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P/0245/2020: EMA decision of 15 July 2020 on the granting of a product-specific waiver for icosasodium{26-[(2-acetamido-2-deoxy-β-Dgalactopyranosyl) oxy]-14,14-bis{[(3-{6-[(2-acetamido-2-deoxy-β-Dgalactopyranosyl) oxy]hexyl}... (EMEA-002786-PIP01-20) (PDF/271.83 KB) (new)

Adopted
First published: 17/06/2021
EMA/316760/2020
List item

P/0249/2020 - EMA decision of 15 July 2020 on the granting of a product specific waiver for ravagalimab (EMEA-002617-PIP02-19) (PDF/173.58 KB) (new)

Adopted
First published: 17/06/2021
EMA/356096/2020
List item

P/0265/2020 : EMA decision of 15 July 2020 on the granting of a product specific waiver for sutimlimab (EMEA-002542-PIP02-19) (PDF/208.87 KB) (new)

Adopted
First published: 17/06/2021
EMA/366136/2020
List item

Etifoxine : List of nationally authorised medicinal products - PSUSA/00001321/202010 (PDF/128.21 KB) (new)

Last updated: 17/06/2021
Active substance: etifoxine
Procedure number: PSUSA/00001321/202010
Regulatory outcome: Maintenance
List item

P/0251/2020 : EMA decision of 15 July 2020 on the granting of a product specific waiver for rosuvastatin / ezetimibe (Coroswera) (EMEA-002202-PIP02-20) (PDF/274.24 KB) (new)

Adopted
First published: 17/06/2021
EMA/316712/2020
List item

P/0095/2020 : EMA decision of 18 March 2020 on the agreement of a paediatric investigation plan and on the granting of a waiver for cannabidiol (Epidyolex) (EMEA-001964-PIP02-19) (PDF/193.35 KB) (new)

Adopted
First published: 17/06/2021
EMA/115522/2020
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P/0280/2020 : EMA decision of 20 July 2020 on the granting of a product specific waiver for Nivolumab (Opdivo) (EMEA-001407-PIP03-20) (PDF/194.14 KB) (new)

Adopted
First published: 17/06/2021
EMA/392270/2020
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P/0236/2021: EMA decision of 8 June 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for tixagevimab (AZD8895) (EMEA-002900-PIP01-20) (PDF/275.11 KB) (new)

Adopted
First published: 17/06/2021
EMA/300113/2021
List item

P/0221/2021: EMA decision of 9 June 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for bamlanivimab (EMEA-002952-PIP01-21) (PDF/245.29 KB) (new)

Adopted
First published: 17/06/2021
EMA/245846/2021
List item

Epinephrine / lidocaine : List of nationally authorised medicinal products - PSUSA/00001233/202009 (PDF/134.99 KB) (new)

Last updated: 17/06/2021
Active substance: epinephrine, lidocaine
Procedure number: PSUSA/00001233/202009
Regulatory outcome: Maintenance
List item

P/0235/2021: EMA decision of 8 June 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for cilgavimab (AZD1061) (EMEA-002925-PIP01-20) (PDF/273.33 KB) (new)

Adopted
First published: 17/06/2021
EMA/300136/2021
List item

P/0246/2020: EMA decision of 15 July 2020 on the granting of a product specific waiver for neratinib (Nerlynx), (EMEA-002783-PIP01-20) (PDF/226.51 KB) (new)

Adopted
First published: 16/06/2021
EMA/316758/2020
List item

P/0259/202: EMA decision of 17 July 2020 on the granting of a product specific waiver for humanised antibody targeting the inducible T cell costimulatory receptor (EMEA-002781-PIP01-20) (PDF/218.56 KB) (new)

Adopted
First published: 16/06/2021
EMA/366507/2020
List item

P/0260/2020: EMA decision of 15 July 2020 on the refusal of a paediatric investigation plan and on the granting of a waiver for human fibrinogen (EMEA-002769-PIP01-20) (PDF/243.73 KB) (new)

Adopted
First published: 16/06/2021
EMA/366114/2020
List item

P/0261/2020: EMA decision of 17 July 2020 on the granting of a product specific waiver for bisoprolol (fumarate) / trimetazidine (dihydrochloride) (EMEA-002768-PIP01-20) (PDF/267.42 KB) (new)

Adopted
First published: 16/06/2021
EMA/366694/2020
List item

P/0262/2020: EMA decision of 15 July 2020 on the refusal of a product specific waiver for recombinant human IgG1λ monoclonal Fab antibody (EMEA-002766-PIP01-20) (PDF/233.9 KB) (new)

Adopted
First published: 16/06/2021
EMA/366113/2020
List item

P/0263/2020: EMA decision of 15 July 2020 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for Insulin 287 (EMEA-002761-PIP01-20) (PDF/301.35 KB) (new)

Adopted
First published: 16/06/2021
EMA/366139/2020
List item

P/0247/2020: EMA decision on the agreement of 15 July 2020 on the granting of a product specific waiver for sitagliptin (hydrochloride monohydrate) / metformin (hydrochloride) (EMEA-002732-PIP02-20) (PDF/219.56 KB) (new)

Adopted
First published: 16/06/2021
EMA/362161/2020
List item

P/0275/2020: EMA decision of 15 July 2020 on the agreement of a paediatric investigation plan and on the granting of a waiver for lonapegsomatropin (EMEA-002692-PIP01-19) (PDF/194.32 KB) (new)

Adopted
First published: 16/06/2021
EMA/369130/2020
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P/0248/2020: EMA decision of 15 July 2020 on the agreement of a paediatric investigation plan and on the granting of a waiver for ondansetron (hydrochloride) (EMEA-002623-PIP01-19) (PDF/221.21 KB) (new)

Adopted
First published: 16/06/2021
EMA/356098/2020
List item

P/0252/2020: EMA decision of 15 July 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral for pegzilarginase (EMEA-001925-PIP02-19) (PDF/229.75 KB) (new)

Adopted
First published: 16/06/2021
EMA/362119/2020
List item

P/0252/2020: EMA decision on the agreement of a paediatric investigation plan and on the granting of a deferral for pegzilarginase (EMEA-001925-PIP02-19) (new)

Adopted
First published: 16/06/2021
EMA/362119/2020
List item

P/0252/2020: EMA decision on the agreement of a paediatric investigation plan and on the granting of a deferral for pegzilarginase (EMEA-001925-PIP02-19) (new)

Adopted
First published: 16/06/2021
EMA/362119/2020
List item

P/0252/2020: EMA decision on the agreement of a paediatric investigation plan and on the granting of a deferral for pegzilarginase (EMEA-001925-PIP02-19) (new)

Adopted
First published: 16/06/2021
EMA/362119/2020
List item

P/0252/2020: EMA decision on the agreement of a paediatric investigation plan and on the granting of a deferral for pegzilarginase (EMEA-001925-PIP02-19) (new)

Adopted
First published: 16/06/2021
EMA/362119/2020

12055 results

P/0245/2020: EMA decision of 15 July 2020 on the granting of a product-specific waiver for icosasodium{26-[(2-acetamido-2-deoxy-β-Dgalactopyranosyl) oxy]-14,14-bis{[(3-{6-[(2-acetamido-2-deoxy-β-Dgalactopyranosyl) oxy]hexyl}... (EMEA-002786-PIP01-20) (PDF/271.83 KB) (new)

P/0249/2020 - EMA decision of 15 July 2020 on the granting of a product specific waiver for ravagalimab (EMEA-002617-PIP02-19) (PDF/173.58 KB) (new)

P/0265/2020 : EMA decision of 15 July 2020 on the granting of a product specific waiver for sutimlimab (EMEA-002542-PIP02-19) (PDF/208.87 KB) (new)

Etifoxine : List of nationally authorised medicinal products - PSUSA/00001321/202010 (PDF/128.21 KB) (new)

P/0251/2020 : EMA decision of 15 July 2020 on the granting of a product specific waiver for rosuvastatin / ezetimibe (Coroswera) (EMEA-002202-PIP02-20) (PDF/274.24 KB) (new)

P/0095/2020 : EMA decision of 18 March 2020 on the agreement of a paediatric investigation plan and on the granting of a waiver for cannabidiol (Epidyolex) (EMEA-001964-PIP02-19) (PDF/193.35 KB) (new)

P/0280/2020 : EMA decision of 20 July 2020 on the granting of a product specific waiver for Nivolumab (Opdivo) (EMEA-001407-PIP03-20) (PDF/194.14 KB) (new)

P/0236/2021: EMA decision of 8 June 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for tixagevimab (AZD8895) (EMEA-002900-PIP01-20) (PDF/275.11 KB) (new)

P/0221/2021: EMA decision of 9 June 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for bamlanivimab (EMEA-002952-PIP01-21) (PDF/245.29 KB) (new)

Epinephrine / lidocaine : List of nationally authorised medicinal products - PSUSA/00001233/202009 (PDF/134.99 KB) (new)

P/0235/2021: EMA decision of 8 June 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for cilgavimab (AZD1061) (EMEA-002925-PIP01-20) (PDF/273.33 KB) (new)

P/0246/2020: EMA decision of 15 July 2020 on the granting of a product specific waiver for neratinib (Nerlynx), (EMEA-002783-PIP01-20) (PDF/226.51 KB) (new)

P/0259/202: EMA decision of 17 July 2020 on the granting of a product specific waiver for humanised antibody targeting the inducible T cell costimulatory receptor (EMEA-002781-PIP01-20) (PDF/218.56 KB) (new)

P/0260/2020: EMA decision of 15 July 2020 on the refusal of a paediatric investigation plan and on the granting of a waiver for human fibrinogen (EMEA-002769-PIP01-20) (PDF/243.73 KB) (new)

P/0261/2020: EMA decision of 17 July 2020 on the granting of a product specific waiver for bisoprolol (fumarate) / trimetazidine (dihydrochloride) (EMEA-002768-PIP01-20) (PDF/267.42 KB) (new)

P/0262/2020: EMA decision of 15 July 2020 on the refusal of a product specific waiver for recombinant human IgG1λ monoclonal Fab antibody (EMEA-002766-PIP01-20) (PDF/233.9 KB) (new)

P/0263/2020: EMA decision of 15 July 2020 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for Insulin 287 (EMEA-002761-PIP01-20) (PDF/301.35 KB) (new)

P/0247/2020: EMA decision on the agreement of 15 July 2020 on the granting of a product specific waiver for sitagliptin (hydrochloride monohydrate) / metformin (hydrochloride) (EMEA-002732-PIP02-20) (PDF/219.56 KB) (new)

P/0275/2020: EMA decision of 15 July 2020 on the agreement of a paediatric investigation plan and on the granting of a waiver for lonapegsomatropin (EMEA-002692-PIP01-19) (PDF/194.32 KB) (new)

P/0248/2020: EMA decision of 15 July 2020 on the agreement of a paediatric investigation plan and on the granting of a waiver for ondansetron (hydrochloride) (EMEA-002623-PIP01-19) (PDF/221.21 KB) (new)

P/0252/2020: EMA decision of 15 July 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral for pegzilarginase (EMEA-001925-PIP02-19) (PDF/229.75 KB) (new)

P/0252/2020: EMA decision on the agreement of a paediatric investigation plan and on the granting of a deferral for pegzilarginase (EMEA-001925-PIP02-19) (new)

P/0252/2020: EMA decision on the agreement of a paediatric investigation plan and on the granting of a deferral for pegzilarginase (EMEA-001925-PIP02-19) (new)

P/0252/2020: EMA decision on the agreement of a paediatric investigation plan and on the granting of a deferral for pegzilarginase (EMEA-001925-PIP02-19) (new)

P/0252/2020: EMA decision on the agreement of a paediatric investigation plan and on the granting of a deferral for pegzilarginase (EMEA-001925-PIP02-19) (new)