5470 results
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Human medicine European public assessment report (EPAR): Pregabalin Pfizer (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 10/04/2014, Revision: 29, Authorised, Last updated: 20/03/2023Pregabalin Pfizer Mental Disorders Nervous … report (EPAR) for Pregabalin Pfizer. It explains how the Agency … on how to use Pregabalin Pfizer. For practical information … -
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Human medicine European public assessment report (EPAR): Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited)
pemetrexed ditromethamine, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 24/04/2017,
, Revision: 7, Withdrawn, Last updated: 29/07/2021
Pemetrexed Pfizer (previously known as Pemetrexed … Pemetrexed Pfizer (previously known as Pemetrexed … Public statement Pemetrexed Pfizer Cessation of validity of … -
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Human medicine European public assessment report (EPAR): Pemetrexed Pfizer (previously Pemetrexed Hospira)
pemetrexed disodium, pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 19/11/2015,, Revision: 14, Authorised, Last updated: 21/09/2022
Pemetrexed Pfizer (previously Pemetrexed Hospira) Cancer Neoplasms Carcinoma … Pemetrexed Pfizer (previously Pemetrexed Hospir … Pemetrexed Pfizer (previously Pemetrexed Hospira) pemetrexed pemetrexed … -
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News: Update on investigation by Italian authorities into the supply of stolen medicines
Last updated: 03/06/2014Update on investigation by Italian authorities into the supply … authorities in Italy and Germany: Italian medicines agency (AIFA) Paul … announced investigation by Italian authorities into the supply … -
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News: New manufacturing sites and new formulation approved for COVID-19 vaccine from BioNTech/Pfizer
CHMP, Last updated: 18/10/2021COVID-19 vaccine from BioNTech/Pfizer … developed by BioNTech and Pfizer. One site, located in Monza … Italy, is operated by Patheon Italia S.p.A. The other in Anagni … -
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Press release: Pfizer withdraws its marketing authorisation application for Exulett (dalbavancin)
Last updated: 10/09/2008Pfizer withdraws its marketing authorisation … been formally notified by Pfizer of its decision to withdraw … EMEA/476868/2008 PRESS RELEASE Pfizer withdraws its marketing authorisation … -
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News: Additional manufacturing capacity for BioNTech/Pfizer’s COVID-19 vaccine
CHMP, Last updated: 01/06/2021manufacturing capacity for BioNTech/Pfizer’s COVID-19 vaccine … manufacturing and filling lines at Pfizer’s vaccine manufacturing site … developed by BioNTech and Pfizer, in the European Union. Based … -
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News: More flexible storage conditions for BioNTech/Pfizer’s COVID-19 vaccine
CHMP, Last updated: 17/05/2021storage conditions for BioNTech/Pfizer’s COVID-19 vaccine … developed by BioNTech and Pfizer, that will facilitate the … -
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News: Two additional manufacturing sites for BioNTech/Pfizer’s COVID-19 vaccine
CHMP, Last updated: 22/06/2021manufacturing sites for BioNTech/Pfizer’s COVID-19 vaccine … developed by BioNTech and Pfizer. One site, located in Reinbek … -
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Press release: Pfizer Limited withdraws its application for an extension of the indication for Macugen (pegaptanib sodium)
Last updated: 19/07/2011Pfizer Limited withdraws its application … been formally notified by Pfizer Limited of its decision to … injection. On 14 June 2010, Pfizer Limited submitted an application … -
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News: Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from BioNTech/Pfizer and Moderna
CHMP, Last updated: 23/04/2021COVID-19 vaccines from BioNTech/Pfizer and Moderna … Scaled-up processes for BioNTech/Pfizer’s COVID-19 vaccine EMA … associated process scale up at Pfizer’s vaccine manufacturing site … -
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News: Increase in manufacturing capacity for COVID-19 vaccine from BioNTech/Pfizer
CHMP, Last updated: 09/09/2021COVID-19 vaccine from BioNTech/Pfizer … COVID-19 vaccine from BioNTech/Pfizer … -
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News: Increase in manufacturing capacity for COVID-19 vaccines from Janssen, Moderna and BioNTech/Pfizer
CHMP, Last updated: 16/12/2021Janssen, Moderna and BioNTech/Pfizer … Janssen, Moderna and BioNTech/Pfizer … -
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News: Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech / Pfizer and Moderna
CHMP, Last updated: 24/08/2021vaccines from BioNTech / Pfizer and Moderna … developed by BioNTech and Pfizer. The site, located in Saint … -
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News: Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application
CHMP, Last updated: 15/12/2020assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing … assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing … -
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Press release: Pfizer withdraws its application to change the marketing authorisation for Viagra 50 mg (sildenafil) from prescription-only to non-prescription
Last updated: 20/11/2008Pfizer withdraws its application … been formally notified by Pfizer Limited of its decision to … EMEA/619122/2008 PRESS RELEASE Pfizer withdraws its application … -
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News: Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna
CHMP, Last updated: 26/03/2021from AstraZeneca, BioNTech/Pfizer and Moderna … storage conditions for BioNTech/Pfizer’s COVID-19 vaccine A new … -
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Direct healthcare professional communication (DHPC): Champix (varenicline) - lots to be recalled due to presence of impurity N-nitroso-varenicline above the Pfizer acceptable daily intake limit
Active substance: varenicline, DHPC type: Quality defect, Last updated: 15/07/2021N-nitroso-varenicline above the Pfizer acceptable daily intake limit Tobacco … N-nitroso-varenicline above the Pfizer acceptable daily intake limit … N-nitroso-varenicline above the Pfizer acceptable daily intake … -
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Human medicine European public assessment report (EPAR): Staquis
Crisaborole, Dermatitis, Atopic
Date of authorisation: 27/03/2020,
, Revision: 6, Withdrawn, Last updated: 08/02/2022
PDF/318.99 KB) (PDF/318.99 KB) Italian (PDF/280.3 KB) (PDF/280.3 … marketing authorisation holder, Pfizer Europe MA EEIG, which notified … this medicinal product is Pfizer Europe MA EEIG. Staquis … -
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Human medicine European public assessment report (EPAR): Raylumis
Tanezumab, Osteoarthritis; Pain
Date of refusal: 15/11/2021, Refused, Last updated: 15/02/2022applied for authorisation, Pfizer Europe MA EEIG, may ask for … applied for authorisation, Pfizer Europe MA EEIG, may ask for … -
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Human medicine European public assessment report (EPAR): Palonosetron Hospira
palonosetron hydrochloride, Nausea; Vomiting; Cancer
Date of authorisation: 08/04/2016,, Revision: 4, Withdrawn, Last updated: 08/04/2022
PDF/694.79 KB) (PDF/694.79 KB) Italian (PDF/644.63 KB) (PDF/644.63 … marketing authorisation holder, Pfizer Europe MA EEIG, had not … initial authorisation. Pfizer Europe MA EEIG confirmed … -
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Human medicine European public assessment report (EPAR): Vydura (updated)
Rimegepant, Migraine Disorders
Date of authorisation: 25/04/2022,, Revision: 4, Authorised, Last updated: 21/03/2023
PDF/138.05 KB) (PDF/138.05 KB) Italian (PDF/117.4 KB) (PDF/117.4 … -
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Human medicine European public assessment report (EPAR): Lifmior
etanercept, Arthritis, Psoriatic; Spondylitis, Ankylosing; Psoriasis
Date of authorisation: 13/02/2017, Revision: 8, Withdrawn, Last updated: 20/02/2020PDF/736.23 KB) (PDF/736.23 KB) Italian (PDF/663.91 KB) (PDF/663.91 … -
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Human medicine European public assessment report (EPAR): Nyvepria
pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020,, 
, Revision: 4, Authorised, Last updated: 05/11/2021
PDF/129.49 KB) (PDF/129.49 KB) Italian (PDF/108.75 KB) (PDF/108.75 … -
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Human medicine European public assessment report (EPAR): Champix
varenicline, Tobacco Use Cessation
Date of authorisation: 25/09/2006, Revision: 37, Authorised, Last updated: 18/10/2021PDF/96.02 KB) (PDF/96.02 KB) Italian (PDF/85.37 KB) (PDF/85.37 …