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Dacarbazine : List of nationally authorised medicinal products - PSUSA/00000919/202302 (PDF/107.38 KB) (new)

Last updated: 04/10/2023
Active substance: dacarbazine
Procedure number: PSUSA/00000919/202302
Regulatory outcome: Maintenance
List item

Agenda of the CVMP meeting 3-5 October 2023 (PDF/269.23 KB) (new)

Draft
First published: 03/10/2023
EMA/440934/2023
List item

News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 September 2023 (updated)

PRAC, Last updated: 29/09/2023
List item

Mefloquine : List of nationally authorised medicinal products - PSUSA/00001955/202302 (PDF/164.36 KB) (new)

Last updated: 29/09/2023
Active substance: mefloquine
Procedure number: PSUSA/00001955/202302
Regulatory outcome: Maintenance
List item

Saccharomyces boulardii : List of nationally authorised medicinal products - PSUSA/00009284/202302 (PDF/375.39 KB) (new)

Last updated: 29/09/2023
Active substance: saccharomyces boulardii
Procedure number: PSUSA/00009284/202302
Regulatory outcome: Maintenance
List item

Haemophilus type b conjugate vaccines : List of nationally authorised medicinal products - PSUSA/00001584/202302 (PDF/261.45 KB) (new)

Last updated: 29/09/2023
Active substance: haemophilus type b conjugate vaccines
Procedure number: PSUSA/00001584/202302
Regulatory outcome: Maintenance
List item

Ipratropium / salbutamol : List of nationally authorised medicinal products - PSUSA/00001781/202301 (PDF/117.04 KB) (new)

Last updated: 29/09/2023
Active substance: ipratropium, salbutamol
Procedure number: PSUSA/00001781/202301
Regulatory outcome: Maintenance
List item

Ipratropium : List of nationally authorised medicinal products - PSUSA/00001780/202301 (PDF/155.42 KB) (new)

Last updated: 29/09/2023
Active substance: ipratropium
Procedure number: PSUSA/00001780/202301
Regulatory outcome: Maintenance
List item

Sodium citrate (extracorporeal use) : List of nationally authorised medicinal products - PSUSA/00010986/202301 (PDF/171.06 KB) (new)

Last updated: 29/09/2023
Active substance: sodium citrate (extracorporeal use)
Procedure number: PSUSA/00010986/202301
Regulatory outcome: Maintenance
List item

Influenza vaccine (split virion, inactivated) (non centrally authorised products) : List of nationally authorised medicinal products - PSUSA/00010298/202303 (PDF/1.09 MB) (new)

Last updated: 29/09/2023
Active substance: influenza vaccine (split virion, inactivated) (non centrally authorised products)
Procedure number: PSUSA/00010298/202303
Regulatory outcome: Maintenance
List item

Haemophilus type b and meningococcal group C conjugate vaccine : List of nationally authorised medicinal products - PSUSA/00001583/202302 (PDF/149.66 KB) (new)

Last updated: 29/09/2023
Active substance: haemophilus type b and meningococcal group c conjugate vaccine
Procedure number: PSUSA/00001583/202302
Regulatory outcome: Maintenance
List item

Influenza vaccine (surface antigen, inactivated) : List of nationally authorised medicinal products - PSUSA/00001744/202303 (PDF/134.22 KB) (new)

Last updated: 29/09/2023
Active substance: influenza vaccine (surface antigen, inactivated)
Procedure number: PSUSA/00001744/202303
Regulatory outcome: Maintenance
List item

P/0375/2022: EMA decision of 9 September 2022 on the agreement of a paediatric investigation plan for ex vivo expanded autologous human keratinocytes containing epidermal stem cells genetically modified with a gamma-retroviral (RV) (EMEA-003137-PIP01-21) (PDF/196.25 KB) (new)

Adopted
First published: 28/09/2023
EMA/706927/2022
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P/0370/2022 : of 9 September 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for ibrexafungerp citrate (EMEA-002535-PIP04-21) (PDF/243.4 KB) (new)

Adopted
First published: 28/09/2023
EMA/697763/2022
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P/0403/2022 : EMA decision of 9 September 2022 on the granting of a product specific waiver for pegcetacoplan (Aspaveli), (EMEA-002600-PIP04-22) (PDF/175.91 KB) (new)

Adopted
First published: 28/09/2023
EMA/709243/2022
List item

P/0393/2022 : EMA decision of 9 September 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for clazakizumab (EMEA-001371-PIP02-21) (PDF/196.25 KB) (new)

Adopted
First published: 28/09/2023
EMA/677940/2022
List item

Fenoterol / ipratropium : List of nationally authorised medicinal products - PSUSA/00001367/202302 (PDF/186.09 KB) (new)

Last updated: 28/09/2023
Active substance: fenoterol, ipratropium
Procedure number: PSUSA/00001367/202302
Regulatory outcome: Maintenance
List item

P/0443/2022 : EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for marstacimab (EMEA- 002285-PIP02-19-M02) (PDF/252.3 KB) (new)

Adopted
First published: 28/09/2023
EMA/823989/2022
List item

P/0442/2022 : EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for monovalent, recombinant, replication-incompetent human adenovirus serotype...from the RSV A2 strain (EMEA-002172-PIP02-17-M02) (PDF/266.98 KB) (new)

Adopted
First published: 28/09/2023
EMA/824453/2022
List item

P/0441/2022 : EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cefiderocol (Fetcroja), (EMEA-002133-PIP01-17-M03) (PDF/226.13 KB) (new)

Adopted
First published: 28/09/2023
EMA/788938/2022
List item

P/0458/2022 : EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for insulin human (NTRA-2112/ELGN-2112) (EMEA-002116-PIP01-17-M01) (PDF/241.99 KB) (new)

Adopted
First published: 28/09/2023
EMA/776153/2022
List item

P/0453/2022 : EMA decision of 24 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for vosoritide (Voxzogo), (EMEA-002033-PIP01-16-M03) (PDF/215.04 KB) (new)

Adopted
First published: 28/09/2023
EMA/834945/2022
List item

P/0460/2022 : EMA decision of 28 October 2022 on the granting of a product specific waiver for telmisartan / rosuvastatin (calcium) (EMEA-003262- PIP01-22) (PDF/204.66 KB) (new)

Adopted
First published: 28/09/2023
EMA/790490/2022
List item

P/0461/2022 : EMA decision of 28 October 2022 on the granting of a product specific waiver for finasteride / tadalafil (EMEA-003261-PIP01-22) (PDF/210.6 KB) (new)

Adopted
First published: 28/09/2023
EMA/790520/2022
List item

P/0459/2022 : EMA decision of 28 October 2022 on the granting of a product specific waiver for derivative of (3S,3'S,3a'S,10a'S)-3'- phenyl-3',3a',10',10a'-tetrahydro-1'H-spiro[indoline....[2',3':4,5]pyrrolo[1,2-b]indazol]-2- one (EMEA-003260-PIP01-22) (PDF/206.36 KB) (new)

Adopted
First published: 28/09/2023
EMA/790454/2022

14869 results

Dacarbazine : List of nationally authorised medicinal products - PSUSA/00000919/202302 (PDF/107.38 KB) (new)

Agenda of the CVMP meeting 3-5 October 2023 (PDF/269.23 KB) (new)

News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 September 2023 (updated)

Mefloquine : List of nationally authorised medicinal products - PSUSA/00001955/202302 (PDF/164.36 KB) (new)

Saccharomyces boulardii : List of nationally authorised medicinal products - PSUSA/00009284/202302 (PDF/375.39 KB) (new)

Haemophilus type b conjugate vaccines : List of nationally authorised medicinal products - PSUSA/00001584/202302 (PDF/261.45 KB) (new)

Ipratropium / salbutamol : List of nationally authorised medicinal products - PSUSA/00001781/202301 (PDF/117.04 KB) (new)

Ipratropium : List of nationally authorised medicinal products - PSUSA/00001780/202301 (PDF/155.42 KB) (new)

Sodium citrate (extracorporeal use) : List of nationally authorised medicinal products - PSUSA/00010986/202301 (PDF/171.06 KB) (new)

Influenza vaccine (split virion, inactivated) (non centrally authorised products) : List of nationally authorised medicinal products - PSUSA/00010298/202303 (PDF/1.09 MB) (new)

Haemophilus type b and meningococcal group C conjugate vaccine : List of nationally authorised medicinal products - PSUSA/00001583/202302 (PDF/149.66 KB) (new)

Influenza vaccine (surface antigen, inactivated) : List of nationally authorised medicinal products - PSUSA/00001744/202303 (PDF/134.22 KB) (new)

P/0375/2022: EMA decision of 9 September 2022 on the agreement of a paediatric investigation plan for ex vivo expanded autologous human keratinocytes containing epidermal stem cells genetically modified with a gamma-retroviral (RV) (EMEA-003137-PIP01-21) (PDF/196.25 KB) (new)

P/0370/2022 : of 9 September 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for ibrexafungerp citrate (EMEA-002535-PIP04-21) (PDF/243.4 KB) (new)

P/0403/2022 : EMA decision of 9 September 2022 on the granting of a product specific waiver for pegcetacoplan (Aspaveli), (EMEA-002600-PIP04-22) (PDF/175.91 KB) (new)

P/0393/2022 : EMA decision of 9 September 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for clazakizumab (EMEA-001371-PIP02-21) (PDF/196.25 KB) (new)

Fenoterol / ipratropium : List of nationally authorised medicinal products - PSUSA/00001367/202302 (PDF/186.09 KB) (new)

P/0443/2022 : EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for marstacimab (EMEA- 002285-PIP02-19-M02) (PDF/252.3 KB) (new)

P/0442/2022 : EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for monovalent, recombinant, replication-incompetent human adenovirus serotype...from the RSV A2 strain (EMEA-002172-PIP02-17-M02) (PDF/266.98 KB) (new)

P/0441/2022 : EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cefiderocol (Fetcroja), (EMEA-002133-PIP01-17-M03) (PDF/226.13 KB) (new)

P/0458/2022 : EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for insulin human (NTRA-2112/ELGN-2112) (EMEA-002116-PIP01-17-M01) (PDF/241.99 KB) (new)

P/0453/2022 : EMA decision of 24 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for vosoritide (Voxzogo), (EMEA-002033-PIP01-16-M03) (PDF/215.04 KB) (new)

P/0460/2022 : EMA decision of 28 October 2022 on the granting of a product specific waiver for telmisartan / rosuvastatin (calcium) (EMEA-003262- PIP01-22) (PDF/204.66 KB) (new)

P/0461/2022 : EMA decision of 28 October 2022 on the granting of a product specific waiver for finasteride / tadalafil (EMEA-003261-PIP01-22) (PDF/210.6 KB) (new)

P/0459/2022 : EMA decision of 28 October 2022 on the granting of a product specific waiver for derivative of (3S,3'S,3a'S,10a'S)-3'- phenyl-3',3a',10',10a'-tetrahydro-1'H-spiro[indoline....[2',3':4,5]pyrrolo[1,2-b]indazol]-2- one (EMEA-003260-PIP01-22) (PDF/206.36 KB) (new)