Medicines

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Fluocinolone acetonide (intravitreal implant in applicator): List of nationally authorised medicinal products - PSUSA/00010224/201508 (PDF/83.47 KB)

Last updated: 18/10/2016
Active substance: Fluocinolone acetonide
Procedure number: PSUSA/00010224/201508
Regulatory outcome: Maintenance
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Tapentadol: List of nationally authorised medicinal products - PSUSA/00002849/201411 EMA (PDF/267.5 KB)

Last updated: 19/10/2016
Active substance: tapentadol
Procedure number: PSUSA/00002849/201411
Regulatory outcome: Maintenance
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Olodaterol: List of nationally authorised medicinal products - PSUSA/00010245/201603 (PDF/87.16 KB)

Last updated: 18/10/2016
Active substance: olodaterol
Procedure number: PSUSA/00010245/201603
Regulatory outcome: Maintenance
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Methylphenidate: List of nationally authorised medicinal products - PSUSA/00002024/201710 (PDF/639.97 KB)

Last updated: 19/06/2018
Active substance: methylphenidate
Procedure number: PSUSA/00002024/201710
Regulatory outcome: Maintenance
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Lactitol: List of nationally authorised medicinal products - PSUSA/00001819/201509 (PDF/80.68 KB)

Last updated: 17/10/2016
Active substance: lactitol
Procedure number: PSUSA/00001819/201509
Regulatory outcome: Maintenance
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Terbinafine: List of nationally authorised medicinal products - PSUSA/00002896/201709 (PDF/247.53 KB)

Last updated: 18/05/2018
Active substance: terbinafine
Procedure number: PSUSA/00002896/201709
Regulatory outcome: Maintenance
List item

Fluocinolone acetonide (intravitreal implant in applicator): List of nationally authorised medicinal products - PSUSA/00010224/201502 (PDF/72.49 KB)

Last updated: 18/10/2016
Active substance: Fluocinolone acetonide
Procedure number: PSUSA/00010224/201502
Regulatory outcome: Maintenance
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Aceclofenac : List of nationally authorised medicinal products - PSUSA/00000022/201703 (PDF/118.21 KB)

Last updated: 01/12/2017
Active substance: aceclofenac
Procedure number: PSUSA/00000022/201703
Regulatory outcome: Maintenance
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Fenspiride: List of nationally authorised medicinal products - PSUSA/00001368/201704 (PDF/102.69 KB)

Last updated: 12/12/2017
Active substance: fenspiride
Procedure number: PSUSA/00001368/201704
Regulatory outcome: Maintenance
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Benserazide / levodopa: List of nationally authorised medicinal products - PSUSA/00000330/201706 (PDF/182.3 KB)

Last updated: 09/02/2018
Active substance: benserazide, levodopa
Procedure number: PSUSA/00000330/201706
Regulatory outcome: Maintenance
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Mycophenolic acid (apart from mycophenolate mofetil): List of nationally authorised medicinal products - PSUSA/00010243/201605 (PDF/168.49 KB)

Last updated: 12/12/2016
Active substance: mycophenolic acid
Procedure number: PSUSA/00010243/201605
Regulatory outcome: Maintenance
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Paricalcitol: List of nationally authorised medicinal products - PSUSA/00002316/201608 (PDF/130 KB)

Last updated: 10/04/2017
Active substance: paricalcitol
Procedure number: PSUSA/00002316/201608
Regulatory outcome: Maintenance
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Methysergide: List of nationally authorised medicinal products -PSUSA/00002030/201502 (PDF/65.04 KB)

Last updated: 18/10/2016
Active substance: methysergide
Procedure number: PSUSA/00002030/201502
Regulatory outcome: Maintenance
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Human coagulation factor VIII (inhibitor bypassing fraction): List of nationally authorised medicinal products - PSUSA/00009174/201702 (PDF/131.91 KB)

Last updated: 05/10/2017
Active substance: Human coagulation factor VIII
Procedure number: PSUSA/00009174/201702
Regulatory outcome: Maintenance
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Betahistine: List of nationally authorised medicinal products - PSUSA/00000389/201712 (PDF/217.94 KB)

Last updated: 10/09/2018
Active substance: betahistine
Procedure number: PSUSA/00000389/201712
Regulatory outcome: Maintenance
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Omeprazole: List of nationally authorised medicinal products - PSUSA/00002215/201704 (PDF/362.06 KB)

Last updated: 08/12/2017
Active substance: omeprazole
Procedure number: PSUSA/00002215/201704
Regulatory outcome: Maintenance
List item

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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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
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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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Isoflurane: List of nationally authorised medicinal products - PSUSA/00001786/201610 (PDF/97.95 KB)

Last updated: 10/07/2017
Active substance: isoflurane
Procedure number: PSUSA/00001786/201610
Regulatory outcome: Maintenance
List item

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
List item

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

1107 results

Fluocinolone acetonide (intravitreal implant in applicator): List of nationally authorised medicinal products - PSUSA/00010224/201508 (PDF/83.47 KB)

Tapentadol: List of nationally authorised medicinal products - PSUSA/00002849/201411 EMA (PDF/267.5 KB)

Olodaterol: List of nationally authorised medicinal products - PSUSA/00010245/201603 (PDF/87.16 KB)

Methylphenidate: List of nationally authorised medicinal products - PSUSA/00002024/201710 (PDF/639.97 KB)

Lactitol: List of nationally authorised medicinal products - PSUSA/00001819/201509 (PDF/80.68 KB)

Terbinafine: List of nationally authorised medicinal products - PSUSA/00002896/201709 (PDF/247.53 KB)

Fluocinolone acetonide (intravitreal implant in applicator): List of nationally authorised medicinal products - PSUSA/00010224/201502 (PDF/72.49 KB)

Aceclofenac : List of nationally authorised medicinal products - PSUSA/00000022/201703 (PDF/118.21 KB)

Fenspiride: List of nationally authorised medicinal products - PSUSA/00001368/201704 (PDF/102.69 KB)

Benserazide / levodopa: List of nationally authorised medicinal products - PSUSA/00000330/201706 (PDF/182.3 KB)

Mycophenolic acid (apart from mycophenolate mofetil): List of nationally authorised medicinal products - PSUSA/00010243/201605 (PDF/168.49 KB)

Paricalcitol: List of nationally authorised medicinal products - PSUSA/00002316/201608 (PDF/130 KB)

Methysergide: List of nationally authorised medicinal products -PSUSA/00002030/201502 (PDF/65.04 KB)

Human coagulation factor VIII (inhibitor bypassing fraction): List of nationally authorised medicinal products - PSUSA/00009174/201702 (PDF/131.91 KB)

Betahistine: List of nationally authorised medicinal products - PSUSA/00000389/201712 (PDF/217.94 KB)

Omeprazole: List of nationally authorised medicinal products - PSUSA/00002215/201704 (PDF/362.06 KB)

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)

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)

Isoflurane: List of nationally authorised medicinal products - PSUSA/00001786/201610 (PDF/97.95 KB)

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

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