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Declaration of interests: Svetoslava Radomirova Naydenova (PDF/27.17 KB)

First published: 19/11/2019
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Glipizide : List of nationally authorised medicinal products - PSUSA/00001535/201901 (PDF/163.49 KB)

Last updated: 19/11/2019
Active substance: glipizide
Procedure number: PSUSA/00001535/201901
Regulatory outcome: Maintenance
List item

Germanium (68Ge) chloride / gallium (68Ga) chloride : List of nationally authorised medicinal products - PSUSA/00010364/201903 (PDF/137.41 KB)

Last updated: 19/11/2019
Active substance: Germanium (68Ge) chloride / Gallium (68Ga) chloride
Procedure number: PSUSA/00010364/201903
Regulatory outcome: Maintenance
List item

Benepali-H-C-PSUSA-00010452-201901 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/68.62 KB)

First published: 19/11/2019
EMA/626220/2019
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Bravecto-V-C-2526-II-0036 : EPAR - Assessment Report - Variation (PDF/287.43 KB)

Adopted
First published: 19/11/2019
EMA/519278/2019
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Bravecto-V-C-2526-II-0033-G : EPAR - Assessment Report - Variation (PDF/325.42 KB)

Adopted
First published: 19/11/2019
EMA/519277/2019
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Minutes of the CHMP meeting 16-19 September 2019 (PDF/1.07 MB)

Adopted
First published: 19/11/2019
EMA/CHMP/599241/2019
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Referral: Tylosin injectable for sheep

tylosin, ?> associated names: See annex I, Article 35
Status: European Commission final decision, opinion/position date: 20/06/2019, EC decision date: 20/09/2019, Last updated: 19/11/2019
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Tylosin injectable for sheep Article-35 referral - Annex I, II, III (PDF/257.25 KB)

First published: 19/11/2019
Bulgarian
(PDF/365.89 KB)

Croatian
(PDF/298.66 KB)

Czech
(PDF/290.36 KB)

Danish
(PDF/254.37 KB)

Dutch
(PDF/256.64 KB)

Estonian
(PDF/245.71 KB)

Finnish
(PDF/245.1 KB)

French
(PDF/260.99 KB)

German
(PDF/267.83 KB)

Greek
(PDF/309 KB)

Hungarian
(PDF/304.81 KB)

Italian
(PDF/255.04 KB)

Latvian
(PDF/298.04 KB)

Lithuanian
(PDF/301.33 KB)

Maltese
(PDF/337.05 KB)

Polish
(PDF/311.21 KB)

Portuguese
(PDF/261.97 KB)

Romanian
(PDF/302.88 KB)

Slovak
(PDF/309.22 KB)

Slovenian
(PDF/288.4 KB)

Spanish
(PDF/263.68 KB)

Swedish
(PDF/253.63 KB)
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Tylosin injectable for sheep Article-35 referral - Questions and answers on withdrawal periods for injectable veterinary medicines containing tylosin when given to sheep (PDF/113.58 KB)

First published: 19/11/2019
EMA/510184/2019
Bulgarian
(PDF/118.99 KB)

Croatian
(PDF/134.33 KB)

Czech
(PDF/133.77 KB)

Danish
(PDF/109.74 KB)

Dutch
(PDF/110.69 KB)

Estonian
(PDF/107.64 KB)

Finnish
(PDF/107.95 KB)

French
(PDF/111.37 KB)

German
(PDF/113.12 KB)

Greek
(PDF/135.08 KB)

Hungarian
(PDF/131.1 KB)

Italian
(PDF/108.95 KB)

Latvian
(PDF/131.25 KB)

Lithuanian
(PDF/132.13 KB)

Maltese
(PDF/136.57 KB)

Polish
(PDF/133.24 KB)

Portuguese
(PDF/111.95 KB)

Romanian
(PDF/130.86 KB)

Slovak
(PDF/131.84 KB)

Slovenian
(PDF/130.79 KB)

Spanish
(PDF/110.49 KB)

Swedish
(PDF/110.22 KB)
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Defitelio : EPAR - Risk-management-plan summary (PDF/87.25 KB)

First published: 19/11/2019
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P/0037/2019: EMA decision of 29 January 2019 on the granting of a product specific waiver for binimetinib (Mektovi), (EMEA-001454-PIP05-18) (PDF/169.97 KB)

First published: 19/11/2019
EMA/887187/2018
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Agenda - HMPC agenda of the 18-20 November 2019 meeting (PDF/263.19 KB)

First published: 19/11/2019
EMA/HMPC/621895/2019
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P/0256/2019: EMA decision of 16 July 2019 on the acceptance of a modification of an agreed paediatric investigation plan for durvalumab (Imfinzi), (EMEA-0020128-PIP01-16-M01) (PDF/207.46 KB)

Adopted
First published: 19/11/2019
EMA/313775/2019
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P/0245/2019: EMA decision of 17 July 2019 on the acceptance of a modification of an agreed paediatric investigation plan for tremelimumab (EMEA-002029-PIP01-16-M01) (PDF/185.75 KB)

Adopted
First published: 19/11/2019
EMA/359092/2019
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P/0244/2019: EMA decision of 17 July 2019 on the acceptance of a modification of an agreed paediatric investigation plan for EMEA-002215-PIP01-17-M02 (PDF/201.81 KB)

Adopted
First published: 19/11/2019
EMA/364843/2019
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COMP meeting report on the review of applications for orphan designation: November 2019 (PDF/176.46 KB)

Adopted
First published: 18/11/2019
EMA/COMP/557148/2019
List item

Methylphenidate: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002024/201810 (PDF/37.83 KB)

Last updated: 18/11/2019
Active substance: methylphenidate
Procedure number: PSUSA/00002024/201810
Regulatory outcome: Variation
(PDF/120.96 KB)

(PDF/39.43 KB)

(PDF/51.58 KB)

Bulgarian
(PDF/118.81 KB)

Croatian
(PDF/114.21 KB)

Czech
(PDF/106.34 KB)

Dutch
(PDF/41.23 KB)

Estonian
(PDF/40.47 KB)

Finnish
(PDF/38.53 KB)

French
(PDF/40.23 KB)

German
(PDF/41.35 KB)

Hungarian
(PDF/105.54 KB)

Icelandic
(PDF/36.3 KB)

Italian
(PDF/41.46 KB)

Latvian
(PDF/122.54 KB)

Lithuanian
(PDF/106.61 KB)

Maltese
(PDF/129.24 KB)

Norwegian
(PDF/109.35 KB)

Polish
(PDF/123.5 KB)

Portuguese
(PDF/63.31 KB)

Romanian
(PDF/122.08 KB)

Slovak
(PDF/114.7 KB)

Slovenian
(PDF/101.18 KB)

Spanish
(PDF/42.15 KB)
List item

Abraxane-H-C-PSUSA-00010123-201901 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/65.36 KB)

First published: 18/11/2019
EMA/564160/2019
List item

Ex ante publicity of a negotiated procedure: EMA/2019/40/LD – Legal advice in relation to procurement matters and contracts under EU procurement and Dutch law (PDF/123.55 KB)

First published: 18/11/2019
EMA/583396/2019
List item

Draft VICH GL59 Harmonisation of criteria to waive laboratory animal batch safety testing for vaccines for veterinary use (PDF/370.09 KB)

Draft: consultation open
First published: 18/11/2019
Consultations dates: from 18/11/2019 to 10/04/2020
List item

VICH GL59 Harmonisation of criteria to waive laboratory animal batch safety testing for vaccines for veterinary use

Last updated: 18/11/2019
List item

Responsible use of antibiotics: what’s your role? (PDF/478.5 KB)

First published: 18/11/2019
List item

P/0251/2019: EMA decision of 16 July 2019 on the acceptance of a modification of an agreed paediatric investigation plan for eravacycline (Xerava), (EMEA-001555-PIP01-13-M03) (PDF/235.48 KB)

Adopted
First published: 18/11/2019
EMA/369862/2019
List item

P/0235/2019: EMA decision of 16 July 2019 on the acceptance of a modification of an agreed paediatric investigation plan for afatinib (Giotrif), (EMEA-001596-PIP02-17-M01) (PDF/190.05 KB)

Adopted
First published: 18/11/2019
EMA/640003/2008

57370 results

Declaration of interests: Svetoslava Radomirova Naydenova (PDF/27.17 KB)

Glipizide : List of nationally authorised medicinal products - PSUSA/00001535/201901 (PDF/163.49 KB)

Germanium (68Ge) chloride / gallium (68Ga) chloride : List of nationally authorised medicinal products - PSUSA/00010364/201903 (PDF/137.41 KB)

Benepali-H-C-PSUSA-00010452-201901 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/68.62 KB)

Bravecto-V-C-2526-II-0036 : EPAR - Assessment Report - Variation (PDF/287.43 KB)

Bravecto-V-C-2526-II-0033-G : EPAR - Assessment Report - Variation (PDF/325.42 KB)

Minutes of the CHMP meeting 16-19 September 2019 (PDF/1.07 MB)

Referral: Tylosin injectable for sheep

Tylosin injectable for sheep Article-35 referral - Annex I, II, III (PDF/257.25 KB)

Tylosin injectable for sheep Article-35 referral - Questions and answers on withdrawal periods for injectable veterinary medicines containing tylosin when given to sheep (PDF/113.58 KB)

Defitelio : EPAR - Risk-management-plan summary (PDF/87.25 KB)

P/0037/2019: EMA decision of 29 January 2019 on the granting of a product specific waiver for binimetinib (Mektovi), (EMEA-001454-PIP05-18) (PDF/169.97 KB)

Agenda - HMPC agenda of the 18-20 November 2019 meeting (PDF/263.19 KB)

P/0256/2019: EMA decision of 16 July 2019 on the acceptance of a modification of an agreed paediatric investigation plan for durvalumab (Imfinzi), (EMEA-0020128-PIP01-16-M01) (PDF/207.46 KB)

P/0245/2019: EMA decision of 17 July 2019 on the acceptance of a modification of an agreed paediatric investigation plan for tremelimumab (EMEA-002029-PIP01-16-M01) (PDF/185.75 KB)

P/0244/2019: EMA decision of 17 July 2019 on the acceptance of a modification of an agreed paediatric investigation plan for EMEA-002215-PIP01-17-M02 (PDF/201.81 KB)

COMP meeting report on the review of applications for orphan designation: November 2019 (PDF/176.46 KB)

Methylphenidate: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002024/201810 (PDF/37.83 KB)

Abraxane-H-C-PSUSA-00010123-201901 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/65.36 KB)

Ex ante publicity of a negotiated procedure: EMA/2019/40/LD – Legal advice in relation to procurement matters and contracts under EU procurement and Dutch law (PDF/123.55 KB)

Draft VICH GL59 Harmonisation of criteria to waive laboratory animal batch safety testing for vaccines for veterinary use (PDF/370.09 KB)

VICH GL59 Harmonisation of criteria to waive laboratory animal batch safety testing for vaccines for veterinary use

Responsible use of antibiotics: what’s your role? (PDF/478.5 KB)

P/0251/2019: EMA decision of 16 July 2019 on the acceptance of a modification of an agreed paediatric investigation plan for eravacycline (Xerava), (EMEA-001555-PIP01-13-M03) (PDF/235.48 KB)

P/0235/2019: EMA decision of 16 July 2019 on the acceptance of a modification of an agreed paediatric investigation plan for afatinib (Giotrif), (EMEA-001596-PIP02-17-M01) (PDF/190.05 KB)