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Human medicines European public assessment report (EPAR): Sitagliptin SUN, sitagliptin fumarate, Date of authorisation: 09/12/2021, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 26, 2025 0

Human medicines European public assessment report (EPAR): Sitagliptin SUN, sitag...

Human medicines European public assessment report (EPAR): MenQuadfi, meningococcal group A, C, W-135 and Y conjugate vaccine, Date of authorisation: 18/11/2020, Revision: 19, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 26, 2025 0

Human medicines European public assessment report (EPAR): MenQuadfi, meningococc...

ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Scientific guideline

ICH Guideline M13A on bioequivalence for immediate-rele...

Feb 26, 2025 0

ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage for...

Investigation of bioequivalence - Scientific guideline

Investigation of bioequivalence - Scientific guideline

Feb 26, 2025 0

Investigation of bioequivalence - Scientific guideline

Human medicines European public assessment report (EPAR): Bimervax, COVID-19 Vaccine (recombinant, adjuvanted),selvacovatein,damlecovatein, Date of authorisation: 30/03/2023, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 26, 2025 0

Human medicines European public assessment report (EPAR): Bimervax, COVID-19 Vac...

Human medicines European public assessment report (EPAR): Duaklir Genuair, aclidinium bromide,formoterol, Date of authorisation: 19/11/2014, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 26, 2025 0

Human medicines European public assessment report (EPAR): Duaklir Genuair, aclid...

Human medicines European public assessment report (EPAR): Eklira Genuair, aclidinium bromide, Date of authorisation: 20/07/2012, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 26, 2025 0

Human medicines European public assessment report (EPAR): Eklira Genuair, aclidi...

Human medicines European public assessment report (EPAR): Giotrif, afatinib, Date of authorisation: 25/09/2013, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 26, 2025 0

Human medicines European public assessment report (EPAR): Giotrif, afatinib, Dat...

Herbal medicinal product: Pilosellae herba cum radiceArray, F: Assessment finalised

Herbal medicinal product: Pilosellae herba cum radiceAr...

Feb 26, 2025 0

Herbal medicinal product: Pilosellae herba cum radiceArray, F: Assessment finalised

Agenda - PDCO agenda of the 25-28 February 2025 meeting

Feb 26, 2025 0

Agenda - PDCO agenda of the 25-28 February 2025 meeting

EMEA-003063-PIP02-22

EMEA-003063-PIP02-22

Feb 26, 2025 0

EMEA-003063-PIP02-22

EMEA-000786-PIP01-09-M02

EMEA-000786-PIP01-09-M02

Feb 26, 2025 0

EMEA-000786-PIP01-09-M02

Human medicines European public assessment report (EPAR): Xtandi, enzalutamide, Date of authorisation: 21/06/2013, Date of refusal: 26/04/2013, Revision: 26, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 25, 2025 0

Human medicines European public assessment report (EPAR): Xtandi, enzalutamide, ...

Medicinal products for human use: monthly figures - Jan...

Feb 25, 2025 0

Medicinal products for human use: monthly figures - January 2025

CTIS newsflash - 25 February 2025

Feb 25, 2025 0

CTIS newsflash - 25 February 2025

Human medicines European public assessment report (EPAR): Stelara, ustekinumab, Date of authorisation: 15/01/2009, Revision: 50, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 25, 2025 0

Human medicines European public assessment report (EPAR): Stelara, ustekinumab, ...

Human medicines European public assessment report (EPAR): Brimica Genuair, aclidinium,formoterol fumarate dihydrate, Date of authorisation: 19/11/2014, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 25, 2025 0

Human medicines European public assessment report (EPAR): Brimica Genuair, aclid...

Human medicines European public assessment report (EPAR): Eptifibatide Accord, eptifibatide, Date of authorisation: 11/01/2016, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 25, 2025 0

Human medicines European public assessment report (EPAR): Eptifibatide Accord, e...

Human medicines European public assessment report (EPAR): Bretaris Genuair, aclidinium bromide, Date of authorisation: 20/07/2012, Revision: 20, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 25, 2025 0

Human medicines European public assessment report (EPAR): Bretaris Genuair, acli...

Human medicines European public assessment report (EPAR): Trumenba, meningococcal group b vaccine (recombinant, adsorbed), Date of authorisation: 24/05/2017, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 25, 2025 0

Human medicines European public assessment report (EPAR): Trumenba, meningococca...

Human medicines European public assessment report (EPAR): Seladelpar Gilead, Seladelpar lysine dihydrate, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 25, 2025 0

Human medicines European public assessment report (EPAR): Seladelpar Gilead, Sel...

Human medicines European public assessment report (EPAR): Tacforius, tacrolimus, Date of authorisation: 08/12/2017, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 25, 2025 0

Human medicines European public assessment report (EPAR): Tacforius, tacrolimus,...

Questions and answers for biological medicinal products

Questions and answers for biological medicinal products

Feb 25, 2025 0

Questions and answers for biological medicinal products

Human medicines European public assessment report (EPAR): Pregabalin Pfizer, pregabalin, Date of authorisation: 10/04/2014, Revision: 34, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 25, 2025 0

Human medicines European public assessment report (EPAR): Pregabalin Pfizer, pre...

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