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Estradiol-containing (0.01% w/w) medicinal products for topical use Article 31 referral - Annex II (PDF/175 KB) (new)

First published: 08/04/2020
Bulgarian
(PDF/186.6 KB)

Croatian
(PDF/185.48 KB)

Czech
(PDF/157.84 KB)

Danish
(PDF/164.64 KB)

Dutch
(PDF/163.43 KB)

Estonian
(PDF/144.27 KB)

Finnish
(PDF/158.97 KB)

French
(PDF/166.92 KB)

German
(PDF/156.81 KB)

Greek
(PDF/200.73 KB)

Hungarian
(PDF/159.32 KB)

Italian
(PDF/160.6 KB)

Latvian
(PDF/192.62 KB)

Lithuanian
(PDF/187.55 KB)

Maltese
(PDF/210.11 KB)

Polish
(PDF/169.46 KB)

Portuguese
(PDF/168.75 KB)

Romanian
(PDF/175.81 KB)

Slovak
(PDF/178.72 KB)

Slovenian
(PDF/191.88 KB)

Spanish
(PDF/166.08 KB)

Swedish
(PDF/163.15 KB)
List item

New product information wording: extracts from PRAC recommendations on signals adopted at the 9-12 March 2020 PRAC (PDF/189.15 KB) (updated)

Adopted
First published: 08/04/2020
Last updated: 08/04/2020
EMA/PRAC/111218/2020 Corr2
Bulgarian
(PDF/237.1 KB)

Croatian
(PDF/220.38 KB)

Czech
(PDF/241.46 KB)

Danish
(PDF/228.33 KB)

Dutch
(PDF/237.9 KB)

Estonian
(PDF/206.47 KB)

Finnish
(PDF/206.46 KB)

French
(PDF/208.06 KB)

German
(PDF/209.38 KB)

Greek
(PDF/241.15 KB)

Hungarian
(PDF/232.66 KB)

Icelandic
(PDF/204.7 KB)

Italian
(PDF/197.34 KB)

Latvian
(PDF/237.51 KB)

Lithuanian
(PDF/238.27 KB)

Maltese
(PDF/237.7 KB)

Norwegian
(PDF/189.73 KB)

Polish
(PDF/241.71 KB)

Portuguese
(PDF/210.43 KB)

Romanian
(PDF/233.64 KB)

Slovak
(PDF/233.2 KB)

Slovenian
(PDF/225.48 KB)

Spanish
(PDF/207.33 KB)

Swedish
(PDF/196.79 KB)
List item

Pitavastatin: List of nationally authorised medicinal products - PSUSA/00010502/201907 (PDF/158.42 KB) (new)

Last updated: 07/04/2020
Active substance: pitavastatin
Procedure number: PSUSA/00010502/201907
Regulatory outcome: Variation
List item

Ibuprofen / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00001711/201907 (PDF/368.58 KB) (new)

Last updated: 07/04/2020
Active substance: Ibuprofen, pseudoephedrine
Procedure number: PSUSA/00001711/201907
Regulatory outcome: Variation
List item

Ibuprofen / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the product Information and timetable for the implementation - PSUSA/00001711/201907 (PDF/75.46 KB) (new)

Last updated: 07/04/2020
Active substance: Ibuprofen, pseudoephedrine
Procedure number: PSUSA/00001711/201907
Regulatory outcome: Variation
Bulgarian
(PDF/71.28 KB)

Croatian
(PDF/78.08 KB)

Czech
(PDF/77.56 KB)

Danish
(PDF/76.94 KB)

Dutch
(PDF/76.14 KB)

Estonian
(PDF/67.37 KB)

Finnish
(PDF/68.49 KB)

French
(PDF/72.91 KB)

German
(PDF/82.49 KB)

Greek
(PDF/67.71 KB)

Hungarian
(PDF/76.21 KB)

Italian
(PDF/98.79 KB)

Latvian
(PDF/87.28 KB)

Lithuanian
(PDF/81.05 KB)

Maltese
(PDF/88.12 KB)

Polish
(PDF/73.46 KB)

Portuguese
(PDF/77.42 KB)

Romanian
(PDF/70.61 KB)

Slovak
(PDF/74.82 KB)

Slovenian
(PDF/68.29 KB)

Spanish
(PDF/74.28 KB)

Swedish
(PDF/71.78 KB)
List item

PRAC recommendations on signals adopted at the 9-12 March 2020 PRAC meeting (PDF/253.45 KB) (updated)

Adopted
First published: 06/04/2020
Last updated: 08/04/2020
EMA/PRAC/111214/2020 Corr.3
List item

Pholcodine: List of nationally authorised medicinal products - PSUSA/00002396/201905 (PDF/121.58 KB) (new)

Last updated: 03/04/2020
Active substance: pholcodine
Procedure number: PSUSA/00002396/201905
Regulatory outcome: Variation
List item

Iobitridol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001761/201904 (PDF/183.73 KB) (new)

Last updated: 03/04/2020
Active substance: iobitridol
Procedure number: PSUSA/00001761/201904
Regulatory outcome: Variation
Bulgarian
(PDF/268.18 KB)

Croatian
(PDF/252.01 KB)

Czech
(PDF/208.68 KB)

Danish
(PDF/178.19 KB)

Dutch
(PDF/180.34 KB)

Estonian
(PDF/157.98 KB)

Finnish
(PDF/156.85 KB)

German
(PDF/188.1 KB)

Greek
(PDF/170.04 KB)

Hungarian
(PDF/230.15 KB)

Icelandic
(PDF/166.49 KB)

Italian
(PDF/187.3 KB)

Latvian
(PDF/338.22 KB)

Lithuanian
(PDF/228.35 KB)

Maltese
(PDF/241.92 KB)

Norwegian
(PDF/180.4 KB)

Polish
(PDF/233.28 KB)

Portuguese
(PDF/190.26 KB)

Romanian
(PDF/242.3 KB)

Slovak
(PDF/166.89 KB)

Slovenian
(PDF/238.13 KB)

Spanish
(PDF/179.41 KB)

Swedish
(PDF/182.38 KB)
List item

Iobitridol: List of nationally authorised medicinal products - PSUSA/00001761/201904 (PDF/382.03 KB) (new)

Last updated: 03/04/2020
Active substance: iobitridol
Procedure number: PSUSA/00001761/201904
Regulatory outcome: Variation
List item

Ulipristal acetate 5mg medicinal products Article-31 referral - Assessment report on temporary measures (PDF/374.44 KB) (new)

Adopted
First published: 02/04/2020
EMA/70192/2018
List item

Cyproterone Article-31 referral - PRAC assessment report (PDF/493.5 KB) (new)

Adopted
First published: 01/04/2020
EMA/134740/2020
List item

Fosfomycin (IV formulation): List of nationally authorised medicinal products - PSUSA/00010336/201907 (PDF/114.49 KB) (new)

Last updated: 25/03/2020
Active substance: fosfomycin (IV formulation)
Procedure number: PSUSA/00010336/201907
Regulatory outcome: Maintenance
List item

EudraVigilance Operational Plan - Milestones 2020 to 2022 (PDF/440.4 KB) (new)

Adopted
First published: 25/03/2020
EMA/509378/2019
List item

Fosfomycin (oral formulation): List of nationally authorised medicinal products - PSUSA/00010326/201907 (PDF/146.67 KB) (new)

Last updated: 25/03/2020
Active substance: fosfomycin (oral formulation)
Procedure number: PSUSA/00010326/201907
Regulatory outcome: Maintenance
List item

Ulipristal acetate 5 mg for uterine fibroids not to be used during ongoing review of liver injury risk (PDF/130.14 KB) (new)

First published: 23/03/2020
List item

Amsacrine: List of nationally authorised medicinal products - PSUSA/00000199/201906 (PDF/103.6 KB) (new)

Last updated: 19/03/2020
Active substance: amsacrine
Procedure number: PSUSA/00000199/201906
Regulatory outcome: Maintenance
List item

Human hemin: List of nationally authorised medicinal products - PSUSA/00001629/201905 (PDF/140.87 KB) (new)

Last updated: 19/03/2020
Active substance: human hemin
Procedure number: PSUSA/00001629/201905
Regulatory outcome: Maintenance
List item

Allergen for therapy: Phleum Pratense (oromucosal use, product authorised via mutually recognition procedure): List of nationally authorised medicinal products - PSUSA/00010475/201907 (PDF/116.13 KB) (new)

Last updated: 19/03/2020
Active substance: allergen for therapy: Phleum Pratense (oromucosal use, product authorised via mutually recognition procedure)
Procedure number: PSUSA/00010475/201907
Regulatory outcome: Maintenance
List item

Bromocriptine : List of nationally authorised medicinal products - PSUSA/00000438/201810 (PDF/143.91 KB) (new)

Last updated: 18/03/2020
Active substance: bromocriptine
Procedure number: PSUSA/00000438/201810
Regulatory outcome: Maintenance
List item

Human coagulation factor viii / human von willebrand factor : List of nationally authorised medicinal products - PSUSA/00001621/201810 (PDF/398.36 KB) (new)

Last updated: 18/03/2020
Active substance: Human coagulation factor VIII, human von willebrand factor
Procedure number: PSUSA/00001621/201810
Regulatory outcome: Maintenance
List item

Nimodipine: List of nationally authorised medicinal products - PSUSA/00002166/201811 (PDF/163.62 KB) (new)

Last updated: 18/03/2020
Active substance: Nimodipine
Procedure number: PSUSA/00002166/201811
Regulatory outcome: Maintenance
List item

Mitoxantrone: List of nationally authorised medicinal products - PSUSA/00002076/201906 (PDF/254.15 KB) (new)

Last updated: 18/03/2020
Active substance: mitoxantrone
Procedure number: PSUSA/00002076/201906
Regulatory outcome: Maintenance
List item

Human coagulation factor IX: List of nationally authorised medicinal products - PSUSA/00001617/201907 (PDF/325.01 KB) (new)

Last updated: 17/03/2020
Active substance: human coagulation factor IX
Procedure number: PSUSA/00001617/201907
Regulatory outcome: Maintenance
List item

Methadone: List of nationally authorised medicinal products - PSUSA/00002004/201905 (PDF/173.45 KB) (new)

Last updated: 17/03/2020
Active substance: methadone
Procedure number: PSUSA/00002004/201905
Regulatory outcome: Variation
List item

PRAC statistics: March 2020 (PDF/632.07 KB) (new)

First published: 13/03/2020

1706 results

Estradiol-containing (0.01% w/w) medicinal products for topical use Article 31 referral - Annex II (PDF/175 KB) (new)

New product information wording: extracts from PRAC recommendations on signals adopted at the 9-12 March 2020 PRAC (PDF/189.15 KB) (updated)

Pitavastatin: List of nationally authorised medicinal products - PSUSA/00010502/201907 (PDF/158.42 KB) (new)

Ibuprofen / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00001711/201907 (PDF/368.58 KB) (new)

Ibuprofen / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the product Information and timetable for the implementation - PSUSA/00001711/201907 (PDF/75.46 KB) (new)

PRAC recommendations on signals adopted at the 9-12 March 2020 PRAC meeting (PDF/253.45 KB) (updated)

Pholcodine: List of nationally authorised medicinal products - PSUSA/00002396/201905 (PDF/121.58 KB) (new)

Iobitridol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001761/201904 (PDF/183.73 KB) (new)

Iobitridol: List of nationally authorised medicinal products - PSUSA/00001761/201904 (PDF/382.03 KB) (new)

Ulipristal acetate 5mg medicinal products Article-31 referral - Assessment report on temporary measures (PDF/374.44 KB) (new)

Cyproterone Article-31 referral - PRAC assessment report (PDF/493.5 KB) (new)

Fosfomycin (IV formulation): List of nationally authorised medicinal products - PSUSA/00010336/201907 (PDF/114.49 KB) (new)

EudraVigilance Operational Plan - Milestones 2020 to 2022 (PDF/440.4 KB) (new)

Fosfomycin (oral formulation): List of nationally authorised medicinal products - PSUSA/00010326/201907 (PDF/146.67 KB) (new)

Ulipristal acetate 5 mg for uterine fibroids not to be used during ongoing review of liver injury risk (PDF/130.14 KB) (new)

Amsacrine: List of nationally authorised medicinal products - PSUSA/00000199/201906 (PDF/103.6 KB) (new)

Human hemin: List of nationally authorised medicinal products - PSUSA/00001629/201905 (PDF/140.87 KB) (new)

Allergen for therapy: Phleum Pratense (oromucosal use, product authorised via mutually recognition procedure): List of nationally authorised medicinal products - PSUSA/00010475/201907 (PDF/116.13 KB) (new)

Bromocriptine : List of nationally authorised medicinal products - PSUSA/00000438/201810 (PDF/143.91 KB) (new)

Human coagulation factor viii / human von willebrand factor : List of nationally authorised medicinal products - PSUSA/00001621/201810 (PDF/398.36 KB) (new)

Nimodipine: List of nationally authorised medicinal products - PSUSA/00002166/201811 (PDF/163.62 KB) (new)

Mitoxantrone: List of nationally authorised medicinal products - PSUSA/00002076/201906 (PDF/254.15 KB) (new)

Human coagulation factor IX: List of nationally authorised medicinal products - PSUSA/00001617/201907 (PDF/325.01 KB) (new)

Methadone: List of nationally authorised medicinal products - PSUSA/00002004/201905 (PDF/173.45 KB) (new)

PRAC statistics: March 2020 (PDF/632.07 KB) (new)