ANEXO I FICHA TÉCNICA O RESUMEN DE LAS …

Q12 Step 2b Technical and regulatory …

ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management EMA/CHMP/ICH/804273/2017 Page 3/36

  Product, Management, Lifecycle, Product lifecycle management

Guideline on good pharmacovigilance practices …

9 December 2013 . EMA/816292/2011 Rev 1* Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report (Rev 1)

  Guidelines, Good, Practices, Guideline on good pharmacovigilance practices, Pharmacovigilance

Guideline on good pharmacovigilance practices (GVP)

Guideline on good pharmacovigilance practices (GVP) – Module IX (Rev 1) EMA/827661/2011 Rev 1 Page 2/25

  Good, Practices

Guideline on good pharmacovigilance practices …

Guideline on good pharmacovigilance practices (GVP) – Module VIII (Rev 3) EMA/813938/2011 Rev 3 Page 2/28

  Guidelines, Good, Practices, Guideline on good pharmacovigilance practices, Pharmacovigilance

Guideline for good clinical practice E6(R2)

Guideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 2/70 Document History First Codification History Date New Codification

  Good, Practices, Clinical, Good clinical practice

Guideline for good clinical practice E6(R2)

Guideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 2/75 10 Document History 11 First Codification History Date New Codification November

  Guidelines, Good, Practices, Clinical, Good clinical practice e6

Guideline on good pharmacovigilance practices …

harmful physical or psychological effects [DIR 2001/83/EC Art 1(1 6)]. 74 Adverse event (AE); synonym: Adverse experience 75 Any untoward medical occurrence in a patient or clinical- trial subject administered a medicinal product

  Guidelines, Good, Practices, Guideline on good pharmacovigilance practices, Pharmacovigilance

European Medicines Agency

© EMEA 2006 2 SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS ICH Harmonised Tripartite Guideline

  Guidelines, European, Agency, Medicine, Harmonised, European medicines agency, Ich harmonised

products1/traditional herbal medicinal products

There is no expectation that existing herbal medicinal products on the market will be affected by this guideline, with the exception of traditional herbal medicinal products for human use that were already

  Product, Medicinal, Traditional, Herbal, Products1 traditional herbal medicinal products, Products1

Q7 Q&A - good manufacturing practice for active ...

ICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients – questions and answers EMA/CHMP/ICH/468930/2015 Page 2/37

  Good, Practices, Pharmaceutical, Manufacturing, Active, Ingredients, Good manufacturing practice for active, Good manufacturing practice for active pharmaceutical ingredients

FACHINFORMATION (ZUSAMMENFASSUNG DER …

Infektion, Krebserkrankung, hämatopoeti-sche Stammzelltransplantation, nephroti-sches Syndrom) sind keine Daten zur Si-cherheit und Immunogenität für Prevenar13

IMMUNISATION SCHEDULE ACKERMANS PRIVATE …

immunisation schedule ackermans private clinic . epi schedule : additional private (supplied by state) vaccines :

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This book belongs to - CYH

page 2 Welcome to your child’s health and development record How to use this record Use it to check and record your child’s: > health and development

Immunisation - CYH

page 11 Immunisation What is immunisation and why does my child need it? Immunisation is a simple, safe and effective way to protect children (and adults) from serious diseases.

  Immunisation

INFANRIX hexa New Zealand Datasheet - Medsafe

1 INFANRIX hexa New Zealand Datasheet . INFANRIX hexa is a combined diphtheria-tetanus-acellular pertussis, hepatitis B, enhanced inactivated polio vaccine and Haemophilus influenzae type b vaccine.

  Datasheet, Zealand, Infanrix, Exha, Infanrix hexa new zealand datasheet

National Immunisation Program Schedule …

National Immunisation Program Schedule Queensland Age Vaccine Disease Routine childhood vaccinations plus additional vaccines for: Aboriginal & …

  Programs, Schedule, National, Queensland, Immunisation, National immunisation program schedule, National immunisation program schedule queensland

WHO PACKAGE INSERT

Synflorix™ Page 4 of 9 WHO Package insert (Final) For children at high-risk for pneumococcal disease (such as children with sickle cell disease, asplenia,

  Packages, Insert, Who package insert