Medicines

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Direct healthcare professional communication (DHPC): Picato (ingenol mebutate) – Suspension of the marketing authorisation due to risk of skin malignancy

Active substance: Ingenol mebutate, DHPC type: Interim measures, Referral - Article 20 procedure, Last updated: 14/02/2020
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Direct healthcare professional communication (DHPC): Ulipristal acetate 5 mg for uterine fibroids not to be used during ongoing review of liver injury risk

Active substance: ulipristal acetate, DHPC type: Interim measures, Last updated: 23/03/2020
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Levobupivacaine: List of nationally authorised medicinal products - PSUSA/00001848/201712 (PDF/254.62 KB)

Last updated: 17/09/2018
Active substance: levobupivacaine
Procedure number: PSUSA/00001848/201712
Regulatory outcome: Maintenance
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Landiolol: List of nationally authorised medicinal products - PSUSA/00010570/201802 (PDF/122.96 KB)

Last updated: 14/09/2018
Active substance: landiolol
Procedure number: PSUSA/00010570/201802
Regulatory outcome: Maintenance
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Hydrochlorothiazide / spironolactone: List of nationally authorised medicinal products - PSUSA/00001662/201801 (PDF/69.12 KB)

Last updated: 13/09/2018
Active substance: spironolactone, hydrochlorothiazide
Procedure number: PSUSA/00001662/201801
Regulatory outcome: Maintenance
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Sertindole: List of nationally authorised medicinal products - PSUSA/00002695/201801 (PDF/105.81 KB)

Last updated: 13/09/2018
Active substance: sertindole
Procedure number: PSUSA/00002695/201801
Regulatory outcome: Maintenance
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Haemophilus influenzae / klebsiella ozaenae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus pneumoniae / streptococcus pyogenes / streptococcus viridans vaccine: List of nationally... (PDF/123.87 KB)

Last updated: 13/09/2018
Active substance: streptococcus viridans vaccine, streptococcus pyogenes, streptococcus pneumoniae, staphylococcus aureus, moraxella catarrhalis, klebsiella pneumoniae, klebsiella ozaenae, haemophilus influenzae
Procedure number: PSUSA/00001582/201712
Regulatory outcome: Maintenance
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Celecoxib: List of nationally authorised medicinal products - PSUSA/00000616/201712 (PDF/173.46 KB)

Last updated: 13/09/2018
Active substance: Celecoxib
Procedure number: PSUSA/00000616/201712
Regulatory outcome: Maintenance
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Amitriptyline/perphenazine: List of nationally authorised medicinal products - PSUSA/00000170/201801 (PDF/46.5 KB)

Last updated: 13/09/2018
Active substance: perphenazine, amitriptyline
Procedure number: PSUSA/00000170/201801
Regulatory outcome: Maintenance
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Hypericum perforatum L., herba: List of nationally authorised medicinal products - PSUSA/00001701/201801 (PDF/198.44 KB)

Last updated: 13/09/2018
Active substance: hypericum perforatum L., herba
Procedure number: PSUSA/00001701/201801
Regulatory outcome: Maintenance
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Amiodarone: List of nationally authorised medicinal products - PSUSA/00000166/201712 (PDF/141.23 KB)

Last updated: 13/09/2018
Active substance: amiodarone
Procedure number: PSUSA/00000166/201712
Regulatory outcome: Maintenance
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Cefprozil: List of nationally authorised medicinal products - PSUSA/00000605/201712 (PDF/84.44 KB)

Last updated: 13/09/2018
Active substance: cefprozil
Procedure number: PSUSA/00000605/201712
Regulatory outcome: Maintenance
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Lubiprostone: List of nationally authorised medicinal products - PSUSA/00010290/201801 (PDF/95.2 KB)

Last updated: 12/09/2018
Active substance: Lubiprostone
Procedure number: PSUSA/00010290/201801
Regulatory outcome: Maintenance
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Cimicifuga racemosa (L.) nutt., rhizome: List of nationally authorised medicinal products - PSUSA/00000755/201801 (PDF/123.44 KB)

Last updated: 12/09/2018
Active substance: cimicifuga racemosa (L.) nutt., rhizoma
Procedure number: PSUSA/00000755/201801
Regulatory outcome: Maintenance
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Tobramycin (nebuliser solution) (apart from centrally authorised product): List of nationally authorised medicinal products - PSUSA/00009316/201712 (PDF/156.43 KB)

Last updated: 11/09/2018
Active substance: Tobramycin
Procedure number: PSUSA/00009316/201712
Regulatory outcome: Maintenance
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Cyproheptadine: List of nationally authorised medicinal products - PSUSA/00000902/201712 (PDF/56.47 KB)

Last updated: 11/09/2018
Active substance: cyproheptadine
Procedure number: PSUSA/00000902/201712
Regulatory outcome: Maintenance
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Acebutolol: List of nationally authorised medicinal products - PSUSA/00000018/201712 (PDF/68.24 KB)

Last updated: 11/09/2018
Active substance: acebutolol
Procedure number: PSUSA/00000018/201712
Regulatory outcome: Maintenance
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Felodipine: List of nationally authorised medicinal products - PSUSA/00001356/201712 (PDF/179.53 KB)

Last updated: 11/09/2018
Active substance: felodipine
Procedure number: PSUSA/00001356/201712
Regulatory outcome: Maintenance
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Furosemide: List of nationally authorised medicinal products - PSUSA/00001491/201801 (PDF/184.36 KB)

Last updated: 10/09/2018
Active substance: Furosemide
Procedure number: PSUSA/00001491/201801
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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Tetanus vaccines: List of nationally authorised medicinal products - PSUSA/00002910/201801 (PDF/103.97 KB)

Last updated: 10/09/2018
Active substance: tetanus vaccines
Procedure number: PSUSA/00002910/201801
Regulatory outcome: Maintenance
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Phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010430/201711 (PDF/59.69 KB)

Last updated: 10/09/2018
Active substance: Tropicamide, Phenylephrine hydrochloride
Procedure number: PSUSA/00010430/201711
Regulatory outcome: Maintenance
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Ciprofloxacin hydrochloride / hydrocortisone: List of nationally authorised medicinal products - PSUSA/00000774/201711 (PDF/56.21 KB)

Last updated: 10/09/2018
Active substance: hydrocortisone, ciprofloxacin hydrochloride
Procedure number: PSUSA/00000774/201711
Regulatory outcome: Maintenance
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Azelastin: List of nationally authorised medicinal products - PSUSA/00000277/201712 (PDF/220.2 KB)

Last updated: 10/09/2018
Active substance: azelastine
Procedure number: PSUSA/00000277/201712
Regulatory outcome: Maintenance
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Enalapril / nitrendipine: List of nationally authorised medicinal products - PSUSA/00001213/201801 (PDF/92.67 KB)

Last updated: 10/09/2018
Active substance: nitrendipine, enalapril
Procedure number: PSUSA/00001213/201801
Regulatory outcome: Maintenance

1027 results

Direct healthcare professional communication (DHPC): Picato (ingenol mebutate) – Suspension of the marketing authorisation due to risk of skin malignancy

Direct healthcare professional communication (DHPC): Ulipristal acetate 5 mg for uterine fibroids not to be used during ongoing review of liver injury risk

Levobupivacaine: List of nationally authorised medicinal products - PSUSA/00001848/201712 (PDF/254.62 KB)

Landiolol: List of nationally authorised medicinal products - PSUSA/00010570/201802 (PDF/122.96 KB)

Hydrochlorothiazide / spironolactone: List of nationally authorised medicinal products - PSUSA/00001662/201801 (PDF/69.12 KB)

Sertindole: List of nationally authorised medicinal products - PSUSA/00002695/201801 (PDF/105.81 KB)

Haemophilus influenzae / klebsiella ozaenae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus pneumoniae / streptococcus pyogenes / streptococcus viridans vaccine: List of nationally... (PDF/123.87 KB)

Celecoxib: List of nationally authorised medicinal products - PSUSA/00000616/201712 (PDF/173.46 KB)

Amitriptyline/perphenazine: List of nationally authorised medicinal products - PSUSA/00000170/201801 (PDF/46.5 KB)

Hypericum perforatum L., herba: List of nationally authorised medicinal products - PSUSA/00001701/201801 (PDF/198.44 KB)

Amiodarone: List of nationally authorised medicinal products - PSUSA/00000166/201712 (PDF/141.23 KB)

Cefprozil: List of nationally authorised medicinal products - PSUSA/00000605/201712 (PDF/84.44 KB)

Lubiprostone: List of nationally authorised medicinal products - PSUSA/00010290/201801 (PDF/95.2 KB)

Cimicifuga racemosa (L.) nutt., rhizome: List of nationally authorised medicinal products - PSUSA/00000755/201801 (PDF/123.44 KB)

Tobramycin (nebuliser solution) (apart from centrally authorised product): List of nationally authorised medicinal products - PSUSA/00009316/201712 (PDF/156.43 KB)

Cyproheptadine: List of nationally authorised medicinal products - PSUSA/00000902/201712 (PDF/56.47 KB)

Acebutolol: List of nationally authorised medicinal products - PSUSA/00000018/201712 (PDF/68.24 KB)

Felodipine: List of nationally authorised medicinal products - PSUSA/00001356/201712 (PDF/179.53 KB)

Furosemide: List of nationally authorised medicinal products - PSUSA/00001491/201801 (PDF/184.36 KB)

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

Tetanus vaccines: List of nationally authorised medicinal products - PSUSA/00002910/201801 (PDF/103.97 KB)

Phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010430/201711 (PDF/59.69 KB)

Ciprofloxacin hydrochloride / hydrocortisone: List of nationally authorised medicinal products - PSUSA/00000774/201711 (PDF/56.21 KB)

Azelastin: List of nationally authorised medicinal products - PSUSA/00000277/201712 (PDF/220.2 KB)

Enalapril / nitrendipine: List of nationally authorised medicinal products - PSUSA/00001213/201801 (PDF/92.67 KB)