128 results
Keyword Nitroderm TTS Remove keyword
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Referral: Fentanyl-ratiopharm_TTS
fentanyl, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/07/2007, EC decision date: 23/10/2007, Last updated: 14/12/2007Fentanyl-ratiopharm 25/50/75/100 μg/h TTS and associated names, is … Fentanyl-ratiopharm 25/50/75/100 μg/h TTS and associated names, transdermal … Fentanylratiopharm 25/50/75/100 μg/h TTS and associated names, that … -
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021,
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, Revision: 23, Authorised, Last updated: 12/08/2022
thrombocytopenia syndrome, TTS) and Guillain-Barré syndrome … thrombocytopenia syndrome (TTS) after receiving the vaccine … -
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EMA workshop on thrombosis with thrombocytopenia syndrome
Online, 27/06/2022, Last updated: 06/07/2022thrombocytopenia syndrome (TTS), an extremely rare but serious … studies of vaccine-induced TTS Session 2. Clinical characterisation … Clinical characterisation of TTS Session 3. Understanding … -
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News: EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome
Last updated: 07/06/2021thrombocytopenia syndrome (TTS) following vaccination with … and Haemostasis (ISTH). 2 TTS requires rapid identification … experience from managing TTS and heparin-induced thrombocytopenia … -
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Human medicine European public assessment report (EPAR): Jcovden (previously COVID-19 Vaccine Janssen)
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021,, , , Revision: 22, Authorised, Last updated: 28/07/2022
thrombocytopenia syndrome [TTS], capillary leak syndrome … given to people who have had TTS following vaccination with … -
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News: Vaxzevria: further advice on blood clots and low blood platelets
CHMP, Last updated: 21/05/2021thrombocytopenia syndrome, TTS) after receiving the vaccine … thrombocytopenia syndrome (TTS) after previously receiving … receiving this vaccine. As TTS requires specialist treatment … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021
CHMP, Last updated: 17/09/2021thrombocytopenia syndrome, TTS) and on the use of a second … following the initial reports of TTS associated with the vaccine … data, including the latest TTS data from spontaneous reports … -
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National expert: Ralf Reinhard Tönjes, Paul Ehrlich Institute (updated)
- Declaration of interests - 80.25 KB | PDF
- Curriculum Vitae - 26.8 KB | PDF
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 13 January 2022
PRAC, Last updated: 14/01/2022thrombosis with thrombocytopenia (TTS) that occurred following … the majority of suspected TTS events were reported worldwide … people who have experienced TTS following vaccination with … -
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News: COVID-19 Vaccine Janssen: EMA recommendation on booster dose
CHMP, Last updated: 15/12/2021combination with thrombocytopenia (TTS) or other very rare side … -
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National expert: Inês Ribeiro-Vaz, National Authority of Medicines and Health Products, I.P. (updated)
- Declaration of interests - 79.88 KB | PDF
- Curriculum Vitae - 22.16 KB | PDF
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Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) (updated)
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 30/06/2015,
, Revision: 14, Authorised, Last updated: 13/09/2022
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Human medicine European public assessment report (EPAR): Aripiprazole Zentiva
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 25/06/2015,, Revision: 9, Authorised, Last updated: 26/08/2022
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Human medicine European public assessment report (EPAR): Aripiprazole Sandoz (updated)
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 20/08/2015,, Revision: 9, Authorised, Last updated: 01/09/2022
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Human medicine European public assessment report (EPAR): Aripiprazole Accord
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 15/11/2015,, Revision: 15, Authorised, Last updated: 13/07/2022
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Human medicine European public assessment report (EPAR): Abilify
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 04/06/2004, Revision: 49, Authorised, Last updated: 08/04/2022 -
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Human medicine European public assessment report (EPAR): Nuvaxovid (updated)
SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,, , Revision: 4, Authorised, Last updated: 13/09/2022
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Human medicine European public assessment report (EPAR): Xofigo
radium (223Ra) dichloride, Prostatic Neoplasms
Date of authorisation: 13/11/2013,, Revision: 12, Authorised, Last updated: 07/07/2022
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National expert: Ilko Getov, Bulgarian Drug Agency (updated)
- Declaration of interests - 80.09 KB | PDF
- Curriculum Vitae - 24.87 KB | PDF
cost (primer for fentanyl TTS in Bulgaria), Boll. Chim … -
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Human medicine European public assessment report (EPAR): Sifrol
pramipexole dihydrochloride monohydrate, Restless Legs Syndrome; Parkinson Disease
Date of authorisation: 13/10/1997, Revision: 36, Authorised, Last updated: 12/08/2022 -
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Human medicine European public assessment report (EPAR): Mirapexin
pramipexole dihydrochloride monohydrate, Restless Legs Syndrome; Parkinson Disease
Date of authorisation: 23/02/1998, Revision: 39, Authorised, Last updated: 12/08/2022 -
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Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,, , , Revision: 29, Authorised, Last updated: 23/09/2022
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection
Date of authorisation: 06/01/2021,, , , Revision: 29, Authorised, Last updated: 23/09/2022
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Human medicine European public assessment report (EPAR): Nexavar
sorafenib, Carcinoma, Hepatocellular; Carcinoma, Renal Cell
Date of authorisation: 19/07/2006,
, Revision: 30, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Idelvion
albutrepenonacog alfa, Hemophilia B
Date of authorisation: 11/05/2016,, Revision: 10, Authorised, Last updated: 15/12/2021