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Opinion/decision on a Paediatric investigation plan (PIP): Omvoh, Mirikizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastrointestinal disorders, PIP number: P/0534/2023

Opinion/decision on a Paediatric investigation plan (PI...

Feb 13, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Omvoh, Mirikizumab, d...

EMEA-002329-PIP02-20-M03

EMEA-002329-PIP02-20-M03

Feb 13, 2025 0

EMEA-002329-PIP02-20-M03

EMEA-002798-PIP04-23

EMEA-002798-PIP04-23

Feb 13, 2025 0

EMEA-002798-PIP04-23

Opinion/decision on a Paediatric investigation plan (PIP): Uplizna, Inebilizumab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Immune system disorders, PIP number: P/0531/2023

Opinion/decision on a Paediatric investigation plan (PI...

Feb 13, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Uplizna, Inebilizumab...

Human medicines European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories), mercaptopurine, Date of authorisation: 09/03/2012, Revision: 17, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 13, 2025 0

Human medicines European public assessment report (EPAR): Xaluprine (previously ...

Human medicines European public assessment report (EPAR): Lydisilka, estetrol,drospirenone, Date of authorisation: 19/05/2021, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 13, 2025 0

Human medicines European public assessment report (EPAR): Lydisilka, estetrol,dr...

Implementation strategy of ICH Guideline M12 on drug in...

Feb 13, 2025 0

Implementation strategy of ICH Guideline M12 on drug interaction studies

ICH M12 on drug interaction studies - Scientific guideline

ICH M12 on drug interaction studies - Scientific guideline

Feb 13, 2025 0

ICH M12 on drug interaction studies - Scientific guideline

Opinion/decision on a Paediatric investigation plan (PIP): Vaborem, meropenem trihydrate,vaborbactam, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0530/2023

Opinion/decision on a Paediatric investigation plan (PI...

Feb 13, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Vaborem, meropenem tr...

New product information wording – Extracts from PRAC re...

Feb 13, 2025 0

New product information wording – Extracts from PRAC recommendations on signals ...

Human medicines European public assessment report (EPAR): Drovelis, estetrol,drospirenone, Date of authorisation: 19/05/2021, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 13, 2025 0

Human medicines European public assessment report (EPAR): Drovelis, estetrol,dro...

Human medicines European public assessment report (EPAR): Skytrofa (previously Lonapegsomatropin Ascendis Pharma), lonapegsomatropin, Date of authorisation: 11/01/2022, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 12, 2025 0

Human medicines European public assessment report (EPAR): Skytrofa (previously L...

Human medicines European public assessment report (EPAR): Actelsar HCT, telmisartan,hydrochlorothiazide, Date of authorisation: 13/03/2013, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 12, 2025 0

Human medicines European public assessment report (EPAR): Actelsar HCT, telmisar...

Human medicines European public assessment report (EPAR): Copalia HCT, amlodipine,valsartan,hydrochlorothiazide, Date of authorisation: 03/11/2009, Revision: 27, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 12, 2025 0

Human medicines European public assessment report (EPAR): Copalia HCT, amlodipin...

Human medicines European public assessment report (EPAR): Exforge HCT, amlodipine besilate,valsartan,hydrochlorothiazide, Date of authorisation: 15/10/2009, Revision: 27, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 12, 2025 0

Human medicines European public assessment report (EPAR): Exforge HCT, amlodipin...

Budesonide, prolonged release tablets, 9 mg product- specific bioequivalence guidance

Budesonide, prolonged release tablets, 9 mg product- sp...

Feb 12, 2025 0

Budesonide, prolonged release tablets, 9 mg product- specific bioequivalence gui...

Human medicines European public assessment report (EPAR): Dafiro HCT, amlodipine besilate,valsartan,hydrochlorothiazide, Date of authorisation: 03/11/2009, Revision: 29, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 12, 2025 0

Human medicines European public assessment report (EPAR): Dafiro HCT, amlodipine...

Human medicines European public assessment report (EPAR): Exforge, amlodipine,valsartan, Date of authorisation: 16/01/2007, Revision: 34, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 12, 2025 0

Human medicines European public assessment report (EPAR): Exforge, amlodipine,va...

Human medicines European public assessment report (EPAR): Copalia, amlodipine,valsartan, Date of authorisation: 15/01/2007, Revision: 32, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 12, 2025 0

Human medicines European public assessment report (EPAR): Copalia, amlodipine,va...

Human medicines European public assessment report (EPAR): Dafiro, amlodipine,valsartan, Date of authorisation: 15/01/2007, Revision: 33, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 12, 2025 0

Human medicines European public assessment report (EPAR): Dafiro, amlodipine,val...

Budesonide, gastro-resistant hard capsules, 3 mg, gastro- resistant granules, 9 mg product-specific bioequivalence guidance

Budesonide, gastro-resistant hard capsules, 3 mg, gastr...

Feb 12, 2025 0

Budesonide, gastro-resistant hard capsules, 3 mg, gastro- resistant granules, 9 ...

Budesonide, gastro-resistant hard capsules with prolonged release properties, 3 mg, product-specific bioequivalence guidance

Budesonide, gastro-resistant hard capsules with prolong...

Feb 12, 2025 0

Budesonide, gastro-resistant hard capsules with prolonged release properties, 3 ...

Human medicines European public assessment report (EPAR): Piqray, alpelisib, Date of authorisation: 27/07/2020, Revision: 15, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 12, 2025 0

Human medicines European public assessment report (EPAR): Piqray, alpelisib, Dat...

Opinion/decision on a Paediatric investigation plan (PIP): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222), decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Vaccines, PIP number: P/0273/2024

Opinion/decision on a Paediatric investigation plan (PI...

Feb 12, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Vaxzevria (previously...

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