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Phenobarbital: List of nationally authorised medicinal products - PSUSA/00002370/202001 (PDF/153.67 KB)

authorised medicinal products - PSUSA/00002370/202001 … authorised medicinal products - PSUSA/00002370/202001 EMA/273764/2021 18/05/2021 … phenobarbital* Procedure no.: PSUSA/00002370/202001 …

Last updated: 18/05/2021
Active substance: phenobarbital
Procedure number: PSUSA/00002370/202001
Regulatory outcome: Variation
List item

Phenobarbital: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002370/202001 (PDF/83.26 KB)

for the implementation - PSUSA/00002370/202001 … for the implementation - PSUSA/00002370/202001 Other languages: bg cs da …

Last updated: 18/05/2021
Active substance: phenobarbital
Procedure number: PSUSA/00002370/202001
Regulatory outcome: Variation
Bulgarian
(PDF/72.54 KB)

Croatian
(PDF/102.1 KB)

Czech
(PDF/312 KB)

Danish
(PDF/90.95 KB)

Dutch
(PDF/149.73 KB)

Estonian
(PDF/56.75 KB)

Finnish
(PDF/105.95 KB)

French
(PDF/59.79 KB)

German
(PDF/106.03 KB)

Greek
(PDF/119.62 KB)

Hungarian
(PDF/39.17 KB)

Icelandic
(PDF/30.56 KB)

Italian
(PDF/177.02 KB)

Latvian
(PDF/112.19 KB)

Lithuanian
(PDF/246.62 KB)

Maltese
(PDF/151.84 KB)

Norwegian
(PDF/59.1 KB)

Polish
(PDF/122.67 KB)

Portuguese
(PDF/117.75 KB)

Romanian
(PDF/145.13 KB)

Slovak
(PDF/145.05 KB)

Slovenian
(PDF/81.66 KB)

Spanish
(PDF/41.01 KB)

Swedish
(PDF/112.46 KB)
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Lorazepam: List of nationally authorised medicinal products - PSUSA/00001909/202001 (PDF/156.49 KB)

authorised medicinal products - PSUSA/00001909/202001 … authorised medicinal products - PSUSA/00001909/202001 …

Last updated: 09/10/2020
Active substance: lorazepam
Procedure number: PSUSA/00001909/202001
Regulatory outcome: Maintenance
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Sevoflurane: List of nationally authorised medicinal products - PSUSA/00002698/202001 (PDF/148.85 KB)

authorised medicinal products - PSUSA/00002698/202001 … authorised medicinal products - PSUSA/00002698/202001 …

Last updated: 12/10/2020
Active substance: sevoflurane
Procedure number: PSUSA/00002698/202001
Regulatory outcome: Maintenance
List item

Celiprolol: List of nationally authorised medicinal products - PSUSA/00000617/202001 (PDF/125.53 KB)

authorised medicinal products - PSUSA/00000617/202001 … authorised medicinal products - PSUSA/00000617/202001 …

Last updated: 11/09/2020
Active substance: celiprolol
Procedure number: PSUSA/00000617/202001
Regulatory outcome: Maintenance
List item

Sertindole: List of nationally authorised medicinal products - PSUSA/00002695/202001 (PDF/175.05 KB)

authorised medicinal products - PSUSA/00002695/202001 … authorised medicinal products - PSUSA/00002695/202001 …

Last updated: 11/09/2020
Active substance: sertindole
Procedure number: PSUSA/00002695/202001
Regulatory outcome: Maintenance
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Amisulpride: List of nationally authorised medicinal products - PSUSA/00000167/202001 (PDF/272.94 KB)

authorised medicinal products - PSUSA/00000167/202001 … authorised medicinal products - PSUSA/00000167/202001 …

Last updated: 14/09/2020
Active substance: amisulpride
Procedure number: PSUSA/00000167/202001
Regulatory outcome: Maintenance
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Gaxilose: List of nationally authorised medicinal products - PSUSA/00010283/202001 (PDF/99.71 KB)

authorised medicinal products - PSUSA/00010283/202001 … authorised medicinal products - PSUSA/00010283/202001 …

Last updated: 21/10/2020
Active substance: gaxilose
Procedure number: PSUSA/00010283/202001
Regulatory outcome: Maintenance
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Mequitazine : List of nationally authorised medicinal products - PSUSA/00001986/202001 (PDF/116.83 KB)

authorised medicinal products - PSUSA/00001986/202001 … authorised medicinal products - PSUSA/00001986/202001 EMA/639912/2020 01/12/2020 …

Last updated: 01/12/2020
Active substance: mequitazine
Procedure number: PSUSA/00001986/202001
Regulatory outcome: Variation
List item

Verapamil: List of nationally authorised medicinal products - PSUSA/00003105/202001 (PDF/171.96 KB)

authorised medicinal products - PSUSA/00003105/202001 … authorised medicinal products - PSUSA/00003105/202001 EMA/785069/2018 03/12/2020 …

Last updated: 03/12/2020
Active substance: verapamil
Procedure number: PSUSA/00003105/202001
Regulatory outcome: Variation
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Vancomycin: List of nationally authorised medicinal products - PSUSA/00003097/202001 (PDF/760.25 KB)

authorised medicinal products - PSUSA/00003097/202001 … authorised medicinal products - PSUSA/00003097/202001 EMA/647607/2020 03/12/2020 …

Last updated: 03/12/2020
Active substance: Vancomycin
Procedure number: PSUSA/00003097/202001
Regulatory outcome: Variation
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Iron (parenteral preparations, except for iron dextran): List of nationally authorised medicinal products - PSUSA/00010236/202001 (PDF/328.79 KB)

authorised medicinal products - PSUSA/00010236/202001 … authorised medicinal products - PSUSA/00010236/202001 …

Last updated: 07/09/2020
Active substance: iron
Procedure number: PSUSA/00010236/202001
Regulatory outcome: Variation
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Alitretinoin (oral use): List of nationally authorised medicinal products - PSUSA/00010710/202001 (PDF/144.71 KB)

authorised medicinal products - PSUSA/00010710/202001 … authorised medicinal products - PSUSA/00010710/202001 …

Last updated: 11/09/2020
Active substance: alitretinoin
Procedure number: PSUSA/00010710/202001
Regulatory outcome: Maintenance
List item

Omega-3-acid ethyl esters: List of nationally authorised medicinal products - PSUSA/00010312/202001 (PDF/159.15 KB)

authorised medicinal products - PSUSA/00010312/202001 … authorised medicinal products - PSUSA/00010312/202001 …

Last updated: 11/09/2020
Active substance: omega-3-acid-ethyl esters
Procedure number: PSUSA/00010312/202001
Regulatory outcome: Maintenance
List item

Metamizole sodium / triacetonamine tosilate: List of nationally authorised medicinal products - PSUSA/00001999/202001 (PDF/124.33 KB)

authorised medicinal products - PSUSA/00001999/202001 … authorised medicinal products - PSUSA/00001999/202001 …

Last updated: 11/09/2020
Active substance: metamizole sodium, triacetonamine tosilate
Procedure number: PSUSA/00001999/202001
Regulatory outcome: Maintenance
List item

Lidocaine / phenazone: List of nationally authorised medicinal products - PSUSA/00002359/202001 (PDF/153.81 KB)

authorised medicinal products - PSUSA/00002359/202001 … authorised medicinal products - PSUSA/00002359/202001 …

Last updated: 14/09/2020
Active substance: lidocaine, phenazone
Procedure number: PSUSA/00002359/202001
Regulatory outcome: Maintenance
List item

Beta-alanine: List of nationally authorised medicinal products - PSUSA/00010510/202001 (PDF/103.49 KB)

authorised medicinal products - PSUSA/00010510/202001 … authorised medicinal products - PSUSA/00010510/202001 …

Last updated: 21/09/2020
Active substance: beta-alanine
Procedure number: PSUSA/00010510/202001
Regulatory outcome: Maintenance
List item

Ipratropium salbutamol: List of nationally authorised medicinal products - PSUSA/00001781/202001 (PDF/132.78 KB)

authorised medicinal products - PSUSA/00001781/202001 … authorised medicinal products - PSUSA/00001781/202001 …

Last updated: 07/10/2020
Active substance: ipratropium salbutamol
Procedure number: PSUSA/00001781/202001
Regulatory outcome: Maintenance
List item

Levosalbutamol, salbutamol: List of nationally authorised medicinal products - PSUSA/00010330/202001 (PDF/375.95 KB)

authorised medicinal products - PSUSA/00010330/202001 … authorised medicinal products - PSUSA/00010330/202001 …

Last updated: 21/10/2020
Active substance: levosalbutamol, salbutamol
Procedure number: PSUSA/00010330/202001
Regulatory outcome: Maintenance
List item

Levonorgestrel/ethinylestradiol, ethinylestradiol (combination pack): List of nationally authorised medicinal products - PSUSA/00010442/202001 (PDF/136.52 KB)

authorised medicinal products - PSUSA/00010442/202001 … authorised medicinal products - PSUSA/00010442/202001 …

Last updated: 04/11/2020
Active substance: levonorgestrel/ethinylestradiol, ethinylestradiol (combination pack)
Procedure number: PSUSA/00010442/202001
Regulatory outcome: Variation
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Phenylephrine (ophthalmic formulations): List of nationally authorised medicinal products - PSUSA/00010402/202001 (PDF/131.77 KB)

authorised medicinal products - PSUSA/00010402/202001 … authorised medicinal products - PSUSA/00010402/202001 …

Last updated: 05/11/2020
Active substance: phenylephrine (ophthalmic formulations)
Procedure number: PSUSA/00010402/202001
Regulatory outcome: Variation
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Cyanocobalamin / diclofenac / pyridoxine / thiamine: List of nationally authorised medicinal products - PSUSA/00001041/202001 (PDF/147.59 KB)

authorised medicinal products - PSUSA/00001041/202001 … authorised medicinal products - PSUSA/00001041/202001 …

Last updated: 14/09/2020
Active substance: cyanocobalamin, diclofenac, pyridoxine, thiamine
Procedure number: PSUSA/00001041/202001
Regulatory outcome: Maintenance
List item

Bendamustine hydrochloride: List of nationally authorised medicinal products - PSUSA/00003162/202001 (PDF/142.21 KB)

authorised medicinal products - PSUSA/00003162/202001 … authorised medicinal products - PSUSA/00003162/202001 EMA/599638/2020 10/11/2020 …

Last updated: 10/11/2020
Active substance: bendamustine hydrochloride
Procedure number: PSUSA/00003162/202001
Regulatory outcome: Variation
List item

Levonorgestrel/ethinylestradiol, ethinylestradiol (combination pack): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010442/202001 (PDF/235.48 KB)

for the implementation - PSUSA/00010442/202001 … for the implementation - PSUSA/00010442/202001 …

Last updated: 04/11/2020
Active substance: levonorgestrel/ethinylestradiol, ethinylestradiol (combination pack)
Procedure number: PSUSA/00010442/202001
Regulatory outcome: Variation
(PDF/182.78 KB)

Bulgarian
(PDF/237.09 KB)

Croatian
(PDF/267.42 KB)

Czech
(PDF/214.41 KB)

Danish
(PDF/193.75 KB)

Dutch
(PDF/184.57 KB)

Estonian
(PDF/193.81 KB)

Finnish
(PDF/148.01 KB)

French
(PDF/201.14 KB)

German
(PDF/215.2 KB)

Greek
(PDF/239.28 KB)

Hungarian
(PDF/270.61 KB)

Italian
(PDF/200.26 KB)

Latvian
(PDF/248.32 KB)

Lithuanian
(PDF/256.13 KB)

Maltese
(PDF/301.16 KB)

Polish
(PDF/248.24 KB)

Portuguese
(PDF/198.75 KB)

Romanian
(PDF/253.09 KB)

Slovak
(PDF/193.08 KB)

Slovenian
(PDF/257.27 KB)

Spanish
(PDF/181.51 KB)
List item

Phenylephrine (ophthalmic formulations): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010402/202001 (PDF/80.73 KB)

for the implementation - PSUSA/00010402/202001 … for the implementation - PSUSA/00010402/202001 …

Last updated: 05/11/2020
Active substance: phenylephrine (ophthalmic formulations)
Procedure number: PSUSA/00010402/202001
Regulatory outcome: Variation
(PDF/139.14 KB)

(PDF/83.47 KB)

Bulgarian
(PDF/183.66 KB)

Croatian
(PDF/173.49 KB)

Czech
(PDF/180.25 KB)

Dutch
(PDF/141.12 KB)

Finnish
(PDF/128.24 KB)

French
(PDF/174.93 KB)

German
(PDF/90.14 KB)

Greek
(PDF/179.34 KB)

Hungarian
(PDF/187.76 KB)

Icelandic
(PDF/87.23 KB)

Italian
(PDF/163.87 KB)

Latvian
(PDF/212.36 KB)

Lithuanian
(PDF/176.9 KB)

Maltese
(PDF/188.24 KB)

Norwegian
(PDF/88.27 KB)

Polish
(PDF/183.67 KB)

Portuguese
(PDF/88.96 KB)

Romanian
(PDF/171 KB)

Slovak
(PDF/165.32 KB)

Slovenian
(PDF/174.24 KB)

Spanish
(PDF/191.69 KB)

Swedish
(PDF/87.59 KB)

2355 results

Phenobarbital: List of nationally authorised medicinal products - PSUSA/00002370/202001 (PDF/153.67 KB)

Phenobarbital: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002370/202001 (PDF/83.26 KB)

Lorazepam: List of nationally authorised medicinal products - PSUSA/00001909/202001 (PDF/156.49 KB)

Sevoflurane: List of nationally authorised medicinal products - PSUSA/00002698/202001 (PDF/148.85 KB)

Celiprolol: List of nationally authorised medicinal products - PSUSA/00000617/202001 (PDF/125.53 KB)

Sertindole: List of nationally authorised medicinal products - PSUSA/00002695/202001 (PDF/175.05 KB)

Amisulpride: List of nationally authorised medicinal products - PSUSA/00000167/202001 (PDF/272.94 KB)

Gaxilose: List of nationally authorised medicinal products - PSUSA/00010283/202001 (PDF/99.71 KB)

Mequitazine : List of nationally authorised medicinal products - PSUSA/00001986/202001 (PDF/116.83 KB)

Verapamil: List of nationally authorised medicinal products - PSUSA/00003105/202001 (PDF/171.96 KB)

Vancomycin: List of nationally authorised medicinal products - PSUSA/00003097/202001 (PDF/760.25 KB)

Iron (parenteral preparations, except for iron dextran): List of nationally authorised medicinal products - PSUSA/00010236/202001 (PDF/328.79 KB)

Alitretinoin (oral use): List of nationally authorised medicinal products - PSUSA/00010710/202001 (PDF/144.71 KB)

Omega-3-acid ethyl esters: List of nationally authorised medicinal products - PSUSA/00010312/202001 (PDF/159.15 KB)

Metamizole sodium / triacetonamine tosilate: List of nationally authorised medicinal products - PSUSA/00001999/202001 (PDF/124.33 KB)

Lidocaine / phenazone: List of nationally authorised medicinal products - PSUSA/00002359/202001 (PDF/153.81 KB)

Beta-alanine: List of nationally authorised medicinal products - PSUSA/00010510/202001 (PDF/103.49 KB)

Ipratropium salbutamol: List of nationally authorised medicinal products - PSUSA/00001781/202001 (PDF/132.78 KB)

Levosalbutamol, salbutamol: List of nationally authorised medicinal products - PSUSA/00010330/202001 (PDF/375.95 KB)

Levonorgestrel/ethinylestradiol, ethinylestradiol (combination pack): List of nationally authorised medicinal products - PSUSA/00010442/202001 (PDF/136.52 KB)

Phenylephrine (ophthalmic formulations): List of nationally authorised medicinal products - PSUSA/00010402/202001 (PDF/131.77 KB)

Cyanocobalamin / diclofenac / pyridoxine / thiamine: List of nationally authorised medicinal products - PSUSA/00001041/202001 (PDF/147.59 KB)

Bendamustine hydrochloride: List of nationally authorised medicinal products - PSUSA/00003162/202001 (PDF/142.21 KB)

Levonorgestrel/ethinylestradiol, ethinylestradiol (combination pack): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010442/202001 (PDF/235.48 KB)

Phenylephrine (ophthalmic formulations): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010402/202001 (PDF/80.73 KB)