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Mesterolone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010551/202201 (PDF/136.25 KB) (new)

Last updated: 24/11/2022
Active substance: mesterolone
Procedure number: PSUSA/00010551/202201
Regulatory outcome: Variation
Bulgarian
(PDF/169.84 KB)

Croatian
(PDF/215.37 KB)

Czech
(PDF/219.58 KB)

Danish
(PDF/176.79 KB)

Dutch
(PDF/30.63 KB)

Estonian
(PDF/146.64 KB)

Finnish
(PDF/135.05 KB)

French
(PDF/135.64 KB)

German
(PDF/148.22 KB)

Greek
(PDF/141.44 KB)

Hungarian
(PDF/214.92 KB)

Irish
(PDF/87.36 KB)

Italian
(PDF/181.14 KB)

Latvian
(PDF/198.05 KB)

Lithuanian
(PDF/207.17 KB)

Maltese
(PDF/147.91 KB)

Polish
(PDF/102.21 KB)

Portuguese
(PDF/33.27 KB)

Romanian
(PDF/138.03 KB)

Slovak
(PDF/188.57 KB)

Slovenian
(PDF/193.85 KB)

Spanish
(PDF/135.58 KB)

Swedish
(PDF/150.37 KB)
List item

Mesterolone : List of nationally authorised medicinal products - PSUSA/00010551/202201 (PDF/90.53 KB) (new)

Last updated: 24/11/2022
Active substance: mesterolone
Procedure number: PSUSA/00010551/202201
Regulatory outcome: Variation
List item

Gabapentin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001499/202202 (PDF/181.89 KB) (new)

Last updated: 24/11/2022
Active substance: gabapentin
Procedure number: PSUSA/00001499/202202
Regulatory outcome: Variation
Bulgarian
(PDF/331.79 KB)

Croatian
(PDF/291.1 KB)

Czech
(PDF/335.79 KB)

Danish
(PDF/273.1 KB)

Dutch
(PDF/255.45 KB)

Estonian
(PDF/249.17 KB)

Finnish
(PDF/244.21 KB)

French
(PDF/256.58 KB)

German
(PDF/260.32 KB)

Greek
(PDF/334.54 KB)

Hungarian
(PDF/316.42 KB)

Icelandic
(PDF/248.63 KB)

Italian
(PDF/254.79 KB)

Latvian
(PDF/330.38 KB)

Lithuanian
(PDF/312.94 KB)

Maltese
(PDF/350.16 KB)

Norwegian
(PDF/245.27 KB)

Polish
(PDF/329.89 KB)

Portuguese
(PDF/217.94 KB)

Romanian
(PDF/329.16 KB)

Slovak
(PDF/287.47 KB)

Slovenian
(PDF/271.76 KB)

Spanish
(PDF/253.46 KB)

Swedish
(PDF/217.84 KB)
List item

Gabapentin : List of nationally authorised medicinal products - PSUSA/00001499/202202 (PDF/246.58 KB) (new)

Last updated: 24/11/2022
Active substance: gabapentin
Procedure number: PSUSA/00001499/202202
Regulatory outcome: Variation
List item

Draft reflection paper on the application of Article 40(5) of Regulation (EU) 2019/6 for certain categories of variations (PDF/329.61 KB) (new)

Draft: consultation open
First published: 24/11/2022
Consultations dates: from 24/11/2022 to 28/02/2023
EMA/CVMP/64911/2021
List item

Frovatriptan : List of nationally authorised medicinal products - PSUSA/00001484/202203 (PDF/162.29 KB) (new)

Last updated: 23/11/2022
Active substance: frovatriptan
Procedure number: PSUSA/00001484/202203
Regulatory outcome: Maintenance
List item

Carboplatin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000559/202201 (PDF/101.04 KB) (new)

Last updated: 22/11/2022
Active substance: carboplatin
Procedure number: PSUSA/00000559/202201
Regulatory outcome: Variation
Bulgarian
(PDF/106.4 KB)

Croatian
(PDF/101.64 KB)

Czech
(PDF/103.14 KB)

Danish
(PDF/102.36 KB)

Dutch
(PDF/104.69 KB)

Estonian
(PDF/96.24 KB)

Finnish
(PDF/98.32 KB)

French
(PDF/100.86 KB)

German
(PDF/107.68 KB)

Greek
(PDF/110.33 KB)

Hungarian
(PDF/101.41 KB)

Icelandic
(PDF/102.89 KB)

Italian
(PDF/109.94 KB)

Latvian
(PDF/101.01 KB)

Lithuanian
(PDF/99.46 KB)

Maltese
(PDF/108.63 KB)

Norwegian
(PDF/101.32 KB)

Polish
(PDF/101.58 KB)

Portuguese
(PDF/99.94 KB)

Romanian
(PDF/98.77 KB)

Slovak
(PDF/103.95 KB)

Slovenian
(PDF/97.86 KB)

Spanish
(PDF/101.43 KB)

Swedish
(PDF/100.61 KB)
List item

Carboplatin : List of nationally authorised medicinal products - PSUSA/00000559/202201 (PDF/430.69 KB) (new)

Last updated: 22/11/2022
Active substance: carboplatin
Procedure number: PSUSA/00000559/202201
Regulatory outcome: Variation
List item

Minutes of the PRAC meeting 7-10 March 2022 (PDF/875.2 KB) (new)

Adopted
First published: 22/11/2022
EMA/PRAC/856951/2022
List item

PDCO minutes of the 11-14 October 2022 meeting (PDF/545.43 KB) (new)

Adopted
First published: 21/11/2022
EMA/PDCO/850696/2022
List item

New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2022 PRAC meeting (PDF/217.94 KB) (new)

Adopted
First published: 21/11/2022
EMA/PRAC/845794/2022
Bulgarian
(PDF/233.6 KB)

Croatian
(PDF/233.19 KB)

Czech
(PDF/239.37 KB)

Danish
(PDF/218.22 KB)

Dutch
(PDF/218.5 KB)

Estonian
(PDF/210.81 KB)

Finnish
(PDF/216.94 KB)

French
(PDF/218.73 KB)

German
(PDF/220.97 KB)

Greek
(PDF/245.43 KB)

Hungarian
(PDF/229.72 KB)

Icelandic
(PDF/224.01 KB)

Italian
(PDF/217.66 KB)

Latvian
(PDF/247.36 KB)

Lithuanian
(PDF/242.43 KB)

Maltese
(PDF/245.49 KB)

Norwegian
(PDF/211.77 KB)

Polish
(PDF/242.63 KB)

Portuguese
(PDF/211.74 KB)

Romanian
(PDF/231.79 KB)

Slovak
(PDF/242.89 KB)

Slovenian
(PDF/238.95 KB)

Spanish
(PDF/200.02 KB)

Swedish
(PDF/217.97 KB)
List item

PRAC recommendations on signals adopted at the 24-27 October 2022 PRAC (PDF/288.84 KB) (new)

Adopted
First published: 21/11/2022
EMA/PRAC/845793/2022
List item

Terlipressin-containing medicinal products Article-31 referral - PRAC assessment report (PDF/2.38 MB) (new)

Adopted
First published: 18/11/2022
EMA/885651/2022
List item

Draft guideline on the development and data requirements of potency tests for cell-based therapy products and the relation to clinical efficacy (PDF/323.29 KB) (new)

Draft: consultation open
First published: 18/11/2022
Consultations dates: from 18/11/2022 to 28/02/2023
EMA/CVMP/NTWP/179287/2022
List item

Mesalazine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001990/202202 (PDF/35.56 KB) (new)

Last updated: 18/11/2022
Active substance: Mesalazine
Procedure number: PSUSA/00001990/202202
Regulatory outcome: Variation
Bulgarian
(PDF/72.85 KB)

Croatian
(PDF/68.12 KB)

Czech
(PDF/108.81 KB)

Danish
(PDF/35.8 KB)

Dutch
(PDF/38.05 KB)

Estonian
(PDF/35.23 KB)

Finnish
(PDF/40.27 KB)

French
(PDF/34.85 KB)

German
(PDF/101.04 KB)

Greek
(PDF/108.64 KB)

Hungarian
(PDF/108.88 KB)

Icelandic
(PDF/36.29 KB)

Italian
(PDF/40.13 KB)

Latvian
(PDF/111.68 KB)

Lithuanian
(PDF/78.67 KB)

Maltese
(PDF/72.09 KB)

Norwegian
(PDF/40.41 KB)

Polish
(PDF/74.69 KB)

Portuguese
(PDF/40.72 KB)

Romanian
(PDF/96.69 KB)

Slovak
(PDF/111.57 KB)

Slovenian
(PDF/65.04 KB)

Spanish
(PDF/35.83 KB)

Swedish
(PDF/39.43 KB)
List item

Mesalazine : List of nationally authorised medicinal products - PSUSA/00001990/202202 (PDF/602.72 KB) (new)

Last updated: 18/11/2022
Active substance: Mesalazine
Procedure number: PSUSA/00001990/202202
Regulatory outcome: Variation
List item

Austria - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021 (PDF/243.64 KB) (new)

First published: 18/11/2022
List item

Belgium - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021 (PDF/242.79 KB) (new)

First published: 18/11/2022
List item

Bulgaria - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021 (PDF/239.2 KB) (new)

First published: 18/11/2022
List item

Croatia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021 (PDF/262.01 KB) (new)

First published: 18/11/2022
List item

Cyprus - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021 (PDF/245.53 KB) (new)

First published: 18/11/2022
List item

Czechia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021 (PDF/243.01 KB) (new)

First published: 18/11/2022
List item

Denmark - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021 (PDF/237.73 KB) (new)

First published: 18/11/2022
List item

Estonia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021 (PDF/243.19 KB) (new)

First published: 18/11/2022
List item

Finland - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021 (PDF/239.88 KB) (new)

First published: 18/11/2022

13724 results

Mesterolone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010551/202201 (PDF/136.25 KB) (new)

Mesterolone : List of nationally authorised medicinal products - PSUSA/00010551/202201 (PDF/90.53 KB) (new)

Gabapentin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001499/202202 (PDF/181.89 KB) (new)

Gabapentin : List of nationally authorised medicinal products - PSUSA/00001499/202202 (PDF/246.58 KB) (new)

Draft reflection paper on the application of Article 40(5) of Regulation (EU) 2019/6 for certain categories of variations (PDF/329.61 KB) (new)

Frovatriptan : List of nationally authorised medicinal products - PSUSA/00001484/202203 (PDF/162.29 KB) (new)

Carboplatin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000559/202201 (PDF/101.04 KB) (new)

Carboplatin : List of nationally authorised medicinal products - PSUSA/00000559/202201 (PDF/430.69 KB) (new)

Minutes of the PRAC meeting 7-10 March 2022 (PDF/875.2 KB) (new)

PDCO minutes of the 11-14 October 2022 meeting (PDF/545.43 KB) (new)

New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2022 PRAC meeting (PDF/217.94 KB) (new)

PRAC recommendations on signals adopted at the 24-27 October 2022 PRAC (PDF/288.84 KB) (new)

Terlipressin-containing medicinal products Article-31 referral - PRAC assessment report (PDF/2.38 MB) (new)

Draft guideline on the development and data requirements of potency tests for cell-based therapy products and the relation to clinical efficacy (PDF/323.29 KB) (new)

Mesalazine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001990/202202 (PDF/35.56 KB) (new)

Mesalazine : List of nationally authorised medicinal products - PSUSA/00001990/202202 (PDF/602.72 KB) (new)

Austria - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021 (PDF/243.64 KB) (new)

Belgium - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021 (PDF/242.79 KB) (new)

Bulgaria - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021 (PDF/239.2 KB) (new)

Croatia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021 (PDF/262.01 KB) (new)

Cyprus - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021 (PDF/245.53 KB) (new)

Czechia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021 (PDF/243.01 KB) (new)

Denmark - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021 (PDF/237.73 KB) (new)

Estonia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021 (PDF/243.19 KB) (new)

Finland - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021 (PDF/239.88 KB) (new)