Argentina - Drug Information Association

European Union - EMA/769460/2010 - P/315/2010: Decision on the Application
for Agreement of a Paediatric Investigation Plan for Modified allergen extract of
grass pollen, 22-Dec-2010
The Paediatric Committee has given a positive opinion for a request for agreement of Paediatric Investigation Plan for the
active substance Modified allergen extract of grass pollen. - Applicant: ROXALL Medizin GmbH. - Conditions: Treatment of
allergic rhinitis / rhino-conjunctivitis. - Pharmaceutical form: Suspension for injection. - Route of administration:
Subcutaneous use. More detailed information regarding the Paediatric Investigation Plan (PIP): - Proposed PIP indication:
For the subcutaneous treatment of allergic rhinitis / rhino-conjunctivitis due to pollen of the group of sweet grasses of the
Poaceae (Gramineae) family. - Age subset: From 5 years to less than 18 years of age. - Date of completion of the PIP: By
October 2026. - Deferral: Yes.
Document date: 22-Dec-2010
Type of text: Opinion, PDCO Opinion
Regulatory version: None
Language: English
European Union - EMA/778420/2010 - P/329/2010: Decision on the Application
for Agreement of a Paediatric Investigation Plan for Aqueous allergen extract of
birch, alder and hazel pollen, 22-Dec-2010
The Paediatric Committee has given a positive opinion for a request for agreement of Paediatric Investigation Plan for the
active substance Aqueous allergen extract of birch, alder and hazel pollen. - Applicant: ROXALL Medizin GmbH. - Conditions:
Treatment of allergic rhinitis / rhino-conjunctivitis. - Pharmaceutical form: Oral solution. - Route of administration:
Sublingual use. More detailed information regarding the Paediatric Investigation Plan (PIP): - Proposed PIP indication:
Treatment of allergic rhinitis / rhino-conjunctivitis due to tree pollen of the birch group. - Age subset: From 5 years to less
than 18 years of age. - Date of completion of the PIP: By October 2025. - Deferral: Yes.
Document date: 22-Dec-2010
Type of text: Opinion, PDCO Opinion
Regulatory version: None
Language: English
European Union - EMA/800116/2010 - P/339/2010: Decision on the Application
for Agreement of a Paediatric Investigation Plan for Modified allergen extract of
Dermatophagoides pteronyssinus and Dermatophagoides farinae, 22-Dec-2010
The Paediatric Committee has given a Positive Opinion for a request for agreement of Paediatric Investigation Plan for the
active substance Modified allergen extract of Dermatophagoides pteronyssinus and Dermatophagoides farinae. - Applicant:
ROXALL Medizin GmbH - Condition: Treatment of allergic rhinitis/rhino-conjunctivitis - Pharmaceutical form: Suspension for
injection - Route of administration: Subcutaneous use More detailed information regarding the Paediatric Investigation Plan
(PIP): - Proposed PIP indication: Treatment of allergic rhinitis/rhino-conjunctivitis due to house dust mite allergens. - Age
subset: From 5 to less than 18 years of age. - Date of completion of the PIP: By September 2025 - Deferral: Yes
Document date: 22-Dec-2010
Type of text: Opinion, PDCO Opinion
Regulatory version: None
Language: English
European Union - EMA/801965/2010 - P/342/2010: Decision on the Application
for Agreement of a Paediatric Investigation Plan for Modified allergen extract of
dermatophagoides pteronyssinus and dermatophagoides farinae, 22-Dec-2010
The Paediatric Committee has given a Positive Opinion for a request for agreement of Paediatric Investigation Plan for the
active substance Modified allergen extract of dermatophagoides pteronyssinus and dermatophagoides farinae. - Applicant:
ROXALL Medizin GmbH - Condition: Treatment of allergic rhinitis/rhino-conjunctivitis - Pharmaceutical form: Suspension for
injection - Route of administration: Subcutaneous use More detailed information regarding the Paediatric Investigation Plan
(PIP): - Proposed PIP indication: Treatment of allergic rhinitis/rhino-conjunctivitis due to house dust mite allergens. - Age
subset: From 5 to less than 18 years of age. - Date of completion of the PIP: By September 2027 - Deferral: Yes
Document date: 22-Dec-2010
Type of text: Opinion, PDCO Opinion
Regulatory version: None
Language: English
European Union - EMA/802042/2010 - P/341/2010: Decision on the Application
for Agreement of a Paediatric Investigation Plan for Modified allergen extract of
dermatophagoides farinae, 22-Dec-2010
The Paediatric Committee has given a Positive Opinion for a request for agreement of Paediatric Investigation Plan for the