborole, Bevacizumab, Dapagliflozin, Silodosin, Knowledge management, Macimorelin, Turoctocog alfa, Adalimumab, Web sites (World Wide Web), Marketing, Drugs, Company business management, Knowledge management, Business, international
Abstract

Amsterdam: European Medicines Agency has issued the following document: 30 Churchill Place * Canary Wharf * London E14 5EU * United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 [...]

Published
2019

6. EMA|PRAC|765002|2018 Inspections, Human Medicines Pharmacovigilance and Committees Division Pharmacovigilance Risk Assessment Committee (PRAC)

Subjects
Deferiprone, Empagliflozin, Apremilast, Fidaxomicin, Hypoglycemic agents, Micafungin, Rolapitant, Ambrisentan, Peramivir, Tolcapone, Edoxaban, Ticagrelor, Fenofibrate, Ramucirumab, Atazanavir, Emtricitabine, Ivacaftor, Febuxostat, Nivolumab, Osimertinib, Monoclonal antibodies, Miglustat, Rivaroxaban, Pembrolizumab, Lumacaftor, Bedaquiline, Florbetapir, Cariprazine, Bevacizumab, Antidepressants, Nintedanib, Silodosin, Eltrombopag, Turoctocog alfa, Risk assessment, Antineoplastic agents, Duloxetine, Canakinumab, Insulin aspart, Escitalopram, Everolimus, Alogliptin, Exenatide, Milnacipran, Certolizumab pegol, Insulin glargine, Ipilimumab, Drugs, Desvenlafaxine, Adalimumab, Business, international
Abstract

Amsterdam: European Medicines Agency has issued the following document: is authorised provided the source is acknowledged. 29 October 2018 EMA/PRAC/765002/2018 Inspections, Human Medicines Pharmacovigilance and Committees Division Pharmacovigilance Risk Assessment [...]

Published
2019

7. EMA|790869|2018 Inspections, Human Medicines Pharmacovigilance and Committees Division Committee for medicinal products for human use (CHMP)

Subjects
Cabazitaxel, Monoclonal antibodies, Miglustat, Pembrolizumab, Lumacaftor, Apalutamide, Ramucirumab, Atazanavir, Blinatumomab, Ivacaftor, Bevacizumab, Nivolumab, Glycerol phenylbutyrate, Saxagliptin, Dapagliflozin, Silodosin, Macimorelin, Eltrombopag, Turoctocog alfa, Antineoplastic agents, Deferasirox, Canakinumab, Carfilzomib, Ipilimumab, Drugs, Adalimumab, Business, international
Abstract

Amsterdam: European Medicines Agency has issued the following document: Draft agenda for the meeting on 12-15 November 2018 Chair: Harald Enzmann - Vice-Chair: Bruno Sepodes 12 November 2018, 13:00 - [...]

Published
2019

8. EMA|754134|2018 Inspections, Human Medicines Pharmacovigilance and Committees Division Paediatric Committee (PDCO)

Subjects
Perampanel, Fidaxomicin, Azilsartan medoxomil, Axicabtagene ciloleucel, Bupivacaine, Cobimetinib, Monoclonal antibodies, Cobicistat, Dolutegravir, Rifamycins, Bedaquiline, Lumacaftor, Palbociclib, Indapamide, Vedolizumab, Rilpivirine, Indacaterol, Ivacaftor, Darunavir, Telmisartan, Regadenoson, Turoctocog alfa, Antineoplastic agents, Semaglutide, Health, Pazopanib, Belimumab, Drugs, Business, international
Abstract

Amsterdam: European Medicines Agency has issued the following document: Draft agenda for the meeting on 13-16 November 2018 Chair: Dirk Mentzer - Vice-Chair: Koenraad Norga 13 November 2018, 14:00- 19:00, [...]

Published
2019

9. Paediatric Committee (PDCO) Draft agenda for the meeting on 11-14 December 2018

Subjects
Telmisartan, Ocrelizumab, Tazobactam, Niraparib, Rilpivirine, Regadenoson, Semaglutide, Venetoclax, Guselkumab, Ivacaftor, Nivolumab, Turoctocog alfa, Indapamide, Naloxegol, Dolutegravir, Tromethamine, Liraglutide, Rifamycins, Vedolizumab, Dienogest, Azilsartan medoxomil, Empagliflozin, Business, international
Abstract

Amsterdam: European Medicines Agency has issued the following document: Draft agenda for the meeting on 11-14 December 2018 Chair: Dirk Mentzer - Vice-Chair: Koenraad Norga 11 December 2018, 14:00- 19:00, [...]

Published
2019

10. Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of the meeting on the meeting on 29-31 October 2018

Subjects
Risk assessment, Tocilizumab, Certolizumab pegol, Roflumilast, Bimatoprost, Apixaban, Cabergoline, BCG, Velpatasvir, Turoctocog alfa, Cobimetinib, Dexmedetomidine, Rivaroxaban, Voxilaprevir, Canakinumab, Sofosbuvir, Antidepressants, Desvenlafaxine, Duloxetine, Escitalopram, Milnacipran, Business, international
Abstract

Amsterdam: European Medicines Agency has issued the following document: Chair: S Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/822441/2018 Page 2/80 Table of contents 1. Introduction 12 1.1. Welcome and declarations of [...]

Published
2019

11. Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use January 2019

Subjects
Ioflupane, Lifitegrast, Deferasirox, Delafloxacin, Clopidogrel, Tigecycline, Turoctocog alfa, Enasidenib, Dolutegravir, Dexmedetomidine, Ibalizumab, Pegvaliase, Edaravone, Adalimumab, Netarsudil, Avatrombopag, Crisaborole, Posaconazole, Pegfilgrastim, Clofarabine, Angiotensin II, Trientine, Febuxostat, Atazanavir, Dapagliflozin, Imipenem, Ambrisentan, Cabazitaxel, Knowledge management, Web sites (World Wide Web), Marketing, Drugs, Business, international
Abstract

Amsterdam: European Medicines Agency has issued the following document: 30 Churchill Place * Canary Wharf * London E14 5EU * United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 [...]

Published
2019

12. Committee for medicinal products for human use (CHMP) Final agenda for the meeting on 25-28 March 2019

Subjects
Plerixafor, Tazobactam, Adalimumab, Crisaborole, Macitentan, Deferasirox, Posaconazole, Ramucirumab, Angiotensin II, Trientine, Turoctocog alfa, Pembrolizumab, Palonosetron, Carglumic acid, Liraglutide, Fluciclovine, Pomalidomide, Imipenem, Business, international
Abstract

Amsterdam: European Medicines Agency has issued the following document: Chair: Harald Enzmann - Vice-Chair: Bruno Sepodes 25 March 2019, 13:00 - 19:30, room 1C - Amsterdam, The Netherlands 26 March [...]

Published
2019

13. Paediatric Committee (PDCO) Minutes of the meeting on 11-14 December 2018

Subjects
Telmisartan, Ocrelizumab, Tazobactam, Niraparib, Rilpivirine, Semaglutide, Regadenoson, Venetoclax, Guselkumab, Ivacaftor, Nivolumab, Indapamide, Turoctocog alfa, Naloxegol, Dolutegravir, Liraglutide, Tromethamine, Rifamycins, Vedolizumab, Dienogest, Azilsartan medoxomil, Empagliflozin, Business, international
Abstract

Amsterdam: European Medicines Agency has issued the following document: Chair: Dirk Mentzer - Vice-Chair: Koenraad Norga 11 December 2018, 14:00- 19:00, room 3E 12 December 2018, 08:30- 19:00, room 3E [...]

Published
2019

14. European Medicines Agency decision P|0046|2019

Subjects
Novo Nordisk A/S, Pediatrics, Drugs, Turoctocog alfa, Business, international
Abstract

Amsterdam: European Medicines Agency has issued the following document: of 29 January 2019 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on [...]

Published
2019

15. Summary of opinion1 (initial authorisation) Esperoct

Subjects
Turoctocog alfa, Backup software, Business, international, European Union, Esperoct (Medication)
Abstract

Amsterdam: European Medicines Agency has issued the following document: Official address Domenico Scarlattilaan 6 ? 1083 HS Amsterdam ? The Netherlands An agency of the European Union Address for visits [...]

Published
2019

16. Committee for medicinal products for human use (CHMP) Final agenda for the meeting on 23-26 April 2019

Subjects
Ioflupane, Lifitegrast, Vilanterol, Avatrombopag, Pegfilgrastim, Olaparib, Ivacaftor, Turoctocog alfa, Pembrolizumab, Enasidenib, Dolutegravir, Dexmedetomidine, Ibalizumab, Ambrisentan, Cabazitaxel, Edaravone, Monoclonal antibodies, Antineoplastic agents, Hypoglycemic agents, Insulin aspart, Lapatinib, Insulin lispro, Clofarabine, Dapagliflozin, Ustekinumab, Business, international
Abstract

Amsterdam: European Medicines Agency has issued the following document: Chair: Harald Enzmann - Vice-Chair: Bruno Sepodes 23 April 2019, 13:00 - 19:30, room 1C 24 April 2019, 08:30 - 19:30, [...]

Published
2019

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