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News: Paediatric Committee elects Koenraad Norga as its new chair

PDCO, Last updated: 24/07/2019
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PDCO monthly report of opinions on paediatric investigation plans and other activities 25-28 June 2019 (PDF/150.99 KB)

Adopted
First published: 17/07/2019
EMEA/PDCO/380229/2019
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Rules of procedure for the Patients and Consumers Working Party (PCWP) and the Healthcare Professionals Working Party (HCPWP) (PDF/169.36 KB)

First published: 20/02/2019
Last updated: 13/05/2019
EMA/109591/2018 Rev.1
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Guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS) / limited market - Revsion 2 (PDF/249.21 KB)

First published: 14/12/2018
Last updated: 11/03/2019
EMA/CVMP/388694/2014 Rev.2 Corr.
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Applications for new human medicines under evaluation by the CHMP: October 2018 (PDF/98.25 KB)

First published: 03/10/2018
Last updated: 18/10/2018
EMA/674542/2018
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Applications for new human medicines under evaluation by the CHMP: September 2018 (PDF/99.74 KB)

First published: 07/09/2018
Last updated: 18/10/2018
EMA/596452/2018
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Applications for new human medicines under evaluation by the CHMP: June 2018 (PDF/100.48 KB)

First published: 08/06/2018
Last updated: 20/06/2018
EMA/382940/2018 Corr.
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Applications for new human medicines under evaluation by the CHMP: May 2018 (PDF/99.65 KB)

First published: 14/05/2018
Last updated: 14/05/2018
EMA/280696/2018
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Trydonis : EPAR - Medicine overview (PDF/48.63 KB)

First published: 02/05/2018
Last updated: 09/09/2019
EMA/188673/2019
Bulgarian
(PDF/121.19 KB)

Croatian
(PDF/110.88 KB)

Czech
(PDF/115.45 KB)

Danish
(PDF/96.04 KB)

Dutch
(PDF/96.61 KB)

Estonian
(PDF/94.58 KB)

Finnish
(PDF/96.01 KB)

French
(PDF/97.07 KB)

German
(PDF/96.82 KB)

Greek
(PDF/130.44 KB)

Hungarian
(PDF/110.24 KB)

Italian
(PDF/96.34 KB)

Latvian
(PDF/123.05 KB)

Lithuanian
(PDF/114.31 KB)

Maltese
(PDF/123.01 KB)

Polish
(PDF/115.02 KB)

Portuguese
(PDF/96.47 KB)

Romanian
(PDF/121.51 KB)

Slovak
(PDF/114.53 KB)

Slovenian
(PDF/108.06 KB)

Spanish
(PDF/96.54 KB)

Swedish
(PDF/95.77 KB)
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Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.) : EPAR - Medicine overview (PDF/95.84 KB)

First published: 26/04/2018
Last updated: 06/09/2019
EMA/486960/2019
Bulgarian
(PDF/121.25 KB)

Croatian
(PDF/110.99 KB)

Czech
(PDF/114.91 KB)

Danish
(PDF/96.05 KB)

Dutch
(PDF/96.65 KB)

Estonian
(PDF/94.53 KB)

Finnish
(PDF/96.39 KB)

French
(PDF/97.21 KB)

German
(PDF/96.89 KB)

Greek
(PDF/130.52 KB)

Hungarian
(PDF/110.34 KB)

Italian
(PDF/96.4 KB)

Latvian
(PDF/123.07 KB)

Lithuanian
(PDF/113.13 KB)

Maltese
(PDF/123.07 KB)

Polish
(PDF/115.07 KB)

Portuguese
(PDF/96.58 KB)

Romanian
(PDF/121.91 KB)

Slovak
(PDF/114.42 KB)

Slovenian
(PDF/109.44 KB)

Spanish
(PDF/96.62 KB)

Swedish
(PDF/95.82 KB)
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Shingrix : EPAR - Medicine overview (PDF/116.03 KB)

First published: 28/03/2018
Last updated: 28/09/2020
EMA/422738/2020
Bulgarian
(PDF/139.86 KB)

Croatian
(PDF/139.92 KB)

Czech
(PDF/138.71 KB)

Danish
(PDF/114.85 KB)

Dutch
(PDF/115.07 KB)

Estonian
(PDF/112.23 KB)

Finnish
(PDF/114.2 KB)

French
(PDF/116.18 KB)

German
(PDF/119.49 KB)

Greek
(PDF/137.45 KB)

Hungarian
(PDF/139.48 KB)

Italian
(PDF/115.62 KB)

Latvian
(PDF/155.49 KB)

Lithuanian
(PDF/138.39 KB)

Maltese
(PDF/147.6 KB)

Polish
(PDF/141.05 KB)

Portuguese
(PDF/116.32 KB)

Romanian
(PDF/137.35 KB)

Slovak
(PDF/139.1 KB)

Slovenian
(PDF/137.06 KB)

Spanish
(PDF/116.02 KB)

Swedish
(PDF/114.93 KB)
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Elebrato Ellipta : EPAR - Medicine overview (PDF/70.11 KB)

First published: 25/01/2018
Last updated: 04/01/2019
Bulgarian
(PDF/104.88 KB)

Croatian
(PDF/96.36 KB)

Czech
(PDF/100.94 KB)

Danish
(PDF/75.44 KB)

Dutch
(PDF/76.12 KB)

Estonian
(PDF/86.47 KB)

Finnish
(PDF/75.18 KB)

French
(PDF/77.14 KB)

German
(PDF/77.29 KB)

Greek
(PDF/114.87 KB)

Hungarian
(PDF/98.18 KB)

Italian
(PDF/75.65 KB)

Latvian
(PDF/107.33 KB)

Lithuanian
(PDF/99.33 KB)

Maltese
(PDF/102.71 KB)

Polish
(PDF/101.82 KB)

Portuguese
(PDF/76.29 KB)

Romanian
(PDF/106.17 KB)

Slovak
(PDF/100.28 KB)

Slovenian
(PDF/94.64 KB)

Spanish
(PDF/76.73 KB)

Swedish
(PDF/75.92 KB)
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Clynav : EPAR - Medicine overview (PDF/123.75 KB)

First published: 20/07/2017
Last updated: 25/09/2020
EMA/278771/2016
Bulgarian
(PDF/147.73 KB)

Croatian
(PDF/154.74 KB)

Czech
(PDF/143.66 KB)

Danish
(PDF/122.02 KB)

Dutch
(PDF/124.55 KB)

Estonian
(PDF/121.65 KB)

Finnish
(PDF/121.56 KB)

French
(PDF/114.31 KB)

German
(PDF/129.27 KB)

Greek
(PDF/145.86 KB)

Hungarian
(PDF/146.53 KB)

Italian
(PDF/122.79 KB)

Latvian
(PDF/152.07 KB)

Lithuanian
(PDF/143.91 KB)

Maltese
(PDF/155.45 KB)

Polish
(PDF/155.98 KB)

Portuguese
(PDF/125.69 KB)

Romanian
(PDF/143.1 KB)

Slovak
(PDF/145.87 KB)

Slovenian
(PDF/144.17 KB)

Spanish
(PDF/124.64 KB)

Swedish
(PDF/122.73 KB)
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Standard operating procedure for evaluation procedure for applications and requests for the establishment or review of Maximum Residue Limits (MRLs) (PDF/211.11 KB)

Adopted
First published: 10/05/2017
Last updated: 10/05/2017
Legal effective date: 05/05/2017
SOP/V/4150
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Empliciti : EPAR - Medicine overview (PDF/71.5 KB)

First published: 19/05/2016
Last updated: 24/10/2019
EMA/463919/2019
Bulgarian
(PDF/97.65 KB)

Croatian
(PDF/90.34 KB)

Czech
(PDF/96.14 KB)

Danish
(PDF/69.91 KB)

Dutch
(PDF/70.09 KB)

Estonian
(PDF/68.25 KB)

Finnish
(PDF/69.82 KB)

French
(PDF/71.63 KB)

German
(PDF/71.64 KB)

Greek
(PDF/103.86 KB)

Hungarian
(PDF/89.6 KB)

Italian
(PDF/69.89 KB)

Latvian
(PDF/93.44 KB)

Lithuanian
(PDF/93.66 KB)

Maltese
(PDF/102.23 KB)

Polish
(PDF/95.43 KB)

Portuguese
(PDF/70.7 KB)

Romanian
(PDF/91.74 KB)

Slovak
(PDF/94.11 KB)

Slovenian
(PDF/88.37 KB)

Spanish
(PDF/70.58 KB)

Swedish
(PDF/70.09 KB)
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Ionsys : EPAR - Medicine overview (PDF/541.35 KB)

First published: 30/11/2015
Last updated: 06/11/2018
EMA/639971/2015
Bulgarian
(PDF/622.86 KB)

Croatian
(PDF/96.17 KB)

Czech
(PDF/606.8 KB)

Danish
(PDF/78.75 KB)

Dutch
(PDF/545.31 KB)

Estonian
(PDF/79.01 KB)

Finnish
(PDF/543.59 KB)

French
(PDF/81.05 KB)

German
(PDF/81.28 KB)

Greek
(PDF/627.93 KB)

Hungarian
(PDF/547.89 KB)

Italian
(PDF/79.71 KB)

Latvian
(PDF/604.16 KB)

Lithuanian
(PDF/566.53 KB)

Maltese
(PDF/607.9 KB)

Polish
(PDF/603.26 KB)

Portuguese
(PDF/80.28 KB)

Romanian
(PDF/96.65 KB)

Slovak
(PDF/604.16 KB)

Slovenian
(PDF/596.95 KB)

Spanish
(PDF/545.72 KB)

Swedish
(PDF/545.77 KB)
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Timetable: Extension application (PDF/248.24 KB) (updated)

First published: 02/07/2015
Last updated: 22/12/2020
Legal effective date: 18/12/2020
EMA/412809/2015 Rev.5
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Work instructions for Committee for Medicinal Products for Veterinary Use (CVMP) press release procedure and publication of documents adopted by CVMP (PDF/134.5 KB)

Adopted
First published: 07/05/2015
Last updated: 07/05/2015
Legal effective date: 01/05/2015
WIN/V/4001
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Work instructions for secretarial tasks for initial preparation and update of veterinary European public assessment reports (EPARs) (PDF/174.36 KB)

Adopted
First published: 07/05/2015
Last updated: 10/02/2016
Legal effective date: 08/02/2016
WIN/V/4035
List item

Kalydeco-H-C-2494-II-0009 : EPAR - Assessment Report - Variation (PDF/2.19 MB)

Adopted
First published: 22/09/2014
Last updated: 16/12/2020
EMA/CHMP/360053/2014 Corr.1
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Relvar Ellipta : EPAR - Procedural steps taken and scientific information after authorisation (PDF/154.01 KB)

First published: 13/08/2014
Last updated: 13/05/2019
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Anoro Ellipta : EPAR - All Authorised presentations (PDF/28.26 KB)

First published: 16/06/2014
Last updated: 16/10/2018
Bulgarian
(PDF/52.65 KB)

Croatian
(PDF/35.61 KB)

Czech
(PDF/47.07 KB)

Danish
(PDF/20.86 KB)

Dutch
(PDF/27.85 KB)

Estonian
(PDF/57.87 KB)

Finnish
(PDF/37.5 KB)

French
(PDF/27.31 KB)

German
(PDF/23.12 KB)

Greek
(PDF/54.38 KB)

Hungarian
(PDF/40.84 KB)

Icelandic
(PDF/109.16 KB)

Italian
(PDF/55.6 KB)

Latvian
(PDF/46.24 KB)

Lithuanian
(PDF/62.62 KB)

Maltese
(PDF/60.15 KB)

Norwegian
(PDF/41.44 KB)

Polish
(PDF/59.61 KB)

Portuguese
(PDF/28.39 KB)

Romanian
(PDF/57.99 KB)

Slovak
(PDF/43.15 KB)

Slovenian
(PDF/30.32 KB)

Spanish
(PDF/29.08 KB)

Swedish
(PDF/54.35 KB)
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Lojuxta : EPAR - Procedural steps taken and scientific information after authorisation (PDF/204.88 KB)

First published: 11/03/2014
Last updated: 25/03/2020
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Tafinlar : EPAR - Procedural steps taken and scientific information after authorisation (PDF/279.79 KB)

First published: 18/09/2013
Last updated: 17/01/2020
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Standard operating procedure for surveillance of centrally authorised veterinary medicinal products (PDF/156.52 KB)

Adopted
First published: 03/10/2011
Last updated: 21/08/2015
Legal effective date: 18/08/2015
SOP/V/4032

30 results

News: Paediatric Committee elects Koenraad Norga as its new chair

PDCO monthly report of opinions on paediatric investigation plans and other activities 25-28 June 2019 (PDF/150.99 KB)

Rules of procedure for the Patients and Consumers Working Party (PCWP) and the Healthcare Professionals Working Party (HCPWP) (PDF/169.36 KB)

Guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS) / limited market - Revsion 2 (PDF/249.21 KB)

Applications for new human medicines under evaluation by the CHMP: October 2018 (PDF/98.25 KB)

Applications for new human medicines under evaluation by the CHMP: September 2018 (PDF/99.74 KB)

Applications for new human medicines under evaluation by the CHMP: June 2018 (PDF/100.48 KB)

Applications for new human medicines under evaluation by the CHMP: May 2018 (PDF/99.65 KB)

Trydonis : EPAR - Medicine overview (PDF/48.63 KB)

Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.) : EPAR - Medicine overview (PDF/95.84 KB)

Shingrix : EPAR - Medicine overview (PDF/116.03 KB)

Elebrato Ellipta : EPAR - Medicine overview (PDF/70.11 KB)

Clynav : EPAR - Medicine overview (PDF/123.75 KB)

Standard operating procedure for evaluation procedure for applications and requests for the establishment or review of Maximum Residue Limits (MRLs) (PDF/211.11 KB)

Empliciti : EPAR - Medicine overview (PDF/71.5 KB)

Ionsys : EPAR - Medicine overview (PDF/541.35 KB)

Timetable: Extension application (PDF/248.24 KB) (updated)

Work instructions for Committee for Medicinal Products for Veterinary Use (CVMP) press release procedure and publication of documents adopted by CVMP (PDF/134.5 KB)

Work instructions for secretarial tasks for initial preparation and update of veterinary European public assessment reports (EPARs) (PDF/174.36 KB)

Kalydeco-H-C-2494-II-0009 : EPAR - Assessment Report - Variation (PDF/2.19 MB)

Relvar Ellipta : EPAR - Procedural steps taken and scientific information after authorisation (PDF/154.01 KB)

Anoro Ellipta : EPAR - All Authorised presentations (PDF/28.26 KB)

Lojuxta : EPAR - Procedural steps taken and scientific information after authorisation (PDF/204.88 KB)

Tafinlar : EPAR - Procedural steps taken and scientific information after authorisation (PDF/279.79 KB)

Standard operating procedure for surveillance of centrally authorised veterinary medicinal products (PDF/156.52 KB)