WHO Pharmaceuticals Newsletter No. 4, 2015

OMS, 1 de septiembre de 2015

Contenidos

Regulatory Matters

Abiraterone acetate ............................................................................ 5

Adefovir pivoxil ....................................................................................5

Anagliptin ............................................................................................ 5

Asunaprevir and daclatasvir hydrochloride ..........................................5

Crizotinib ........................................................................................... ..6

Denosumab ......................................................................................... 6

Dimethyl fumarate................................................................................6

Ethinylestradiol /etonogestrel vaginal ring .......................................... 7

Ferumoxytol ........................................................................................ 7

Fusidic acid and HMG-CoA reductase inhibitors .................................. 7

Ibuprofen ............................................................................................. 8

Indapamide ........................................................................................... 8

Influenza HA vaccine .......................................................................... ..8

Interferon beta-1a ................................................................................ 9

Ivabradine ............................................................................................. 9

Methotrexate ....................................................................................... 10

Methylphenidate transdermal system ................................................. 10

Methylprednisolone (intravenous injection) ......................................... 10

Non-aspirin Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) ............ 11

Pregabalin .............................................................................................11

Sorafenib .............................................................................................. 12

Technetium (99mTc) hydroxymethylenediphosphonate injection ......... 12

Tramadol hydrochloride ..................................................................... ...12

Ustekinumab ..........................................................................................13

Ziprasidone ............................................................................................13

Safety of medicines

Codeine Cough-and-Cold Medicines in Children .............................15

Combined hormonal birth control products ....................................15

Denosumab ..................................................................................... 15

Diazoxide ........................................................................................ 16

Febuxostat ...................................................................................... 16

Ibuprofen in high dose (≥2400mg/day).......................................... 16

Influenza vaccine ............................................................................. 17

Latanoprost eye drop ...................................................................... 17

Melatonin ......................................................................................... 18

Sodium glucose co-transporter 2 (SGLT2) inhibitors (canagliflozin,

dapagliflozin, empagliflozin) ..... 18

Zoledronic acid infusion ..................................................................... 18

Signal

Atomoxetine and Dystonia in paediatric patients .................................. 20

Vemurafenib and Tumour lysis syndrome ............................................ 25

Feature

Summary of Recommendations from the Twelfth Meeting of the WHO

Advisory Committee on Safety of Medicinal Products (ACSoMP) .............. 30

Implementing Patient Reporting of Adverse Reactions in Ghana ............. 32

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