Contents Of Vaccines

En attente d'une révision interne par Agence européenne des médicaments a propos de leur gestion de la demande.

Dear European Medicines Agency,

Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting documents which contain the following information:

exact contents of vaccines they put a baby in spain

Yours faithfully,

federico

EMA Info, Agence européenne des médicaments

Dear Federico,
 
Thank you for your e-mail dated 06 Nov 2012 in which you apply for access
to documents held by the European Medicines Agency (EMA).
 
Provision of information in an open and transparent manner is part of the
mission of the Agency.
 
We will deal with your request as soon as possible and in accordance with
the principles and limits established in Regulation (EC) 1049/2001
regarding public access to European Parliament, Council and Commission
documents as applicable to the EMA pursuant to article 73 of Regulation
(EC) 726/2004.
 
This regulation sets out provisions which guarantee openness and
transparency of the activities of European Institutions, whilst also
ensuring the protection of certain public and private interests.
 
We have reviewed your request and in accordance with Article 6(2) of the
Regulation (EC) 1049/2001, we would be grateful if you could specify which
products (Trade name or INN) you refer to and whether you mean composition
as per the Summary of Product Characteristics (SmPC) or something else?
 
Please note that the EMA only regulates centrally authorised products.
 
To assist you, please find herewith a link to the "European Medicines
Agency policy on access to documents (related to medicinal products for
human and veterinary use)":
 
[1]http://www.ema.europa.eu/ema/index.jsp?c...
and the "Output of the European Medicines Agency policy on access to
documents related to medicinal products for human and veterinary
use", which lists categories of documents held by the European Medicines
Agency:
 
[2]http://www.ema.europa.eu/docs/en_GB/docu...
 
We look forward to receiving your clarification.
 
 
 
Kind Regards,
 
Document & Information Services
European Medicines Agency
7 Westferry Circus
Canary Wharf
London
E14 4HB
United Kingdom

[3][EMA request email]
[4]http://www.ema.europa.eu
 
Frequently Asked Questions (FAQs) have now been published on the Agency's
website. It comprises answers to the most commonly asked questions
submitted to the EMA. You are invited to consult it here:
[5]http://www.ema.europa.eu/ema/index.jsp?c...

This message and any attachment contain information which may be
confidential or otherwise protected from disclosure. It is intended for
the addressee(s) only and should not be relied upon as legal advice unless
it is otherwise stated. If you are not the intended recipient(s) (or
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Dear EMA Info,

Me gustaria saber el contenido exacto de las siguientes vacunas:

men c, baxter

DTPa +Hib + Po, sanofi-pasteur

Hep b, sanofi pasteur

prevenar
rotateq,

- Antígeno
- Conservantes
- Adyuvantes
- Aditivos o agentes estabilizantes
- Agentes residuales
- Productos animales
- Productos humanos

Yours sincerely,

federico

EMA Info, Agence européenne des médicaments

Estimado señor Federico,

Gracias por ponerse en contacto con la Agencia Europea de Medicamentos.

De acuerdo con las normas recogidas en el Código de Conducta de la Agencia, responderemos a su solicitud lo más rápidamente posible.
No dude en ponerse en contacto con nosotros para cualquier pregunta que tenga en relación con su solicitud.

Atentamente,

Document and Information Services

European Medicines Agency
7 Westferry Circus
Canary Wharf
London
E14 4HB
United Kingdom

[EMA request email]
http://www.ema.europa.eu

Frequently Asked Questions (FAQs) have now been published on the Agency's website. It comprises answers to the most commonly asked questions submitted to the EMA. You are invited to consult it at the following Link http://www.ema.europa.eu/ema/index.jsp?c...

This message and any attachment contain information which may be confidential or otherwise protected from disclosure. It is intended for the addressee(s) only and should not be relied upon as legal advice unless it is otherwise stated. If you are not the intended recipient(s) (or authorised by an addressee who received this message), access to this e-mail, or any disclosure or copying of its contents, or any action taken (or not taken) in reliance on it is unauthorised and may be unlawful. If you have received this e-mail in error, please inform the sender immediately.

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Dear EMA Info,

Still waiting an answer.

Yours sincerely,

federico

EMA Info, Agence européenne des médicaments

Dear Mr Federico,

We would like to confirm that your query dated 10/11/2012 was received and is currently being dealt with by the European Medicines Agency.
Kindly note that when dealing with requests for information, we refer to the rules set in the Agency’s Code of Conduct, according to which we shall ensure that a response is sent within a reasonable time limit, however no later than two months from the date of receipt.
If a request cannot, because of the complexity of the matters which it raises, be decided upon within the above-mentioned time-limit, we will inform you as soon as possible. In that case, a definitive decision will be notified in the shortest time.
For detailed information, please see: http://www.ema.europa.eu/docs/en_GB/docu...
Please do not hesitate to contact us should you require further information.

Kind Regards,
Document and Information Services

European Medicines Agency
7 Westferry Circus
Canary Wharf
London
E14 4HB
United Kingdom

[EMA request email]
http://www.ema.europa.eu

Frequently Asked Questions (FAQs) have now been published on the Agency's website. It comprises answers to the most commonly asked questions submitted to the EMA. You are invited to consult it at the following Link http://www.ema.europa.eu/ema/index.jsp?c...

This message and any attachment contain information which may be confidential or otherwise protected from disclosure. It is intended for the addressee(s) only and should not be relied upon as legal advice unless it is otherwise stated. If you are not the intended recipient(s) (or authorised by an addressee who received this message), access to this e-mail, or any disclosure or copying of its contents, or any action taken (or not taken) in reliance on it is unauthorised and may be unlawful. If you have received this e-mail in error, please inform the sender immediately.

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External Queries, Agence européenne des médicaments

2 Attachments

Por favor dénos su opinión- [1]http://www.surveymonkey.com/s/S7MBDM9

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Estimado Federico:

 

Gracias por su consulta del 10 de Noviembre 2012 en relación al contenido
de algunas vacunas.

 

El contenido exacto de cualquier medicamento, incluido el de las vacunas,
se puede encontrar en la sección 6 del prospecto. El prospecto de los
medicamentos que han sido evaluados de manera central (es decir, los
medicamentos evaluados por la Agencia Europea de Medicamentos que reciben
autorización de comercialización válida en la Unión Europea) se
publica en la pagina web de la Agencia junto con otra información
(llamada Informe Público Europeo de Evaluación (EPAR)) en el siguiente
enlace:
[3]http://www.ema.europa.eu/ema/index.jsp?c...

 

De las vacunas mencionadas en su consulta, tres de ellas han sido
autorizadas bajo el procedimiento centralizado y su contenido se
especifica a continuación. Sin embargo, las vacunas de Baxter (Meningitis
C) y de Sanofi Pasteur (DTPa + Hib + Polio) están autorizadas bajo
procedimientos nacionales por lo que para mas información le recomendamos
contactar con la Autoridad Nacional competente, que en España es la
Agencia Española de Medicamentos y Productos Sanitarios
([4]www.aemps.gob.es ).

 

El contenido de la vacuna para la Hepatitis B de Sanofi Pasteur (nombre
comercial HBVaxPro) es el siguiente:

 

·         El principio activo es:

AntÃgeno de superficie del virus de la hepatitis B, recombinante (HBsAg) *
...... 5 microgramos Adsorbido en sulfato hidroxifosfato de aluminio
amorfo (0,25 miligramos Al^+).

* producido en levadura Saccharomyces cerevisiae (cepa 2150-2-3) mediante
tecnologÃa recombinante de ADN.

·         Los demás componentes son cloruro de sodio, borato de sodio y
agua para preparaciones inyectables.

 

Para más información sobre HBVaxPro vea el siguiente enlace:

[5]http://www.ema.europa.eu/ema/index.jsp?c...

Para ver el prospecto:

[6]http://www.ema.europa.eu/docs/es_ES/docu...

 

El contenido de Prevenar es:

·         Principios activos:

Cada dosis de 0,5 ml contiene:

Polisacárido del serotipo neumocócico 4* 2 microgramos

Polisacárido del serotipo neumocócico 6B* 4 microgramos

Polisacárido del serotipo neumocócico 9V* 2 microgramos

Polisacárido del serotipo neumocócico 14* 2 microgramos

Polisacárido del serotipo neumocócico 18C* 2 microgramos

Polisacárido del serotipo neumocócico 19F* 2 microgramos

Polisacárido del serotipo neumocócico 23F* 2 microgramos

* Conjugado con la proteÃna transportadora CRM197 y adsorbido a fosfato de
aluminio (0,5 mg)

·         Los demás componentes son cloruro sódico y agua para
preparaciones inyectables.

 

Para más información sobre Prevenar vea el siguiente enlace:

[7]http://www.ema.europa.eu/ema/index.jsp?c...

Para ver el prospecto:

[8]http://www.ema.europa.eu/docs/es_ES/docu...

 

El contenido de RotaTeq es:

·         Los principios activos de RotaTeq son 5 cepas reasortantes de
rotavirus humano-bovinos:

G1 2,2 x 10^6 Unidades Infecciosas

G2 2,8 x 10^6 Unidades Infecciosas

G3 2,2 x 10^6 Unidades Infecciosas

G4 2,0 x 10^6 Unidades Infecciosas

P1A[8] 2,3 x 10^6 Unidades Infecciosas

·         Los demás componentes de RotaTeq son: sacarosa, citrato de
sodio, dihidrógeno fosfato de sodio monohidrato, hidróxido de sodio,
polisorbato 80, medio de cultivo (que contiene sales inorgánicas,
aminoácidos y vitaminas) y agua purificada.

 

Para más información sobre RotaTeq vea el siguiente enlace:

[9]http://www.ema.europa.eu/ema/index.jsp?c...

Para ver el prospecto:

[10]http://www.ema.europa.eu/docs/es_ES/docu...

 

Esperamos que esta información le sea de ayuda.

 

Un cordial saludo,

Federica Castellani

Medical Information

European Medicines Agency

7 Westferry Circus, Canary Wharf
London E14 4HB
United Kingdom
[11][EMA request email]
[12]http://www.ema.europa.eu

[13]Frequently Asked Questions (FAQs) with answers to the most commonly
asked questions have now been published on the Agency's website.

 

 

This message and any attachment contain information which may be
confidential or otherwise protected from disclosure. It is intended for
the addressee(s) only and should not be relied upon as legal advice unless
it is otherwise stated. If you are not the intended recipient(s) (or
authorised by an addressee who received this message), access to this
e-mail, or any disclosure or copying of its contents, or any action taken
(or not taken) in reliance on it is unauthorised and may be unlawful. If
you have received this e-mail in error, please inform the sender
immediately.

 

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