78 results
Keyword NovoRapid Penfill Remove keyword
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Human medicine European public assessment report (EPAR): NovoRapid
insulin aspart, Diabetes Mellitus
Date of authorisation: 07/09/1999, Revision: 31, Authorised, Last updated: 23/11/2020NovoRapid Metabolic Diseases Nutritional … assessment report (EPAR) for NovoRapid. It explains how the Agency … practical advice on how to use NovoRapid. For practical information … -
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Press release: Batches of the insulin medicine NovoMix 30 FlexPen and Penfill to be recalled
CHMP, Last updated: 25/10/2013medicine NovoMix 30 FlexPen and Penfill to be recalled … medicine NovoMix 30 FlexPen and Penfill. The affected batches are … using NovoMix 30 FlexPen/Penfill from the affected batches … -
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Human medicine European public assessment report (EPAR): Insulin aspart Sanofi
insulin aspart, Diabetes Mellitus
Date of authorisation: 25/06/2020,
, Revision: 3, Authorised, Last updated: 27/01/2022
Insulin aspart Sanofi is NovoRapid. Insulin aspart Sanofi contains … Insulin aspart Sanofi with NovoRapid have shown that the active … highly similar to that in NovoRapid in terms of structure, purity … -
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Human medicine European public assessment report (EPAR): Fiasp
insulin aspart, Diabetes Mellitus
Date of authorisation: 09/01/2017, Revision: 8, Authorised, Last updated: 23/09/2021effective as another insulin, NovoRapid. Both Fiasp and NovoRapid contain insulin aspart but … the start of the meal) with NovoRapid (given at mealtime). In this … given Fiasp after a meal or NovoRapid at mealtime (0.35 and 0.23 … -
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Human medicine European public assessment report (EPAR): Kirsty (previously Kixelle)
insulin aspart, Diabetes Mellitus
Date of authorisation: 05/02/2021,
, , Revision: 1, Authorised, Last updated: 14/09/2021
reference medicine for Kirsty is NovoRapid. For more information on biosimilar … studies comparing Kirsty with NovoRapid have shown that the active … highly similar to that in NovoRapid in terms of structure, purity … -
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Human medicine European public assessment report (EPAR): Actrapid
human insulin, Diabetes Mellitus
Date of authorisation: 07/10/2002, Revision: 17, Authorised, Last updated: 21/10/2020available as vials, cartridges (Penfill) or prefilled pens (NovoLet … available as vials, cartridges (Penfill) or prefilled pens (NovoLet … available as vials, cartridges (Penfill) or prefilled pens (NovoLet … -
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Human medicine European public assessment report (EPAR): Protaphane
insulin human, Diabetes Mellitus
Date of authorisation: 07/10/2002, Revision: 18, Authorised, Last updated: 27/10/2020available as vials, cartridges (Penfill), or pre-filled pens (InnoLet … available as vials, cartridges (Penfill), or pre-filled pens (InnoLet … -
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Human medicine European public assessment report (EPAR): Actraphane
insulin human, Diabetes Mellitus
Date of authorisation: 07/10/2002, Revision: 19, Authorised, Last updated: 15/10/2020available as vials, cartridges (Penfill) or prefilled pens (InnoLet … available as vials, cartridges (Penfill) or prefilled pens (InnoLet … -
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Human medicine European public assessment report (EPAR): Mixtard
insulin human, Diabetes Mellitus
Date of authorisation: 07/10/2002, Revision: 19, Authorised, Last updated: 12/10/2020available as vials, cartridges (Penfill) or pre-filled pens (InnoLet … available as vials, cartridges (Penfill) or pre-filled pens (InnoLet … available as vials, cartridges (Penfill) or pre-filled pens (InnoLet … -
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Human medicine European public assessment report (EPAR): Insulatard
insulin human, Diabetes Mellitus
Date of authorisation: 07/10/2002, Revision: 20, Authorised, Last updated: 23/11/2020available as vials, cartridges (Penfill), or pre-filled pens (InnoLet … available as vials, cartridges (Penfill), or pre-filled pens (InnoLet … EU/1/02/233/005 Insulatard Penfill 100 iu/ml Suspension for … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2016 (corrected)
CHMP, Last updated: 21/09/2016NovoRapid … -
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National expert: Irene Nowotny, Paul Ehrlich Institute (updated)
- Declaration of interests - 80.29 KB | PDF
- Curriculum Vitae - 19.43 KB | PDF
aspart and Japan-approved NovoRapid in healthy Japanese subjects … -
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National expert: Susanne Høpner Rasmussen, Danish Medicines Agency (updated)
- Declaration of interests - 80.54 KB | PDF
- Curriculum Vitae - 16.77 KB | PDF
NovoMix Diabetes Mellitus NovoRapid Diabetes Mellitus 2.2 Consultancy … -
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Human medicine European public assessment report (EPAR): NovoMix
insulin aspart, Diabetes Mellitus
Date of authorisation: 01/08/2000, Revision: 28, Authorised, Last updated: 12/11/2020consists of a 3 ml cartridge (Penfill) of type 1 glass with a cap … -
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Human medicine European public assessment report (EPAR): Levemir
Insulin detemir, Diabetes Mellitus
Date of authorisation: 01/06/2004, Revision: 29, Authorised, Last updated: 13/07/2021 -
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Human medicine European public assessment report (EPAR): Ryzodeg
insulin aspart, insulin degludec, Diabetes Mellitus
Date of authorisation: 21/01/2013, Revision: 13, Authorised, Last updated: 23/09/2021 -
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Human medicine European public assessment report (EPAR): Tresiba
insulin degludec, Diabetes Mellitus
Date of authorisation: 20/01/2013, Revision: 16, Authorised, Last updated: 05/04/2022 -
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Human medicine European public assessment report (EPAR): Truvelog Mix 30
insulin aspart, Diabetes Mellitus
Date of authorisation: 25/04/2022,, , Authorised, Last updated: 15/06/2022
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Human medicine European public assessment report (EPAR): Edistride (updated)
dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2; Heart Failure, Systolic; Heart Failure; Renal Insufficiency, Chronic
Date of authorisation: 09/11/2015, Revision: 21, Authorised, Last updated: 06/03/2023 -
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Human medicine European public assessment report (EPAR): Forxiga (updated)
dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2; Heart Failure, Systolic; Heart Failure; Renal Insufficiency, Chronic
Date of authorisation: 11/11/2012, Revision: 27, Authorised, Last updated: 06/03/2023 -
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Human medicine European public assessment report (EPAR): Insulin lispro Sanofi
insulin lispro, Diabetes Mellitus
Date of authorisation: 19/07/2017,, Revision: 7, Authorised, Last updated: 07/04/2022
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Human medicine European public assessment report (EPAR): Apidra
insulin glulisine, Diabetes Mellitus
Date of authorisation: 27/09/2004, Revision: 31, Authorised, Last updated: 13/12/2021Humalog (insulin lispro) or NovoRapid (insulin aspart) under the … -
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Opinion on medicine for use outside EU: Actrapid
insulin human, Diabetes Mellitus, ATC code: A10AC01 Opinion number: H-W-005779, Positive opinion Opinion date: 22/04/2022, Last updated: 22/07/2022 -
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Opinion on medicine for use outside EU: Insulatard
Insulin human (RDNA), Diabetes Mellitus, ATC code: A10AC01 Opinion number: H-W-005780, Positive opinion Opinion date: 22/04/2022, Last updated: 28/07/2022EMEA/H/W/005780 /003 Insulatard Penfill 100 IU/ml Suspension for … EMEA/H/W/005780 /004 Insulatard Penfill 100 IU/ml Suspension for … EMEA/H/W/005780 /005 Insulatard Penfill 100 IU/ml Suspension for … -
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PRAC recommendations on safety signals (updated)
Last updated: 06/03/2023