24 results
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Human medicine European public assessment report (EPAR): Fertavid
follitropin beta, Infertility; Hypogonadism
Date of authorisation: 19/03/2009, Revision: 12, Withdrawn, Last updated: 23/06/2020transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic … -
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Human medicine European public assessment report (EPAR): GONAL-f
follitropin alfa, Anovulation; Reproductive Techniques, Assisted; Infertility, Female; Hypogonadism
Date of authorisation: 20/10/1995, Revision: 25, Authorised, Last updated: 06/09/2022fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT). GONAL-f … fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer. • GONAL-f in … -
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Human medicine European public assessment report (EPAR): Ovaleap
follitropin alfa, Anovulation
Date of authorisation: 27/09/2013,
, Revision: 9, Authorised, Last updated: 03/10/2019
fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer; Ovaleap in association … -
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Human medicine European public assessment report (EPAR): Bemfola
follitropin alfa, Anovulation
Date of authorisation: 26/03/2014,, Revision: 10, Authorised, Last updated: 19/12/2022
fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT); follitropin … -
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Human medicine European public assessment report (EPAR): Puregon
follitropin beta, Infertility; Hypogonadism
Date of authorisation: 02/05/1996, Revision: 34, Authorised, Last updated: 29/03/2023transfer (IVF/ET), gamete intrafallopian transfer (GIFT) and intracytoplasmic … -
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National expert: Antonio Battisti, Ministry Of Health (updated)
- Declaration of interests - 39.85 KB | PDF
- Curriculum Vitae - 53.09 KB | PDF
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Human medicine European public assessment report (EPAR): Cetrotide
cetrorelix (as acetate), Ovulation; Ovulation Induction
Date of authorisation: 12/04/1999, Revision: 27, Authorised, Last updated: 12/04/2023embryo transfer and gamete intrafallopian transfer results in a lower … -
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Human medicine European public assessment report (EPAR): Maviret
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,
, Revision: 21, Authorised, Last updated: 02/03/2023
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Human medicine European public assessment report (EPAR): Jemperli
dostarlimab, Endometrial Neoplasms
Date of authorisation: 21/04/2021,
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, Revision: 6, Authorised, Last updated: 19/12/2022
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Human medicine European public assessment report (EPAR): Jardiance (updated)
empagliflozin, Diabetes Mellitus, Type 2
Date of authorisation: 22/05/2014, Revision: 27, Authorised, Last updated: 16/05/2023 -
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Human medicine European public assessment report (EPAR): Brineura
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,, , 
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, Revision: 6, Authorised, Last updated: 16/08/2022
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Human medicine European public assessment report (EPAR): Elmiron
pentosan polysulfate sodium, Cystitis, Interstitial
Date of authorisation: 02/06/2017, Revision: 14, Authorised, Last updated: 15/07/2022 -
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National expert: Astrid Thomas, European Medicines Agency (updated)
- Declaration of interests - 40.61 KB | PDF
- Curriculum Vitae - 62.84 KB | PDF
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Direct healthcare professional communication (DHPC): Respreeza (human alpha-1-proteinase inhibitor): Sterility issue with the infusion device co-packed with Respreeza 4.000 mg and 5.000 mg
Active substance: Human alpha1-proteinase inhibitor, DHPC type: Medicine shortage, Last updated: 26/03/2021alternative infusion set (BBraun Intrafix® Primeline Art. No. 4062981L … alternative infusion set (BBraun Intrafix® Primeline Art. No. 4062981L … -
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Referral: Zyrtec
cetirizine, Article 30 referrals
Status: European Commission final decision, opinion/position date: 30/05/2008, EC decision date: 06/10/2008, Last updated: 16/10/2008 -
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Direct healthcare professional communication (DHPC): Menopur (menotropins’ for injection) – quality defect leading to supply shortage
Active substance: menotropin, DHPC type: Medicine shortage, Last updated: 17/04/2023transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic … -
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Referral: Intravenous iron-containing medicinal products
ferric carboxymaltose, iron dextran, sodium ferric gluconate, iron isomaltoside, iron sucrose, Article 31 referrals
Status: European Commission final decision, opinion/position date: 27/06/2013, EC decision date: 13/09/2013, Last updated: 28/07/2021 -
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National expert: Dieter Deforce, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 40.05 KB | PDF
- Curriculum Vitae - 190.57 KB | PDF
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Opinion/decision on a Paediatric investigation plan (PIP): Human recombinant follicle-stimulating hormone (FE 999049)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001183-PIP02-13, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for injection
Decision date: 08/08/2014, Last updated: 22/08/2014, Compliance check: Xtransfer (IVT/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic … -
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Requirements for the production and control of immunological veterinary medicinal products - Scientific guideline
Last updated: 24/06/2022 -
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Similar biological medicinal products containing recombinant follicle-stimulating hormone - Scientific guideline
Last updated: 06/03/2013 -
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EudraVigilance Veterinary
Last updated: 24/06/2022 -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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CHMP: meeting archive 2001-2009
Last updated: 18/11/2013