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P/0477/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for sodium zirconium cyclosilicate (Lokelma) (EMEA-001539-PIP01-13-M05) (PDF/221.12 KB) (new)

First published: 01/02/2023
EMA/627439/2021
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CAT quarterly highlights and approved ATMPs - January 2023 (PDF/300.34 KB) (new)

First published: 01/02/2023
EMA/CAT/50775/2023
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Lanreotide : List of nationally authorised medicinal products - PSUSA/00001826/202205 (PDF/206.91 KB) (new)

Last updated: 24/01/2023
Active substance: lanreotide
Procedure number: PSUSA/00001826/202205
Regulatory outcome: Maintenance
List item

Vinorelbine : List of nationally authorised medicinal products - PSUSA/00003124/202204 (PDF/226.24 KB) (new)

Last updated: 24/01/2023
Active substance: vinorelbine
Procedure number: PSUSA/00003124/202204
Regulatory outcome: Variation
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Ivermectin (systemic use) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010377/202204 (PDF/112.1 KB) (new)

Last updated: 23/01/2023
Active substance: Ivermectin
Procedure number: PSUSA/00010377/202204
Regulatory outcome: Variation
Bulgarian
(PDF/131.31 KB)

Croatian
(PDF/137.49 KB)

Czech
(PDF/138.09 KB)

Danish
(PDF/104.48 KB)

Dutch
(PDF/115.18 KB)

Estonian
(PDF/121.41 KB)

Finnish
(PDF/110.09 KB)

French
(PDF/113.8 KB)

German
(PDF/117 KB)

Greek
(PDF/130.42 KB)

Hungarian
(PDF/136.75 KB)

Italian
(PDF/130.36 KB)

Latvian
(PDF/142.99 KB)

Lithuanian
(PDF/103.32 KB)

Maltese
(PDF/132.44 KB)

Polish
(PDF/110.92 KB)

Portuguese
(PDF/113.74 KB)

Romanian
(PDF/131.99 KB)

Slovak
(PDF/133.13 KB)

Slovenian
(PDF/127.69 KB)

Spanish
(PDF/113.13 KB)

Swedish
(PDF/112.77 KB)
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Ivermectin (systemic use) : List of nationally authorised medicinal products - PSUSA/00010377/202204 (PDF/135.14 KB) (new)

Last updated: 23/01/2023
Active substance: Ivermectin
Procedure number: PSUSA/00010377/202204
Regulatory outcome: Variation
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PDCO work plan 2023 (PDF/184.9 KB) (new)

Adopted
First published: 20/01/2023
EMA/PDCO/867297/2022
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P/0071/2022 : EMA decision of 11 March 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (14S)-8-[3-(2-{dispiro[2.0.2^(4).1^(3)]heptan-7-yl}ethoxy).....(EMEA-003052-PIP01-21) (PDF/266.82 KB) (new)

Adopted
First published: 19/01/2023
EMA/71025/2022
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Paediatric Committee (PDCO): 17-20 January 2023 (updated)

Virtual meeting, from 17/01/2023 to 20/01/2023, Last updated: 17/01/2023
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Agenda of the PDCO meeting 17-20 January 2023 (PDF/405.12 KB) (new)

First published: 17/01/2023
EMA/PDCO/2399/2023
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Committee for Advanced Therapies (CAT): 18-19 January 2023 (new)

European Medicines Agency, Amsterdam, the Netherlands, from 18/01/2023 to 19/01/2023, Last updated: 16/01/2023
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P/0248/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ibalizumab (Trogarzo), (EMEA-002311-PIP01-17-M02) (PDF/815.75 KB) (updated)

Adopted
First published: 18/07/2022
Last updated: 16/01/2023
EMA/318043/2021
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P/0363/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for autologous tumourinfiltrating lymphocytes (LN-144/LN-145) (EMEA-002776-PIP01-20-M01) (PDF/223.99 KB) (new)

Adopted
First published: 13/01/2023
EMA/439884/2021
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P/0398/2021 : EMA decision of 30 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for selpercatinib (Retsevmo), (EMEA-002544-PIP01-18-M01) (PDF/236.48 KB) (new)

Adopted
First published: 13/01/2023
EMA/531413/2021 corr
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P/0370/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for narsoplimab (EMEA-002479-PIP01-18-M01) (PDF/251.15 KB) (new)

Adopted
First published: 13/01/2023
EMA/464468/2021
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P/0353/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for berotralstat (EMEA-002449-PIP02-18-M01) (PDF/263.51 KB) (new)

Adopted
First published: 13/01/2023
EMA/464380/2021
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P/0382/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for fidanacogene elaparvovec (EMEA-002362-PIP02-19-M01) (PDF/218.31 KB) (new)

Adopted
First published: 13/01/2023
EMA/464308/2021
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EMA/470768/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for Pneumococcal Polyssacharide Serotype 6A conjugated to CRM197 carrier protein.....(EMEA- 002330-PIP01-18-M01) (PDF/258.74 KB) (new)

Adopted
First published: 13/01/2023
EMA/470768/2021
List item

P/0395/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for rezafungin acetate (EMEA-002319-PIP01-17-M01) (PDF/229.34 KB) (new)

Adopted
First published: 13/01/2023
EMA/440414/2021
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P/0350/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for aztreonam (ATM)/ avibactam (AVI) , (EMEA-002283-PIP01-17-M02) (PDF/217.74 KB) (new)

Adopted
First published: 13/01/2023
EMA/471941/2021
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P/0393/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dasiglucagon (EMEA- 002233-PIP01-17-M01) (PDF/233.02 KB) (new)

Adopted
First published: 13/01/2023
EMA/470766/2021
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P/0394/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for solriamfetol (EMEA- 002184-PIP01-17-M01) (PDF/198.75 KB) (new)

Adopted
First published: 13/01/2023
EMA/470765/2021
List item

P/0374/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant Clostridioides difficile toxoid A / recombinant Clostridioides difficile toxoid B (EMEA-002112-PIP01-16- M01) (PDF/223.71 KB) (new)

Adopted
First published: 12/01/2023
EMA/470764/2021
List item

P/0351/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for entrectinib (Rozlytrek), (EMEA-002096-PIP01-16-M03) (PDF/236.08 KB) (new)

Adopted
First published: 12/01/2023
EMA/418758/2021
List item

P/0365/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for mexiletine (hydrochloride) (Namuscla), (EMEA-002012-PIP01-16-M03) (PDF/254.59 KB) (new)

Adopted
First published: 12/01/2023
EMA/418757/2021

6718 results

P/0477/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for sodium zirconium cyclosilicate (Lokelma) (EMEA-001539-PIP01-13-M05) (PDF/221.12 KB) (new)

CAT quarterly highlights and approved ATMPs - January 2023 (PDF/300.34 KB) (new)

Lanreotide : List of nationally authorised medicinal products - PSUSA/00001826/202205 (PDF/206.91 KB) (new)

Vinorelbine : List of nationally authorised medicinal products - PSUSA/00003124/202204 (PDF/226.24 KB) (new)

Ivermectin (systemic use) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010377/202204 (PDF/112.1 KB) (new)

Ivermectin (systemic use) : List of nationally authorised medicinal products - PSUSA/00010377/202204 (PDF/135.14 KB) (new)

PDCO work plan 2023 (PDF/184.9 KB) (new)

P/0071/2022 : EMA decision of 11 March 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (14S)-8-[3-(2-{dispiro[2.0.2^(4).1^(3)]heptan-7-yl}ethoxy).....(EMEA-003052-PIP01-21) (PDF/266.82 KB) (new)

Paediatric Committee (PDCO): 17-20 January 2023 (updated)

Agenda of the PDCO meeting 17-20 January 2023 (PDF/405.12 KB) (new)

Committee for Advanced Therapies (CAT): 18-19 January 2023 (new)

P/0248/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ibalizumab (Trogarzo), (EMEA-002311-PIP01-17-M02) (PDF/815.75 KB) (updated)

P/0363/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for autologous tumourinfiltrating lymphocytes (LN-144/LN-145) (EMEA-002776-PIP01-20-M01) (PDF/223.99 KB) (new)

P/0398/2021 : EMA decision of 30 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for selpercatinib (Retsevmo), (EMEA-002544-PIP01-18-M01) (PDF/236.48 KB) (new)

P/0370/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for narsoplimab (EMEA-002479-PIP01-18-M01) (PDF/251.15 KB) (new)

P/0353/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for berotralstat (EMEA-002449-PIP02-18-M01) (PDF/263.51 KB) (new)

P/0382/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for fidanacogene elaparvovec (EMEA-002362-PIP02-19-M01) (PDF/218.31 KB) (new)

EMA/470768/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for Pneumococcal Polyssacharide Serotype 6A conjugated to CRM197 carrier protein.....(EMEA- 002330-PIP01-18-M01) (PDF/258.74 KB) (new)

P/0395/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for rezafungin acetate (EMEA-002319-PIP01-17-M01) (PDF/229.34 KB) (new)

P/0350/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for aztreonam (ATM)/ avibactam (AVI) , (EMEA-002283-PIP01-17-M02) (PDF/217.74 KB) (new)

P/0393/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dasiglucagon (EMEA- 002233-PIP01-17-M01) (PDF/233.02 KB) (new)

P/0394/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for solriamfetol (EMEA- 002184-PIP01-17-M01) (PDF/198.75 KB) (new)

P/0374/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant Clostridioides difficile toxoid A / recombinant Clostridioides difficile toxoid B (EMEA-002112-PIP01-16- M01) (PDF/223.71 KB) (new)

P/0351/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for entrectinib (Rozlytrek), (EMEA-002096-PIP01-16-M03) (PDF/236.08 KB) (new)

P/0365/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for mexiletine (hydrochloride) (Namuscla), (EMEA-002012-PIP01-16-M03) (PDF/254.59 KB) (new)