ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Slentrol
5 mg/ml oral solution for dogs
Active substance:
Dirlotapide 5 mg/ml
For a full list of excipients, see section 6.1.
Oral solution
A colourless to pale yellow solution
4.1 Targetspecies
Dogs
As an aid in the management of overweight and obesity in adult dogs. To be used as part of an overall
weight management programme which also includes appropriate dietary changes and exercise
practice.
Do not use in dogs in the growth phase.
Do not use in pregnant or lactating dogs.
Do not use in animals with impaired liver function.
Do not use in case of hypersensitivity to the active substance or excipient.
Do not use in animals in which overweight or obesity is caused by a concomitant systemic disease
such as hypothyroidism or hyperadrenocorticism.
Do not use in cats due to the risk of development of hepatic lipidosis.
In clinical trials, treated animals rapidly regained weight following cessation of treatment when diet
was not restricted. In order to avoid this rebound weight gain, it is necessary to feed the animals to
maintenance energy requirements. Thus, during treatment or at the end of treatment at the latest, an
appropriate feeding and exercise regimen should be implemented in order to ensure long term
maintenance of the body weight.
The liver function of dogs potentially suspected of suffering from a liver disease or dysfunction should
be evaluated before commencing treatment with the product .
2/21
Any clinical indication of liver disease or dysfunction during treatment should be investigated through
the evaluation of liver function. Any indication of progressive liver damage or of dysfunction should
result in the discontinuation of the treatment.
In the treatment phase, because food intake is reduced as when using a traditional non-medical calorie
restriction method, care must be taken to ensure that protein, vitamins, essential fatty acids and minerals
supplied by the consumed daily food ration meet minimal recommended requirements in order to
ensure a complete and balanced nutritional supply.
If vomiting, diarrhoea or significantly reduced appetite or excessive weight loss occurs, treatment
should be interrupted and the advice of a veterinarian should be sought. Resolution of adverse reactions
will occur shortly after the suspension of treatment. Dosing may be recommenced at the same or at a
reduced dose volume, (reduced by 25%), but if vomiting reoccurs, the veterinary product may need to
be withdrawn.
Fertility studies have not been conducted in the target species – use in dogs intended for breeding
should be subject to a risk-benefit analysis.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
In case of contact with the skin, wash off any product immediately with soap and water. Slentrol may
cause eye-irritation. Avoid contact with eyes. If accidental eye exposure occurs, flush the eyes
immediately with clean water.
When product is drawn into syringe, administer immediately.
Where the product has been administered on food, discard unconsumed food immediately to avoid
unintentional ingestion by other animals or persons in the household. Slentrol ingestion can be harmful
to children and pregnant women.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the
label to the physician.
In clinical studies, vomiting, sometimes accompanied by signs of lethargy, anorexia or diarrhoea was
observed during treatment with the product. These signs typically started during the first month of
treatment (about 30% of dogs showed at least one vomiting event and up to 12% showed any of the
other signs) and decreased continuously during the course of treatment. Some dogs (less than 10%)
experienced repeated vomiting (i.e. more than once every 20 days on average).
Sporadic and mild ALT elevations up to 4 times the upper reference range and not associated with
histopathological liver lesions or noticeable changes in other liver parameters may be observed in
some dogs during the course of treatment.
On rare occasions, reports of change of behaviour such as polyphagia, or very rarely reports of
aggression associated with food and feeding have been observed in Slentrol treated dogs. If these
changes were observed, treatment should be stopped.
Do not use in dogs during pregnancy and lactation. MTP inhibitors (microsomal trigylyceride transfer
protein inhibitors) as a class, have the potential to disrupt yolk sac development and laboratory studies
on rats and rabbits have shown evidence of embryolethality, teratogenicity, and developmental
toxicity.
3/21
Interactions with other drug types have not been specifically investigated. Therefore, for dogs
receiving treatments in addition to the product, drug interactions should be monitored closely.
Dogs should undergo a physical examination by a veterinarian before commencing treatment, and a
desired body weight or body condition score identified. To ensure correct dosing during the treatment
period the owner should seek advice from the responsible veterinarian in connection to each monthly
dose adjustment.
The recommended starting dose of the product is 0.05 mg/kg initial bodyweight per day (0.01
ml/kg/day). After two weeks of therapy, the initial dose (number of ml administered) should be
increased by 100% (doubled). Following these initial 4 weeks of therapy, dogs should be weighed
monthly during treatment with the product and dose adjustments are made monthly according to effect
as described below.
The duration of treatment with the product must not exceed 12 months and the dose of the product
must not exceed a maximum of 0.2 ml /kg current body weight (1 mg/kg dirlotapide).
Administer the product once daily directly into the mouth or on a small amount of food. The product
can be administered with or without food.
At the end of each month of therapy, the percentage of body weight loss should be determined. If the
body weight loss since previous monthly weighing has been 3% body weight per month (equivalent
to 0.1% body weight per day); the dose (number of ml administered) should be kept the same.. If the
bodyweight loss since previous monthly weighing has been <3% body weight per month, the dose
should be increased without adjusting for the dog’s current body weight. The first time a conditional
increase is required, the dose should be increased by 100%, (doubled). In subsequent required
conditional increases, the dose should be increased by 50% (increasing the dose volume to 1.5 times
the volume administered in the previous month) up to a maximum dose of the product of 0.2 ml/kg
current body weight. These adjustments should be continued until the weight targeted at the start of
therapy is achieved.
Although not observed in clinical trials, in the case where body weight loss since previous monthly
weighing has been 12% per month (equivalent to 0.4% body weight per day), the dose should be
reduced by 25%.
According to clinical studies, a mean weight loss of about 18 to 20% after six months of weight loss
therapy can be anticipated.
DOSE PROGRESSION TABLE DURING WEIGHT LOSS
Dose Level
Trigger for Increase
Volume to administer in ml
1 (Start)
Not Applicable
Dose 1 = Starting Dose = Initial BW x
0.01 ml/kg
2 (automatic day 14
increase)
Not Applicable (Systematic)
Dose 2 = Dose 1 x 2
4/21
DOSE PROGRESSION TABLE DURING WEIGHT LOSS
Dose Level
Trigger for Increase
Volume to administer in ml
3 (conditional)
First monthly weighing where
body weight loss < 3% per
month since previous
weighing
Dose 3 = Dose 2 x 2
4 (conditional)
Second monthly weighing
where body weight loss < 3%
per month since previous
weighing
Dose 4 = Dose 3 x 1.5
5 (conditional)
Third monthly weighing
where body weight loss < 3%
per month since previous
weighing
Dose 5 = Dose 4 x 1.5
6 (conditional)
Fourth monthly weighing
where body weight loss < 3%
per month since previous
weighing
Dose 6 = Dose 5 x 1.5
3 % body weight loss per month = 0.7 % per week = 0.1 % per day
The lowest validated dose for the dosing device is 0.05 ml. This is the starting dose for a 5 kg dog.
Overdose up to 10 times the maximum authorised dose of 1 mg/kg current body weight may produce
vomiting or diarrhoea or increased ALT/AST levels. These signs will resolve spontaneously following
discontinuation of product administration.
Not applicable.
5.
Pharmacotherapeutic group: Peripherally acting antiobesity products, ATCvet code: QA08AB91
5.1 Pharmacodynamicproperties
Dirlotapide is a potent selective inhibitor of the microsomal triglyceride transfer protein (MTP). The
microsomal triglyceride transfer protein (MTP) is pivotal for the absorption and distribution of fat.
The inhibition of intestinal and hepatic MTP reduces plasma cholesterol and triglyceride
concentration. The selective inhibition of intestinal MTP also reduces intestinal fat absorption.
Clinical and pharmacodynamic data strongly suggest that the efficacy of dirlotapide results from a
primary local action in the gut after oral administration. This is consistent with in vivo data generated
in mice which shows that dirlotapide has selectivity for intestinal MTP. The effect is mainly mediated
indirectly due to reduced feed intake during therapy.
As a consequence of reducing intestinal fat absorption, dirlotapide reduces food intake in dogs in a
dose dependent manner. This food inhibitory effect of dirlotapide results from a primary local effect
on the gastrointestinal tract following oral administration, and is not a result of systemic exposure.
5/21
The efficacy of dirlotapide has been demonstrated with various types of diets, representing the whole
range of fat contents available in commercial diets.
5.2 Pharmacokineticproperties
Systemic blood levels of dirlotapide are not well correlated with efficacy in the dog.
Dirlotapide exhibited rapid oral absorption with mean C
max
values in the range of 8.5- 115, ng/ml, at
0.5 to 4 hours post-treatment (mean T
max
: 1.0 to 2.1 h). Mean oral bioavailability values were
approximately 24%- 41% for fed dogs and 22% in fasted dogs. Exposure was 1.5x higher in fed
dogs. AUC and C
max
increased with increasing dose but not in a dose-proportional manner. In a 14-
day repeated dose study, AUC
increased 3-fold for Day 14 vs. Day 1. In a 3-month study, exposures
were 2x higher at Day 29 but returned to Day 1 values at days 56 and 87. There is no sex effect on
pharmacokinetic parameters
In a radiolabeled metabolism study, the primary route for excretion was via the faeces with minimal
excretion via urine (<1%). Additionally, dirlotapide is highly protein bound (>99%) in dog plasma.
6.1 List of excipients
Medium chain triglycerides
6.2 Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be physically mixed
with other veterinary medicinal products.
The product is not miscible with water. Oral dosing devices used for measuring the dose may be
cleaned with water but must be dried before re-use.
6.3 Shelflife
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Shelf-life after first opening the immediate packaging: 3 months.
6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
Light sensitive. Store in the original container
6.5 Nature and composition of immediate packaging
Polypropylene bottles of 20, 50 and 150 ml fitted with a low density polyethylene (LDPE) bottle adapter
(PIBA) and a child resistant closure.
Bottles of 20ml are packed with two dosing devices of 1ml.
Bottles of 50ml are packed with two dosing devices of 3ml.
Bottles of 150ml are packed with two dosing devices of 10ml.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
product should be disposed of in accordance with local requirements.
6/21
7.
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
EU/2/07/071/001-003
13.04.2007
10.12.2010
Detailed information on this product is available on the website of the European Medicines Agency
(EMA)
http://www.ema.europa.eu
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
7/21
ANNEX II
A. MANUFACTURING AUTHORISATION HOLDER(S)
RESPONSIBLE FOR BATCH RELEASE
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION REGARDING SUPPLY OR USE
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
D.
STATEMENT OF THE MRLs
8/21
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Pfizer Service Company
Hoge Wei 10
1930 Zaventem
Belgium
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
Veterinary medicinal product subject to prescription.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO SAFE AND EFFECTIVE USE
Not applicable
D. STATEMENT OF THE MRLs
Not applicable
9/21
ANNEX III
LABELLING AND PACKAGE LEAFLET
10/21
A. LABELLING
11/21
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
1.
SLENTROL
5 mg/ml oral solution for dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Dirlotapide 5mg/ml
3.
Oral solution
4.
PACKAGE SIZE
20ml packed with 2 dosing devices of 1ml
50ml packed with 2 dosing devices of 3ml
150ml packed with 2 dosing devices of 10ml
5.
Dogs
6.
For the treatment of excessive body weight in dogs.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use. Read the package leaflet before use.
8.
Not applicable.
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
12/21
10. EXPIRY DATE
EXP {month/year}
Once broached, use within 3 months.
11. SPECIAL STORAGE CONDITIONS
Store in the original container
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS , IF ANY
Should be disposed of in accordance with local requirements.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE
For animal treatment only- to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
EU/2/07/071/001 20ml
EU/2/07/071/002 50ml
EU/2/07/071/003 150ml
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
13/21
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
1.
SLENTROL
5 mg/ml oral solution for dogs
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
3.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
20ml
50ml
150ml
4.
ROUTE(S) OF ADMINISTRATION
Oral use.
5.
Not applicable
6.
BATCH NUMBER
Lot
7.
EXPIRY DATE
EXP {month/year}
Once opened, use within 3 months
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
14/21
B. PACKAGE LEAFLET
15/21
PACKAGE LEAFLET
SLENTROL 5 mg/ml oral solution for dogs
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Manufacturer for the batch release:
Pfizer Service Company
Hoge Wei 10
1930 Zaventem
Belgium
2.
SLENTROL 5 mg/ml oral solution for dogs
Dirlotapide
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Dirlotapide 5 mg/ml presented as a colourless to pale yellow solution.
4.
As an aid in the management of overweight and obesity in adult dogs. Your veterinary surgeon will
identify a target weight and explain how SLENTROL should be used as part of an overall weight
management programme which also includes appropriate dietary changes and exercise practice.
5.
Do not use in dogs in the growth phase.
Do not use in pregnant or lactating dogs.
Do not use in animals with impaired liver function.
Do not use in case of hypersensitivity to the active substance or excipient.
Do not use in animals in which overweight or obesity is caused by a concomitant systemic disease
such as hypothyroidism or hyperadrenocorticism.
Do not use in cats due to the risk of development of hepatic lipidosis.
16/21
6.
ADVERSE REACTIONS
Some dogs may show one or more vomiting events, sometimes accompanied by signs of tiredness,
disinterest in food or diarrhoea, which reoccur occasionally during the course of treatment. These
signs typically started during the first month of treatment (about 30% of dogs showed at least one
vomiting event and up to 12% showed any of the other signs) and decreased continuously during the
course of treatment. Some dogs (less than 10%) experienced repeated vomiting (i.e. more than once
every 20 days on average). If your dog suffers from repeated vomiting, diarrhoea or significantly
reduced appetite and excessive weight loss, you should consult your veterinary surgeon who may
advise you to stop therapy.
Sporadic and mild alanine aminotransferase elevations up to 4 times the upper reference range and not
associated with histopathological liver lesions or noticeable changes in other liver parameters may be
observed in some dogs during the course of treatment.
On rare occasions, reports of change of behaviour such as polyphagia, or very rarely reports of
aggression associated with food and feeding have been observed in Slentrol treated dogs. If these
changes were observed, treatment should be stopped.
If you notice any serious effects not mentioned in this leaflet, please inform your veterinary surgeon.
7.
Dogs
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Advice for Dog Owner
The veterinarian will examine your dog at the beginning of treatment and recommend a starting dose.
The veterinarian will advise you when dose adjustments become necessary.
Advice for Veterinarian
The recommended starting dose of SLENTROL is 0.05mg/kg (0.01 ml/kg) by oral administration.
After two weeks of therapy, the initial dose volume should be doubled. Following these initial 4 weeks
of therapy, dose adjustments are made monthly according to effect as described in section 9.
9.
ADVICE ON CORRECT ADMINISTRATION
Advice for Dog Owner
Withdraw product from the bottle using the supplied dosing device and administer the product once
daily directly into the mouth or on a small amount of food. The product can be administered with or
without food. To ensure correct dosing during the treatment period the owner should seek advice from
the responsible veterinarian in connection to each monthly dose adjustment.
Advice for Veterinarian
Dogs should undergo a physical examination before commencing treatment, and a desired body
weight or a body condition score identified.
The recommended starting dose of the product is 0.05 mg/kg initial bodyweight per day (0.01
ml/kg/day). After two weeks of therapy, the initial dose (number of ml administered) should be
increased by 100% (doubled). Following these initial 4 weeks of therapy, dogs should be weighed
monthly during treatment with the product and dose adjustments are made monthly according to effect
as described below.
17/21
At the end of each month of therapy, the percentage of body weight loss should be determined. If the
body weight loss since previous monthly weighing has been 3% body weight per month (equivalent
to 0.1% body weight per day); the dose (number of ml administered) should be kept the same. If the
bodyweight loss since previous monthly weighing has been <3% body weight per month, the dose
should be increased without adjusting for the dog’s current body weight. The first time a conditional
increase is required, the dose should be increased by 100%, (doubled). In subsequent required
conditional increases, the dose should be increased by 50% (increasing the dose volume to 1.5 times
the volume administered in the previous month) up to a maximum dose of the product of 0.2 ml/kg
current body weight. These adjustments should be continued until the weight targeted at the start of
therapy is achieved.
Although not observed in clinical trials, in the case where body weight loss since previous monthly
weighing has been 12% per month (equivalent to 0.4% body weight per day), the dose should be
reduced by 25%.
According to clinical studies, a mean weight loss of about 18 to 20% after six months of weight loss
therapy can be anticipated.
The duration of treatment with the product must not exceed 12 months and the dose of the product
must not exceed a maximum of 0.2 ml /kg current body weight (1 mg/kg dirlotapide).
DOSE PROGRESSION TABLE DURING WEIGHT LOSS
Dose Level
Trigger for Increase
Volume to administer in ml
1 (Start)
Not Applicable
Dose 1 = Starting Dose = Initial
BW x 0.01 ml/kg
2 (automatic day 14
increase)
Not Applicable (Systematic)
Dose 2 = Dose 1 x 2
3 (conditional)
First monthly weighing where
body weight loss < 3% per month
since previous weighing
Dose 3 = Dose 2 x 2
4 (conditional)
Second monthly weighing where
body weight loss < 3% per month
since previous weighing
Dose 4 = Dose 3 x 1.5
5 (conditional)
Third monthly weighing where
body weight loss < 3% per month
since previous weighing
Dose 5 = Dose 4 x 1.5
6 (conditional)
Fourth monthly weighing where
body weight loss < 3% per month
since previous weighing
Dose 6 = Dose 5 x 1.5
3 % body weight loss per month = 0.7 % per week = 0.1 % per day
The lowest validated dose for the dosing device is 0.05 ml. This is the starting dose for a 5 kg dog.
10. WITHDRAWAL PERIOD
Not applicable
18/21
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
This veterinary medicinal product does not require any special storage conditions.
Light sensitive. Store in the original container.
Do not use after the expiry date stated on the bottle
Shelf-life after first opening the container: 3 months
12. SPECIAL WARNING(S)
Advice for Dog Owner
SLENTROL must not be used during pregnancy and lactation.
Fertility studies have not been conducted in the target species – use in dogs intended for breeding
should be subject to a risk-benefit analysis by your veterinarian.
In the absence of compatibility studies, this veterinary medicinal product must not be physically mixed
with other veterinary medicinal products.
The product is not miscible with water. Oral dosing devices used for measuring the dose may be
cleaned with water but must be dried before re-use.
In clinical trials, treated animals rapidly regained weight following cessation of treatment when diet
was not restricted. In order to avoid this rebound weight gain, it is necessary to feed the animals to
maintenance energy requirements. Thus, during treatment or at the end of treatment at the latest, an
appropriate feeding and exercise regimen should be implemented in order to ensure long term
maintenance of the body weight.
Wash hands after use. In case of contact with the skin, wash off any product immediately with soap
and water
.
SLENTROL may cause eye-irritation. Avoid contact with eyes
.
If accidental eye exposure
occurs, flush the eyes immediately with clean water.
When product is drawn into syringe, administer immediately.
Where the product has been administered on food, discard unconsumed food immediately to avoid
unintentional ingestion by other animals or persons in the household. Slentrol ingestion can be harmful
to children and pregnant women.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the
label to the physician.
Advice for Veterinarian
The liver function of dogs suspected of suffering from a liver disease or dysfunction should be
evaluated, before commencing treatment with the product. Dogs with evidence of liver dysfunction
should not be treated with the veterinary product.
Any clinical suspicion of liver disease or dysfunction during treatment should be investigated through
the evaluation of liver function. Because the product is contraindicated in cases of liver dysfunction,
any indication of progressive liver damage or of dysfunction should result in the discontinuation of
the treatment. Sporadic and mild serum alanine aminotransferase (ALT) elevations up to 4 times the
upper reference range are not a reason for discontinuing therapy in the absence of any indication of
liver dysfunction.
Do not use in dogs during pregnancy and lactation. MTP inhibitors (microsomal trigylyceride transfer
protein inhibitors) as a class, have the potential to disrupt yolk sac development and laboratory
studies on rats and rabbits have shown evidence of embryolethality, teratogenicity, and
developmental toxicity.
19/21
During treatment, because food intake is reduced as when using a traditional non-medical calorie
restriction method, care must be taken to ensure that protein, vitamins, essential fatty acids and
minerals supplied by the daily food ration meet minimal recommended requirements in order to
ensure a complete and balanced nutritional supply.
In clinical trials, treated animals rapidly regained weight following cessation of treatment when diet
was not restricted. In order to avoid this rebound weight gain, it is necessary to feed the animals to
maintenance energy requirements. Thus, during treatment or at the end of treatment at the latest, an
appropriate feeding and exercise regimen should be implemented in order to ensure long term
maintenance of the body weight.
If vomiting, diarrhoea or significantly reduced appetite or excessive weight loss occurs, treatment
should be interrupted. Resolution of adverse reactions will occur shortly after the suspension of
treatment. In case of excessive weight loss greater than 12% per month, the dose volume of the
product should be reduced (by 25%).
Overdose up to 10 times the maximum authorised dose of 1 mg/kg current body weight may produce
vomiting or diarrhoea or increased ALT/AST levels. These signs will resolve spontaneously following
discontinuation of product administration.
Interactions with other drug types have not been specifically investigated. Therefore, for dogs
receiving treatments in addition to the product, drug interactions should be monitored closely.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS , IF ANY
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should
help to protect the environment.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
10.12.2010
Detailed information on this product is available on the website of the European Medicines Agency
(EMA)
http://www.ema.europa.eu
15. OTHER INFORMATION
Polypropylene bottles of 20, 50 and 150 ml
Bottles of 20ml are packed with two dosing devices of 1 ml.
Bottles of 50ml are packed with two dosing devices of 3 ml.
Bottles of 150ml are packed with two dosing devices of 10 ml.
Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of
the marketing authorisation holder.
België/Belgique/Belgien
Pfizer Animal Health s.a.,
Tél.: +32 (0)2 554 62 11
Luxembourg
Pfizer Animal Health s.a.,
Tél.: + 32 (0)2 554 62 11
20/21
Република България
Pfizer Luxembourg SARL
Tel: + 359 2 970 43 21
Magyarország
Pfizer Kft.
Tel: +361 488 3695
Česká republika
Pfizer Animal Health
Tel: +420 283 004 111
Malta
Agrimed Limited
Tel: +356 21 465 797
Danmark
Pfizer Oy Animal Health
Tlf: +358 (0)9 4300 40
Nederland
Pfizer Animal Health B.V.,
Tel: +31 (0)10 4064 600
Deutschland
Pfizer GmbH
Tel:
+
49 30-5500 5501
Norge
Pfizer Oy Animal Health
Tlf: +358 (0)9 4300 40
Eesti
Pfizer Animal Health
Tel: +370 5 269 17 96
Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 52 11 57 20
Ελλάδα
Pfizer Hellas A.E.
Τηλ.: +30 210 6785800
Polska
Pfizer Trading Polska Sp. z.o.o.
Tel: +48 22 335 61 00
España
Pfizer S.A.
Tel: +34 91 4909900
Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 55 00
France
Pfizer
Tél: +33 (0)1 58 07 46 00
Romania
Pfizer Romania SRL
Tel: + 0040 21 207 28 93
Ireland
Pfizer Healthcare Ireland, trading as:
Pfizer Animal Health
Tel: +353 (0) 1 467 6500
Slovenija
Pfizer Luxembourg SARL
Tel: +386 (0) 1 52 11 670
Ìsland
Pfizer Oy Animal Health
Tel: +358 (0)9 4300 40
Slovenská republika
Pfizer Luxembourg SARL o.z.
Tel: + 421 2 3355 5500
Italia
Pfizer Italia S.r.l.,
Tel: +39 06 3318 2933
Suomi/Finland
Pfizer Oy Animal Health,
Puh/Tel: +358 (0)9 4300 40
Kύπρος
Pfizer Hellas A.E.
Τηλ.: +30 210 6785800
Sverige
Pfizer Oy Animal Health
Tel: +358 (0)9 4300 40
L
atvija
Pfizer Animal Health
Tel: +370 5 269 17 96
United Kingdom
Pfizer Ltd
Tel: +44 (0) 1304 616161
Lietuva
Pfizer Animal Health
Tel: +370 5 269 17 96
21/21
Source: European Medicines Agency
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