Medicines

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Varicella zoster-immunoglobulin : List of nationally authorised medicinal products - PSUSA/00010266/201612 (PDF/70.05 KB)

Last updated: 07/09/2017
Active substance: varicella zoster-immunoglobulin
Procedure number: PSUSA/00010266/201612
Regulatory outcome: Maintenance
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Triamcinolone (intraocular formulations): List of nationally authorised medicinal products - PSUSA/00010292/201703 (PDF/80.97 KB)

Last updated: 06/11/2017
Active substance: triamcinolone
Procedure number: PSUSA/00010292/201703
Regulatory outcome: Maintenance
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Bemetizide / triamterene: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00009076/201506 (PDF/748.16 KB)

Last updated: 18/10/2016
Active substance: bemetizide, triamterene
Procedure number: PSUSA/00009076/201506
Regulatory outcome: Variation
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Carboplatin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000559/201601 (PDF/75.55 KB)

Last updated: 03/01/2017
Active substance: carboplatin
Procedure number: PSUSA/00000559/201601
Regulatory outcome: Variation
Bulgarian
(PDF/101.59 KB)

Croatian
(PDF/103.21 KB)

Czech
(PDF/296.34 KB)

Danish
(PDF/99.05 KB)

Dutch
(PDF/106.32 KB)

Estonian
(PDF/95.88 KB)

Finnish
(PDF/220.29 KB)

French
(PDF/103.89 KB)

German
(PDF/55.22 KB)

Greek
(PDF/99.68 KB)

Hungarian
(PDF/232.73 KB)

Icelandic
(PDF/104.75 KB)

Italian
(PDF/106.83 KB)

Latvian
(PDF/342.06 KB)

Lithuanian
(PDF/283.76 KB)

Maltese
(PDF/109.21 KB)

Norwegian
(PDF/102.23 KB)

Polish
(PDF/103.85 KB)

Portuguese
(PDF/99.2 KB)

Romanian
(PDF/99.56 KB)

Slovak
(PDF/104.73 KB)

Slovenian
(PDF/98.5 KB)

Spanish
(PDF/104.35 KB)

Swedish
(PDF/101.81 KB)
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Etifoxine: List of nationally authorised medicinal products - PSUSA/00001321/201410 (PDF/99.48 KB)

Last updated: 18/10/2016
Active substance: etifoxine
Procedure number: PSUSA/00001321/201410
Regulatory outcome: Maintenance
List item

Bismuth subcitrate potassium / metronidazole / tetracycline: CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00010199/201505 (PDF/2.65 MB)

Last updated: 18/10/2016
Active substance: Bismuth subcitrate potassium, Metronidazole, tetracycline
Procedure number: PSUSA/00010199/201505
Regulatory outcome: Maintenance
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Germanium (68Ge) chloride / gallium (68Ga) chloride : List of nationally authorised medicinal products - PSUSA/00010364/201609 (PDF/84.77 KB)

Last updated: 15/05/2017
Active substance: gallium (68Ga) chloride, germanium (68Ge) chloride
Procedure number: PSUSA/00010364/201609
Regulatory outcome: Maintenance
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Human fibrinogen: List of nationally authorised medicinal products - PSUSA/00001624/201506 (PDF/140.41 KB)

Last updated: 17/10/2016
Active substance: human fibrinogen
Procedure number: PSUSA/00001624/201506
Regulatory outcome: Maintenance
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Leuprorelin: List of nationally authorised medicinal products - PSUSA/00001844/201707 (PDF/482.37 KB)

Last updated: 04/06/2018
Active substance: leuprorelin
Procedure number: PSUSA/00001844/201707
Regulatory outcome: Variation
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Nitrofurantoin / nifurtoinol: List of nationally authorised medicinal products - PSUSA/00002174/201502 (PDF/99.24 KB)

Last updated: 18/10/2016
Active substance: nitrofurantoin, nifurtoinol
Procedure number: PSUSA/00002174/201502
Regulatory outcome: Maintenance
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Haemophilus type b conjugate vaccines : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001584/201702 (PDF/20.66 KB)

Last updated: 23/11/2017
Active substance: haemophilus type b conjugate vaccines
Procedure number: PSUSA/00001584/201702
Regulatory outcome: Variation
Bulgarian
(PDF/65.44 KB)

Croatian
(PDF/58.24 KB)

Czech
(PDF/71.8 KB)

Danish
(PDF/89.75 KB)

Dutch
(PDF/28.06 KB)

Estonian
(PDF/25.83 KB)

Finnish
(PDF/65.97 KB)

French
(PDF/25.19 KB)

German
(PDF/69.21 KB)

Greek
(PDF/66.03 KB)

Hungarian
(PDF/63.39 KB)

Icelandic
(PDF/56.19 KB)

Italian
(PDF/40.49 KB)

Latvian
(PDF/54.37 KB)

Lithuanian
(PDF/52.52 KB)

Maltese
(PDF/51.05 KB)

Norwegian
(PDF/54.86 KB)

Polish
(PDF/56.28 KB)

Portuguese
(PDF/33.14 KB)

Romanian
(PDF/55.13 KB)

Slovak
(PDF/83.9 KB)

Slovenian
(PDF/101.75 KB)

Spanish
(PDF/26.71 KB)

Swedish
(PDF/91.15 KB)
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Hydrochlorothiazide / lisinopril: List of nationally authorised medicinal products - PSUSA/00001654/201602 (PDF/96.95 KB)

Last updated: 17/10/2016
Active substance: hydrochlorothiazide, lisinopril
Procedure number: PSUSA/00001654/201602
Regulatory outcome: Maintenance
List item

Misoprostol (gastrointestinal indication): List of nationally authorised medicinal products - PSUSA/00010291/201506 (PDF/75.42 KB)

Last updated: 18/10/2016
Active substance: misoprostol
Procedure number: PSUSA/00010291/201506
Regulatory outcome: Maintenance
List item

Pilocarpine (ophthalmic formulation): List of nationally authorised medicinal products - PSUSA/00002410/201608 (PDF/89.04 KB)

Last updated: 12/05/2017
Active substance: pilocarpine
Procedure number: PSUSA/00002410/201608
Regulatory outcome: Maintenance
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Ciprofloxacin hydrochloride, hydrocortisone: List of nationally authorised medicinal products - PSUSA/00000774/201411 (PDF/77.2 KB)

Last updated: 17/10/2016
Active substance: ciprofloxacin hydrochloride, hydrocortisone
Procedure number: PSUSA/00000774/201411
Regulatory outcome: Maintenance
List item

Ampicillin / sulbactam: CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00000197/201502 (PDF/1.32 MB)

Last updated: 17/10/2016
Active substance: ampicillin, Sulbactam
Procedure number: PSUSA/00000197/201502
Regulatory outcome: Variation
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Topotecan: List of nationally authorised medicinal products - PSUSA/00002997/201505 (PDF/159.79 KB)

Last updated: 17/10/2016
Active substance: topotecan
Procedure number: PSUSA/00002997/201505
Regulatory outcome: Maintenance
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Glipizide: List of nationally authorised medicinal products - PSUSA/00001535/201601 (PDF/90.76 KB)

Last updated: 17/10/2016
Active substance: glatiramer
Procedure number: PSUSA/00001535/201601
Regulatory outcome: Maintenance
List item

Levocabastine: List of nationally authorised medicinal products - PSUSA/00001849/201711 (PDF/115.5 KB)

Last updated: 19/07/2018
Active substance: levocabastine
Procedure number: PSUSA/00001849/201711
Regulatory outcome: Maintenance
List item

Botulinum toxin a - haemagglutinin complex: CMDh scientific conclusions and grounds for the variation, amendments to the product information, conditions to the MA and timetable for the implementation - PSUSA/00000427/201... (PDF/530.74 KB)

Last updated: 25/10/2016
Active substance: botulinum toxin a - haemagglutinin complex
Procedure number: PSUSA/00000427/201512
Regulatory outcome: Variation
List item

Carvedilol / ivabradine: List of nationally authorised medicinal products - PSUSA/00010586/201711 (PDF/286.77 KB)

Last updated: 29/06/2018
Active substance: Carvedilol, ivabradine
Procedure number: PSUSA/00010586/201711
Regulatory outcome: Maintenance
List item

Dexamethasone (apart from centrally authorised products): List of nationally authorised medicinal products - PSUSA/00000973/201601 (PDF/137.26 KB)

Last updated: 30/11/2016
Active substance: dexamethasone
Procedure number: PSUSA/00000973/201601
Regulatory outcome: Variation
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Tretinoin (topical formulations): List of nationally authorised medicinal products - PSUSA/00003016/201708 (PDF/83.39 KB)

Last updated: 24/05/2018
Active substance: Tretinoin
Procedure number: PSUSA/00003016/201708
Regulatory outcome: Maintenance
List item

Influenza vaccine (split virion, inactivated, prepared in cell cultures): List of nationally authorised medicinal products - PSUSA/00010299/201703 (PDF/91.07 KB)

Last updated: 26/10/2017
Active substance: Influenza vaccine (split virion, inactivated, prepared in cell cultures)
Procedure number: PSUSA/00010299/201703
Regulatory outcome: Maintenance
List item

Midodrine: List of nationally authorised medicinal products - PSUSA/00003178/201606 (PDF/140.01 KB)

Last updated: 13/02/2017
Active substance: midodrine
Procedure number: PSUSA/00003178/201606
Regulatory outcome: Maintenance

2499 results

Varicella zoster-immunoglobulin : List of nationally authorised medicinal products - PSUSA/00010266/201612 (PDF/70.05 KB)

Triamcinolone (intraocular formulations): List of nationally authorised medicinal products - PSUSA/00010292/201703 (PDF/80.97 KB)

Bemetizide / triamterene: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00009076/201506 (PDF/748.16 KB)

Carboplatin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000559/201601 (PDF/75.55 KB)

Etifoxine: List of nationally authorised medicinal products - PSUSA/00001321/201410 (PDF/99.48 KB)

Bismuth subcitrate potassium / metronidazole / tetracycline: CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00010199/201505 (PDF/2.65 MB)

Germanium (68Ge) chloride / gallium (68Ga) chloride : List of nationally authorised medicinal products - PSUSA/00010364/201609 (PDF/84.77 KB)

Human fibrinogen: List of nationally authorised medicinal products - PSUSA/00001624/201506 (PDF/140.41 KB)

Leuprorelin: List of nationally authorised medicinal products - PSUSA/00001844/201707 (PDF/482.37 KB)

Nitrofurantoin / nifurtoinol: List of nationally authorised medicinal products - PSUSA/00002174/201502 (PDF/99.24 KB)

Haemophilus type b conjugate vaccines : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001584/201702 (PDF/20.66 KB)

Hydrochlorothiazide / lisinopril: List of nationally authorised medicinal products - PSUSA/00001654/201602 (PDF/96.95 KB)

Misoprostol (gastrointestinal indication): List of nationally authorised medicinal products - PSUSA/00010291/201506 (PDF/75.42 KB)

Pilocarpine (ophthalmic formulation): List of nationally authorised medicinal products - PSUSA/00002410/201608 (PDF/89.04 KB)

Ciprofloxacin hydrochloride, hydrocortisone: List of nationally authorised medicinal products - PSUSA/00000774/201411 (PDF/77.2 KB)

Ampicillin / sulbactam: CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00000197/201502 (PDF/1.32 MB)

Topotecan: List of nationally authorised medicinal products - PSUSA/00002997/201505 (PDF/159.79 KB)

Glipizide: List of nationally authorised medicinal products - PSUSA/00001535/201601 (PDF/90.76 KB)

Levocabastine: List of nationally authorised medicinal products - PSUSA/00001849/201711 (PDF/115.5 KB)

Botulinum toxin a - haemagglutinin complex: CMDh scientific conclusions and grounds for the variation, amendments to the product information, conditions to the MA and timetable for the implementation - PSUSA/00000427/201... (PDF/530.74 KB)

Carvedilol / ivabradine: List of nationally authorised medicinal products - PSUSA/00010586/201711 (PDF/286.77 KB)

Dexamethasone (apart from centrally authorised products): List of nationally authorised medicinal products - PSUSA/00000973/201601 (PDF/137.26 KB)

Tretinoin (topical formulations): List of nationally authorised medicinal products - PSUSA/00003016/201708 (PDF/83.39 KB)

Influenza vaccine (split virion, inactivated, prepared in cell cultures): List of nationally authorised medicinal products - PSUSA/00010299/201703 (PDF/91.07 KB)

Midodrine: List of nationally authorised medicinal products - PSUSA/00003178/201606 (PDF/140.01 KB)