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Beractant : List of nationally authorised medicines - PSUSA/00000384/202010 (PDF/148.85 KB) (new)

Last updated: 16/06/2021
Active substance: beractant
Procedure number: PSUSA/00000384/202010
Regulatory outcome: Maintenance
List item

Amlodipine / atorvastatin / perindopril - List of nationally authorised medicinal products - PSUSA/00010431/202010 (PDF/300.67 KB) (new)

Last updated: 15/06/2021
Active substance: amlodipine, Atorvastatin, Perindopril
Procedure number: PSUSA/00010431/202010
Regulatory outcome: Maintenance
List item

Rubidium chloride RB-82 - List of nationally authorised medicinal products - PSUSA-00010806-202010 (PDF/104.25 KB) (new)

Last updated: 15/06/2021
Active substance: Rubidium (82Rb) chloride
Procedure number: PSUSA-00010806-202010
Regulatory outcome: Maintenance
List item

Agenda - CVMP agenda of the 15-17 June 2021 meeting (PDF/288.17 KB) (new)

Draft
First published: 15/06/2021
EMA/308464/2021
List item

Bivalrudin : List of nationally authorised medicinal products - PSUSA/00000421/202009 (PDF/188.71 KB) (new)

Last updated: 15/06/2021
Active substance: bivalrudin
Procedure number: PSUSA/00000421/202009
Regulatory outcome: Maintenance
List item

Idebenone : List of nationally authorised medicinal products - PSUSA/00001721/202009 (PDF/103.05 KB) (new)

Last updated: 11/06/2021
Active substance: idebenone
Procedure number: PSUSA/00001721/202009
Regulatory outcome: Maintenance
List item

News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2021 (new)

PRAC, Last updated: 11/06/2021
List item

PRAC statistics: June 2021 (PDF/579.62 KB) (new)

First published: 11/06/2021
List item

News: COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis (new)

PRAC, Last updated: 11/06/2021
List item

News: Vaxzevria: EMA advises against use in people with history of capillary leak syndrome (new)

PRAC, Last updated: 11/06/2021
List item

Lidocaine : List of nationally authorised medicinal products - PSUSA/00001861/202009 (PDF/437.03 KB) (new)

Last updated: 11/06/2021
Active substance: lidocaine
Procedure number: PSUSA/00001861/202009
Regulatory outcome: Maintenance
List item

Desflurane : List of nationally authorised medicinal products - PSUSA/00000958/202009 (PDF/147.82 KB) (new)

Last updated: 11/06/2021
Procedure number: PSUSA/00000958/202009
Regulatory outcome: Maintenance
List item

Direct healthcare professional communication (DHPC): Venclyxto - (venetoclax) film coated tablets: Updated recommendations on tumour lysis syndrome (TLS) in CLL patients (PDF/223.2 KB) (new)

First published: 10/06/2021
Dissemination date: 10/06/2021
List item

Monthly report on application procedures, guidelines and related documents for veterinary medicines: April 2021 (PDF/260.45 KB) (new)

Adopted
First published: 10/06/2021
EMA/195931/2021
List item

Agenda - PRAC draft agenda of meeting 7-10 June 2021 (PDF/734.41 KB) (new)

Draft
First published: 07/06/2021
EMA/PRAC/319890/2021
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EU VICH adverse event report implementation guide (PDF/680.16 KB) (new)

Draft: consultation open
First published: 04/06/2021
Consultations dates: from 04/06/2021 to 04/08/2021
EMA/186368/2021
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Monthly report on application procedures, guidelines and related documents for veterinary medicines: March 2021 (PDF/257.84 KB) (new)

Adopted
First published: 04/06/2021
EMA/195931/2021
List item

Naftifine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002109/202008 (PDF/85.84 KB) (new)

Last updated: 03/06/2021
Active substance: naftifine
Procedure number: PSUSA/00002109/202008
Regulatory outcome: Variation
Bulgarian
(PDF/86.72 KB)

Croatian
(PDF/126.64 KB)

Czech
(PDF/96.84 KB)

Danish
(PDF/100.06 KB)

Dutch
(PDF/113.31 KB)

Estonian
(PDF/109.25 KB)

Finnish
(PDF/109.15 KB)

French
(PDF/112 KB)

German
(PDF/103.79 KB)

Greek
(PDF/115.51 KB)

Hungarian
(PDF/132.55 KB)

Italian
(PDF/115.67 KB)

Latvian
(PDF/100.72 KB)

Lithuanian
(PDF/119.66 KB)

Maltese
(PDF/132 KB)

Polish
(PDF/96.7 KB)

Portuguese
(PDF/112.54 KB)

Romanian
(PDF/130.38 KB)

Slovak
(PDF/119.95 KB)

Slovenian
(PDF/126.81 KB)

Spanish
(PDF/78.97 KB)

Swedish
(PDF/111.69 KB)
List item

Naftifine: List of nationally authorised medicinal products - PSUSA/00002109/202008 (PDF/115.84 KB) (new)

Last updated: 03/06/2021
Active substance: naftifine
Procedure number: PSUSA/00002109/202008
Regulatory outcome: Variation
List item

Direct healthcare professional communication (DHPC): Vaxzevria/COVID-19 Vaccine AstraZeneca: Risk of thrombosis in combination with thrombocytopenia - Updated information (PDF/155.7 KB) (new)

First published: 02/06/2021
List item

Phenytoin: List of nationally authorised medicinal products - PSUSA/00002392/202008 (PDF/146.64 KB) (new)

Last updated: 01/06/2021
Active substance: phenytoin
Procedure number: PSUSA/00002392/202008
Regulatory outcome: Variation
List item

Phenytoin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002392/202008 (PDF/130.15 KB) (new)

Last updated: 01/06/2021
Active substance: phenytoin
Procedure number: PSUSA/00002392/202008
Regulatory outcome: Variation
Bulgarian
(PDF/135.61 KB)

Croatian
(PDF/141.43 KB)

Czech
(PDF/134.46 KB)

Danish
(PDF/136.96 KB)

Dutch
(PDF/155.15 KB)

Estonian
(PDF/108.9 KB)

Finnish
(PDF/129.67 KB)

French
(PDF/129.75 KB)

German
(PDF/142.7 KB)

Greek
(PDF/136.33 KB)

Hungarian
(PDF/133.66 KB)

Italian
(PDF/151.1 KB)

Latvian
(PDF/134.12 KB)

Lithuanian
(PDF/133.37 KB)

Maltese
(PDF/142.15 KB)

Norwegian
(PDF/129.5 KB)

Polish
(PDF/133.74 KB)

Portuguese
(PDF/138 KB)

Romanian
(PDF/137.51 KB)

Slovak
(PDF/140.17 KB)

Slovenian
(PDF/135.18 KB)

Spanish
(PDF/123.18 KB)

Swedish
(PDF/130.52 KB)
List item

Veterinary Medicines Regulation highlights - Issue 5 (PDF/1.02 MB) (new)

First published: 31/05/2021
Issue 5
List item

PRAC recommendations on signals adopted at the 3-6 May 2021 PRAC meeting (PDF/367.08 KB) (new)

Adopted
First published: 31/05/2021
EMA/PRAC/250777/2021
List item

New product information wording: extracts from PRAC recommendations on signals Adopted at the 3-6 May 2021 PRAC (PDF/249.02 KB) (new)

Adopted
First published: 31/05/2021
EMA/PRAC/250778/2021
Bulgarian
(PDF/288.71 KB)

Croatian
(PDF/276.83 KB)

Czech
(PDF/279.52 KB)

Danish
(PDF/260.29 KB)

Dutch
(PDF/267.45 KB)

Estonian
(PDF/238.76 KB)

Finnish
(PDF/238.25 KB)

French
(PDF/244.12 KB)

German
(PDF/252.94 KB)

Greek
(PDF/290.16 KB)

Hungarian
(PDF/278.73 KB)

Icelandic
(PDF/245.99 KB)

Italian
(PDF/240.01 KB)

Latvian
(PDF/276.03 KB)

Lithuanian
(PDF/291.06 KB)

Maltese
(PDF/292.29 KB)

Norwegian
(PDF/269.68 KB)

Polish
(PDF/289.72 KB)

Portuguese
(PDF/256.12 KB)

Romanian
(PDF/276.95 KB)

Slovak
(PDF/286.11 KB)

Slovenian
(PDF/273.29 KB)

Spanish
(PDF/252.91 KB)

Swedish
(PDF/245.71 KB)

11864 results

Beractant : List of nationally authorised medicines - PSUSA/00000384/202010 (PDF/148.85 KB) (new)

Amlodipine / atorvastatin / perindopril - List of nationally authorised medicinal products - PSUSA/00010431/202010 (PDF/300.67 KB) (new)

Rubidium chloride RB-82 - List of nationally authorised medicinal products - PSUSA-00010806-202010 (PDF/104.25 KB) (new)

Agenda - CVMP agenda of the 15-17 June 2021 meeting (PDF/288.17 KB) (new)

Bivalrudin : List of nationally authorised medicinal products - PSUSA/00000421/202009 (PDF/188.71 KB) (new)

Idebenone : List of nationally authorised medicinal products - PSUSA/00001721/202009 (PDF/103.05 KB) (new)

News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2021 (new)

PRAC statistics: June 2021 (PDF/579.62 KB) (new)

News: COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis (new)

News: Vaxzevria: EMA advises against use in people with history of capillary leak syndrome (new)

Lidocaine : List of nationally authorised medicinal products - PSUSA/00001861/202009 (PDF/437.03 KB) (new)

Desflurane : List of nationally authorised medicinal products - PSUSA/00000958/202009 (PDF/147.82 KB) (new)

Direct healthcare professional communication (DHPC): Venclyxto - (venetoclax) film coated tablets: Updated recommendations on tumour lysis syndrome (TLS) in CLL patients (PDF/223.2 KB) (new)

Monthly report on application procedures, guidelines and related documents for veterinary medicines: April 2021 (PDF/260.45 KB) (new)

Agenda - PRAC draft agenda of meeting 7-10 June 2021 (PDF/734.41 KB) (new)

EU VICH adverse event report implementation guide (PDF/680.16 KB) (new)

Monthly report on application procedures, guidelines and related documents for veterinary medicines: March 2021 (PDF/257.84 KB) (new)

Naftifine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002109/202008 (PDF/85.84 KB) (new)

Naftifine: List of nationally authorised medicinal products - PSUSA/00002109/202008 (PDF/115.84 KB) (new)

Direct healthcare professional communication (DHPC): Vaxzevria/COVID-19 Vaccine AstraZeneca: Risk of thrombosis in combination with thrombocytopenia - Updated information (PDF/155.7 KB) (new)

Phenytoin: List of nationally authorised medicinal products - PSUSA/00002392/202008 (PDF/146.64 KB) (new)

Phenytoin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002392/202008 (PDF/130.15 KB) (new)

Veterinary Medicines Regulation highlights - Issue 5 (PDF/1.02 MB) (new)

PRAC recommendations on signals adopted at the 3-6 May 2021 PRAC meeting (PDF/367.08 KB) (new)

New product information wording: extracts from PRAC recommendations on signals Adopted at the 3-6 May 2021 PRAC (PDF/249.02 KB) (new)