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P/0152/2017: EMA decision of 7 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M05) (PDF/674.71 KB)

Adopted
First published: 25/07/2017
Last updated: 14/01/2021
EMA/305258/2017
List item

Guidance on paediatric submissions (PDF/443.54 KB)

First published: 24/03/2020
Last updated: 13/11/2020
EMA/672643/2017 Rev. 3
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PDCO monthly report of opinions on paediatric investigation plans and other activities 25-28 February 2020 (PDF/156.09 KB)

Adopted
First published: 28/08/2020
Last updated: 15/09/2020
EMEA/120052/2020 Corr.1
List item

Olanzapine Teva : EPAR - Product Information (PDF/502.99 KB)

First published: 24/11/2009
Last updated: 27/05/2020
Bulgarian
(PDF/1.06 MB)

Croatian
(PDF/1013.01 KB)

Czech
(PDF/757.7 KB)

Danish
(PDF/978.72 KB)

Dutch
(PDF/933.49 KB)

Estonian
(PDF/966.91 KB)

Finnish
(PDF/929.55 KB)

French
(PDF/965.06 KB)

German
(PDF/1 MB)

Greek
(PDF/910.49 KB)

Hungarian
(PDF/606.82 KB)

Icelandic
(PDF/926.59 KB)

Italian
(PDF/953.45 KB)

Latvian
(PDF/1.08 MB)

Lithuanian
(PDF/1.05 MB)

Maltese
(PDF/1.08 MB)

Norwegian
(PDF/994.57 KB)

Polish
(PDF/1.02 MB)

Portuguese
(PDF/943.21 KB)

Romanian
(PDF/696.96 KB)

Slovak
(PDF/638.81 KB)

Slovenian
(PDF/1010.15 KB)

Spanish
(PDF/966.43 KB)

Swedish
(PDF/906.36 KB)
List item

Olanzapine Teva : EPAR - Procedural steps taken and scientific information after authorisation (PDF/290.26 KB)

First published: 24/11/2009
Last updated: 27/05/2020
List item

PDCO meeting dates for 2019, 2020 and 2021 (PDF/219.03 KB)

First published: 06/03/2017
Last updated: 14/04/2020
EMA/650782/2019 Rev. 3
List item

CAT rules of procedure (PDF/243.56 KB)

First published: 13/03/2009
Last updated: 02/04/2020
EMEA/CAT/ EMEA/454446/2008 Rev. 3
List item

P/0090/2019: EMA decision of 22 March 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral for ivacaftor / tezacaftor/ potassium (benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl)cyclopropyl]ethoxy}-1Hpyrazol- 1-yl)-2-[ (PDF/194.87 KB)

Adopted
First published: 24/06/2019
Last updated: 01/10/2019
EMA/130877/2019 Corr.
List item

P/0034/2019: EMA decision of 29 January 2019 on the acceptance of a modification of an agreed paediatric investigation plan for azilsartan medoxomil (Edarbi), (EMEA-000237-PIP01-08-M08) (PDF/177.74 KB)

Adopted
First published: 16/04/2019
Last updated: 16/04/2019
EMA/900651/2018
List item

PDCO opinion template (annex I and II) (DOC/264.5 KB)

First published: 20/09/2010
Last updated: 20/03/2019
List item

European Medicines Agency / PDCO summary-report template (DOC/434 KB)

First published: 15/12/2008
Last updated: 20/03/2019
List item

Template letter for applicant - waiving right for a re-examination request (DOC/25 KB)

First published: 05/04/2016
Last updated: 20/03/2019
List item

Minutes - PDCO minutes of the 16-19 October 2018 meeting (PDF/479.97 KB)

Adopted
First published: 05/02/2019
Last updated: 18/02/2019
EMA/PDCO/724133/2018 Corr.
List item

P/0277/2018: EMA decision of 12 September 2018 on the granting of a product specific waiver for levofloxacin / dexamethasone (EMEA-002375-PIP01-18) (PDF/76.01 KB)

First published: 18/01/2019
Last updated: 12/02/2019
EMA/517237/2018 Corr.
List item

PDCO monthly report of opinions on paediatric investigation plans and other activities 21-24 August 2018 (PDF/104.25 KB)

First published: 17/09/2018
Last updated: 17/09/2018
EMEA/585656/2018
List item

Draft concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1 (PDF/91.07 KB)

Draft: consultation closed
First published: 17/09/2018
Last updated: 17/09/2018
Consultations dates: from 17/09/2018 to 16/12/2018
EMA/PDCO/362462/2016
List item

Agenda - Paediatric strategy forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients (PDF/734.71 KB)

Draft
First published: 19/04/2018
Last updated: 30/08/2018
EMA/242738/2018
List item

Minutes - PDCO minutes of the 24-27 July 2018 meeting (PDF/383.67 KB)

Adopted
First published: 28/08/2018
Last updated: 28/08/2018
EMA/PDCO/514093/2018
List item

Agenda - PDCO agenda of the 21-24 August 2018 meeting (PDF/168.44 KB)

Draft
First published: 28/08/2018
Last updated: 28/08/2018
EMA/527101/2018
List item

Scientific recommendation on classification of advanced therapy medicinal products: Cultured human olfactory ensheathing cells and olfactory nerve fibroblasts (PDF/76.03 KB)

First published: 23/08/2018
Last updated: 23/08/2018
EMA/496382/2018
List item

Scientific recommendation on classification of advanced therapy medicinal products: Autologous CD34+ cells transduced with a lentiviral vector containing the FANCA gene (PDF/75.6 KB)

First published: 23/08/2018
Last updated: 23/08/2018
EMA/496459/2018
List item

Minutes of the CAT meeting 18-20 April 2018 (PDF/287.85 KB)

Adopted
First published: 23/08/2018
Last updated: 23/08/2018
EMA/CAT/252351/2018
List item

Minutes of the CAT meeting 23-25 May 2018 (PDF/401.37 KB)

Adopted
First published: 23/08/2018
Last updated: 23/08/2018
EMA/CAT/354919/2018
List item

PDCO monthly report of opinions on paediatric investigation plans and other activities 24-27 July 2018 (PDF/120.93 KB)

First published: 10/08/2018
Last updated: 10/08/2018
EMA/PDCO/530202/2018
List item

Minutes - PDCO minutes of the 26-29 June 2018 meeting (PDF/426.99 KB)

Adopted
First published: 06/08/2018
Last updated: 06/08/2018
EMA/PDCO/437683/2018

5325 results

P/0152/2017: EMA decision of 7 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M05) (PDF/674.71 KB)

Guidance on paediatric submissions (PDF/443.54 KB)

PDCO monthly report of opinions on paediatric investigation plans and other activities 25-28 February 2020 (PDF/156.09 KB)

Olanzapine Teva : EPAR - Product Information (PDF/502.99 KB)

Olanzapine Teva : EPAR - Procedural steps taken and scientific information after authorisation (PDF/290.26 KB)

PDCO meeting dates for 2019, 2020 and 2021 (PDF/219.03 KB)

CAT rules of procedure (PDF/243.56 KB)

P/0090/2019: EMA decision of 22 March 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral for ivacaftor / tezacaftor/ potassium (benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl)cyclopropyl]ethoxy}-1Hpyrazol- 1-yl)-2-[ (PDF/194.87 KB)

P/0034/2019: EMA decision of 29 January 2019 on the acceptance of a modification of an agreed paediatric investigation plan for azilsartan medoxomil (Edarbi), (EMEA-000237-PIP01-08-M08) (PDF/177.74 KB)

PDCO opinion template (annex I and II) (DOC/264.5 KB)

European Medicines Agency / PDCO summary-report template (DOC/434 KB)

Template letter for applicant - waiving right for a re-examination request (DOC/25 KB)

Minutes - PDCO minutes of the 16-19 October 2018 meeting (PDF/479.97 KB)

P/0277/2018: EMA decision of 12 September 2018 on the granting of a product specific waiver for levofloxacin / dexamethasone (EMEA-002375-PIP01-18) (PDF/76.01 KB)

PDCO monthly report of opinions on paediatric investigation plans and other activities 21-24 August 2018 (PDF/104.25 KB)

Draft concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1 (PDF/91.07 KB)

Agenda - Paediatric strategy forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients (PDF/734.71 KB)

Minutes - PDCO minutes of the 24-27 July 2018 meeting (PDF/383.67 KB)

Agenda - PDCO agenda of the 21-24 August 2018 meeting (PDF/168.44 KB)

Scientific recommendation on classification of advanced therapy medicinal products: Cultured human olfactory ensheathing cells and olfactory nerve fibroblasts (PDF/76.03 KB)

Scientific recommendation on classification of advanced therapy medicinal products: Autologous CD34+ cells transduced with a lentiviral vector containing the FANCA gene (PDF/75.6 KB)

Minutes of the CAT meeting 18-20 April 2018 (PDF/287.85 KB)

Minutes of the CAT meeting 23-25 May 2018 (PDF/401.37 KB)

PDCO monthly report of opinions on paediatric investigation plans and other activities 24-27 July 2018 (PDF/120.93 KB)

Minutes - PDCO minutes of the 26-29 June 2018 meeting (PDF/426.99 KB)