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2533 results

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Shortage of Metalyse (tenecteplase) (PDF/153.46 KB) (updated)

First published: 23/09/2022
Last updated: 11/05/2023
EMA/706012/2022 Rev 1
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Shortage of Actilyse (alteplase) and Actilyse Cathflo (alteplase) (PDF/157.65 KB) (updated)

First published: 23/09/2022
Last updated: 11/05/2023
EMA/734545/2022 Rev 1
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Menopur (menotropin) supply shortage (PDF/166.44 KB)

First published: 05/04/2023
Last updated: 24/04/2023
EMA/111629/2023 Rev.1
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Zerbaxa (ceftolozane / tazobactam) supply shortage (PDF/329.75 KB)

First published: 22/12/2020
Last updated: 14/04/2023
EMA/694164/2020 Rev. 2
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DepoCyte (cytarabine) supply shortage (PDF/306.08 KB)

First published: 19/01/2017
Last updated: 03/04/2023
EMA/371236/2017 Rev.2
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Ozempic (semaglutide) supply shortage (PDF/199.78 KB)

First published: 19/10/2022
Last updated: 15/03/2023
EMA/798839/2022 Rev.1
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Cetrotide (cetrorelix acetate) supply shortage (PDF/781.43 KB)

First published: 10/08/2022
Last updated: 15/02/2023
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Amoxicillin and amoxicillin/clavulanic acid supply shortage (PDF/180.52 KB)

First published: 27/01/2023
Last updated: 06/02/2023
EMA/27040/2023
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Dorzolamide : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003168/202202 (PDF/36.95 KB)

Last updated: 25/11/2022
Active substance: dorzolamide
Procedure number: PSUSA/00003168/202202
Regulatory outcome: Variation
Bulgarian
(PDF/86.28 KB)

Croatian
(PDF/69.52 KB)

Czech
(PDF/81.98 KB)

Danish
(PDF/39.28 KB)

Dutch
(PDF/39.36 KB)

Estonian
(PDF/38.34 KB)

Finnish
(PDF/38.46 KB)

French
(PDF/40.04 KB)

German
(PDF/32.7 KB)

Greek
(PDF/89.72 KB)

Hungarian
(PDF/69.13 KB)

Icelandic
(PDF/42.28 KB)

Irish
(PDF/38.75 KB)

Italian
(PDF/42.01 KB)

Latvian
(PDF/80.69 KB)

Lithuanian
(PDF/84.38 KB)

Maltese
(PDF/82.53 KB)

Norwegian
(PDF/39.12 KB)

Polish
(PDF/84.34 KB)

Portuguese
(PDF/39.03 KB)

Romanian
(PDF/80.09 KB)

Slovak
(PDF/70.86 KB)

Slovenian
(PDF/76.3 KB)

Spanish
(PDF/39.52 KB)

Swedish
(PDF/40.2 KB)
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Orgalutran (ganirelix) supply shortage (PDF/272 KB)

First published: 16/02/2017
Last updated: 08/11/2022
EMA/46102/2017 Rev.1
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Betamethasone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000391/202101 (PDF/156.56 KB)

Last updated: 18/10/2022
Active substance: betamethasone
Procedure number: PSUSA/00000391/202101
Regulatory outcome: Variation
Bulgarian
(PDF/126.38 KB)

Croatian
(PDF/218.18 KB)

Czech
(PDF/411.72 KB)

Danish
(PDF/156.89 KB)

Dutch
(PDF/135.15 KB)

Estonian
(PDF/150.55 KB)

Finnish
(PDF/113.87 KB)

French
(PDF/192.49 KB)

German
(PDF/107.8 KB)

Greek
(PDF/126.78 KB)

Hungarian
(PDF/215.99 KB)

Icelandic
(PDF/125.77 KB)

Italian
(PDF/123.46 KB)

Latvian
(PDF/165.6 KB)

Lithuanian
(PDF/429.9 KB)

Maltese
(PDF/90.56 KB)

Norwegian
(PDF/182.53 KB)

Polish
(PDF/206.42 KB)

Portuguese
(PDF/156.53 KB)

Romanian
(PDF/130.4 KB)

Slovak
(PDF/125.51 KB)

Slovenian
(PDF/198.26 KB)

Spanish
(PDF/157.21 KB)

Swedish
(PDF/175.82 KB)
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Natpar (parathyroid hormone) supply shortage (PDF/178.29 KB)

First published: 02/05/2022
Last updated: 05/10/2022
EMA/232874/2022 Rev. 1
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Visudyne (verteporfin) supply shortage (PDF/143.24 KB)

First published: 08/11/2021
Last updated: 12/08/2022
EMA/587325/2021 Rev. 1
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Bisoprolol / hydrochlorothiazide : List of nationally authorised medicinal products - PSUSA/00000420/202111 (PDF/220.18 KB)

Last updated: 13/07/2022
Active substance: bisoprolol, hydrochlorothiazide
Procedure number: PSUSA/00000420/202111
Regulatory outcome: Maintenance
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Isotretinoin (oral formulations) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/202105 (PDF/172.42 KB)

Last updated: 31/05/2022
Active substance: isotretinoin (oral formulations)
Procedure number: PSUSA/00010488/202105
Regulatory outcome: Variation
Bulgarian
(PDF/269.83 KB)

Croatian
(PDF/39.8 KB)

Czech
(PDF/178.5 KB)

Danish
(PDF/168.46 KB)

Dutch
(PDF/193.1 KB)

Estonian
(PDF/243.64 KB)

Finnish
(PDF/158.17 KB)

French
(PDF/38.02 KB)

German
(PDF/227.2 KB)

Greek
(PDF/342.74 KB)

Hungarian
(PDF/122.72 KB)

Icelandic
(PDF/156.29 KB)

Italian
(PDF/181.64 KB)

Latvian
(PDF/331.18 KB)

Lithuanian
(PDF/132.27 KB)

Maltese
(PDF/182.37 KB)

Norwegian
(PDF/113.01 KB)

Polish
(PDF/258.27 KB)

Portuguese
(PDF/131.59 KB)

Romanian
(PDF/254.52 KB)

Slovak
(PDF/183.34 KB)

Slovenian
(PDF/307.82 KB)

Spanish
(PDF/166.42 KB)

Swedish
(PDF/173.38 KB)
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Paracetamol (IV formulation) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002311/202105 (PDF/136.32 KB)

Last updated: 07/04/2022
Active substance: paracetamol (IV formulation)
Procedure number: PSUSA/00002311/202105
Regulatory outcome: Variation
Bulgarian
(PDF/192.3 KB)

Croatian
(PDF/195.36 KB)

Czech
(PDF/159.35 KB)

Danish
(PDF/162.18 KB)

Dutch
(PDF/140.68 KB)

Estonian
(PDF/92.08 KB)

Finnish
(PDF/136.2 KB)

French
(PDF/138.09 KB)

German
(PDF/143.47 KB)

Greek
(PDF/171.42 KB)

Hungarian
(PDF/219.74 KB)

Icelandic
(PDF/134.29 KB)

Italian
(PDF/182.7 KB)

Latvian
(PDF/125.25 KB)

Lithuanian
(PDF/120.98 KB)

Maltese
(PDF/120.5 KB)

Norwegian
(PDF/153.3 KB)

Polish
(PDF/204.5 KB)

Portuguese
(PDF/159.76 KB)

Romanian
(PDF/201.4 KB)

Slovak
(PDF/188.03 KB)

Slovenian
(PDF/230.38 KB)

Spanish
(PDF/154.91 KB)

Swedish
(PDF/172.08 KB)
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Remifentanil : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002617/202105 (PDF/147.75 KB)

Last updated: 06/04/2022
Active substance: remifentanil
Procedure number: PSUSA/00002617/202105
Regulatory outcome: Variation
Bulgarian
(PDF/337.89 KB)

Croatian
(PDF/268.55 KB)

Czech
(PDF/443.34 KB)

Danish
(PDF/388.37 KB)

Dutch
(PDF/328.14 KB)

Estonian
(PDF/271.48 KB)

Finnish
(PDF/321.82 KB)

French
(PDF/336.01 KB)

German
(PDF/330.82 KB)

Greek
(PDF/335.2 KB)

Hungarian
(PDF/468.29 KB)

Italian
(PDF/378.5 KB)

Latvian
(PDF/522.33 KB)

Lithuanian
(PDF/270.09 KB)

Maltese
(PDF/367.96 KB)

Norwegian
(PDF/325.44 KB)

Polish
(PDF/370.65 KB)

Portuguese
(PDF/370.07 KB)

Romanian
(PDF/331.4 KB)

Slovak
(PDF/277.26 KB)

Slovenian
(PDF/436.65 KB)

Spanish
(PDF/370.98 KB)

Swedish
(PDF/366.23 KB)
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Dobutamine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001151/202103 (PDF/91.49 KB)

Last updated: 09/03/2022
Active substance: Dobutamine
Procedure number: PSUSA/00001151/202103
Regulatory outcome: Variation
Bulgarian
(PDF/175.59 KB)

Croatian
(PDF/181.04 KB)

Czech
(PDF/195.41 KB)

Danish
(PDF/143.34 KB)

Dutch
(PDF/153.59 KB)

Estonian
(PDF/145.68 KB)

Finnish
(PDF/138.67 KB)

French
(PDF/144.97 KB)

German
(PDF/158.06 KB)

Greek
(PDF/178.29 KB)

Hungarian
(PDF/187.06 KB)

Icelandic
(PDF/154.4 KB)

Italian
(PDF/152.06 KB)

Latvian
(PDF/188.95 KB)

Lithuanian
(PDF/181.58 KB)

Maltese
(PDF/190.13 KB)

Norwegian
(PDF/142.4 KB)

Polish
(PDF/187.4 KB)

Portuguese
(PDF/145.15 KB)

Romanian
(PDF/188.56 KB)

Slovak
(PDF/190.87 KB)

Slovenian
(PDF/178.39 KB)

Spanish
(PDF/146.18 KB)

Swedish
(PDF/142.39 KB)
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Quinapril : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002591/202104 (PDF/80.07 KB)

Last updated: 15/02/2022
Active substance: quinapril
Procedure number: PSUSA/00002591/202104
Regulatory outcome: Variation
Bulgarian
(PDF/81.1 KB)

Croatian
(PDF/103.14 KB)

Czech
(PDF/82.44 KB)

Danish
(PDF/82.97 KB)

Dutch
(PDF/94.26 KB)

Estonian
(PDF/102.53 KB)

Finnish
(PDF/83.63 KB)

French
(PDF/82.76 KB)

German
(PDF/89.59 KB)

Greek
(PDF/80.16 KB)

Hungarian
(PDF/81.46 KB)

Italian
(PDF/101.42 KB)

Latvian
(PDF/112.01 KB)

Lithuanian
(PDF/88.64 KB)

Maltese
(PDF/110.28 KB)

Polish
(PDF/105.59 KB)

Portuguese
(PDF/91.38 KB)

Romanian
(PDF/80.24 KB)

Slovak
(PDF/84.34 KB)

Slovenian
(PDF/108.57 KB)

Spanish
(PDF/81.17 KB)

Swedish
(PDF/80.89 KB)
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Oxycodone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002254/202104 (PDF/205.51 KB)

Last updated: 01/02/2022
Active substance: oxycodone
Procedure number: PSUSA/00002254/202104
Regulatory outcome: Variation
Bulgarian
(PDF/292.01 KB)

Croatian
(PDF/287.67 KB)

Czech
(PDF/161.83 KB)

Danish
(PDF/214.08 KB)

Dutch
(PDF/208.28 KB)

Estonian
(PDF/200.93 KB)

Finnish
(PDF/201.41 KB)

French
(PDF/227.02 KB)

German
(PDF/242.89 KB)

Greek
(PDF/268.51 KB)

Hungarian
(PDF/313.38 KB)

Icelandic
(PDF/213.35 KB)

Italian
(PDF/213.47 KB)

Latvian
(PDF/296.66 KB)

Lithuanian
(PDF/286.49 KB)

Maltese
(PDF/241.3 KB)

Norwegian
(PDF/204.07 KB)

Polish
(PDF/247.98 KB)

Portuguese
(PDF/311.01 KB)

Romanian
(PDF/390.27 KB)

Slovak
(PDF/287.18 KB)

Slovenian
(PDF/284.3 KB)

Spanish
(PDF/210.22 KB)

Swedish
(PDF/194.95 KB)
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Glatiramer - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA-00001529-202011 (PDF/33.83 KB)

Last updated: 20/01/2022
Active substance: glatiramer
Regulatory outcome: Variation
Bulgarian
(PDF/80.29 KB)

Croatian
(PDF/73.59 KB)

Czech
(PDF/134.01 KB)

Danish
(PDF/34.48 KB)

Dutch
(PDF/36.33 KB)

Estonian
(PDF/30.2 KB)

Finnish
(PDF/86.42 KB)

French
(PDF/34.28 KB)

German
(PDF/155.78 KB)

Greek
(PDF/84.1 KB)

Hungarian
(PDF/153.76 KB)

Icelandic
(PDF/36.15 KB)

Italian
(PDF/36.54 KB)

Latvian
(PDF/76.32 KB)

Lithuanian
(PDF/77.31 KB)

Maltese
(PDF/78.4 KB)

Norwegian
(PDF/30.64 KB)

Polish
(PDF/80.05 KB)

Portuguese
(PDF/34.25 KB)

Romanian
(PDF/66.96 KB)

Slovak
(PDF/77.46 KB)

Slovenian
(PDF/66.22 KB)

Spanish
(PDF/35.56 KB)

Swedish
(PDF/34.46 KB)
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Nulojix (belatacept) supply shortage (PDF/132.79 KB)

First published: 17/03/2017
Last updated: 18/01/2022
EMA/730337/2021 Rev.4
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Nafarelin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002105/202102 (PDF/72.61 KB)

Last updated: 14/01/2022
Active substance: nafarelin
Procedure number: PSUSA/00002105/202102
Regulatory outcome: Variation
Bulgarian
(PDF/80.31 KB)

Croatian
(PDF/82.51 KB)

Czech
(PDF/209.8 KB)

Danish
(PDF/76.43 KB)

Dutch
(PDF/74.54 KB)

Estonian
(PDF/79.54 KB)

Finnish
(PDF/68.38 KB)

French
(PDF/82.06 KB)

German
(PDF/80.72 KB)

Greek
(PDF/72.09 KB)

Hungarian
(PDF/72.76 KB)

Icelandic
(PDF/74.93 KB)

Italian
(PDF/101.18 KB)

Latvian
(PDF/95.19 KB)

Lithuanian
(PDF/88.44 KB)

Maltese
(PDF/92.6 KB)

Norwegian
(PDF/71.68 KB)

Polish
(PDF/91.25 KB)

Portuguese
(PDF/90.53 KB)

Romanian
(PDF/79.05 KB)

Slovak
(PDF/83.76 KB)

Slovenian
(PDF/83.27 KB)

Spanish
(PDF/80.73 KB)

Swedish
(PDF/84.17 KB)
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Champix (varenicline) supply shortage (PDF/175.48 KB)

First published: 08/07/2021
Last updated: 24/09/2021
EMA/522543/2021 Rev.11
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RoActemra (tocilizumab) supply shortage (PDF/180.38 KB)

First published: 03/09/2021
Last updated: 14/09/2021
EMA/472078/2021 Rev.1

2533 results

Shortage of Metalyse (tenecteplase) (PDF/153.46 KB) (updated)

Shortage of Actilyse (alteplase) and Actilyse Cathflo (alteplase) (PDF/157.65 KB) (updated)

Menopur (menotropin) supply shortage (PDF/166.44 KB)

Zerbaxa (ceftolozane / tazobactam) supply shortage (PDF/329.75 KB)

DepoCyte (cytarabine) supply shortage (PDF/306.08 KB)

Ozempic (semaglutide) supply shortage (PDF/199.78 KB)

Cetrotide (cetrorelix acetate) supply shortage (PDF/781.43 KB)

Amoxicillin and amoxicillin/clavulanic acid supply shortage (PDF/180.52 KB)

Dorzolamide : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003168/202202 (PDF/36.95 KB)

Orgalutran (ganirelix) supply shortage (PDF/272 KB)

Betamethasone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000391/202101 (PDF/156.56 KB)

Natpar (parathyroid hormone) supply shortage (PDF/178.29 KB)

Visudyne (verteporfin) supply shortage (PDF/143.24 KB)

Bisoprolol / hydrochlorothiazide : List of nationally authorised medicinal products - PSUSA/00000420/202111 (PDF/220.18 KB)

Isotretinoin (oral formulations) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/202105 (PDF/172.42 KB)

Paracetamol (IV formulation) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002311/202105 (PDF/136.32 KB)

Remifentanil : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002617/202105 (PDF/147.75 KB)

Dobutamine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001151/202103 (PDF/91.49 KB)

Quinapril : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002591/202104 (PDF/80.07 KB)

Oxycodone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002254/202104 (PDF/205.51 KB)

Glatiramer - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA-00001529-202011 (PDF/33.83 KB)

Nulojix (belatacept) supply shortage (PDF/132.79 KB)

Nafarelin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002105/202102 (PDF/72.61 KB)

Champix (varenicline) supply shortage (PDF/175.48 KB)

RoActemra (tocilizumab) supply shortage (PDF/180.38 KB)