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GRAZAX 75,000 SQ-T oral lyophilisateallergen extract of gras
2014-04-13 11:45:19 来源: 作者: 【 】 浏览:627次 评论:0
Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
 

1. NAME OF THE MEDICINAL PRODUCT

 

GRAZAX 75,000 SQ-T oral lyophilisate

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Standardised allergen extract of grass pollen from Timothy (Phleum pratense) 75,000 SQ-T* per oral lyophilisate.

* [Standardised Quality units Tablet (SQ-T)]

For a full list of excipients, see section 6.1.

 

 

3. PHARMACEUTICAL FORM

 

Oral lyophilisate

White to off-white circular oral lyophilisate marked with a debossed image on one side.

 

 

4. CLINICAL PARTICULARS

     

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