Article Contents
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
- 3. PHARMACEUTICAL FORM
- 5. PHARMACOLOGICAL PROPERTIES
- 6. PHARMACEUTICAL PARTICULARS
- 9. DATE OF FIRST AUTHORISATION/RENEWAL longer OF THE AUTHORISATION
- 7. MARKETING AUTHORISATION HOLDER
- 8. MARKETING AUTHORISATION NUMBER(S)
- 9. DATE OF FIRST AUTHORISATION/RENEWAL AUTHORISATIONOF THE
- 10. DATE OF REVISION OF THE TEXT
1. NAME OF THE MEDICINAL PRODUCT
Quintanrix powder and suspension for suspension for injection
Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 ml) contains: |
|
|
Diphtheria toxoid1 | not less than 30 | International Units |
Tetanus toxoid1 | not less than 60 | International Units |
Inactivated Bordetella pertussis 2 | not less than 4 | International Units |
Hepatitis B surface antigen (rDNA) 2, 3 |
| 10 micrograms |
Haemophilus influenzae type b polysaccharide |
|
|
(polyribosylribitol phosphate) 2 |
| 2.5 micrograms |
conjugated to tetanus toxoid as a carrier |
| |
|
| authorised |
1 adsorbed on aluminium hydroxide, hydrated | Total: 0.26 milligrams Al3+ | |
2adsorbed on aluminium phosphate | Total: 0.40 milligrams Al3+ | |
| longer |
|
3 produced in Saccharomyces cerevisae cells by recombinant DNA technology
3. PHARMACEUTICAL FORM
Powder and suspension for suspension for injection
The liquid diphtheria, tetanus, pertussis (whole cell), hepatitis B | ||
type b and for booster immunisationProductof young children during the second year of life. | ||
white suspension. | no | |
The lyophilised Haemophilus influenzae type b (HIB) component is a white powder. | ||
4. | CLINICAL PARTICULARS |
|
4.1 | Therapeutic indications |
|
Quintanrix is indicated for primary immunisation of infants (during the first year of life) against
4.2 Posology and method of administration
diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Haemophilus influenzae The useMedicinalof Quintanrix should be determined on the basis of official recommendations.
Posology
Primary vaccination:
The primary vaccination schedule consists of three doses of 0.5 ml to be administered at intervals of at least 4 weeks within the first six months of life in accordance with local official recommendations. The first dose can be administered at 6 weeks of age. The following schedules have been studied in clinical trials:
Quintanrix can be given to children who have received hepatitis B vaccine at birth.
The immunoprophylactic measures for hepatitis B should not be modified for children born to hepatitis B virus carrying mothers. This may require separate administration of hepatitis B vaccine and should follow official recommendations.
Booster vaccination:
After the completion of the primary series, a booster should be administered preferably before the end of the second year of life. Booster administration should be in accordance with official recommendations.
Quintanrix may be used to boost responses to DTP, HBV and HIB antigens if its composition is in accordance with official recommendations for boosting. The booster dose should preferably be given at least 6 months after the last primary dose.
Quintanrix is for deep intramuscular injection, preferably in the anterolateral thigh.
authorised
4.3Contraindications
HIB vaccines. | longer |
Hypersensitivity to the active substances or to any of the excipients.
Quintanrix is
As with other vaccines, the administration of Quintanrix should be postponed in subjects suffering | |
from acute severe febrile illness. The presence of a minor infection, such as a cold, is not a | |
Product | no |
contraindication for vaccination. | |
4.4 Special warnings and special precautions for use |
Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events).
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. For
this reason, the vaccinee should remain under medical supervision for at least 30 minutes.
|
| decision to give |
• | Temperature of ≥ 40.0 °C within 48 hours, not due to another identifiable cause. | considered: |
| ||
• | Collapse or |
|
• | Persistent crying lasting ≥ 3 hours, occurring within 48 hours. |
|
• | Convulsions with or without fever, occurring within 3 days. |
|
| Medicinal | benefits |
|
|
bleeding subjects. A
(without rubbing) for
at least two minutes following administration.
Quintanrix should under no circumstances be administered intravascularly.
The vaccine will not prevent infection caused by other pathogens known to infect the liver such as hepatitis A, hepatitis C and hepatitis E virus.
A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Quintanrix. Vaccinees with a history of febrile convulsions should be closely followed up as such adverse events may occur within 2 to 3 days post vaccination.
The HIB component of the vaccine does not protect against diseases due to capsular serotypes other than type b of Haemophilus influenzae or against meningitis caused by otherauthorisedorganisms.
HIV infection is not considered as a contraindication. The expected immunological response may not be obtained after vaccination of immunosuppressed patients.
Since the capsular polysaccharide antigen is excreted in the urine a positive urine antigen test can be observed within
Antipyretic treatment should be initiated according to locallongertreatment guidelines.
The potential risk of apnoea and the need for respiratory monitoring for
when administering immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or delayed.
4.5 Interaction with other medicinal products and other forms of interaction
In paediatric vaccination it is often practice to | |
Product | no |
injection sites, during the same session. |
Limited data show that there is no interference with the response to
As with other vaccines it may be expected that an adequate response may not be achieved in patients receiving immunosuppressive therapy or patients with immunodeficiency.
4.6 | Pregnancy and lactation |
| Medicinal |
As Quintanrix is not intended for use in adults, information on the safety of the vaccine when used | |
during pregnancy or lactation is not available. | |
4.7 | Effects on ability to drive and use machines |
Not relevant. | |
4.8 | Undesirable effects |
Quintanrix was administered to approximately 1,340 healthy infants from 6 weeks of age as a primary vaccination course in several clinical trials.
In these trials, the most common reactions occurring after vaccine administration were pain at the site of injection, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) and irritability, which were associated with about 50% of the doses administered.
Adverse reactions are listed below. |
| ||
Frequencies are reported as: | authorised | ||
Very common: | (>1/10) | ||
Common: | (>1/100, <1/10) | ||
| |||
Uncommon: | (>1/1,000, <1/100) |
| |
Rare: | (>1/10,000, <1/1,000) |
| |
Very rare: | (<1/10,000) including isolated reports |
| |
Psychiatric disorders: |
|
|
very common: irritability
Nervous system disorders: very common: drowsiness
rare: collapse or
Respiratory, thoracic and mediastinal disorders rare: bronchitis, coughing
Gastrointestinal disorders: very common: loss of appetite rare: vomiting
General disorders and administration site conditions:
very common: pain, redness and swelling, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) common: induration, fever (axillary > 39°C; rectal > 39.5°C)
longer
Quintanrix was administered as a booster to 435 infantsno in the second year of life. As shown with
other vaccines, the booster dose is potentially associated with an increased incidence of minor adverse
events such as fever and localProductreactions.
Adverse reactions reported after booster vaccination are listed below.
Gastrointestinal disorders: very Medicinalcommon: loss of appetite
General disorders and administration site conditions:
very common: pain, redness and swelling, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) common: fever (axillary > 39°C; rectal > 39.5°C)
uncommon: induration
Allergic reactions, including anaphylactoid reactions and urticaria, have been reported very rarely following vaccination with DTP, hepatitis B and HIB containing vaccines.
During post marketing surveillance studies with other hepatitis B containing vaccines, serum sickness like disease and thrombocytopenia have been reported very rarely.
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore it is possible that sensitisation reactions may occur (see section 4.3).

5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
of infants with
The immune response after a
infants were evaluated after vaccination at 6, 10 and 14 weeks of age, 685 after vaccination at 2, 4,
and 6 months of age and 107 after vaccination at 3, 4 and 5 months of age. Results from different
studies show that, overall, 95.5% and 99.9% of subjects had
0.1 IU/ml one month after completion of the primary vaccination course. At this time, the percentage
seronegative subjects (i.e. subjects with
component of the vaccine, which was defined as the appearance of antibodies in initially
Seroprotection and vaccine response rates were similar for the three schedules used, with the exception of
2, 4, 6 months schedule | 3, 4, 5 months schedule | 6, 10, 14 weeks schedule |
N = 672 | no | N = 97 |
N = 107 | ||
98.9% | 95.3% | 92.8% |
in the second year of life, inducesProducta greater than
Limited information exists on the persistence of the immune response after primary vaccination with Quintanrix as well as on the immunogenicity of booster doses. Results from one pilot study showed that, for 63 infants primed according to a 6, 10, 14 week schedule, > 80% still had antibodies to diphtheria, tetanus, HBs and PRP at levels considered to be protective.
antibodiesMedicinalto pertussis. Data from clinical trials show that Quintanrix, when given as a booster dose
to prebooster levels for all vaccine components.
It can be expected that hepatitis D will also be prevented by immunisation with Quintanrix as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
No preclinical safety testing with the vaccine has been conducted.
6. PHARMACEUTICAL PARTICULARS
6.1 | List of excipients |
| |
Lyophilised HIB component: | authorised | ||
Lactose | |||
| |||
Liquid |
| ||
Thiomersal |
| ||
Sodium chloride |
| ||
Water for injections. |
| ||
For adjuvants, see section 2. |
| ||
6.2 | Incompatibilities |
|
In the absence of compatibility studies, the reconstituted Quintanrix vaccine must not be mixed with other medicinal products.
6.3 Shelf life
3 years.
6.4 Special precautions for storage | longer | ||
no | |||
Store in a refrigerator (2°C – 8°C) | |||
Do not freeze. |
| ||
|
| ||
Store in the original package in order to protect from light. | |||
| Product |
|
After reconstitution, it is recommended to inject the vaccine promptly. However the stability has been demonstrated for 8 hours at 25°C after reconstitution.
6.5 Nature and contents of container
Powder in a vial (type I glass) for 1 dose with a stopper (rubber butyl).
0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (rubber butyl) in the following pack sizes:
- pack size of 1 vial of powder plus 1 vial of suspension
6.6 Instructions for use and handling
- pack size of 100 vials of powder plus 100 vials of suspension Not allMedicinalpack sizes may be marketed.
Upon storage, a white deposit and clear supernatant may be observed for the
The
The vaccine is reconstituted by withdrawing the contents of the vial containing the
the powder is completely dissolved. The reconstituted vaccine is a homogeneous turbid white suspension.
Remove and discard the needle used for reconstitution and replace it with a second needle to administer the vaccine. After reconstitution, the vaccine should be injected promptly.
7. | MARKETING AUTHORISATION HOLDER | authorised |
EU/1/04/301/002 | ||
GlaxoSmithKline Biologicals s.a. |
| |
Rue de l'Institut 89 |
| |
| ||
8. | MARKETING AUTHORISATION NUMBER(S) |
|
EU/1/04/301/001
9.DATE OF FIRST AUTHORISATION/RENEWALlongerOF THE AUTHORISATION
- Twinrix paediatric - GlaxoSmithKline Biologicals S.A.
- Pandemrix - GlaxoSmithKline Biologicals S.A.
- Twinrix adult - GlaxoSmithKline Biologicals S.A.
- Adjupanrix (pandemic influenza vaccine (h5n1) (split virion, inactivated, adjuvanted) glaxosmithkline biologicals) - GlaxoSmithKline Biologicals S.A.
- Pumarix - GlaxoSmithKline Biologicals S.A.
- Tritanrix hepb - GlaxoSmithKline Biologicals S.A.
Prescription drugs listed. Manufacturer: "GlaxoSmithKline Biologicals S.A."
| Product | no |
Medicinal |
| |
|
|
1. NAME OF THE MEDICINAL PRODUCT
Quintanrix powder and suspension for suspension for injection, multidose
Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3 produced in Saccharomyces cerevisae cells by recombinant DNA technology This is a multidose container. See section 6.5 for the number of doses per vial.
After reconstitution, 1 dose (0.5 ml) contains: |
|
|
Diphtheria toxoid1 | not less than 30 | International Units |
Tetanus toxoid1 | not less than 60 | International Units |
Inactivated Bordetella pertussis 2 | not less than 4 | International Units |
Hepatitis B surface antigen (rDNA) 2, 3 |
| 10 micrograms |
Haemophilus influenzae type b polysaccharide |
|
|
(polyribosylribitol phosphate) 2 |
| 2.5 micrograms |
conjugated to tetanus toxoid as a carrier |
| |
|
| authorised |
1 adsorbed on aluminium hydroxide, hydrated | Total: 0.26 milligrams Al3+ | |
2adsorbed on aluminium phosphate | Total: 0.40 milligrams Al3+ | |
| longer |
|
3.PHARMACEUTICAL FORM
Powder and suspension for suspension for injectionno
Quintanrix is indicated for primaryProductimmunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Haemophilus influenzae type b and for booster immunisation of young children during the second year of life.
The liquid diphtheria, tetanus, pertussis (whole cell), hepatitis B
The lyophilised Haemophilus influenzae type b (HIB) component is a white powder.
4. | CLINICAL PARTICULARS |
4.1 | Therapeutic indications |
| Medicinal |
The use of Quintanrix should be determined on the basis of official recommendations.
4.2 Posology and method of administration
Posology
Primary vaccination:
The primary vaccination schedule consists of three doses of 0.5 ml to be administered at intervals of at least 4 weeks within the first six months of life in accordance with local official recommendations. The first dose can be administered at 6 weeks of age. The following schedules have been studied in
clinical trials:
Quintanrix can be given to children who have received hepatitis B vaccine at birth.
The immunoprophylactic measures for hepatitis B should not be modifiedauthorisedfor children born to
hepatitis B virus carrying mothers. This may require separate administration of hepatitis B vaccine and should follow official recommendations.
After the completion of the primary series, a booster should be administered preferably before the end of the second year of life. Booster administration should be in accordance with official recommendations.
Quintanrix may be used to boost responses to DTP, HBV and HIB antigens if its composition is in accordance with official recommendations for boosting. The booster dose should preferably be given at least 6 months after the last primary dose.
Quintanrix is for deep intramuscular injection, preferablylongerin the anterolateral thigh.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients.
occurring within 7 days following previous vaccination with pertussis containing vaccine. In these circumstances the vaccination course should be continued with diphtheria, tetanus, hepatitis B and HIB vaccines.
Quintanrix is
As with other vaccines, the administrationProductof Quintanrix should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, such as a cold, is not a contraindication for vaccination.
4.4 Special warnings and special precautions for use
Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events).
| Medicinal | always be |
|
| |
|
| vaccine. |
|
| minutes. |
|
| decision to give |
• | Temperature of ≥ 40.0 °C within 48 hours, not due to another identifiable cause. | considered: |
| ||
• | Collapse or |
|
• | Persistent crying lasting ≥ 3 hours, occurring within 48 hours. |
|
• | Convulsions with or without fever, occurring within 3 days. | benefits |
|
|
Quintanrix should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. A
fine needle can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least two minutes following administration.
Quintanrix should under no circumstances be administered intravascularly.
The vaccine will not prevent infection caused by other pathogens known to infect the liver such as hepatitis A, hepatitis C and hepatitis E virus.
The HIB component of the vaccine does not protect against diseases due to capsular serotypes other than type b of Haemophilus influenzae or against meningitis caused by other organisms.
A history of febrile convulsions,a family history of convulsions or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Quintanrix. Vaccinees with a history of
febrile convulsions should be closely followed up as such adverse events may occur within 2 to 3 days post vaccination.
HIV infection is not considered as a contraindication. The expected immunological response may not be obtained after vaccination of immunosuppressed patients.
authorised
when administering immunisation series to very prematurelongerinfants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratoryno immaturity.
Since the capsular polysaccharide antigen is excreted in the urine a positive urine antigen test can be
observed within
Antipyretic treatment should be initiated according to local treatment guidelines.
The potential risk of apnoea and the need for respiratory monitoring for
As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or
delayed.
4.5 Interaction with otherProductmedicinal products and other forms of interaction
In paediatric vaccination it is often practice to
Limited data show that there is no interference with the response to
As with other vaccines it may be expected that an adequate response may not be achieved in patients
receivingMedicinalimmunosuppressive therapy or patients with immunodeficiency.
4.6 Pregnancy and lactation
As Quintanrix is not intended for use in adults, information on the safety of the vaccine when used during pregnancy or lactation is not available.
4.7 Effects on ability to drive and use machines
Not relevant.
4.8 Undesirable effects
Quintanrix was administered to approximately 1,340 healthy infants from 6 weeks of age as a primary vaccination course in several clinical trials.
In these trials, the most common reactions occurring after vaccine administration were pain at the site of injection, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) and irritability, which were associated with about 50% of the doses administered.
Adverse reactions are listed below. |
|
| authorised | ||
Frequencies are reported as: |
|
|
| ||
Very common: | (>1/10) |
|
| ||
Common: | (>1/100, <1/10) |
|
| ||
Uncommon: | (>1/1,000, <1/100) |
|
| ||
Rare: | (>1/10,000, <1/1,000) |
|
| ||
Very rare: | (<1/10,000) including isolated reports | ||||
Psychiatric disorders: |
|
|
|
| |
very common: irritability |
|
|
| ||
Nervous system disorders: |
|
|
| ||
very common: drowsiness |
|
|
| ||
|
|
|
|
| |
rare: collapse or | |||||
Respiratory, thoracic and mediastinal disorders |
| longer |
| ||
rare: bronchitis, coughing |
|
|
| ||
Gastrointestinal disorders: |
|
|
| ||
very common: loss of appetite |
|
| |||
rare: vomiting |
|
|
|
| |
General disorders and administration site conditions: |
| ||||
very common: pain, redness and swelling, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) | |||||
common: induration, fever (axillary > 39°C; rectal > 39.5°C) |
| ||||
|
| Product | no |
|
|
Nervous system disorders: |
|
|
|
Quintanrix was administered as a booster to 435 infants in the second year of life. As shown with other vaccines, the booster dose is potentially associated with an increased incidence of minor adverse events such as fever and local reactions.
Adverse reactions reported after booster vaccination are listed below.
very Medicinalcommon: drowsiness Gastrointestinal disorders:
very common: loss of appetite
General disorders and administration site conditions:
very common: pain, redness and swelling, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) common: fever (axillary > 39°C; rectal > 39.5°C)
uncommon: induration
Allergic reactions, including anaphylactoid reactions and urticaria, have been reported very rarely following vaccination with DTP, hepatitis B and HIB containing vaccines.
During post marketing surveillance studies with other hepatitis B containing vaccines, serum sickness like disease and thrombocytopenia have been reported very rarely.

This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore it is possible that sensitisation reactions may occur (see section 4.3).
Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
infants were evaluated after vaccination at 6, 10 and 14 weeks of age, 685 after vaccination at 2, 4,
The immune response after a
and 6 months of age and 107 after vaccination at 3, 4 and 5 months of age. Results from different
studies show that, overall, 95.5% and 99.9% of subjects had
seronegative subjects (i.e. subjects with | ||
titre at least equal to | ||
derived antibodies. | no | longer |
|
Seroprotection and vaccine response rates were similar for the three schedules used, with the exception of
2, 4, 6 months schedule | 3, 4, 5 months schedule | 6, 10, 14 weeks schedule |
N = 672 | N = 107 | N = 97 |
98.9% | 95.3% | 92.8% |
Limited information exists onProductthe persistence of the immune response after primary vaccination with Quintanrix as well as on the immunogenicity of booster doses. Results from one pilot study showed
that, for 63 infants primed according to a 6, 10, 14 week schedule, > 80% still had antibodies to diphtheria, tetanus, HBs and PRP at levels considered to be protective.
It can be expected that hepatitis D will also be prevented by immunisation with Quintanrix as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
5.2 | Pharmacokinetic properties |
Not applicable. | |
| Medicinal |
5.3 | Preclinical safety data |
6.1 | List of excipients | authorised |
Lyophilised HIB component: | ||
Lactose | ||
Liquid | ||
Thiomersal | ||
Sodium chloride | ||
Water for injections. | ||
For adjuvants, see section 2. | ||
6.2 | Incompatibilities | |
|
|
In the absence of compatibility studies, the reconstituted Quintanrix vaccine must not be mixed with other medicinal products.
6.3 Shelf life
3 years.
After reconstitution,it is recommended to inject the vaccine promptly. However the stability has been | ||
demonstrated for 8 hours at 25°C after reconstitution. | longer | |
6.4 Special precautions for storage | no |
|
Store in a refrigerator (2°C – 8°C) |
|
Do not freeze.
Store in the original packageProductin order to protect from light. in the following pack sizes:
6.5 Nature and contents of container
Powder in a vial (type I glass) for 2 doses with a stopper (rubber butyl).
1 ml of suspension in a vial (type I glass) for 2 doses with a stopper (rubber butyl)
– packMedicinalsize of 1 vial of powder plus 1 vial of suspension
– pack size of 100 vials of powder plus 100 vials of suspension.
Powder in a vial (type I glass) for 10 doses with a stopper (rubber butyl).
5 ml of suspension in a vial (type I glass) for 10 doses with a stopper (rubber butyl) in a pack size of 50 vials of powder plus 50 vials of suspension.
Not all pack sizes may be marketed.
6.6 Instructions for use and handling
Upon storage, a white deposit and clear supernatant may be observed for the
The
The vaccine is reconstituted by withdrawing the contents of the vial containingauthorisedthe
component by means of a syringe and by adding it to the vial containing the HIB powder. After the addition of the
Remove and discard the needle used for reconstitution and replace it with a second needle to administer the vaccine. After reconstitution, the vaccine should be injected promptly.
When using a multidose vial, each 0.5 ml dose of the reconstituted suspension should be taken with a sterile needle and syringe. As with other vaccines, a dose of vaccine should be withdrawn under strict aseptic conditions and precautions taken to avoid contamination of the contents.
7. MARKETING AUTHORISATION HOLDER
GlaxoSmithKline Biologicals s.a. |
|
|
Rue de l'Institut 89 |
|
|
|
| |
8. MARKETING AUTHORISATION NUMBER(S) | ||
EU/1/04/301/003 | no | longer |
| ||
EU/1/04/301/004 |
| |
|
|
- Pixuvri
- Pedea
- Intelence
- Duoresp spiromax
- Optimark
- Ibandronic acid teva
Prescription drugs listed:
EU/1/04/301/005
9. DATE OF FIRST AUTHORISATION/RENEWAL AUTHORISATIONOF THE
17/02/2005 | Product |
| |
10. DATE OF REVISION OF THE TEXT | |
Medicinal |
|
Comments