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Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/201905 (PDF/159.18 KB) (new)

Last updated: 24/01/2020
Procedure number: PSUSA/00010484/201905
Regulatory outcome: Maintenance
List item

Bemiparin: List of nationally authorised medicinal products - PSUSA/00000312/201904 (PDF/581.04 KB) (new)

Last updated: 23/01/2020
Procedure number: PSUSA/00000312/201904
Regulatory outcome: Maintenance
List item

Misoprostol (gynaecological indication - labour induction): List of nationally authorised medicinal products - PSUSA/00010353/201905 (PDF/201.16 KB) (new)

Last updated: 23/01/2020
Procedure number: PSUSA/00010353/201905
Regulatory outcome: Maintenance
List item

Ozenoxacin: List of nationally authorised medicinal products - PSUSA/00010651/201905 (PDF/113.11 KB) (new)

Last updated: 23/01/2020
Procedure number: PSUSA/00010651/201905
Regulatory outcome: Maintenance
List item

Isoniazide / rifampicin: List of nationally authorised medicinal products - PSUSA/00001792/201905 (PDF/123.59 KB) (new)

Last updated: 23/01/2020
Procedure number: PSUSA/00010651/201905
Regulatory outcome: Maintenance
List item

Macrogol 3350: List of nationally authorised medicinal products - PSUSA/0001924/201905 (PDF/122.76 KB) (new)

Last updated: 23/01/2020
Procedure number: PSUSA/00001924/201905
Regulatory outcome: Maintenance
List item

Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/201905 (PDF/111.95 KB) (new)

Last updated: 23/01/2020
Procedure number: PSUSA/00010288/201905
Regulatory outcome: Maintenance
List item

Macrogol 4000, macrogol 4000 combinations (oral use): List of nationally authorised medicinal products - PSUSA/00010392/201905 (PDF/212.75 KB) (new)

Last updated: 23/01/2020
Procedure number: PSUSA/00010392/201905
Regulatory outcome: Maintenance
List item

Yohimbine: List of nationally authorised medicinal products - PSUSA/00003136/201905 (PDF/102.12 KB) (new)

Last updated: 22/01/2020
Procedure number: PSUSA/00003136/201905
Regulatory outcome: Maintenance
List item

Picato Article-20 referral - Assessment report on provisional measures (PDF/1.89 MB) (new)

Adopted
First published: 21/01/2020
EMA/30347/2020
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Picato Article-20 referral - Annex I (PDF/109.95 KB) (new)

First published: 21/01/2020
List item

Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201905 (PDF/376.77 KB) (new)

Last updated: 20/01/2020
Procedure number: PSUSA/00010488/201905
Regulatory outcome: Variation
List item

Botulinum neurotoxin type a (150 kD) free from complexing proteins: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00009084/201812 (PDF/27.22 KB) (new)

Last updated: 20/01/2020
Procedure number: PSUSA/00009084/201812
Regulatory outcome: Variation
Bulgarian
(PDF/123.89 KB)

Croatian
(PDF/122.2 KB)

Czech
(PDF/103.57 KB)

Danish
(PDF/67.71 KB)

Dutch
(PDF/107.72 KB)

Estonian
(PDF/164.51 KB)

Finnish
(PDF/95.67 KB)

French
(PDF/152.3 KB)

German
(PDF/161.59 KB)

Greek
(PDF/192.3 KB)

Hungarian
(PDF/231.7 KB)

Icelandic
(PDF/148.52 KB)

Italian
(PDF/104.25 KB)

Latvian
(PDF/192.51 KB)

Lithuanian
(PDF/203.76 KB)

Maltese
(PDF/51.91 KB)

Norwegian
(PDF/27.43 KB)

Polish
(PDF/201.15 KB)

Portuguese
(PDF/28.11 KB)

Romanian
(PDF/216.06 KB)

Slovak
(PDF/240.42 KB)

Slovenian
(PDF/97.38 KB)

Spanish
(PDF/172.84 KB)

Swedish
(PDF/98.65 KB)
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 January 2020

PRAC, Last updated: 17/01/2020
List item

Press release: PRAC confirms four-week limit for use of high-strength estradiol creams

PRAC, Last updated: 17/01/2020
List item

Press release: EMA suspends Picato as a precaution while review of skin cancer risk continues

PRAC, Last updated: 17/01/2020
List item

Tirofiban: List of nationally authorised medicinal products - PSUSA/00002974/201905 (PDF/153.94 KB) (new)

Last updated: 17/01/2020
Procedure number: PSUSA/00002974/201905
Regulatory outcome: Maintenance
List item

Estradiol-containing (0.01% w/w) medicinal products for topical use Article 31 referral - PRAC confirms four-week limit for use of high-strength estradiol creams (PDF/126.91 KB) (new)

First published: 17/01/2020
EMA/20248/2020
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PRAC confirms four-week limit for use of high-strength estradiol creams (PDF/126.91 KB) (new)

First published: 17/01/2020
EMA/20248/2020
List item

EMA suspends Picato as a precaution while review of skin cancer risk continues (PDF/124.3 KB) (updated)

First published: 17/01/2020
Last updated: 21/01/2020
EMA/32231/2020
List item

Picato Article-20 referral - EMA suspends Picato as a precaution while review of skin cancer risk continues (PDF/124.3 KB) (updated)

First published: 17/01/2020
Last updated: 21/01/2020
EMA/32231/2020
List item

Lisdexamfetamine: List of nationally authorised medicinal products - PSUSA/00010289/201902 (PDF/147.79 KB) (new)

Last updated: 14/01/2020
Procedure number: PSUSA/00010289/201902
Regulatory outcome: Variation
List item

Erythromycin: List of nationally authorised medicinal products - PSUSA/00001257/201903 (PDF/275.98 KB) (new)

Last updated: 14/01/2020
Procedure number: PSUSA/00001257/201903
Regulatory outcome: Variation
List item

Agenda - PRAC draft agenda of meeting 13-16 January 2020 (PDF/687.87 KB) (new)

Draft
First published: 13/01/2020
EMA/PRAC/645087/2019
List item

Ezetimibe / simvastatin: List of nationally authorised medicinal products - PSUSA/00001347/201903 (PDF/387.95 KB) (new)

Last updated: 10/01/2020
Procedure number: PSUSA/00001347/201903
Regulatory outcome: Variation

1639 results

Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/201905 (PDF/159.18 KB) (new)

Bemiparin: List of nationally authorised medicinal products - PSUSA/00000312/201904 (PDF/581.04 KB) (new)

Misoprostol (gynaecological indication - labour induction): List of nationally authorised medicinal products - PSUSA/00010353/201905 (PDF/201.16 KB) (new)

Ozenoxacin: List of nationally authorised medicinal products - PSUSA/00010651/201905 (PDF/113.11 KB) (new)

Isoniazide / rifampicin: List of nationally authorised medicinal products - PSUSA/00001792/201905 (PDF/123.59 KB) (new)

Macrogol 3350: List of nationally authorised medicinal products - PSUSA/0001924/201905 (PDF/122.76 KB) (new)

Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/201905 (PDF/111.95 KB) (new)

Macrogol 4000, macrogol 4000 combinations (oral use): List of nationally authorised medicinal products - PSUSA/00010392/201905 (PDF/212.75 KB) (new)

Yohimbine: List of nationally authorised medicinal products - PSUSA/00003136/201905 (PDF/102.12 KB) (new)

Picato Article-20 referral - Assessment report on provisional measures (PDF/1.89 MB) (new)

Picato Article-20 referral - Annex I (PDF/109.95 KB) (new)

Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201905 (PDF/376.77 KB) (new)

Botulinum neurotoxin type a (150 kD) free from complexing proteins: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00009084/201812 (PDF/27.22 KB) (new)

News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 January 2020

Press release: PRAC confirms four-week limit for use of high-strength estradiol creams

Press release: EMA suspends Picato as a precaution while review of skin cancer risk continues

Tirofiban: List of nationally authorised medicinal products - PSUSA/00002974/201905 (PDF/153.94 KB) (new)

Estradiol-containing (0.01% w/w) medicinal products for topical use Article 31 referral - PRAC confirms four-week limit for use of high-strength estradiol creams (PDF/126.91 KB) (new)

PRAC confirms four-week limit for use of high-strength estradiol creams (PDF/126.91 KB) (new)

EMA suspends Picato as a precaution while review of skin cancer risk continues (PDF/124.3 KB) (updated)

Picato Article-20 referral - EMA suspends Picato as a precaution while review of skin cancer risk continues (PDF/124.3 KB) (updated)

Lisdexamfetamine: List of nationally authorised medicinal products - PSUSA/00010289/201902 (PDF/147.79 KB) (new)

Erythromycin: List of nationally authorised medicinal products - PSUSA/00001257/201903 (PDF/275.98 KB) (new)

Agenda - PRAC draft agenda of meeting 13-16 January 2020 (PDF/687.87 KB) (new)

Ezetimibe / simvastatin: List of nationally authorised medicinal products - PSUSA/00001347/201903 (PDF/387.95 KB) (new)