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Xylometazoline: List of nationally authorised medicinal products - PSUSA/00003134/202005 (PDF/415.03 KB)

authorised medicinal products - PSUSA/00003134/202005 … authorised medicinal products - PSUSA/00003134/202005 EMA/161057/2021 16/03/2021 … xylometazoline Procedure No: PSUSA/00003134/202005 …

Last updated: 16/03/2021
Active substance: xylometazoline
Procedure number: PSUSA/00003134/202005
Regulatory outcome: Variation
List item

Xylometazoline: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003134/202005 (PDF/42.04 KB)

for the implementation - PSUSA/00003134/202005 … for the implementation - PSUSA/00003134/202005 Other languages: bg cs da …

Last updated: 16/03/2021
Active substance: xylometazoline
Procedure number: PSUSA/00003134/202005
Regulatory outcome: Variation
Bulgarian
(PDF/113.17 KB)

Croatian
(PDF/104.92 KB)

Czech
(PDF/132.01 KB)

Danish
(PDF/44.97 KB)

Dutch
(PDF/31.83 KB)

Estonian
(PDF/40.32 KB)

Finnish
(PDF/42.64 KB)

French
(PDF/38.16 KB)

German
(PDF/44.27 KB)

Greek
(PDF/107.29 KB)

Hungarian
(PDF/106.63 KB)

Icelandic
(PDF/33.25 KB)

Italian
(PDF/38.38 KB)

Latvian
(PDF/96.84 KB)

Lithuanian
(PDF/103.3 KB)

Maltese
(PDF/103.29 KB)

Norwegian
(PDF/37.75 KB)

Polish
(PDF/98.43 KB)

Portuguese
(PDF/37.94 KB)

Romanian
(PDF/95.73 KB)

Slovak
(PDF/101 KB)

Slovenian
(PDF/99.79 KB)

Spanish
(PDF/38.26 KB)

Swedish
(PDF/37.57 KB)
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Tramadol: List of nationally authorised medicinal products - PSUSA/00003002/202005 (PDF/2.3 MB)

authorised medicinal products - PSUSA/00003002/202005 … authorised medicinal products - PSUSA/00003002/202005 EMA/270645/2015 10/03/2021 … tramadol Procedure no.: PSUSA/00003002/202005 List of nationally …

Last updated: 24/03/2021
Active substance: Tramadol
Procedure number: PSUSA/00003002/202005
Regulatory outcome: Variation
List item

Ketobemidone: List of nationally authorised medicinal products - PSUSA/0001807/202005 (PDF/102.96 KB)

authorised medicinal products - PSUSA/0001807/202005 … authorised medicinal products - PSUSA/0001807/202005 EMA/44756/2021 25/01/2021 … ketobemidone Procedure no.: PSUSA/00001807/202005 List of nationally …

Last updated: 25/01/2021
Active substance: ketobemidone
Procedure number: PSUSA/0001807/202005
Regulatory outcome: Maintenance
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Ozenoxacin: List of nationally authorised medicinal products - PSUSA/00010651/202005 (PDF/104.73 KB)

authorised medicinal products - PSUSA/00010651/202005 … authorised medicinal products - PSUSA/00010651/202005 EMA/1973/2021 15/01/2021 … ozenoxacin Procedure no.: PSUSA/00010651/202005 List of nationally …

Last updated: 15/01/2021
Active substance: Ozenoxacin
Procedure number: PSUSA/00010651/202005
Regulatory outcome: Maintenance
List item

Clotiazepam: List of nationally authorised medicinal products - PSUSA/00000827/202005 (PDF/112.25 KB)

authorised medicinal products - PSUSA/00000827/202005 … authorised medicinal products - PSUSA/00000827/202005 EMA/167501/2021 18/03/2021 … clotiazepam Procedure no.: PSUSA/00000827/202005 List of nationally …

Last updated: 18/03/2021
Active substance: clotiazepam
Procedure number: PSUSA/00000827/202005
Regulatory outcome: Variation
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Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/202005 (PDF/118.91 KB)

authorised medicinal products - PSUSA/00010288/202005 … authorised medicinal products - PSUSA/00010288/202005 EMA/34438/2021 20/01/2021 … clevidipine Procedure no.: PSUSA/00010288/202005 List of nationally …

Last updated: 20/01/2021
Active substance: clevidipine
Procedure number: PSUSA/00010288/202005
Regulatory outcome: Maintenance
List item

Nicergoline: List of nationally authorised medicinal products - PSUSA/00002150/202005 (PDF/125.03 KB)

authorised medicinal products - PSUSA/00002150/202005 … authorised medicinal products - PSUSA/00002150/202005 EMA/44757/2021 25/01/2021 … nicergoline Procedure no.: PSUSA/00002150/202005 List of nationally …

Last updated: 25/01/2021
Active substance: nicergoline
Procedure number: PSUSA/00002150/202005
Regulatory outcome: Maintenance
List item

Chlorpromazine: List of nationally authorised medicinal products - PSUSA/00000715/202005 (PDF/115.22 KB)

authorised medicinal products - PSUSA/00000715/202005 … authorised medicinal products - PSUSA/00000715/202005 EMA/44743/2021 25/01/2021 … chlorpromazine Procedure no.: PSUSA/00000715/202005 List of nationally …

Last updated: 25/01/2021
Active substance: chlorpromazine
Procedure number: PSUSA/00000715/202005
Regulatory outcome: Maintenance
List item

Ticlopidine: List of nationally authorised medicinal products - PSUSA/00002952/202005 (PDF/138.13 KB)

authorised medicinal products - PSUSA/00002952/202005 … authorised medicinal products - PSUSA/00002952/202005 EMA/34401/2021 20/01/2021 … ticlopidine Procedure no.: PSUSA/00002952/202005 List of nationally …

Last updated: 20/01/2021
Active substance: ticlopidine
Procedure number: PSUSA/00002952/202005
Regulatory outcome: Maintenance
List item

Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/202005 (PDF/147.38 KB)

authorised medicinal products - PSUSA/00010484/202005 … authorised medicinal products - PSUSA/00010484/202005 EMA/46815/2021 22/01/2021 … methoxyflurane Procedure no.: PSUSA/00010484/202005 List of nationally …

Last updated: 22/01/2021
Active substance: Methoxyflurane
Procedure number: PSUSA/00010484/202005
Regulatory outcome: Maintenance
List item

Mifepristone: List of nationally authorised medicinal products - PSUSA/00002060/202005 (PDF/272.57 KB)

authorised medicinal products - PSUSA/00002060/202005 … authorised medicinal products - PSUSA/00002060/202005 EMA/3063/2021 30/04/2021 … mifepristone Procedure No.: PSUSA/00002060/202005 List of nationally …

Last updated: 30/04/2021
Active substance: mifepristone
Procedure number: PSUSA/00002060/202005
Regulatory outcome: Variation
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Lanreotide: List of nationally authorised medicinal products - PSUSA/00001826/202005 (PDF/258.92 KB)

authorised medicinal products - PSUSA/00001826/202005 … authorised medicinal products - PSUSA/00001826/202005 EMA/4790/2021 05/05/2021 … lanreotide Procedure No.: PSUSA/00001826/202005 List of nationally …

Last updated: 05/05/2021
Active substance: lanreotide
Procedure number: PSUSA/00001826/202005
Regulatory outcome: Maintenance
List item

Formoterol : List of nationally authorised medicinal products - PSUSA/00001469/202005 (PDF/831.46 KB)

authorised medicinal products - PSUSA/00001469/202005 … authorised medicinal products - PSUSA/00001469/202005 EMA/37560/2021 22/01/2021 … formoterol Procedure no.: PSUSA/00001469/202005 List of nationally …

Last updated: 22/01/2021
Active substance: formoterol
Procedure number: PSUSA/00001469/202005
Regulatory outcome: Maintenance
List item

Mometasone: List of nationally authorised medicinal products - PSUSA/00002085/202005 (PDF/838.45 KB)

authorised medicinal products - PSUSA/00002085/202005 … authorised medicinal products - PSUSA/00002085/202005 EMA/382258/2015 21/01/2021 … mometasone Procedure no.: PSUSA/00002085/202005 List of nationally …

Last updated: 21/01/2021
Active substance: mometasone
Procedure number: PSUSA/00002085/202005
Regulatory outcome: Maintenance
List item

Diphtheria / tetanus vaccines (adsorbed), diphtheria vaccines (adsorbed): List of nationally authorised medicinal products - PSUSA/00001128/202005 (PDF/180.61 KB)

authorised medicinal products - PSUSA/00001128/202005 … authorised medicinal products - PSUSA/00001128/202005 … adsorbed) Procedure no.: PSUSA/00001128/202005 List of nationally …

Last updated: 28/01/2021
Active substance: diphtheria vaccine, tetanus vaccine
Procedure number: PSUSA/00001128/202005
Regulatory outcome: Maintenance
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Cyproterone / ethinylestradiol : List of nationally authorised medicinal products - PSUSA/00000906/202005 (PDF/151.58 KB)

authorised medicinal products - PSUSA/00000906/202005 … authorised medicinal products - PSUSA/00000906/202005 EMA/32642/2021 18/01/2021 … ethinylestradiol Procedure no.: PSUSA/00000906/202005 List of nationally …

Last updated: 18/01/2021
Active substance: cyproterone, ethinylestradiol
Procedure number: PSUSA/00000906/202005
Regulatory outcome: Maintenance
List item

Mifepristone / misoprostol: List of nationally authorised medicinal products - PSUSA/00010378/202005 (PDF/125.07 KB)

authorised medicinal products - PSUSA/00010378/202005 … authorised medicinal products - PSUSA/00010378/202005 EMA/34506/2021 19/01/2021 … misoprostol Procedure no.: PSUSA/00010378/202005 List of nationally …

Last updated: 19/01/2021
Active substance: mifepristone, misoprostol
Procedure number: PSUSA/00010378/202005
Regulatory outcome: Maintenance
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Peppermint oil: List of nationally authorised medicinal products - PSUSA/00010436/202005 (PDF/131.77 KB)

authorised medicinal products - PSUSA/00010436/202005 … authorised medicinal products - PSUSA/00010436/202005 EMA/36968/2021 21/01/2021 … peppermint oil Procedure no.: PSUSA/00010436/202005 List of nationally …

Last updated: 21/01/2021
Active substance: peppermint oil
Procedure number: PSUSA/00010436/202005
Regulatory outcome: Maintenance
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Misoprostol (gynaecological indication - labour induction): List of nationally authorised medicinal products - PSUSA/00010353/202005 (PDF/136.2 KB)

authorised medicinal products - PSUSA/00010353/202005 … authorised medicinal products - PSUSA/00010353/202005 20/01/2021 List of nationally … induction) Procedure no.: PSUSA/00010353/202005 List of nationally …

Last updated: 20/01/2021
Active substance: misoprostol
Procedure number: PSUSA/00010353/202005
Regulatory outcome: Maintenance
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Human hemin: List of nationally authorised medicinal products - PSUSA/00001629/202005 (PDF/150.83 KB)

authorised medicinal products - PSUSA/00001629/202005 … authorised medicinal products - PSUSA/00001629/202005 EMA/217572/2021 21/04/2021 … human hemin Procedure no.: PSUSA/00001629/202005 List of nationally …

Last updated: 21/04/2021
Active substance: human hemin
Procedure number: PSUSA/00001629/202005
Regulatory outcome: Maintenance
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Irinotecan (except for liposomal formulations): List of nationally authorised medicinal products - PSUSA/00001783/202005 (PDF/175.17 KB)

authorised medicinal products - PSUSA/00001783/202005 … authorised medicinal products - PSUSA/00001783/202005 EMA/150667/2021 15/03/2021 … formulations) Procedure no.: PSUSA/00001783/202005 List of nationally …

Last updated: 15/03/2021
Active substance: irinotecan
Procedure number: PSUSA/00001783/202005
Regulatory outcome: Variation
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Dexpanthenol xylometazoline: List of nationally authorised medicinal products - PSUSA/00010030/202005 (PDF/252.82 KB)

authorised medicinal products - PSUSA/00010030/202005 … authorised medicinal products - PSUSA/00010030/202005 EMA/36692/2021 21/01/2021 … xylometazoline Procedure no.: PSUSA/00010030/202005 List of nationally …

Last updated: 21/01/2021
Active substance: dexpanthenol xylometazoline
Procedure number: PSUSA/00010030/202005
Regulatory outcome: Maintenance
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Isotretinoin (oral formulations) - List of the nationally authorised medicinal products - PSUSA/00010488/202005 (PDF/446.99 KB)

authorised medicinal products - PSUSA/00010488/202005 … authorised medicinal products - PSUSA/00010488/202005 EMA/353110/2021 22/06/2021 … formulations) Procedure No: PSUSA/00010488/202005 …

Last updated: 22/06/2021
Active substance: isotretinoin (oral formulations)
Procedure number: PSUSA/00010488/202005
Regulatory outcome: Maintenance
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Misoprostol (gynaecological indication - termination of pregnancy) : List of nationally authorised medicinal products - PSUSA/00010354/202005 (PDF/280.86 KB)

authorised medicinal products - PSUSA/00010354/202005 … authorised medicinal products - PSUSA/00010354/202005 EMA/706074/2020 05/05/2021 … pregnancy) Procedure No.: PSUSA/00010354/202005 List of nationally …

Last updated: 05/05/2021
Active substance: misoprostol
Procedure number: PSUSA/00010354/202005
Regulatory outcome: Maintenance

2186 results

Xylometazoline: List of nationally authorised medicinal products - PSUSA/00003134/202005 (PDF/415.03 KB)

Xylometazoline: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003134/202005 (PDF/42.04 KB)

Tramadol: List of nationally authorised medicinal products - PSUSA/00003002/202005 (PDF/2.3 MB)

Ketobemidone: List of nationally authorised medicinal products - PSUSA/0001807/202005 (PDF/102.96 KB)

Ozenoxacin: List of nationally authorised medicinal products - PSUSA/00010651/202005 (PDF/104.73 KB)

Clotiazepam: List of nationally authorised medicinal products - PSUSA/00000827/202005 (PDF/112.25 KB)

Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/202005 (PDF/118.91 KB)

Nicergoline: List of nationally authorised medicinal products - PSUSA/00002150/202005 (PDF/125.03 KB)

Chlorpromazine: List of nationally authorised medicinal products - PSUSA/00000715/202005 (PDF/115.22 KB)

Ticlopidine: List of nationally authorised medicinal products - PSUSA/00002952/202005 (PDF/138.13 KB)

Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/202005 (PDF/147.38 KB)

Mifepristone: List of nationally authorised medicinal products - PSUSA/00002060/202005 (PDF/272.57 KB)

Lanreotide: List of nationally authorised medicinal products - PSUSA/00001826/202005 (PDF/258.92 KB)

Formoterol : List of nationally authorised medicinal products - PSUSA/00001469/202005 (PDF/831.46 KB)

Mometasone: List of nationally authorised medicinal products - PSUSA/00002085/202005 (PDF/838.45 KB)

Diphtheria / tetanus vaccines (adsorbed), diphtheria vaccines (adsorbed): List of nationally authorised medicinal products - PSUSA/00001128/202005 (PDF/180.61 KB)

Cyproterone / ethinylestradiol : List of nationally authorised medicinal products - PSUSA/00000906/202005 (PDF/151.58 KB)

Mifepristone / misoprostol: List of nationally authorised medicinal products - PSUSA/00010378/202005 (PDF/125.07 KB)

Peppermint oil: List of nationally authorised medicinal products - PSUSA/00010436/202005 (PDF/131.77 KB)

Misoprostol (gynaecological indication - labour induction): List of nationally authorised medicinal products - PSUSA/00010353/202005 (PDF/136.2 KB)

Human hemin: List of nationally authorised medicinal products - PSUSA/00001629/202005 (PDF/150.83 KB)

Irinotecan (except for liposomal formulations): List of nationally authorised medicinal products - PSUSA/00001783/202005 (PDF/175.17 KB)

Dexpanthenol xylometazoline: List of nationally authorised medicinal products - PSUSA/00010030/202005 (PDF/252.82 KB)

Isotretinoin (oral formulations) - List of the nationally authorised medicinal products - PSUSA/00010488/202005 (PDF/446.99 KB)

Misoprostol (gynaecological indication - termination of pregnancy) : List of nationally authorised medicinal products - PSUSA/00010354/202005 (PDF/280.86 KB)