318 results
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Veterinary medicine European public assessment report (EPAR): Solensia
frunevetmab, Cats
Date of authorisation: 17/02/2021, Authorised, Last updated: 25/06/2020women trying to conceive, and breastfeeding women should take extreme care … women trying to conceive, and breastfeeding women should take extreme care … women trying to conceive, and breastfeeding women should take extreme care … -
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Workshop on benefit-risk of medicines used during pregnancy and breastfeeding
Virtual meeting, 22/09/2020, Last updated: 12/11/2020and safety for pregnant and breastfeeding women' report. Documents Agenda - Workshop … difficult to treat pregnant & breastfeeding womenand what can EMA do to help … -
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Press release: European Medicines Agency gives guidance for use of antiviral medicines in case of a novel influenza A/H1N1 pandemic
CHMP, Last updated: 08/05/2009zanamivir) in pregnant and breastfeeding women in the case of a declared … body weight. Pregnant and breastfeeding women Following a review of the … zanamivir) in pregnant and breastfeeding women in the case of a declared … -
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News: International cooperation to align approaches for regulation of COVID-19 vaccines and medicines
Last updated: 25/02/2021treatments in pregnant and breastfeeding women, and strengthening collaboration … safe to use in pregnant and breastfeeding women are of particular concern … -
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Human medicine European public assessment report (EPAR): Onivyde pegylated liposomal (previously known as Onivyde)
irinotecan anhydrous free-base, Pancreatic Neoplasms
Date of authorisation: 14/10/2016,
, Revision: 11, Authorised, Last updated: 13/12/2022
irinotecan in the past and to breastfeeding women. For the full list of restrictions … irinotecan in the past and to breastfeeding women. For the full list of restrictions … -
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Human medicine European public assessment report (EPAR): Roteas
edoxaban tosilate, Stroke; Venous Thromboembolism
Date of authorisation: 19/04/2017, Revision: 10, Authorised, Last updated: 09/06/2022not be used in pregnant or breastfeeding women or together with another … -
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Human medicine European public assessment report (EPAR): Teysuno
tegafur, gimeracil, oteracil, Stomach Neoplasms
Date of authorisation: 14/03/2011, Revision: 21, Authorised, Last updated: 04/04/2022this enzyme; pregnant or breastfeeding women; patients with severe leucopenia … enzyme; • pregnant or breastfeeding women; • patients with severe … -
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Human medicine European public assessment report (EPAR): Jayempi
azathioprine, Graft Rejection
Date of authorisation: 21/06/2021, Revision: 1, Authorised, Last updated: 04/03/2022Jayempi must not be used in breastfeeding women. For the full list of side … Jayempi must not be used in breastfeeding women. For the full list of side … -
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Press release: WHO declares influenza pandemic – European Medicines Agency initiates crisis-management plan
Last updated: 12/06/2009and Relenza in pregnant and breastfeeding women following the official declaration … year and in pregnant and breastfeeding women. In addition, the Agency had … and Relenza in pregnant and breastfeeding women following the official declaration … -
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Human medicine European public assessment report (EPAR): Eladynos
abaloparatide, Osteoporosis, Postmenopausal; Osteoporosis
Date of authorisation: 12/12/2022,
, Revision: 2, Authorised, Last updated: 25/08/2023
ingredients, pregnant or breastfeeding women, women who are able to have … ingredients, pregnant or breastfeeding women, women who are able to have … -
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Human medicine European public assessment report (EPAR): Kisplyx
lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016,
, Revision: 20, Authorised, Last updated: 25/07/2023
Kisplyx must not be taken by breastfeeding women. For the full list of restrictions … Kisplyx must not be taken by breastfeeding women. For the full list of restrictions … -
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Human medicine European public assessment report (EPAR): Lixiana
edoxaban tosilate, Stroke; Venous Thromboembolism
Date of authorisation: 19/06/2015, Revision: 17, Authorised, Last updated: 06/07/2023not be used in pregnant or breastfeeding women or in patients also being … -
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Human medicine European public assessment report (EPAR): Xeljanz
Tofacitinib, Arthritis, Rheumatoid
Date of authorisation: 22/03/2017,
Date of refusal: 25/04/2013,
, Revision: 27, Authorised, Last updated: 12/06/2023
function or pregnant and breastfeeding women. Women who are able to have … function or pregnant and breastfeeding women. Women who are able to have … -
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Human medicine European public assessment report (EPAR): Xeloda
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 02/02/2001, Revision: 30, Authorised, Last updated: 26/10/2022enzyme activity; pregnant or breastfeeding women; patients with severe leucopenia … -
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Veterinary medicine European public assessment report (EPAR): Stelfonta
tigilanol tiglate, Dogs
Date of authorisation: 15/01/2020, Revision: 1, Authorised, Last updated: 13/05/2020doctor. Pregnant women and breastfeeding women should take care to avoid … -
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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: 44, Authorised, Last updated: 28/09/2023
adapted vaccines in pregnant or breastfeeding women. However, based on similarity … -
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Human medicine European public assessment report (EPAR): Olumiant (updated)
Baricitinib, Arthritis, Rheumatoid
Date of authorisation: 13/02/2017,, Revision: 16, Authorised, Last updated: 21/09/2023
function or pregnant and breastfeeding women. Women who are able to have … function or pregnant and breastfeeding women. Women who are able to have … -
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Human medicine European public assessment report (EPAR): Jinarc (updated)
Tolvaptan, Polycystic Kidney, Autosomal Dominant
Date of authorisation: 27/05/2015,, Revision: 20, Authorised, Last updated: 18/09/2023
not be used in pregnant and breastfeeding women. For the full list of restrictions … be used in pregnant and breastfeeding women. For the full list of restrictions … -
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Human medicine European public assessment report (EPAR): Lenvima
lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015,, , Revision: 19, Authorised, Last updated: 25/07/2023
Lenvima must not be taken by breastfeeding women. For the full list of restrictions … Lenvima must not be taken by breastfeeding women. For the full list of restrictions … -
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Human medicine European public assessment report (EPAR): Blincyto
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,, , Revision: 17, Authorised, Last updated: 08/05/2023
Blincyto must not be given to breastfeeding women. For the full list of restrictions … -
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Human medicine European public assessment report (EPAR): Opsumit
Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013,, Revision: 22, Authorised, Last updated: 24/03/2023
not be used in pregnant or breastfeeding women or in women who could become … not be used in pregnant or breastfeeding women or in women who could become … -
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Human medicine European public assessment report (EPAR): Aclasta
zoledronic acid, Osteoporosis; Osteitis Deformans; Osteoporosis, Postmenopausal
Date of authorisation: 15/04/2005, Revision: 31, Authorised, Last updated: 16/01/2023levels), or in pregnant or breastfeeding women. Why has Aclasta been approved … levels), or in pregnant or breastfeeding women. Why has Aclasta been approved … -
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Human medicine European public assessment report (EPAR): Quinsair
levofloxacin, Cystic Fibrosis; Respiratory Tract Infections
Date of authorisation: 25/03/2015,, Revision: 15, Authorised, Last updated: 22/12/2022
not be used in pregnant or breastfeeding women. For the full list of restrictions … not be used in pregnant or breastfeeding women. For the full list of restrictions … -
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News: Workshop: safe use of medicines during pregnancy and breastfeeding
Last updated: 08/07/2020and safety for pregnant and breastfeeding women and enable better decision-making … -
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Human medicine European public assessment report (EPAR): Ketoconazole HRA
Ketoconazole, Cushing Syndrome
Date of authorisation: 18/11/2014,, , , Revision: 10, Authorised, Last updated: 07/06/2021
not be used in pregnant or breastfeeding women or patients who have QTc … not be used in pregnant or breastfeeding women or patients who have QTc …