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P/0040/2013: EMA decision of 27 February 2013 on the granting of a product-specific waiver for amlodipine / losartan (EMEA-001380-PIP01-12) (PDF/78.18 KB)

application submitted by Krka, d.d., Novo mesto on 5 October … decision is addressed to Krka, d.d., Novo mesto, Šmarješka … name of the PIP applicant: Krka, d.d., Novo mesto Basis …

Adopted
First published: 23/04/2013
Last updated: 23/04/2013
EMA/24016/2013
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PDCO monthly report of opinions on paediatric investigation plans and other activities 7-9 October 2015 (PDF/95.41 KB)

amlodipine (besilate), from Krka, d.d., Novo mesto, for the … amlodipine (besilate), from Krka, d.d., Novo mesto, for the …

First published: 20/10/2015
Last updated: 20/10/2015
EMA/PDCO/672645/2015
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PDCO monthly report of opinions on paediatric investigation plans and other activities 15-17 July 2015 (PDF/110.03 KB)

tert-butylamine) / rosuvastatin, from Krka, d.d., Novo mesto, for the … tert-butylamine) / rosuvastatin, from Krka, d.d., Novo mesto, for the …

First published: 24/07/2015
Last updated: 24/07/2015
EMA/PDCO/464458/2015
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P/163/2010: EMA decision of 27 August 2010 on the agreement of a paediatric investigation plan and on the granting of a product specific waiver for amlodipine besylate / valsartan, (EMEA-001000-PIP01-10) (PDF/136.34 KB)

application submitted by Krka, d.d., Novo mesto on 12 April … decision is addressed to Krka, d.d., Novo mesto, Šmarješka … name of the PIP applicant: Krka, d.d., Novo mesto Basis for …

Adopted
First published: 06/10/2010
Last updated: 06/10/2010
EMA/476864/2010
List item

P/162/2010: EMA decision of 27 August 2010 on the agreement of a paediatric investigation plan and on the granting of a product specific waiver for perindopril erbumine / amlodipine besylate (EMEA- 000983-PIP01-10) (PDF/136.27 KB)

application submitted by Krka, d.d., Novo mesto on 12 April … decision is addressed to Krka, d.d., Novo mesto, Šmarješka … name of the PIP applicant: Krka, d.d., Novo mesto Basis for …

Adopted
First published: 06/10/2010
Last updated: 06/10/2010
EMA/476893/2010
List item

PDCO monthly report of opinions on paediatric investigation plans and other activities 12–15 September 2017 (PDF/103.4 KB)

EMEA-002202-PIP01-17, from Krka, d.d., Novo mesto, for the …

First published: 16/10/2017
Last updated: 16/10/2017
EMEA/PDCO/644202/2017
List item

PDCO meeting highlights 14-16 July 2010 (PDF/113.84 KB)

amlodipine besylate, from Krka, d.d., Novo mesto, in the … amlodipine besylate, from Krka, d.d., Novo mesto, in the …

First published: 22/07/2010
Last updated: 22/07/2010
EMA/PDCO/451774/2010
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PDCO monthly report of opinions on paediatric investigation plans and other activities 27-29 January 2016 (PDF/100.04 KB)

Ramipril / amlodipine, from Krka, d.d., Novo mesto, for the …

First published: 16/02/2016
Last updated: 16/02/2016
EMA/PDCO/20678/2016
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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)

application submitted by Krka, d.d., Novo mesto on 24 February … decision is addressed to Krka, d.d., Novo mesto, Šmarješka … name of the PIP applicant: Krka, d.d., Novo mesto Information …

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

PDCO monthly report of opinions on paediatric investigation plans and other activities 10-12 December 2014 (PDF/95.95 KB)

amlodipine (besilate), from Krka, d.d., Novo mesto, for the …

First published: 22/12/2014
Last updated: 22/12/2014
EMA/PDCO/780247/2014
List item

PDCO monthly report of opinions on paediatric investigation plans and other activities 16-18 July 2014 (PDF/117.47 KB)

Rosuvastatin / valsartan, from Krka, d.d., Novo mesto, for the …

First published: 29/07/2014
Last updated: 29/07/2014
EMA/443651/2014
List item

PDCO monthly report of opinions on paediatric investigation plans and other activities 19-21 March 2014 (PDF/115.29 KB)

Amlodipine / rosuvastatin, from Krka, d.d., Novo mesto, for the …

First published: 26/03/2014
Last updated: 26/03/2014
EMA/PDCO/130096/2014
List item

Minutes - PDCO minutes of the 12-15 September 2017 meeting (PDF/350.33 KB)

Adopted
First published: 30/11/2017
Last updated: 30/11/2017
EMA/PDCO/612728/2017
List item

PDCO monthly report of opinions on paediatric investigation plans and other activities 10-12 April 2013 (PDF/180.55 KB)

hydrochlorothiazide + rosuvastatin, from Krka, d.d., Novo mesto, for the …

First published: 22/04/2013
Last updated: 22/04/2013
EMA/232769/2013
List item

PDCO monthly report of opinions on paediatric investigation plans and other activities 6-8 February 2013 (PDF/115.47 KB)

Bisoprolol / amlodipine, from Krka, d.d., Novo mesto, for the …

First published: 15/02/2013
Last updated: 15/02/2013
EMA/PDCO/92072/2013
List item

PDCO monthly report of opinions on paediatric investigation plans and other activities 9-11 January 2013 (PDF/118.12 KB)

Amlodipine / losartan, from Krka, d.d., Novo mesto, for the …

First published: 17/01/2013
Last updated: 17/01/2013
EMA/PDCO/24099/2013
List item

PDCO monthly report of opinions on paediatric investigation plans and other activities 3-5 October 2012 (PDF/112.9 KB)

indapamide / amlodipine, from Krka, d.d., Novo mesto, in the …

First published: 11/10/2012
Last updated: 11/10/2012
EMA/PDCO/626247/2012
List item

Minutes - PDCO minutes of the 27-29 January 2016 meeting (PDF/410.49 KB)

Adopted
First published: 03/03/2016
Last updated: 03/03/2016
EMA/PDCO/79065/2015
List item

PDCO minutes of the 19-22 July 2022 meeting (PDF/565.71 KB)

Adopted
First published: 06/10/2022
EMA/PDCO/674607/2022
List item

PDCO meeting report of opinions on paediatric investigation plans and other activities 22-25 February 2022 (PDF/212.27 KB)

EMEA-003151-PIP01-21, from KRKA, d.d., Novo mesto, for the …

Adopted
First published: 12/04/2022
EMA/PDCO/137600/2022
List item

PDCO minutes of the 8-11 November 2022 meeting (PDF/392.92 KB) (new)

Adopted
First published: 05/01/2023
EMA/PDCO/903993/2022

46 results

P/0040/2013: EMA decision of 27 February 2013 on the granting of a product-specific waiver for amlodipine / losartan (EMEA-001380-PIP01-12) (PDF/78.18 KB)

PDCO monthly report of opinions on paediatric investigation plans and other activities 7-9 October 2015 (PDF/95.41 KB)

PDCO monthly report of opinions on paediatric investigation plans and other activities 15-17 July 2015 (PDF/110.03 KB)

P/163/2010: EMA decision of 27 August 2010 on the agreement of a paediatric investigation plan and on the granting of a product specific waiver for amlodipine besylate / valsartan, (EMEA-001000-PIP01-10) (PDF/136.34 KB)

P/162/2010: EMA decision of 27 August 2010 on the agreement of a paediatric investigation plan and on the granting of a product specific waiver for perindopril erbumine / amlodipine besylate (EMEA- 000983-PIP01-10) (PDF/136.27 KB)

PDCO monthly report of opinions on paediatric investigation plans and other activities 12–15 September 2017 (PDF/103.4 KB)

PDCO meeting highlights 14-16 July 2010 (PDF/113.84 KB)

PDCO monthly report of opinions on paediatric investigation plans and other activities 27-29 January 2016 (PDF/100.04 KB)

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)

PDCO monthly report of opinions on paediatric investigation plans and other activities 10-12 December 2014 (PDF/95.95 KB)

PDCO monthly report of opinions on paediatric investigation plans and other activities 16-18 July 2014 (PDF/117.47 KB)

PDCO monthly report of opinions on paediatric investigation plans and other activities 19-21 March 2014 (PDF/115.29 KB)

Minutes - PDCO minutes of the 12-15 September 2017 meeting (PDF/350.33 KB)

PDCO monthly report of opinions on paediatric investigation plans and other activities 10-12 April 2013 (PDF/180.55 KB)

PDCO monthly report of opinions on paediatric investigation plans and other activities 6-8 February 2013 (PDF/115.47 KB)

PDCO monthly report of opinions on paediatric investigation plans and other activities 9-11 January 2013 (PDF/118.12 KB)

PDCO monthly report of opinions on paediatric investigation plans and other activities 3-5 October 2012 (PDF/112.9 KB)

Minutes - PDCO minutes of the 27-29 January 2016 meeting (PDF/410.49 KB)

PDCO minutes of the 19-22 July 2022 meeting (PDF/565.71 KB)

PDCO meeting report of opinions on paediatric investigation plans and other activities 22-25 February 2022 (PDF/212.27 KB)

PDCO minutes of the 8-11 November 2022 meeting (PDF/392.92 KB) (new)